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Four months gel viagra kamagra Generic antabuse cost. From the time my dad was diagnosed with pancreatic cancer to the time that he died was just 4 months. It’s hard to believe that more than 21 years have passed since that experience and how it changed my personal and professional passion to create a world where pancreatic cancer patients can thrive gel viagra kamagra.

And while we still have a lot of work to do, there have been continuous incremental advances over the last 20 years -- most recently, advancements in the role of genetic and tumor testing for patients and family members -- that give me reason to be very hopeful about what lies ahead and the opportunity to significantly change patient outcomes.Like most, I knew very little about pancreatic cancer before my father's diagnosis, but as soon as I heard those words, I went online and quickly learned there was a lack of information, resources, and research devoted to the disease. Back then, very little was known about pancreatic cancer -- only a handful of researchers were studying it and the 5-year survival rate was just 4%. I was angry that gel viagra kamagra my dad and thousands of other patients were given no hope.

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In my role as president and CEO, I am honored to have the opportunity to work with the pancreatic cancer community and I have watched PanCAN become the driving force for accelerating progress. Funding over $149M in pancreatic cancer research to date, supporting patients and their families through our Patient Services program, and building a passionate and energetic community of volunteers and advocates who are raising funds and awareness to drive our mission.I have always been inspired by patient advocates, witnessing firsthand what patients and their families do for PanCAN in honor of their loved ones to change the future for pancreatic cancer patients, but I had a gel viagra kamagra newfound realization about the importance of patient advocates when I became a patient myself. In 2018, I was diagnosed with breast cancer, discovered during a routine mammogram.

I consider myself exceptionally fortunate -- gel viagra kamagra my diagnosis was early-stage thanks to breast cancer screening -- and after surgery, I was cancer-free. I also had genetic testing done, which is standard for breast cancer patients, to determine what treatments might be best for me and to understand my family’s risk of certain kinds of cancer. After that experience, I was so incredibly grateful to the breast cancer advocates who had come before me and pushed for early detection and better treatments for the disease.This experience reinforced how important it is to celebrate the incremental advances being made every year for pancreatic cancer patients because I know with each piece of new information, we unlock the mysteries of this challenging disease.Due to advances in research, it is now recommended that all pancreatic cancer patients get genetic testing for inherited cancer mutations and biomarker testing of their tumor to determine their best treatment options.

And for the first time, new guidelines released by the National Comprehensive Cancer Network (NCCN) indicate that knowing gel viagra kamagra your genetic risk may be important for family members who’ve had only one first-degree relative diagnosed with pancreatic cancer. It is important to understand your risk, stay informed, and be your own best advocate. November is Pancreatic Cancer Awareness Month and PanCAN is emphasizing the importance of testing for both patients and their families.

Knowledge is power, and we want people to take three simple steps that gel viagra kamagra could save their lives. Talk, test, and take control.For first-degree relatives of pancreatic cancer patients, we recommend that you talk to your doctor or genetic counselor to help you understand whether you should have genetic testing. PanCAN Patient Services can help you prepare for that conversation.For those already diagnosed with pancreatic cancer, PanCAN strongly recommends genetic testing for inherited mutations as soon as possible after diagnosis, which can help inform family members of their gel viagra kamagra own risk as well as potentially impact the patient’s treatment options.

We also recommend that all pancreatic cancer patients receive biomarker testing of their tumor tissue through a precision medicine service like PanCAN’s Know Your Tumor to understand if their tumor biology may help inform treatment decisions. Today, pancreatic cancer patients and their families have more information and options than when my father was diagnosed with the disease. And I have no doubt that with the continued relentless effort of PanCAN advocates, there will be a day in the future when someone is gel viagra kamagra diagnosed with pancreatic cancer early because there is an early detection test and cured because there are new treatments.

In the meantime, each day we are taking steps that accelerate the rate of progress. Talk, test, and take gel viagra kamagra control. Three simple steps that provide information and empowerment now for pancreatic cancer patients and their families.

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And while we still have a lot of work to do, there have been continuous incremental advances over the last 20 years -- most recently, advancements in the role of genetic and tumor testing for patients and family members -- that give me reason to be very hopeful about what lies ahead and the opportunity to significantly change patient outcomes.Like most, I knew very little about pancreatic cancer before my father's diagnosis, but as soon as I heard those words, I went online and quickly learned there was a lack of information, resources, and research devoted to the disease. Back then, very little was known about pancreatic cancer -- only a handful of researchers were studying it and the 5-year survival rate was just 4%. I was kamagra oral jelly thailand price angry that my dad and thousands of other patients were given no hope.

They were offered no treatment options and sent home to get their affairs in order. That hopelessness and anger inspired me to take action, kamagra oral jelly thailand price and soon after my father died, I discovered the Pancreatic Cancer Action Network (PanCAN) in 1999, a newly formed organization at the time. I began my journey with PanCAN as a volunteer and was hired as the organization’s first full-time employee in 2000.

In my role as president and CEO, I am honored to have the opportunity to work with the pancreatic cancer community and I have watched PanCAN become the driving force for accelerating progress. Funding over kamagra oral jelly thailand price $149M in pancreatic cancer research to date, supporting patients and their families through our Patient Services program, and building a passionate and energetic community of volunteers and advocates who are raising funds and awareness to drive our mission.I have always been inspired by patient advocates, witnessing firsthand what patients and their families do for PanCAN in honor of their loved ones to change the future for pancreatic cancer patients, but I had a newfound realization about the importance of patient advocates when I became a patient myself. In 2018, I was diagnosed with breast cancer, discovered during a routine mammogram.

I consider myself exceptionally fortunate kamagra oral jelly thailand price -- my diagnosis was early-stage thanks to breast cancer screening -- and after surgery, I was cancer-free. I also had genetic testing done, which is standard for breast cancer patients, to determine what treatments might be best for me and to understand my family’s risk of certain kinds of cancer. After that experience, I was so incredibly grateful to the breast cancer advocates who had come before me and pushed for early detection and better treatments for the disease.This experience reinforced how important it is to celebrate the incremental advances being made every year for pancreatic cancer patients because I know with each piece of new information, we unlock the mysteries of this challenging disease.Due to advances in research, it is now recommended that all pancreatic cancer patients get genetic testing for inherited cancer mutations and biomarker testing of their tumor to determine their best treatment options.

And for the first time, new guidelines released by the National kamagra oral jelly thailand price Comprehensive Cancer Network (NCCN) indicate that knowing your genetic risk may be important for family members who’ve had only one first-degree relative diagnosed with pancreatic cancer. It is important to understand your risk, stay informed, and be your own best advocate. November is Pancreatic Cancer Awareness Month and PanCAN is emphasizing the importance of testing for both patients and their families.

Knowledge is power, and we want people to take three kamagra oral jelly thailand price simple steps that could save their lives. Talk, test, and take control.For first-degree relatives of pancreatic cancer patients, we recommend that you talk to your doctor or genetic counselor to help you understand whether you should have genetic testing. PanCAN Patient Services can help you prepare for that conversation.For those already diagnosed with pancreatic cancer, PanCAN strongly recommends genetic testing for inherited mutations as soon as possible after diagnosis, which can help inform family members of their own risk as well as potentially impact the patient’s treatment kamagra oral jelly thailand price options.

We also recommend that all pancreatic cancer patients receive biomarker testing of their tumor tissue through a precision medicine service like PanCAN’s Know Your Tumor to understand if their tumor biology may help inform treatment decisions. Today, pancreatic cancer patients and their families have more information and options than when my father was diagnosed with the disease. And I have no doubt that with the continued relentless effort of PanCAN advocates, there will be a day in the future when someone is diagnosed with pancreatic cancer early because there is an early detection test and cured kamagra oral jelly thailand price because there are new treatments.

In the meantime, each day we are taking steps that accelerate the rate of progress. Talk, test, and take control kamagra oral jelly thailand price. Three simple steps that provide information and empowerment now for pancreatic cancer patients and their families.

Learn more at pancan.org. Julie Fleshman is president and CEO of the Pancreatic Cancer Action Network.This article is part of WebMD’s contributor program, which lets people and organizations outside of WebMD submit articles for consideration kamagra oral jelly thailand price on our site. Have an idea for a submission?.

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Encontrar el mejor plan médico privado, o de medicamentos, de kamagra polo chewable tablets uk Medicare entre docenas de opciones es lo suficientemente difícil sin incluir estrategias de can you buy kamagra online venta engañosas. Sin embargo, funcionarios federales dicen que están aumentando las quejas de personas mayores engañadas para que compren pólizas sin su consentimiento, o atraídas por información cuestionable, que pueden no cubrir sus medicamentos ni incluir a sus médicos. En respuesta, los Centros kamagra polo chewable tablets uk de Servicios de Medicare y Medicaid (CMS) han amenazado con penalizar a las compañías de seguros privadas que venden planes de medicamentos y Medicare Advantage (MA), si ellas o los agentes que trabajan en su nombre engañan a los consumidores.

La agencia también ha revisado las reglas que facilitan a los beneficiarios abandonar planes en los que no se inscribieron, o salir de aquéllos en los que fueron inscriptos a través de engaños, solo para descubrir que los beneficios prometidos no existían, o que no podían ver a sus proveedores. Los problemas son especialmente frecuentes durante el período de inscripción abierta de Medicare, que comenzó el 15 de octubre y se extiende hasta el 7 de diciembre. Una trampa común kamagra polo chewable tablets uk comienza con una llamada telefónica como la que recibió Linda Heimer, de Iowa, en octubre.

Heimer no contesta el teléfono a menos que su identificador de llamadas muestre un número que reconoce, pero esta llamada mostró el número del hospital donde trabaja su médico. La persona al teléfono dijo que necesitaba el número de Medicare de Heimer para asegurarse de que fuera correcto para la nueva tarjeta que recibiría. Cuando Heimer vaciló, la mujer kamagra polo chewable tablets uk dijo.

€œNo estamos pidiendo un número de seguro social o números de banco ni nada por el estilo. Esto está bien”. €œTodavía no puedo creerlo, pero le di mi número de tarjeta”, dijo Heimer kamagra polo chewable tablets uk.

Luego, la persona que llamó le hizo preguntas sobre su historial médico y se ofreció a enviarle una prueba de saliva “absolutamente gratis”. Fue entonces cuando Heimer empezó a sospechar y colgó. Se comunicó con kamagra polo chewable tablets uk la línea de ayuda 1-800-MEDICARE para obtener un nuevo número de Medicare, y llamó a la Línea de ayuda de la red AARP Fraud Watch Network y a la Comisión Federal de Comercio.

Pero más tarde esa mañana, el teléfono volvió a sonar y esta vez el identificador de llamadas mostró un número que coincidía con la línea de ayuda gratuita de Medicare. Cuando respondió, reconoció la voz de la misma mujer. €œNo eres de kamagra polo chewable tablets uk Medicare”, le dijo Heimer.

€œSí, sí, sí, somos”, insistió la mujer. Heimer colgó de nuevo. Han pasado solo dos semanas kamagra polo chewable tablets uk desde que Heimer reveló su número de Medicare a una extraña y, hasta ahora, nada ha salido mal.

Pero, con ese número, los estafadores podrían facturar a Medicare por servicios y suministros médicos que los beneficiarios nunca reciben, y podrían inscribir a personas mayores en un plan Medicare Advantage o de medicamentos sin su conocimiento. En California, kamagra polo chewable tablets uk los informes de prácticas de venta engañosas de Medicare Advantage y planes de medicamentos han sido las principales quejas ante la Senior Medicare Patrol del estado durante los últimos dos años, dijo Sandy Morales, administradora de casos del grupo. La patrulla es un programa financiado por el gobierno federal que ayuda a las personas mayores a desentrañar problemas con sus seguros.

A nivel nacional, la Senior Medicare Patrol ha enviado a los CMS y al Inpector General de Salud y Servicios Sociales 74% más casos para su Investigación en los primeros nueve meses de este año que en todo 2020, dijo Rebecca Kinney, directora de la Oficina de Administración para la Vida Comunitaria del Consejo de Información y Asesoramiento sobre Atención Médica del departamento de salud, que supervisa las patrullas. Dijo que espera que lleguen más quejas durante el kamagra polo chewable tablets uk período de inscripción abierta de Medicare. Y en octubre, funcionarios de los CMS advirtieron a las compañías de seguros privadas que venden Medicare Advantage y planes de medicamentos que los requisitos federales prohíben las prácticas de venta engañosas.

Kathryn Coleman, directora del Grupo de Administración de Contratos de Planes de Salud y Medicamentos de Medicare de los CMS, dijo en un memorando a las aseguradoras que la agencia está preocupada por los anuncios que promueven ampliamente los beneficios del plan Advantage que están disponibles solo en un área limitada o para un número restringido de beneficiarios. Los CMS también han recibido quejas sobre información de ventas que podrían interpretarse como provenientes del gobierno, y tácticas de presión para lograr que las personas mayores se kamagra polo chewable tablets uk inscriban, señaló. Coleman recordó a las empresas que son “responsables de sus materiales y actividades de marketing, incluido el marketing realizado en nombre de un plan de MA por los representantes de ventas”.

Las empresas que violen las reglas federales de marketing pueden ser multadas y/o enfrentar suspensiones de inscripción. Un vocero de CMS no pudo proporcionar ejemplos de infractores recientes, o sus sanciones kamagra polo chewable tablets uk. Si los beneficiarios descubren un problema antes del 31 de marzo, la fecha en que finaliza el período de cancelación de la inscripción de tres meses cada año, tienen una oportunidad de cambiarse a otro plan o al Medicare original.

(Aquellos que eligen este último pueden no poder comprar un seguro complementario o Medigap, con raras excepciones, en todos los estados excepto en cuatro. Connecticut, Maine, Massachusetts y kamagra polo chewable tablets uk Nueva York). Después de marzo, generalmente están “atados” a sus planes Advantage o de medicamentos por todo el año, a menos que sean elegibles para una de las raras excepciones a la regla.

Este año, los CMS mostraron otra solución, por primera vez. Los funcionarios pueden otorgar un “período de inscripción kamagra polo chewable tablets uk especial” para las personas que quieran abandonar su plan debido a tácticas de venta engañosas. Estos incluyen “situaciones en las que un beneficiario presenta una alegación verbal o escrita de que su inscripción en un plan MA o de la Parte D se basó en información engañosa o incorrecta… [o] donde un beneficiario declara que estaba inscrito en un plan sin su conocimiento”, de acuerdo con el Manual de Atención Administrada de Medicare.

€œEsta es una válvula de seguridad realmente importante para los beneficiarios que claramente va más allá de la oportunidad limitada de cambiar de plan cuando alguien siente que eligió mal”, dijo David Lipschutz, director asociado del Center for Medicare Advocacy. Para utilizar la nueva opción, los beneficiarios deben comunicarse con el programa de asistencia de seguro médico de su estado en kamagra polo chewable tablets uk www.shiphelp.org/. La opción de dejar un plan también está disponible si una cantidad significativa de miembros del plan no puede acceder a los médicos u hospitales que se suponía que estaban en la red de proveedores.

No obstante, las estafas continúan en todo el país, dicen los kamagra polo chewable tablets uk expertos. Un comercial de televisión engañoso en el área de San Francisco ha atraído a las personas mayores con una serie de nuevos servicios que incluyen beneficios dentales, de la vista, de transporte e incluso “reembolso de dinero a su cuenta del Seguro Social”, dijo Morales. Los beneficiarios le han dicho a su grupo que cuando pidieron información estaban “inscritos por error en un plan en el que nunca habían dado la autrorización para ser inscriptos”, dijo.

En agosto, un adulto mayor de Ohio recibió una llamada de alguien que le decía que kamagra polo chewable tablets uk Medicare estaba emitiendo nuevas tarjetas debido a la pandemia de erectile dysfunction treatment. Cuando no dio su número de Medicare, la persona que llamó se enojó y el beneficiario se sintió amenazado, dijo Chris Reeg, director del Programa de Información sobre Seguros de Salud para Personas Mayores de Ohio. Reeg dijo que otra persona mayor recibió una llamada de un vendedor con malas noticias.

No estaba recibiendo kamagra polo chewable tablets uk todos los beneficios de Medicare a los que tenía derecho. La beneficiaria proporcionó su número de Medicare y otra información, pero no se dio cuenta de que la persona que llamaba la estaba inscribiendo en un plan Medicare Advantage. Se enteró cuando visitó a su médico, quien no aceptó su nuevo seguro.

En el oeste de Nueva York, el culpable es una postal de aspecto oficial, dijo Beth Nelson, directora principal de la patrulla de Medicare kamagra polo chewable tablets uk del estado. €œNuestros registros indican… que puede ser elegible para recibir beneficios adicionales”, dice, tentadora. Cuando la clienta de Nelson llamó al número que figura en la tarjeta en septiembre para obtener más detalles, proporcionó su número de Medicare y luego terminó en un plan Medicare Advantage sin su consentimiento.

La estafadora kamagra polo chewable tablets uk de Heimer fue persistente. Contó que cuando la mujer intentó comunicarse con ella por tercera vez, el identificador de llamadas mostraba el número de teléfono de otro hospital local. Heimer le dijo que había denunciado las llamadas a los CMS, la línea de ayuda de la red AARP Fraud Watch Network y la FTC.

Eso finalmente kamagra polo chewable tablets uk funcionó. La mujer colgó abruptamente. Susan Jaffe.

Jaffe.KHN@gmail.com, @SusanJaffe Related Topics Contact kamagra polo chewable tablets uk Us Submit a Story TipCan’t see the audio player?. Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts.

Congress appears to be making progress on its huge social spending bill, but even if it passes the House kamagra polo chewable tablets uk as planned the week of Nov. 15, it’s unlikely it can get through the Senate before the Thanksgiving deadline that Democrats set for themselves. Meanwhile, the cost of kamagra polo chewable tablets uk employer-provided health insurance continues to rise, even with so many people forgoing care during the kamagra.

The annual KFF survey of employers reported that the average cost of a job-based family plan has risen to more than $22,000. To provide what their workers most need, however, this year many employers added additional coverage of mental health care and telehealth. This week’s panelists are Julie Rovner of KHN, Alice Miranda Ollstein of Politico, Anna Edney of Bloomberg News kamagra polo chewable tablets uk and Rebecca Adams of CQ Roll Call.

Among the takeaways from this week’s episode. Moderate Democrats who were worried about the price tag of the social spending bill said during negotiations last week that they wanted to see the full analysis of spending and costs from the Congressional Budget Office. But members of the House probably kamagra polo chewable tablets uk won’t get that score before voting on the bill.

CBO instead is releasing its assessments piecemeal as analysts go through specific sections of the huge bill.If the House passes the bill next week, which leadership is pledging, the legislation could still undergo major revisions in the Senate. Some provisions will be subject to the Byrd Rule, which says items in this type of bill must be related to the budget. Republicans are expected to challenge parts of the bill, and the parliamentarian will have to rule on whether their objections kamagra polo chewable tablets uk are valid.Among the provisions that some moderate Democratic senators might object to are the paid family leave and the mechanism for lowering Medicare drug prices.Congress is looking at a very busy end of the year, which could complicate passage of the social spending bill.

Leaders already postponed a bill to raise the debt ceiling and the annual federal spending bills until early December.A federal judge has blocked Texas Republican Gov. Greg Abbott’s order prohibiting mask mandates in schools. But a final resolution kamagra polo chewable tablets uk is likely some time away as the case is appealed.

Disability rights groups, which had sued to stop the governor’s order, argued that the ban was keeping children with health problems who are at high risk from erectile dysfunction treatment from coming to school.Despite opposition from conservative leaders to treatment mandates, the vast majority of workers have had their shots, either because they wanted them or their employer mandated it. Lawsuits brought against those workplace requirements may not signal a broad opposition among the population.In its survey of employers’ health plans, KFF found that premiums are still increasing faster than wages as health costs continue to rise. Leaders of both political parties say they would like to reduce the kamagra polo chewable tablets uk cost of care, but no magic pill appears likely.

Instead, lawmakers generally are more inclined to have the government pick up a bigger portion of the country’s health care costs when not finding a way to cut that spending.One key challenge in addressing rising health care spending in Congress is the power of the health care industry. With the close political party margins on Capitol Hill, it is fairly easy for the industries to use their contributions to pick off a couple of members and keep major reform from passing.The KFF survey also documented the wide expansion of telehealth coverage during the kamagra. Although employers and the government have been concerned that telehealth adds to spending because it duplicates services or allows doctors kamagra polo chewable tablets uk to charge for services they once performed over the phone without billing, it will be hard to put this genie back in the bottle.

Consumers like the convenience. And some services, such as mental kamagra polo chewable tablets uk health therapy or medical consultations for rural residents, are much easier. Also this week, Rovner interviews Rebecca Love, a nurse, academic and entrepreneur who has thought a lot about the future of the nursing profession and where it fits into the U.S.

Health care system Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read, too. Julie Rovner kamagra polo chewable tablets uk. Washington Monthly’s “The Doctor Will Not See You Now,” by Merrill Goozner.

Alice Miranda Ollstein. NPR’s “Despite Calls to Improve, Air Travel Is Still kamagra polo chewable tablets uk a Nightmare for Many With Disabilities,” by Joseph Shapiro and Allison Mollenkamp. Rebecca Adams.

KHN’s “Patients Went Into the Hospital for Care. After Testing Positive There for erectile dysfunction treatment, Some Never Came Out,” by Christina kamagra polo chewable tablets uk Jewett. Anna Edney.

Bloomberg News’ “All Those 23andMe Spit Tests Were Part of a Bigger Plan,” by Kristen V Brown. To hear kamagra polo chewable tablets uk all our podcasts, click here. And subscribe to KHN’s What the Health?.

on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. Related Topics Contact Us Submit a Story TipSwitching seniors to Medicare Advantage plans has cost taxpayers tens of billions of dollars more than keeping them in original Medicare, kamagra polo chewable tablets uk a cost that has exploded since 2018 and is likely to rise even higher, new research has found. Richard Kronick, a former federal health policy researcher and a professor at the University of California-San Diego, said his analysis of newly released Medicare Advantage billing data estimates that Medicare overpaid the private health plans by more than $106 billion from 2010 through 2019 because of the way the private plans charge for sicker patients.

Nearly $34 billion of that new spending came during 2018 and 2019, the latest payment period available, according to Kronick. The Centers for Medicare & kamagra polo chewable tablets uk. Medicaid Services made the 2019 billing data public for the first time in late September.

€œThey are paying [Medicare Advantage plans] way more than they should,” said Kronick, who served as deputy assistant secretary for health policy in the Department of Health and Human Services during the Obama administration. Medicare Advantage, a kamagra polo chewable tablets uk fast-growing alternative to original Medicare, is run primarily by major insurance companies. The health plans have enrolled nearly 27 million members, or about 45% of people eligible for Medicare, according to AHIP, an industry trade group formerly known as America’s Health Insurance Plans.

The industry argues that the plans generally offer extra benefits, such as eyeglasses and dental care, not available under original Medicare and that most seniors who join the kamagra polo chewable tablets uk health plans are happy they did so. €œSeniors and taxpayers alike have come to expect high-quality, high-value health coverage from MA [Medicare Advantage] plans,” said AHIP spokesperson David Allen. Yet critics have argued for years that Medicare Advantage costs taxpayers too much.

The industry also has been kamagra polo chewable tablets uk the target of multiple government investigations and Department of Justice lawsuits that allege widespread billing abuse by some plans. The payment issue has been getting a closer look as some Democrats in Congress search for ways to finance the Biden administration’s social spending agenda. Medicare Advantage plans also are scrambling to attract new members by advertising widely during the fall open-enrollment period, which ends next month.

€œIt’s hard to miss the big red flag that Medicare is grossly overpaying these plans when you see that beneficiaries have more than 30 plans available in their area and are being bombarded daily by TV, magazine and billboard ads,” said Cristina Boccuti, director of health policy at West Health, a group kamagra polo chewable tablets uk that seeks to cut health care costs and has supported Kronick’s research. Kronick called the growth in Medicare Advantage costs a “systemic problem across the industry,” which CMS has failed to rein in. He said some plans saw “eye-popping” revenue gains, while others had more modest increases.

Giant insurer kamagra polo chewable tablets uk UnitedHealthcare, which in 2019 had about 6 million Medicare Advantage members, received excess payments of some $6 billion, according to Kronick. The company had no comment. €œThis is not small change,” said Joshua Gordon, director of health policy for the Committee for a Responsible Federal Budget, a nonpartisan group.

€œThe problem is just getting worse and worse.” Responding to written questions, a CMS spokesperson said the agency “is committed to ensuring that kamagra polo chewable tablets uk payments to Medicare Advantage plans are appropriate. It is CMS’s responsibility to make sure that Medicare Advantage plans are living up to their role, and the agency will certainly hold the plans to the standards that they should meet.” Making any cuts to Medicare Advantage payments faces stiff opposition, however. On Oct.

15, 13 U.S kamagra polo chewable tablets uk. Senators, including Sen. Kyrsten Sinema (D-Ariz.) sent a letter to CMS opposing any payment reductions, which they said “could lead to higher costs and premiums, reduce vital benefits, and undermine advances made to improve health outcomes and health equity” for people enrolled in the plans.

Much of the kamagra polo chewable tablets uk debate centers on the complex method used to pay the health plans. In original Medicare, medical providers bill for http://www.massage-energiecenter.at/?page_id=53 each service they provide. By contrast, Medicare Advantage plans are paid using a coding formula called a “risk score” kamagra polo chewable tablets uk that pays higher rates for sicker patients and less for those in good health.

That means the more serious medical conditions the plans diagnose the more money they get — sometimes thousands of dollars more per patient over the course of a year with little monitoring by CMS to make sure the higher fees are justified. Congress recognized the problem in 2005 and directed CMS to set an annual “coding intensity adjustment” to reduce Medicare Advantage risk scores and keep them more in line with original Medicare. But since kamagra polo chewable tablets uk 2018, CMS has set the coding adjustment at 5.9%, the minimum amount required by law.

Boccuti said that adjustment is “too low,” adding that health plans “are inventing new ways to increase their enrollees’ risk scores, which gain them higher monthly payments from Medicare.” Some of these coding strategies have been the target of whistleblower lawsuits and government investigations that allege health plans illegally manipulated risk scores by making patients appear sicker than they were, or by billing for medical conditions patients did not have. In one recent case, the Justice Department accused Kaiser Permanente health plans of obtaining about $1 billion by inflating risk scores. In a statement, the insurer kamagra polo chewable tablets uk disputed the allegations.

(KHN is not affiliated with Kaiser Permanente.) Legal or not, the rise in Medicare Advantage coding means taxpayers pay much more for similar patients who join the health plans than for those in original Medicare, according to Kronick. He said there is “little evidence” that higher payments to Medicare Advantage are justified because their enrollees are sicker than the average senior. Kronick, who kamagra polo chewable tablets uk has studied the coding issue for years, both inside government and out, said that risk scores in 2019 were 19% higher across Medicare Advantage plans than in original Medicare.

The Medicare Advantage scores rose by 4 percentage points between 2017 and 2019, faster than the average in past years, he said. Kronick said that if CMS keeps the current coding adjustment in place, spending on Medicare Advantage will increase by $600 billion from 2023 through 2031. While some of that money would provide patients with extra health benefits, Kronick estimates that as much as two-thirds of it could be kamagra polo chewable tablets uk going toward profits for insurance companies.

AHIP, the industry trade group, did not respond to questions about the coding controversy. But a report prepared for AHIP warned in September that payments tied to risk scores are a “key component” in how health plans calculate benefits they provide and that even a slight increase in the coding adjustment would prompt plans to cut benefits or charge patients more. That threat sounds alarms for many lawmakers, according to Kronick kamagra polo chewable tablets uk.

€œUnder pressure from Congress, CMS is not doing the job it should do,” he said. €œIf they do what the law tells them to do, they will get yelled at loudly, and not too many people will applaud.” Fred Schulte. fschulte@kff.org, @fredschulte Related Topics Contact Us Submit a Story TipFinding the best private Medicare drug or medical insurance plan among kamagra polo chewable tablets uk dozens of choices is tough enough without throwing misleading sales tactics into the mix.

Yet federal officials say complaints are rising from seniors tricked into buying policies — without their consent or lured by questionable information — that may not cover their drugs or include their doctors. In response, kamagra polo chewable tablets uk the Centers for Medicare &. Medicaid Services has threatened to penalize private insurance companies selling Medicare Advantage and drug plans if they or agents working on their behalf mislead consumers.

The agency has also revised rules making it easier for beneficiaries to escape plans they didn’t sign up for or enrolled in only to discover promised benefits didn’t exist or they couldn’t see their providers. The problems are especially prevalent kamagra polo chewable tablets uk during Medicare’s open-enrollment period, which began Oct. 15 and runs through Dec.

7. A common trap begins with a phone call like the one Linda Heimer, an kamagra polo chewable tablets uk Iowa resident, received in October. She won’t answer the phone unless her caller ID displays a number she recognizes, but this call showed the number of the hospital where her doctor works.

The person on the phone said she needed Heimer’s Medicare number to make sure it was correct for the new card she would receive. When Heimer hesitated, the woman kamagra polo chewable tablets uk said, “We’re not asking for a Social Security number or bank numbers or anything like that. This is OK.” “I can’t believe this, but I gave her my card number,” said Heimer.

Then the caller asked questions about her medical history and offered to send her a saliva test “absolutely free.” That’s when Heimer became suspicious and hung up. She contacted the 1-800-MEDICARE helpline to get a new Medicare number and called the AARP Fraud Watch Network Helpline and the Federal Trade kamagra polo chewable tablets uk Commission. But later that morning the phone rang again and this time the caller ID displayed a number matching the toll-free Medicare helpline.

When she answered, she recognized the voice of the same woman. €œYou’re not kamagra polo chewable tablets uk from Medicare,” Heimer told her. €œYes, yes, yes, we are,” the woman insisted.

Heimer hung up again. It’s been only two kamagra polo chewable tablets uk weeks since Heimer disclosed her Medicare number to a stranger and, so far, nothing’s gone wrong. But armed with that number, scammers could bill Medicare for services and medical supplies that beneficiaries never receive, and the scammers could sign seniors up for a Medicare Advantage or drug plan without their knowledge.

In California, reports of deceptive sales practices for Medicare Advantage and drug plans have been the top complaints to the state Senior Medicare Patrol for the past two years, said Sandy Morales, a case manager for the group. The patrol is a federally funded kamagra polo chewable tablets uk program that helps seniors untangle insurance problems. Nationwide, the Senior Medical Patrol has sent 74% more cases in the first nine months of this year than in all of 2020 to CMS and the Health and Human Services Inspector General for investigation, said Rebecca Kinney, director of the Administration for Community Living’s Office of Healthcare Information and Counseling at HHS, which oversees the patrols.

She expects more complaints to come kamagra polo chewable tablets uk in during Medicare’s open-enrollment period. And last month, CMS officials warned the private insurance companies selling Medicare Advantage and drug plans that federal requirements prohibit deceptive sales practices. Kathryn Coleman, director of CMS’ Medicare Drug and Health Plan Contract Administration Group, said in a memo to insurers that the agency is concerned about ads widely promoting Advantage plan benefits that are available only in a limited area or to a restricted number of beneficiaries.

CMS has also received complaints about kamagra polo chewable tablets uk sales information that could be construed as coming from the government and pressure tactics to get seniors to enroll, she noted. Coleman reminded the companies they are “accountable and responsible for their marketing materials and activities, including marketing completed on a MA plan’s behalf” by sales representatives. Companies that violate federal marketing rules can be fined and/or face enrollment suspensions.

But a CMS spokesperson could not provide examples of recent violators or kamagra polo chewable tablets uk their penalties. If beneficiaries discover a problem before March 31, the date the three-month disenrollment period ends each year, they have one chance to switch to another plan or to original Medicare. (Those who choose the latter may be unable to buy supplemental or Medigap insurance, with rare exceptions, in all but four states.

Connecticut, Maine, Massachusetts and New York.) After March, they are generally locked into their kamagra polo chewable tablets uk Advantage or drug plans for the entire year unless they’re eligible for one of the rare exceptions to the rule. CMS this year spelled out another remedy for the first time. Officials can grant a “special enrollment period” for people who want to leave their plan because of deceptive sales tactics.

These include “situations in which a beneficiary provides a verbal or written allegation that his or her enrollment in a MA or Part D plan was based upon misleading kamagra polo chewable tablets uk or incorrect information … [or] where a beneficiary states that he or she was enrolled into a plan without his or her knowledge,” according to the Medicare Managed Care Manual. €œThis is a really important safety valve for beneficiaries that clearly goes beyond just the limited opportunity to switch plans when someone feels buyer’s remorse,” said David Lipschutz, associate director of the Center for Medicare Advocacy. To use the new option, beneficiaries should contact their state’s health insurance assistance program at www.shiphelp.org/.

The option to leave is also available if a significant number of plan members are kamagra polo chewable tablets uk unable to access the doctors or hospitals that were supposed to be in the provider network. Nonetheless, the scams continue around the country, experts say. A misleading television commercial in the San Francisco area has enticed seniors with a host of new benefits including dental, vision, transportation benefits and even “money back into your Social Security account,” said Morales.

Beneficiaries have told her group that when they called for information kamagra polo chewable tablets uk they were “erroneously enrolled into a plan that they never gave permission to enroll into,” she said. In August, an Ohio senior received a call from someone telling him Medicare was issuing new cards because of the erectile dysfunction treatment kamagra. When he wouldn’t provide his Medicare number, the caller became angry and the beneficiary felt threatened, said Chris kamagra polo chewable tablets uk Reeg, director of the Ohio Senior Health Insurance Information Program.

Reeg said another senior received a call from a salesperson with bad news. She wasn’t getting all the benefits from Medicare she was entitled to. The beneficiary provided her Medicare number kamagra polo chewable tablets uk and other information but didn’t realize the caller was enrolling her in a Medicare Advantage plan.

She found out when she visited her doctor, who did not accept her new insurance. In western New York, the culprit is an official-looking postcard, said Beth Nelson, the state’s Senior Medicare Patrol director. €œOur records indicate … you may be eligible to kamagra polo chewable tablets uk receive additional benefits,” it says, enticingly.

When Nelson’s client called the number on the card in September for more details, she provided her Medicare number and later ended up in a Medicare Advantage plan without her consent. Heimer’s scammer was persistent. When the stranger tried to reach her a third time, kamagra polo chewable tablets uk Heimer said, the caller ID displayed the phone number of another local hospital.

She told the woman she had reported the calls to CMS, the AARP Fraud Watch Network Helpline and the FTC. That finally did the trick — the woman abruptly hung up. Susan Jaffe kamagra polo chewable tablets uk.

Jaffe.KHN@gmail.com, @SusanJaffe Related Topics Contact Us Submit a Story TipAs the erectile dysfunction treatment kamagra burns through its second year, the path forward for American workers remains unsettled, with many continuing to work from home while policies for maintaining a safe workplace evolve. In its 2021 Employer Health Benefits Survey, released Wednesday, KFF found that many employers have ramped up mental health and other benefits to provide support for their workers during uncertain times. Meanwhile, the proportion of employers offering health insurance to their workers remained steady, and kamagra polo chewable tablets uk increases for health insurance premiums and out-of-pocket health expenses were moderate, in line with the rise in pay.

Deductibles were largely unchanged from the previous two years. €œWith the kamagra, I’m not sure that employers wanted to make big changes in their plans, because so many other things were disrupted,” said Gary Claxton, a senior vice president at KFF and director of the Health Care Marketplace Project. (KHN is kamagra polo chewable tablets uk an editorially independent program of the foundation.) Reaching out to a dispersed workforce is also a challenge, with on-site activities like employee benefits fairs curtailed or eliminated.

€œIt’s hard to even communicate changes right now,” Claxton said. Many employers reported that since the kamagra started they’ve made changes to their mental health and substance use benefits. Nearly 1,700 nonfederal public and private companies completed the full kamagra polo chewable tablets uk survey.

At companies with at least 50 workers, 39% have made such changes, including. 31% that increased the ways employees can tap into mental health services, kamagra polo chewable tablets uk such as telemedicine.16% that offered employee assistance programs or other new resources for mental health.6% that expanded access to in-network mental health providers.4% that reduced cost sharing for such visits.3% that increased coverage for out-of-network services. Workers are taking advantage of the services.

Thirty-eight percent of the largest companies with 1,000 or more workers reported that their workers used more mental health services in 2021 than the year before, while 12% of companies with at least 50 workers said their workers upped their use of mental health services. Thundermist Health kamagra polo chewable tablets uk Center is a federally qualified health center that serves three communities in Rhode Island. The center’s health plan offers employees an HMO and a preferred provider organization, and 227 workers are enrolled.

When the kamagra hit, the health plan reduced the copayments for behavioral health visits to zero from $30. €œWe wanted to encourage people to get help who were feeling any stress or concerns,” said Cynthia Farrell, associate vice president for human resources at Thundermist kamagra polo chewable tablets uk. Once the kamagra ends, if the health center adds a copayment again, it won’t be more than $15, she said.

The kamagra also changed the way many companies handled their wellness programs. More than half of those with at least 50 workers expanded these programs during the kamagra polo chewable tablets uk kamagra. The most common change?.

Expanding online counseling services, reported by 38% of companies with 50 to 199 workers and 58% of companies with 200 or more workers. Another popular change was expanding or changing existing wellness programs kamagra polo chewable tablets uk to meet the needs of people who are working from home, reported by 17% of the smaller companies and 34% of the larger companies that made changes. Beefing up telemedicine services was a popular way for employers to make services easier to access for workers, who may have been working remotely or whose clinicians, including mental health professionals, may not have been seeing patients in person.

In 2021, 95% of employers offered at least some health care services through telemedicine, compared with 85% last year. These were often video appointments, but a growing number of companies allowed telemedicine visits by kamagra polo chewable tablets uk telephone or other communication modes, as well as expanded the number of services offered this way and the types of providers that can use them. About 155 million people in the U.S.

Have employer-sponsored health care. The kamagra didn’t change the proportion of employers that kamagra polo chewable tablets uk offered coverage to their workers. It has remained mostly steady at 59% for the past decade.

Size matters, however, and while 99% of companies with at least 200 workers kamagra polo chewable tablets uk offers health benefits, only 56% of those with fewer than 50 workers do so. In 2021, average premiums for both family and single coverage rose 4%, to $22,221 for families and $7,739 for single coverage. Workers with family coverage contribute $5,969 toward their coverage, on average, while those with single coverage pay an average of $1,299.

The annual premium change was in kamagra polo chewable tablets uk line with workers’ wage growth of 5% and inflation of 1.9%. But during the past 10 years, average premium increases have substantially exceeded increases in wages and inflation. Workers pay 17% of the premium for single coverage and 28% of that for family coverage, on average.

The employer pays the rest. Deductibles have remained steady in 2021. The average deductible for single coverage was $1,669, up 68% over the decade but not much different from the previous two years, when the deductible was $1,644 in 2020 and $1,655 in 2019.

Eighty-five percent of workers have a deductible now. 10 years ago, the figure was 74%. Health care spending has slowed during the kamagra, as people delay or avoid care that isn’t essential.

Half of large employers with at least 200 workers reported that health care use by workers was about what they expected in the most recent quarter. But nearly a third said that utilization has been below expectations, and 18% said it was above it, the survey found. At Thundermist Health Center, fewer people sought out health care last year, so the self-funded health plan, which pays employee claims directly rather than using insurance for that purpose, fell below its expected spending, Farrell said.

That turned out to be good news for employees, whose contribution to their plan didn’t change. €œThis year was the first year in a very long time that we didn’t have to change our rates,” Farrell said. The survey was conducted between January and July 2021.

It was published in the journal Health Affairs and KFF also released additional details in its full report. Michelle Andrews. andrews.khn@gmail.com, @mandrews110 Related Topics Contact Us Submit a Story Tip.

Encontrar el mejor plan médico privado, kamagra oral jelly thailand price o check this site out de medicamentos, de Medicare entre docenas de opciones es lo suficientemente difícil sin incluir estrategias de venta engañosas. Sin embargo, funcionarios federales dicen que están aumentando las quejas de personas mayores engañadas para que compren pólizas sin su consentimiento, o atraídas por información cuestionable, que pueden no cubrir sus medicamentos ni incluir a sus médicos. En respuesta, los Centros de Servicios de Medicare y Medicaid (CMS) han amenazado con penalizar a las compañías de seguros privadas que venden planes de medicamentos y Medicare Advantage (MA), si ellas o los agentes que trabajan en su nombre engañan a los kamagra oral jelly thailand price consumidores. La agencia también ha revisado las reglas que facilitan a los beneficiarios abandonar planes en los que no se inscribieron, o salir de aquéllos en los que fueron inscriptos a través de engaños, solo para descubrir que los beneficios prometidos no existían, o que no podían ver a sus proveedores.

Los problemas son especialmente frecuentes durante el período de inscripción abierta de Medicare, que comenzó el 15 de octubre y se extiende hasta el 7 de diciembre. Una trampa kamagra oral jelly thailand price común comienza con una llamada telefónica como la que recibió Linda Heimer, de Iowa, en octubre. Heimer no contesta el teléfono a menos que su identificador de llamadas muestre un número que reconoce, pero esta llamada mostró el número del hospital donde trabaja su médico. La persona al teléfono dijo que necesitaba el número de Medicare de Heimer para asegurarse de que fuera correcto para la nueva tarjeta que recibiría.

Cuando Heimer kamagra oral jelly thailand price vaciló, la mujer dijo. €œNo estamos pidiendo un número de seguro social o números de banco ni nada por el estilo. Esto está bien”. €œTodavía no puedo kamagra oral jelly thailand price creerlo, pero le di mi número de tarjeta”, dijo Heimer.

Luego, la persona que llamó le hizo preguntas sobre su historial médico y se ofreció a enviarle una prueba de saliva “absolutamente gratis”. Fue entonces cuando Heimer empezó a sospechar y colgó. Se comunicó con la línea de ayuda 1-800-MEDICARE para obtener un nuevo kamagra oral jelly thailand price número de Medicare, y llamó a la Línea de ayuda de la red AARP Fraud Watch Network y a la Comisión Federal de Comercio. Pero más tarde esa mañana, el teléfono volvió a sonar y esta vez el identificador de llamadas mostró un número que coincidía con la línea de ayuda gratuita de Medicare.

Cuando respondió, reconoció la voz de la misma mujer. €œNo eres de Medicare”, le kamagra oral jelly thailand price dijo Heimer. €œSí, sí, sí, somos”, insistió la mujer. Heimer colgó de nuevo.

Han pasado solo dos semanas desde que Heimer kamagra oral jelly thailand price reveló su número de Medicare a una extraña y, hasta ahora, nada ha salido mal. Pero, con ese número, los estafadores podrían facturar a Medicare por servicios y suministros médicos que los beneficiarios nunca reciben, y podrían inscribir a personas mayores en un plan Medicare Advantage o de medicamentos sin su conocimiento. En California, los informes de prácticas de venta engañosas de Medicare Advantage y planes de medicamentos han sido las principales quejas ante la Senior Medicare Patrol kamagra oral jelly thailand price del estado durante los últimos dos años, dijo Sandy Morales, administradora de casos del grupo. La patrulla es un programa financiado por el gobierno federal que ayuda a las personas mayores a desentrañar problemas con sus seguros.

A nivel nacional, la Senior Medicare Patrol ha enviado a los CMS y al Inpector General de Salud y Servicios Sociales 74% más casos para su Investigación en los primeros nueve meses de este año que en todo 2020, dijo Rebecca Kinney, directora de la Oficina de Administración para la Vida Comunitaria del Consejo de Información y Asesoramiento sobre Atención Médica del departamento de salud, que supervisa las patrullas. Dijo que espera que kamagra oral jelly thailand price lleguen más quejas durante el período de inscripción abierta de Medicare. Y en octubre, funcionarios de los CMS advirtieron a las compañías de seguros privadas que venden Medicare Advantage y planes de medicamentos que los requisitos federales prohíben las prácticas de venta engañosas. Kathryn Coleman, directora del Grupo de Administración de Contratos de Planes de Salud y Medicamentos de Medicare de los CMS, dijo en un memorando a las aseguradoras que la agencia está preocupada por los anuncios que promueven ampliamente los beneficios del plan Advantage que están disponibles solo en un área limitada o para un número restringido de beneficiarios.

Los CMS también han recibido quejas sobre información de kamagra oral jelly thailand price ventas que podrían interpretarse como provenientes del gobierno, y tácticas de presión para lograr que las personas mayores se inscriban, señaló. Coleman recordó a las empresas que son “responsables de sus materiales y actividades de marketing, incluido el marketing realizado en nombre de un plan de MA por los representantes de ventas”. Las empresas que violen las reglas federales de marketing pueden ser multadas y/o enfrentar suspensiones de inscripción. Un vocero kamagra oral jelly thailand price de CMS no pudo proporcionar ejemplos de infractores recientes, o sus sanciones.

Si los beneficiarios descubren un problema antes del 31 de marzo, la fecha en que finaliza el período de cancelación de la inscripción de tres meses cada año, tienen una oportunidad de cambiarse a otro plan o al Medicare original. (Aquellos que eligen este último pueden no poder comprar un seguro complementario o Medigap, con raras excepciones, en todos los estados excepto en cuatro. Connecticut, Maine, kamagra oral jelly thailand price Massachusetts y Nueva York). Después de marzo, generalmente están “atados” a sus planes Advantage o de medicamentos por todo el año, a menos que sean elegibles para una de las raras excepciones a la regla.

Este año, los CMS mostraron otra solución, por primera vez. Los funcionarios pueden otorgar un “período de inscripción especial” para las personas que quieran abandonar kamagra oral jelly thailand price su plan debido a tácticas de venta engañosas. Estos incluyen “situaciones en las que un beneficiario presenta una alegación verbal o escrita de que su inscripción en un plan MA o de la Parte D se basó en información engañosa o incorrecta… [o] donde un beneficiario declara que estaba inscrito en un plan sin su conocimiento”, de acuerdo con el Manual de Atención Administrada de Medicare. €œEsta es una válvula de seguridad realmente importante para los beneficiarios que claramente va más allá de la oportunidad limitada de cambiar de plan cuando alguien siente que eligió mal”, dijo David Lipschutz, director asociado del Center for Medicare Advocacy.

Para utilizar kamagra oral jelly thailand price la nueva opción, los beneficiarios deben comunicarse con el programa de asistencia de seguro médico de su estado en www.shiphelp.org/. La opción de dejar un plan también está disponible si una cantidad significativa de miembros del plan no puede acceder a los médicos u hospitales que se suponía que estaban en la red de proveedores. No obstante, las estafas continúan en kamagra oral jelly thailand price todo el país, dicen los expertos. Un comercial de televisión engañoso en el área de San Francisco ha atraído a las personas mayores con una serie de nuevos servicios que incluyen beneficios dentales, de la vista, de transporte e incluso “reembolso de dinero a su cuenta del Seguro Social”, dijo Morales.

Los beneficiarios le han dicho a su grupo que cuando pidieron información estaban “inscritos por error en un plan en el que nunca habían dado la autrorización para ser inscriptos”, dijo. En agosto, un adulto mayor de Ohio recibió una llamada de alguien que kamagra oral jelly thailand price le decía que Medicare estaba emitiendo nuevas tarjetas debido a la pandemia de erectile dysfunction treatment. Cuando no dio su número de Medicare, la persona que llamó se enojó y el beneficiario se sintió amenazado, dijo Chris Reeg, director del Programa de Información sobre Seguros de Salud para Personas Mayores de Ohio. Reeg dijo que otra persona mayor recibió una llamada de un vendedor con malas noticias.

No estaba kamagra oral jelly thailand price recibiendo todos los beneficios de Medicare a los que tenía derecho. La beneficiaria proporcionó su número de Medicare y otra información, pero no se dio cuenta de que la persona que llamaba la estaba inscribiendo en un plan Medicare Advantage. Se enteró cuando visitó a su médico, quien no aceptó su nuevo seguro. En el kamagra oral jelly thailand price oeste de Nueva York, el culpable es una postal de aspecto oficial, dijo Beth Nelson, directora principal de la patrulla de Medicare del estado.

€œNuestros registros indican… que puede ser elegible para recibir beneficios adicionales”, dice, tentadora. Cuando la clienta de Nelson llamó al número que figura en la tarjeta en septiembre para obtener más detalles, proporcionó su número de Medicare y luego terminó en un plan Medicare Advantage sin su consentimiento. La estafadora de kamagra oral jelly thailand price Heimer fue persistente. Contó que cuando la mujer intentó comunicarse con ella por tercera vez, el identificador de llamadas mostraba el número de teléfono de otro hospital local.

Heimer le dijo que había denunciado las llamadas a los CMS, la línea de ayuda de la red AARP Fraud Watch Network y la FTC. Eso finalmente kamagra oral jelly thailand price funcionó. La mujer colgó abruptamente. Susan Jaffe.

Jaffe.KHN@gmail.com, @SusanJaffe Related Topics Contact Us Submit a Story kamagra oral jelly thailand price TipCan’t see the audio player?. Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. Congress appears to be kamagra oral jelly thailand price making progress on its huge social spending bill, but even if it passes the House as planned the week of Nov.

15, it’s unlikely it can get through the Senate before the Thanksgiving deadline that Democrats set for themselves. Meanwhile, the cost of employer-provided health insurance continues to rise, even with so kamagra oral jelly thailand price many people forgoing care during the kamagra. The annual KFF survey of employers reported that the average cost of a job-based family plan has risen to more than $22,000. To provide what their workers most need, however, this year many employers added additional coverage of mental health care and telehealth.

This week’s panelists are Julie Rovner of KHN, Alice kamagra oral jelly thailand price Miranda Ollstein of Politico, Anna Edney of Bloomberg News and Rebecca Adams of CQ Roll Call. Among the takeaways from this week’s episode. Moderate Democrats who were worried about the price tag of the social spending bill said during negotiations last week that they wanted to see the full analysis of spending and costs from the Congressional Budget Office. But members of the House probably won’t get that score before voting on the bill kamagra oral jelly thailand price.

CBO instead is releasing its assessments piecemeal as analysts go through specific sections of the huge bill.If the House passes the bill next week, which leadership is pledging, the legislation could still undergo major revisions in the Senate. Some provisions will be subject to the Byrd Rule, which says items in this type of bill must be related to the budget. Republicans are expected to challenge parts of the bill, and the parliamentarian will have to rule on whether their objections are valid.Among the provisions that some moderate Democratic senators might object to are the paid family leave and the mechanism for lowering Medicare drug prices.Congress is looking at a very busy end of the year, which could complicate passage of kamagra oral jelly thailand price the social spending bill. Leaders already postponed a bill to raise the debt ceiling and the annual federal spending bills until early December.A federal judge has blocked Texas Republican Gov.

Greg Abbott’s order prohibiting mask mandates in schools. But a final resolution is likely some time away kamagra oral jelly thailand price as the case is appealed. Disability rights groups, which had sued to stop the governor’s order, argued that the ban was keeping children with health problems who are at high risk from erectile dysfunction treatment from coming to school.Despite opposition from conservative leaders to treatment mandates, the vast majority of workers have had their shots, either because they wanted them or their employer mandated it. Lawsuits brought against those workplace requirements may not signal a broad opposition among the population.In its survey of employers’ health plans, KFF found that premiums are still increasing faster than wages as health costs continue to rise.

Leaders of both political parties say kamagra oral jelly thailand price they would like to reduce the cost of care, but no magic pill appears likely. Instead, lawmakers generally are more inclined to have the government pick up a bigger portion of the country’s health care costs when not finding a way to cut that spending.One key challenge in addressing rising health care spending in Congress is the power of the health care industry. With the close political party margins on Capitol Hill, it is fairly easy for the industries to use their contributions to pick off a couple of members and keep major reform from passing.The KFF survey also documented the wide expansion of telehealth coverage during the kamagra. Although employers and the government have been concerned that telehealth adds to spending because it duplicates services or allows doctors to charge for services they once performed over kamagra oral jelly thailand price the phone without billing, it will be hard to put this genie back in the bottle.

Consumers like the convenience. And some services, such as mental health therapy or medical consultations for rural residents, are much kamagra oral jelly thailand price easier. Also this week, Rovner interviews Rebecca Love, a nurse, academic and entrepreneur who has thought a lot about the future of the nursing profession and where it fits into the U.S. Health care system Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read, too.

Julie Rovner kamagra oral jelly thailand price. Washington Monthly’s “The Doctor Will Not See You Now,” by Merrill Goozner. Alice Miranda Ollstein. NPR’s “Despite Calls kamagra oral jelly thailand price to Improve, Air Travel Is Still a Nightmare for Many With Disabilities,” by Joseph Shapiro and Allison Mollenkamp.

Rebecca Adams. KHN’s “Patients Went Into the Hospital for Care. After Testing Positive There for erectile dysfunction treatment, Some Never kamagra oral jelly thailand price Came Out,” by Christina Jewett. Anna Edney.

Bloomberg News’ “All Those 23andMe Spit Tests Were Part of a Bigger Plan,” by Kristen V Brown. To hear all our podcasts, click here kamagra oral jelly thailand price. And subscribe to KHN’s What the Health?. on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts.

Related Topics Contact Us Submit a Story TipSwitching seniors to Medicare Advantage plans has cost taxpayers tens of billions of dollars more than keeping them in original Medicare, a cost that has exploded since 2018 and is likely to kamagra oral jelly thailand price rise even higher, new research has found. Richard Kronick, a former federal health policy researcher and a professor at the University of California-San Diego, said his analysis of newly released Medicare Advantage billing data estimates that Medicare overpaid the private health plans by more than $106 billion from 2010 through 2019 because of the way the private plans charge for sicker patients. Nearly $34 billion of that new spending came during 2018 and 2019, the latest payment period available, according to Kronick. The Centers kamagra oral jelly thailand price for Medicare &.

Medicaid Services made the 2019 billing data public for the first time in late September. €œThey are paying [Medicare Advantage plans] way more than they should,” said Kronick, who served as deputy assistant secretary for health policy in the Department of Health and Human Services during the Obama administration. Medicare Advantage, a fast-growing kamagra oral jelly thailand price alternative to original Medicare, is run primarily by major insurance companies. The health plans have enrolled nearly 27 million members, or about 45% of people eligible for Medicare, according to AHIP, an industry trade group formerly known as America’s Health Insurance Plans.

The industry argues that the plans generally offer extra benefits, such as eyeglasses and dental care, not available under original Medicare and that most seniors who join the health plans kamagra oral jelly thailand price are happy they did so. €œSeniors and taxpayers alike have come to expect high-quality, high-value health coverage from MA [Medicare Advantage] plans,” said AHIP spokesperson David Allen. Yet critics have argued for years that Medicare Advantage costs taxpayers too much. The industry kamagra oral jelly thailand price also has been the target of multiple government investigations and Department of Justice lawsuits that allege widespread billing abuse by some plans.

The payment issue has been getting a closer look as some Democrats in Congress search for ways to finance the Biden administration’s social spending agenda. Medicare Advantage plans also are scrambling to attract new members by advertising widely during the fall open-enrollment period, which ends next month. €œIt’s hard to miss the big red flag that Medicare is grossly overpaying these plans kamagra oral jelly thailand price when you see that beneficiaries have more than 30 plans available in their area and are being bombarded daily by TV, magazine and billboard ads,” said Cristina Boccuti, director of health policy at West Health, a group that seeks to cut health care costs and has supported Kronick’s research. Kronick called the growth in Medicare Advantage costs a “systemic problem across the industry,” which CMS has failed to rein in.

He said some plans saw “eye-popping” revenue gains, while others had more modest increases. Giant insurer UnitedHealthcare, which kamagra oral jelly thailand price in 2019 had about 6 million Medicare Advantage members, received excess payments of some $6 billion, according to Kronick. The company had no comment. €œThis is not small change,” said Joshua Gordon, director of health policy for the Committee for a Responsible Federal Budget, a nonpartisan group.

€œThe problem is just getting kamagra oral jelly thailand price worse and worse.” Responding to written questions, a CMS spokesperson said the agency “is committed to ensuring that payments to Medicare Advantage plans are appropriate. It is CMS’s responsibility to make sure that Medicare Advantage plans are living up to their role, and the agency will certainly hold the plans to the standards that they should meet.” Making any cuts to Medicare Advantage payments faces stiff opposition, however. On Oct. 15, 13 kamagra oral jelly thailand price U.S.

Senators, including Sen. Kyrsten Sinema (D-Ariz.) sent a letter to CMS opposing any payment reductions, which they said “could lead to higher costs and premiums, reduce vital benefits, and undermine advances made to improve health outcomes and health equity” for people enrolled in the plans. Much of the debate centers on the complex method used to pay kamagra oral jelly thailand price the health plans. In original Medicare, medical providers bill for each service they provide.

By contrast, Medicare Advantage plans are paid kamagra oral jelly thailand price using a coding formula called a “risk score” that pays higher rates for sicker patients and less for those in good health. That means the more serious medical conditions the plans diagnose the more money they get — sometimes thousands of dollars more per patient over the course of a year with little monitoring by CMS to make sure the higher fees are justified. Congress recognized the problem in 2005 and directed CMS to set an annual “coding intensity adjustment” to reduce Medicare Advantage risk scores and keep them more in line with original Medicare. But since 2018, CMS has set the coding adjustment at 5.9%, kamagra oral jelly thailand price the minimum amount required by law.

Boccuti said that adjustment is “too low,” adding that health plans “are inventing new ways to increase their enrollees’ risk scores, which gain them higher monthly payments from Medicare.” Some of these coding strategies have been the target of whistleblower lawsuits and government investigations that allege health plans illegally manipulated risk scores by making patients appear sicker than they were, or by billing for medical conditions patients did not have. In one recent case, the Justice Department accused Kaiser Permanente health plans of obtaining about $1 billion by inflating risk scores. In a kamagra oral jelly thailand price statement, the insurer disputed the allegations. (KHN is not affiliated with Kaiser Permanente.) Legal or not, the rise in Medicare Advantage coding means taxpayers pay much more for similar patients who join the health plans than for those in original Medicare, according to Kronick.

He said there is “little evidence” that higher payments to Medicare Advantage are justified because their enrollees are sicker than the average senior. Kronick, who has studied the coding issue for years, both inside kamagra oral jelly thailand price government and out, said that risk scores in 2019 were 19% higher across Medicare Advantage plans than in original Medicare. The Medicare Advantage scores rose by 4 percentage points between 2017 and 2019, faster than the average in past years, he said. Kronick said that if CMS keeps the current coding adjustment in place, spending on Medicare Advantage will increase by $600 billion from 2023 through 2031.

While some of that money would provide patients with extra health benefits, Kronick estimates that as much as two-thirds kamagra oral jelly thailand price of it could be going toward profits for insurance companies. AHIP, the industry trade group, did not respond to questions about the coding controversy. But a report prepared for AHIP warned in September that payments tied to risk scores are a “key component” in how health plans calculate benefits they provide and that even a slight increase in the coding adjustment would prompt plans to cut benefits or charge patients more. That threat sounds alarms for many lawmakers, kamagra oral jelly thailand price according to Kronick.

€œUnder pressure from Congress, CMS is not doing the job it should do,” he said. €œIf they do what the law tells them to do, they will get yelled at loudly, and not too many people will applaud.” Fred Schulte. fschulte@kff.org, @fredschulte Related Topics Contact Us Submit a Story TipFinding the best private Medicare drug or medical insurance plan among dozens of choices is tough kamagra oral jelly thailand price enough without throwing misleading sales tactics into the mix. Yet federal officials say complaints are rising from seniors tricked into buying policies — without their consent or lured by questionable information — that may not cover their drugs or include their doctors.

In response, the kamagra oral jelly thailand price Centers for Medicare &. Medicaid Services has threatened to penalize private insurance companies selling Medicare Advantage and drug plans if they or agents working on their behalf mislead consumers. The agency has also revised rules making it easier for beneficiaries to escape plans they didn’t sign up for or enrolled in only to discover promised benefits didn’t exist or they couldn’t see their providers. The problems are especially prevalent during Medicare’s open-enrollment period, which began kamagra oral jelly thailand price Oct.

15 and runs through Dec. 7. A common trap begins with a phone call kamagra oral jelly thailand price like the one Linda Heimer, an Iowa resident, received in October. She won’t answer the phone unless her caller ID displays a number she recognizes, but this call showed the number of the hospital where her doctor works.

The person on the phone said she needed Heimer’s Medicare number to make sure it was correct for the new card she would receive. When Heimer hesitated, the woman said, “We’re not asking for a Social Security number or bank kamagra oral jelly thailand price numbers or anything like that. This is OK.” “I can’t believe this, but I gave her my card number,” said Heimer. Then the caller asked questions about her medical history and offered to send her a saliva test “absolutely free.” That’s when Heimer became suspicious and hung up.

She contacted the 1-800-MEDICARE helpline to get a new Medicare number and called the AARP Fraud Watch Network Helpline and the kamagra oral jelly thailand price Federal Trade Commission. But later that morning the phone rang again and this time the caller ID displayed a number matching the toll-free Medicare helpline. When she answered, she recognized the voice of the same woman. €œYou’re not from kamagra oral jelly thailand price Medicare,” Heimer told her.

€œYes, yes, yes, we are,” the woman insisted. Heimer hung up again. It’s been only two weeks since Heimer kamagra oral jelly thailand price disclosed her Medicare number to a stranger and, so far, nothing’s gone wrong. But armed with that number, scammers could bill Medicare for services and medical supplies that beneficiaries never receive, and the scammers could sign seniors up for a Medicare Advantage or drug plan without their knowledge.

In California, reports of deceptive sales practices for Medicare Advantage and drug plans have been the top complaints to the state Senior Medicare Patrol for the past two years, said Sandy Morales, a case manager for the group. The patrol kamagra oral jelly thailand price is a federally funded program that helps seniors untangle insurance problems. Nationwide, the Senior Medical Patrol has sent 74% more cases in the first nine months of this year than in all of 2020 to CMS and the Health and Human Services Inspector General for investigation, said Rebecca Kinney, director of the Administration for Community Living’s Office of Healthcare Information and Counseling at HHS, which oversees the patrols. She expects more complaints to come in during Medicare’s open-enrollment period kamagra oral jelly thailand price.

And last month, CMS officials warned the private insurance companies selling Medicare Advantage and drug plans that federal requirements prohibit deceptive sales practices. Kathryn Coleman, director of CMS’ Medicare Drug and Health Plan Contract Administration Group, said in a memo to insurers that the agency is concerned about ads widely promoting Advantage plan benefits that are available only in a limited area or to a restricted number of beneficiaries. CMS has also received complaints about sales information kamagra oral jelly thailand price that could be construed as coming from the government and pressure tactics to get seniors to enroll, she noted. Coleman reminded the companies they are “accountable and responsible for their marketing materials and activities, including marketing completed on a MA plan’s behalf” by sales representatives.

Companies that violate federal marketing rules can be fined and/or face enrollment suspensions. But a CMS spokesperson could not provide examples of recent violators kamagra oral jelly thailand price or their penalties. If beneficiaries discover a problem before March 31, the date the three-month disenrollment period ends each year, they have one chance to switch to another plan or to original Medicare. (Those who choose the latter may be unable to buy supplemental or Medigap insurance, with rare exceptions, in all but four states.

Connecticut, Maine, Massachusetts kamagra oral jelly thailand price and New York.) After March, they are generally locked into their Advantage or drug plans for the entire year unless they’re eligible for one of the rare exceptions to the rule. CMS this year spelled out another remedy for the first time. Officials can grant a “special enrollment period” for people who want to leave their plan because of deceptive sales tactics. These include “situations in which a beneficiary provides a verbal or written allegation that his or her enrollment in a MA or Part D plan was based upon misleading or incorrect information … [or] where a beneficiary states that he or she was enrolled into a plan without his or kamagra oral jelly thailand price her knowledge,” according to the Medicare Managed Care Manual.

€œThis is a really important safety valve for beneficiaries that clearly goes beyond just the limited opportunity to switch plans when someone feels buyer’s remorse,” said David Lipschutz, associate director of the Center for Medicare Advocacy. To use the new option, beneficiaries should contact their state’s health insurance assistance program at www.shiphelp.org/. The option to leave is also available if a significant number of plan members are unable to access the kamagra oral jelly thailand price doctors or hospitals that were supposed to be in the provider network. Nonetheless, the scams continue around the country, experts say.

A misleading television commercial in the San Francisco area has enticed seniors with a host of new benefits including dental, vision, transportation benefits and even “money back into your Social Security account,” said Morales. Beneficiaries have told her group that when they called for information they were “erroneously enrolled into a plan that they never gave permission to enroll into,” kamagra oral jelly thailand price she said. In August, an Ohio senior received a call from someone telling him Medicare was issuing new cards because of the erectile dysfunction treatment kamagra. When he wouldn’t provide his Medicare number, the caller became angry and the beneficiary felt threatened, said Chris Reeg, director of the Ohio Senior Health Insurance Information Program kamagra oral jelly thailand price.

Reeg said another senior received a call from a salesperson with bad news. She wasn’t getting all the benefits from Medicare she was entitled to. The beneficiary provided her Medicare number and other information but didn’t realize the caller was enrolling her in kamagra oral jelly thailand price a Medicare Advantage plan. She found out when she visited her doctor, who did not accept her new insurance.

In western New York, the culprit is an official-looking postcard, said Beth Nelson, the state’s Senior Medicare Patrol director. €œOur records indicate … you may be eligible to receive additional benefits,” kamagra oral jelly thailand price it says, enticingly. When Nelson’s client called the number on the card in September for more details, she provided her Medicare number and later ended up in a Medicare Advantage plan without her consent. Heimer’s scammer was persistent.

When the kamagra oral jelly thailand price stranger tried to reach her a third time, Heimer said, the caller ID displayed the phone number of another local hospital. She told the woman she had reported the calls to CMS, the AARP Fraud Watch Network Helpline and the FTC. That finally did the trick — the woman abruptly hung up. Susan Jaffe kamagra oral jelly thailand price.

Jaffe.KHN@gmail.com, @SusanJaffe Related Topics Contact Us Submit a Story TipAs the erectile dysfunction treatment kamagra burns through its second year, the path forward for American workers remains unsettled, with many continuing to work from home while policies for maintaining a safe workplace evolve. In its 2021 Employer Health Benefits Survey, released Wednesday, KFF found that many employers have ramped up mental health and other benefits to provide support for their workers during uncertain times. Meanwhile, the proportion of employers kamagra oral jelly thailand price offering health insurance to their workers remained steady, and increases for health insurance premiums and out-of-pocket health expenses were moderate, in line with the rise in pay. Deductibles were largely unchanged from the previous two years.

€œWith the kamagra, I’m not sure that employers wanted to make big changes in their plans, because so many other things were disrupted,” said Gary Claxton, a senior vice president at KFF and director of the Health Care Marketplace Project. (KHN is an editorially independent kamagra oral jelly thailand price program of the foundation.) Reaching out to a dispersed workforce is also a challenge, with on-site activities like employee benefits fairs curtailed or eliminated. €œIt’s hard to even communicate changes right now,” Claxton said. Many employers reported that since the kamagra started they’ve made changes to their mental health and substance use benefits.

Nearly 1,700 nonfederal public and private companies completed kamagra oral jelly thailand price the full survey. At companies with at least 50 workers, 39% have made such changes, including. 31% that increased the ways employees can tap into mental health services, such as telemedicine.16% that offered employee assistance kamagra oral jelly thailand price programs or other new resources for mental health.6% that expanded access to in-network mental health providers.4% that reduced cost sharing for such visits.3% that increased coverage for out-of-network services. Workers are taking advantage of the services.

Thirty-eight percent of the largest companies with 1,000 or more workers reported that their workers used more mental health services in 2021 than the year before, while 12% of companies with at least 50 workers said their workers upped their use of mental health services. Thundermist Health Center is a federally qualified health center that serves three communities kamagra oral jelly thailand price in Rhode Island. The center’s health plan offers employees an HMO and a preferred provider organization, and 227 workers are enrolled. When the kamagra hit, the health plan reduced the copayments for behavioral health visits to zero from $30.

€œWe wanted to encourage people to get help who were feeling any stress or concerns,” said Cynthia Farrell, associate vice president for human resources at kamagra oral jelly thailand price Thundermist. Once the kamagra ends, if the health center adds a copayment again, it won’t be more than $15, she said. The kamagra also changed the way many companies handled their wellness programs. More than half of those with at least 50 workers expanded these kamagra oral jelly thailand price programs during the kamagra.

The most common change?. Expanding online counseling services, reported by 38% of companies with 50 to 199 workers and 58% of companies with 200 or more workers. Another popular change was expanding or changing existing wellness programs to meet the needs of people who kamagra oral jelly thailand price are working from home, reported by 17% of the smaller companies and 34% of the larger companies that made changes. Beefing up telemedicine services was a popular way for employers to make services easier to access for workers, who may have been working remotely or whose clinicians, including mental health professionals, may not have been seeing patients in person.

In 2021, 95% of employers offered at least some health care services through telemedicine, compared with 85% last year. These were often video appointments, but a growing number of companies allowed telemedicine visits by telephone or other communication modes, as well as expanded the number kamagra oral jelly thailand price of services offered this way and the types of providers that can use them. About 155 million people in the U.S. Have employer-sponsored health care.

The kamagra didn’t change the proportion of kamagra oral jelly thailand price employers that offered coverage to their workers. It has remained mostly steady at 59% for the past decade. Size matters, however, and while 99% of companies with at least 200 workers offers health benefits, only 56% of those with fewer than kamagra oral jelly thailand price 50 workers do so. In 2021, average premiums for both family and single coverage rose 4%, to $22,221 for families and $7,739 for single coverage.

Workers with family coverage contribute $5,969 toward their coverage, on average, while those with single coverage pay an average of $1,299. The annual premium change was in line with workers’ wage kamagra oral jelly thailand price growth of 5% and inflation of 1.9%. But during the past 10 years, average premium increases have substantially exceeded increases in wages and inflation. Workers pay 17% of the premium for single coverage and 28% of that for family coverage, on average.

The employer pays the rest kamagra oral jelly thailand price. Deductibles have remained steady in 2021. The average deductible for single coverage was $1,669, up 68% over the decade but not much different from the previous two years, when the deductible was $1,644 in 2020 and $1,655 in 2019. Eighty-five percent of workers have kamagra oral jelly thailand price a deductible now.

10 years ago, the figure was 74%. Health care spending has slowed during the kamagra, as people delay or avoid care that isn’t essential. Half of large employers with at least 200 workers reported that kamagra oral jelly thailand price health care use by workers was about what they expected in the most recent quarter. But nearly a third said that utilization has been below expectations, and 18% said it was above it, the survey found.

At Thundermist Health Center, fewer people sought out health care last year, so the self-funded health plan, which pays employee claims directly rather than using insurance for that purpose, fell below its expected spending, Farrell said. That turned out to kamagra oral jelly thailand price be good news for employees, whose contribution to their plan didn’t change. €œThis year was the first year in a very long time that we didn’t have to change our rates,” Farrell said. The survey was conducted between January and July 2021.

It was published in the journal Health Affairs and KFF also released additional details in its full report. Michelle Andrews. andrews.khn@gmail.com, @mandrews110 Related Topics Contact Us Submit a Story Tip.

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As rural areas lose physicians and hospitals, home kamagra oral jelly thailand price health agencies often replace primary care providers. The average age of residents living in rural counties is seven years older than in urban counties, and this gap is growing. The need for home health agencies serving the elderly in rural areas will continue to grow over the coming decades.Rural home health agencies face unique challenges. Low concentrations of people are dispersed over large geographic areas leading to long travel times for workers to drive kamagra oral jelly thailand price to clients’ homes.

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End Preamble kamagra oral jelly thailand price [FR Doc. C1-2020-13792 Filed 7-17-20. 8:45 am]BILLING CODE 1301-00-D.

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If you are using public inspection listings for legal research, you should verify the contents of documents against a final, official edition of the Federal Register. Only cheap kamagra supplier uk official editions of the Federal Register provide legal notice to the public and judicial notice to the courts under 44 U.S.C. 1503 &. 1507. Learn more here.Start Preamble Food and Drug Administration, HHS.

Notice of availability. The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (“revised draft guidance”). This revised draft guidance, when finalized, will describe how FDA intends to apply certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to human drug products compounded by State-licensed pharmacies that are not outsourcing facilities and distributed for use within a hospital or health system. First, it addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient. Second, it addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product.

This draft guidance revises the draft guidance issued in 2016 entitled, “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act” (“draft guidance”). FDA is revising the draft guidance to address stakeholder feedback and provide further clarification on policies regarding hospital and health system compounding. This revised draft guidance is not final nor is it in effect at this time. Submit either electronic or written comments on the revised draft guidance by December 6, 2021 to ensure that the Agency considers your comment on this revised draft guidance before it begins work on the final version of the guidance. Submit electronic or written comments on the proposed collection of information in the revised draft guidance by December 6, 2021.

You may submit comments on any guidance at any time as follows. Electronic Submissions Submit electronic comments in the following way. Start Printed Page 55848 • Federal eRulemaking Portal. Https://www.regulations.gov. Follow the instructions for submitting comments.

Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). Written/Paper Submissions Submit written/paper submissions as follows.

• Mail/Hand Delivery/Courier (for written/paper submissions). Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions. All submissions received must include the Docket No.

FDA-2016-D-0271 for “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. And 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments.

The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at. Https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket. For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this revised draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002.

Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the revised draft guidance may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the revised draft guidance. Start Further Info With regard to the revised draft guidance. Tracy Rupp, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993, 301-796-3100.

With regard to the proposed collection of information. Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov. End Further Info End Preamble Start Supplemental Information I. Background FDA is announcing the availability of a revised draft guidance for industry entitled “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Pharmacies located within a hospital, or standalone pharmacies that are part of a health system, frequently provide compounded drug products for administration within the hospital or health system. Some of these compounders seek to compound under section 503A of the FD&C Act (21 U.S.C.

353a) and others have registered with FDA as outsourcing facilities and are subject to section 503B of the FD&C Act (21 U.S.C. 353b). Section 503A of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to be exempt from the following three sections of the FD&C Act. Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice (CGMP) requirements).

Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use). And Section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications). This revised draft guidance proposes policies for FDA's application of certain provisions of section 503A of the FD&C Act to human drug products compounded by State-licensed pharmacies that are not outsourcing facilities and distributed for use within a hospital or health system.

First, the revised draft guidance addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient. Second, it addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product. This revised draft guidance does not apply to human drug products compounded by outsourcing facilities under section 503B of the FD&C Act, compounded drug products that are not distributed for use within a hospital or health system, or drug products compounded for use in animals. In the Federal Register of April 18, 2016 (81 FR 22610), FDA announced the availability of a draft guidance for industry entitled, “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act” Start Printed Page 55849 (“draft guidance”). The draft guidance proposed new policies for the application of section 503A of the FD&C Act to drug products compounded by licensed pharmacists or physicians in State-licensed hospital or health system pharmacies.

In particular, the draft guidance described certain circumstances under which FDA generally would not intend to take action if a hospital or health system pharmacy distributed compounded drug products without first receiving a patient-specific prescription or order. The comment period on the initial draft guidance ended on July 18, 2016. FDA received approximately 76 comments on the draft guidance. FDA is issuing a revised draft guidance with certain changes made in response to received comments or on its own initiative. For example, the prescription requirement enforcement policy described in the revised draft guidance does not consider whether the drug products are distributed only to healthcare facilities that are located within a 1-mile radius of the compounding pharmacy (“1-mile radius policy”).

Instead, the Agency is proposing a two-part, risk-based compliance policy. In addition, the revised draft guidance proposes new policies for hospital and health system pharmacies regarding the provision in section 503A of the FD&C Act which states that to qualify for the exemptions under section 503A of the FD&C Act, among other conditions, a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. FDA is issuing this revised draft guidance to address stakeholders' feedback, reflect additional Agency consideration of the proposed policies, and enable the public to further review and comment before finalization. This revised draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The revised draft guidance, when finalized, will represent the current thinking of FDA on “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” It does not establish any rights for any person and is not binding on FDA or the public.

You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. €œCollection of information” is defined in 44 U.S.C.

3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. We are consolidating the information collection in the revised draft guidance with the information collections and approvals under OMB control number 0910-0800.

With respect to the following collection of information, FDA invites comments on these topics. (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility. (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used. (3) ways to enhance the quality, utility, and clarity of the information to be collected. And (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Human Drug Compounding Under Sections 503A and 503B the Federal Food, Drug, and Cosmetic Act OMB Control Number 0910-0800—Revision This notice solicits comments on certain information collections found in the revised draft guidance entitled “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (“revised draft guidance”). This guidance, when finalized, will support implementation of the copies provisions of the 1997 Food and Drug Administration Modernization Act (FDAMA) (Pub. L. 105-115) discussed in section 503A of the FD&C Act, which were maintained by the 2013 Drug Quality and Security Act (DQSA) (Title I of Pub. L.

113-54). For efficiency of Agency operations, we are revising OMB control number 0910-0800 to include information collections relating to the copies policies for hospital and health system pharmacies that are not outsourcing facilities, as proposed in the revised draft guidance document. As proposed in section III.B of the revised draft guidance, among other conditions, we generally would not intend to take action against a hospital or health system pharmacy that is not an outsourcing facility for compounding a drug product regularly or in inordinate amounts that is essentially a copy of a commercially available drug product, if the compounded drug product is administered only to patients within the hospital or health system and the pharmacy obtains from the prescriber a statement that. (1) Specifies a change between the compounded drug product and the commercially available drug product. (2) indicates that the compounded drug product will be administered only to patients for whom the change produces a significant difference from the commercially available drug product.

And (3) describes the intended patient population for the compounded drug product. In addition, the revised draft guidance specifies that the statement would be maintained in the hospital or health system pharmacy to address routine orders for patients for whom the change produces a significant difference, and a statement would be on file for each prescriber that covers each drug product that is compounded. As provided in section III.B of the revised draft guidance, except for the policy proposed above regarding the documentation of a prescriber's determination of significant difference, we propose to apply the policies described in the guidance, “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (“503A copies guidance”) to drug products compounded by hospital and health system pharmacies that are not outsourcing facilities. As described in section III.B.2 of the 503A copies guidance, and proposed in the revised draft guidance to apply to hospital and health system pharmacies, if a compounder intends to rely on a prescriber determination of significant difference to establish that a compounded drug is not essentially a copy of a commercially available drug product, the compounder should ensure that the determination is documented on the prescription. If a prescription Start Printed Page 55850 does not make clear that the prescriber made the determination required by section 503A(b)(2) of the FD&C Act, or a compounded drug is substituted for the commercially available drug product, the compounder can contact the prescriber and if the prescriber confirms it, make a notation on the prescription that the compounded drug product contains a change that makes a significant difference for the patient.

The notations should be as specific as those described in the 503A copies guidance, and the date of the conversation with the prescriber should be included on the prescription. With respect to the determination of significant difference described above, we estimate that, annually, a total of approximately 3,075 hospital or health system pharmacies (table 1) will obtain a prescriber determination of significant difference. This estimate represents approximately half of the hospitals in the United States, including those that are in health systems. Of these, we estimate that approximately half (1,538) will have hospital or health system pharmacies that will follow the policy in the revised draft guidance, obtaining a statement of significant difference for the intended patient population, and approximately half (1,537) will have hospital or health system pharmacies that will follow the policy with respect to prescriber determination of significant difference in the 503A copies guidance, documenting the notation on the individual patient prescription. This estimate assumes that most pharmacies in smaller hospitals and health systems will follow the policy in the 503A copies guidance because a prescriber determination of significant difference will not be routinely needed and can be most efficiently managed on a patient-by-patient basis.

On the other hand, this estimate assumes that most pharmacies in larger hospitals and health systems will follow the policy in the revised draft guidance because the need for a prescriber determination of significant difference is more routinely necessary and, therefore, most efficiently managed with a statement of significant difference that is maintained in the hospital or health system pharmacy to address routine orders for patients for whom the change produces a significant difference. We estimate that, annually, approximately 1,538 hospital or health system pharmacies following the policy in the revised draft guidance will obtain approximately 30 statements of significant difference for compounded drug products, for a total of approximately 46,140 statements (table 1, row 1). We estimate that the consultation between the hospital or health system pharmacy and the prescriber to obtain the statement of significant difference will require approximately 5 minutes per statement (table 1, row 1). We estimate that, annually, approximately 1,537 hospital or health pharmacies following the policy in the 503A copies guidance will consult a prescriber to determine whether the prescriber has made a determination that the compounded drug product has a change that produces a significant difference for a patient as compared to the comparable commercially available drug and that the compounders will document this determination on approximately 76,850 prescription orders for compounded drug products (table 1, row 2). We estimate that the consultation between the compounder and the prescriber and adding a notation to each prescription that does not already document this determination will take approximately 3 minutes per prescription order (table 1, row 2).

The average burden per consultation and notation for pharmacies following the significant difference policy in the 503A copies guidance, compared to pharmacies following the significant difference policy in the revised draft guidance, is estimated to be less (3 minutes) because the significant difference determination described in the 503A copies policy is specific to one patient, whereas the statement of significant difference in the revised draft guidance describes the intended patient population. In addition, as described in section III.B.3 of the 503A copies guidance, and proposed in the revised draft guidance to apply to hospital and health system pharmacies, if the drug product was compounded because the approved drug product was not commercially available because it was on the FDA drug shortage list, the prescription or a notation on the prescription should note that it was on the drug shortage list and note the date the list was checked. We estimate that a total of approximately 4,613 hospital or health system pharmacies will document this information on approximately 922,600 prescription orders for compounded drug products (table 1, row 3). We estimate that checking FDA's drug shortage list and documenting this information will require approximately 2 minutes per prescription order (table 1, row 3). With respect to maintaining records of the statement of significant difference proposed in section III.B of the revised draft guidance, we estimate that a total of approximately 1,538 hospital or health system pharmacies will maintain approximately 46,140 statements of significant difference (table 2, row 1).

We estimate that maintaining the records will require approximately 2 minutes per record (table 2, row 1). With respect to maintaining records of the significant difference determination, as provided in section III.B.5 of the 503A copies guidance, we estimate that a total of approximately 1,537 hospital or health system pharmacies will maintain approximately 76,850 records (table 2, row 2). We estimate that maintaining records will require approximately 2 minutes per record (table 2, row 2). Also with respect to maintenance of records, as described in section III.B.5 of the 503A copies guidance, and proposed in the revised draft guidance to apply to hospital and health system pharmacies, compounders under section 503A should maintain records of (1) the frequency in which they have compounded drug products that are essentially copies of commercially available drug products and (2) the number of prescriptions that they have filled for compounded drug products that are essentially copies of commercially available drug products. We estimate that a total of approximately 3,075 hospital or health system pharmacies will maintain approximately 61,500 records of prescriptions that they have filled for compounded drug products that are essentially copies of commercially available drug products (table 2, row 3).

We estimate that maintaining the records will require approximately 2 minutes per record (table 2, row 3). We estimate the burden of this collection of information as follows. Start Printed Page 55851 Table 1—Estimated Annual Third-Party Disclosure Burden 1ActivityNumber of respondentsNumber of disclosures per respondentTotal annual disclosuresAverage burden per disclosureTotal hoursConsultation between the hospital or health system pharmacy and the prescriber to document the statement of significant difference (revised draft guidance)1,5383046,140.08 (5 minutes)3,691Consultation between the hospital or health system pharmacy and prescriber and the notation on the prescription documenting the prescriber's determination of significant difference (503A copies guidance)1,5375076,850.05 (3 minutes)3,843Hospital or health system pharmacy checking FDA's drug shortage list and documenting on the prescription that the drug is in shortage (503A copies guidance)4,613200922,600.03 (2 minutes)27,678Total35,2121  There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2—Estimated Annual Recordkeeping Burden 1ActivityNumber of recordkeepersNumber of records per recordkeeperTotal annual recordsAverage burden per recordkeepingTotal hoursRecords of the statement of significant difference (revised draft guidance)1,5383046,140.03 (2 minutes)1,384Records of documentation of significant difference (503A copies guidance)1,5375076,850.03 (2 minutes)2,306Records of frequency and number of prescriptions filled for compounded drug products that are essentially a copy (503A copies guidance)3,0752061,500.03 (2 minutes)1,845Total5,5351  There are no capital costs or operating and maintenance costs associated with this collection of information. IV.

Electronic Access Persons with access to the internet may obtain an electronic version of the revised draft guidance at either https://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm or https://www.regulations.gov. Start Signature Dated. October 4, 2021. Lauren K. Roth, Associate Commissioner for Policy.

End Signature End Supplemental Information [FR Doc. 2021-21970 Filed 10-6-21. 8:45 am]BILLING CODE 4164-01-P.

This document http://magellandigitalmapping.ca/where-to-buy-ventolin is kamagra oral jelly thailand price unpublished. It is scheduled to be published on 11/09/2021. Once it is published kamagra oral jelly thailand price it will be available on this page in an official form. Until then, you can download the unpublished PDF version.

Although we make a concerted effort to reproduce the original document in full on our Public Inspection pages, in some cases graphics may not be kamagra oral jelly thailand price displayed, and non-substantive markup language may appear alongside substantive text. If you are using public inspection listings for legal research, you should verify the contents of documents against a final, official edition of the Federal Register. Only official editions of the Federal Register provide legal notice to the public kamagra oral jelly thailand price and judicial notice to the courts under 44 U.S.C. 1503 &.

1507. Learn more here.Start Preamble Food and Drug Administration, HHS. Notice of availability. The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (“revised draft guidance”).

This revised draft guidance, when finalized, will describe how FDA intends to apply certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to human drug products compounded by State-licensed pharmacies that are not outsourcing facilities and distributed for use within a hospital or health system. First, it addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient. Second, it addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product. This draft guidance revises the draft guidance issued in 2016 entitled, “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act” (“draft guidance”).

FDA is revising the draft guidance to address stakeholder feedback and provide further clarification on policies regarding hospital and health system compounding. This revised draft guidance is not final nor is it in effect at this time. Submit either electronic or written comments on the revised draft guidance by December 6, 2021 to ensure that the Agency considers your comment on this revised draft guidance before it begins work on the final version of the guidance. Submit electronic or written comments on the proposed collection of information in the revised draft guidance by December 6, 2021.

You may submit comments on any guidance at any time as follows. Electronic Submissions Submit electronic comments in the following way. Start Printed Page 55848 • Federal eRulemaking Portal. Https://www.regulations.gov.

Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). Written/Paper Submissions Submit written/paper submissions as follows. • Mail/Hand Delivery/Courier (for written/paper submissions). Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.

1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions. All submissions received must include the Docket No. FDA-2016-D-0271 for “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.

And 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments.

The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at.

Https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf. Docket. For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this revised draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the revised draft guidance may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the revised draft guidance.

Start Further Info With regard to the revised draft guidance. Tracy Rupp, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993, 301-796-3100. With regard to the proposed collection of information.

Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov. End Further Info End Preamble Start Supplemental Information I. Background FDA is announcing the availability of a revised draft guidance for industry entitled “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Pharmacies located within a hospital, or standalone pharmacies that are part of a health system, frequently provide compounded drug products for administration within the hospital or health system. Some of these compounders seek to compound under section 503A of the FD&C Act (21 U.S.C.

353a) and others have registered with FDA as outsourcing facilities and are subject to section 503B of the FD&C Act (21 U.S.C. 353b). Section 503A of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to be exempt from the following three sections of the FD&C Act. Section 501(a)(2)(B) (21 U.S.C.

351(a)(2)(B)) (concerning current good manufacturing practice (CGMP) requirements). Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use). And Section 505 (21 U.S.C.

355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications). This revised draft guidance proposes policies for FDA's application of certain provisions of section 503A of the FD&C Act to human drug products compounded by State-licensed pharmacies that are not outsourcing facilities and distributed for use within a hospital or health system. First, the revised draft guidance addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient. Second, it addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product.

This revised draft guidance does not apply to human drug products compounded by outsourcing facilities under section 503B of the FD&C Act, compounded drug products that are not distributed for use within a hospital or health system, or drug products compounded for use in animals. In the Federal Register of April 18, 2016 (81 FR 22610), FDA announced the availability of a draft guidance for industry entitled, “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act” Start Printed Page 55849 (“draft guidance”). The draft guidance proposed new policies for the application of section 503A of the FD&C Act to drug products compounded by licensed pharmacists or physicians in State-licensed hospital or health system pharmacies. In particular, the draft guidance described certain circumstances under which FDA generally would not intend to take action if a hospital or health system pharmacy distributed compounded drug products without first receiving a patient-specific prescription or order.

The comment period on the initial draft guidance ended on July 18, 2016. FDA received approximately 76 comments on the draft guidance. FDA is issuing a revised draft guidance with certain changes made in response to received comments or on its own initiative. For example, the prescription requirement enforcement policy described in the revised draft guidance does not consider whether the drug products are distributed only to healthcare facilities that are located within a 1-mile radius of the compounding pharmacy (“1-mile radius policy”).

Instead, the Agency is proposing a two-part, risk-based compliance policy. In addition, the revised draft guidance proposes new policies for hospital and health system pharmacies regarding the provision in section 503A of the FD&C Act which states that to qualify for the exemptions under section 503A of the FD&C Act, among other conditions, a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. FDA is issuing this revised draft guidance to address stakeholders' feedback, reflect additional Agency consideration of the proposed policies, and enable the public to further review and comment before finalization. This revised draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115).

The revised draft guidance, when finalized, will represent the current thinking of FDA on “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.

3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. €œCollection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C.

3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. We are consolidating the information collection in the revised draft guidance with the information collections and approvals under OMB control number 0910-0800. With respect to the following collection of information, FDA invites comments on these topics.

(1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility. (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used. (3) ways to enhance the quality, utility, and clarity of the information to be collected. And (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Human Drug Compounding Under Sections 503A and 503B the Federal Food, Drug, and Cosmetic Act OMB Control Number 0910-0800—Revision This notice solicits comments on certain information collections found in the revised draft guidance entitled “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (“revised draft guidance”). This guidance, when finalized, will support implementation of the copies provisions of the 1997 Food and Drug Administration Modernization Act (FDAMA) (Pub. L. 105-115) discussed in section 503A of the FD&C Act, which were maintained by the 2013 Drug Quality and Security Act (DQSA) (Title I of Pub.

L. 113-54). For efficiency of Agency operations, we are revising OMB control number 0910-0800 to include information collections relating to the copies policies for hospital and health system pharmacies that are not outsourcing facilities, as proposed in the revised draft guidance document. As proposed in section III.B of the revised draft guidance, among other conditions, we generally would not intend to take action against a hospital or health system pharmacy that is not an outsourcing facility for compounding a drug product regularly or in inordinate amounts that is essentially a copy of a commercially available drug product, if the compounded drug product is administered only to patients within the hospital or health system and the pharmacy obtains from the prescriber a statement that.

(1) Specifies a change between the compounded drug product and the commercially available drug product. (2) indicates that the compounded drug product will be administered only to patients for whom the change produces a significant difference from the commercially available drug product. And (3) describes the intended patient population for the compounded drug product. In addition, the revised draft guidance specifies that the statement would be maintained in the hospital or health system pharmacy to address routine orders for patients for whom the change produces a significant difference, and a statement would be on file for each prescriber that covers each drug product that is compounded.

As provided in section III.B of the revised draft guidance, except for the policy proposed above regarding the documentation of a prescriber's determination of significant difference, we propose to apply the policies described in the guidance, “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (“503A copies guidance”) to drug products compounded by hospital and health system pharmacies that are not outsourcing facilities. As described in section III.B.2 of the 503A copies guidance, and proposed in the revised draft guidance to apply to hospital and health system pharmacies, if a compounder intends to rely on a prescriber determination of significant difference to establish that a compounded drug is not essentially a copy of a commercially available drug product, the compounder should ensure that the determination is documented on the prescription. If a prescription Start Printed Page 55850 does not make clear that the prescriber made the determination required by section 503A(b)(2) of the FD&C Act, or a compounded drug is substituted for the commercially available drug product, the compounder can contact the prescriber and if the prescriber confirms it, make a notation on the prescription that the compounded drug product contains a change that makes a significant difference for the patient. The notations should be as specific as those described in the 503A copies guidance, and the date of the conversation with the prescriber should be included on the prescription.

With respect to the determination of significant difference described above, we estimate that, annually, a total of approximately 3,075 hospital or health system pharmacies (table 1) will obtain a prescriber determination of significant difference. This estimate represents approximately half of the hospitals in the United States, including those that are in health systems. Of these, we estimate that approximately half (1,538) will have hospital or health system pharmacies that will follow the policy in the revised draft guidance, obtaining a statement of significant difference for the intended patient population, and approximately half (1,537) will have hospital or health system pharmacies that will follow the policy with respect to prescriber determination of significant difference in the 503A copies guidance, documenting the notation on the individual patient prescription. This estimate assumes that most pharmacies in smaller hospitals and health systems will follow the policy in the 503A copies guidance because a prescriber determination of significant difference will not be routinely needed and can be most efficiently managed on a patient-by-patient basis.

On the other hand, this estimate assumes that most pharmacies in larger hospitals and health systems will follow the policy in the revised draft guidance because the need for a prescriber determination of significant difference is more routinely necessary and, therefore, most efficiently managed with a statement of significant difference that is maintained in the hospital or health system pharmacy to address routine orders for patients for whom the change produces a significant difference. We estimate that, annually, approximately 1,538 hospital or health system pharmacies following the policy in the revised draft guidance will obtain approximately 30 statements of significant difference for compounded drug products, for a total of approximately 46,140 statements (table 1, row 1). We estimate that the consultation between the hospital or health system pharmacy and the prescriber to obtain the statement of significant difference will require approximately 5 minutes per statement (table 1, row 1). We estimate that, annually, approximately 1,537 hospital or health pharmacies following the policy in the 503A copies guidance will consult a prescriber to determine whether the prescriber has made a determination that the compounded drug product has a change that produces a significant difference for a patient as compared to the comparable commercially available drug and that the compounders will document this determination on approximately 76,850 prescription orders for compounded drug products (table 1, row 2).

We estimate that the consultation between the compounder and the prescriber and adding a notation to each prescription that does not already document this determination will take approximately 3 minutes per prescription order (table 1, row 2). The average burden per consultation and notation for pharmacies following the significant difference policy in the 503A copies guidance, compared to pharmacies following the significant difference policy in the revised draft guidance, is estimated to be less (3 minutes) because the significant difference determination described in the 503A copies policy is specific to one patient, whereas the statement of significant difference in the revised draft guidance describes the intended patient population. In addition, as described in section III.B.3 of the 503A copies guidance, and proposed in the revised draft guidance to apply to hospital and health system pharmacies, if the drug product was compounded because the approved drug product was not commercially available because it was on the FDA drug shortage list, the prescription or a notation on the prescription should note that it was on the drug shortage list and note the date the list was checked. We estimate that a total of approximately 4,613 hospital or health system pharmacies will document this information on approximately 922,600 prescription orders for compounded drug products (table 1, row 3).

We estimate that checking FDA's drug shortage list and documenting this information will require approximately 2 minutes per prescription order (table 1, row 3). With respect to maintaining records of the statement of significant difference proposed in section III.B of the revised draft guidance, we estimate that a total of approximately 1,538 hospital or health system pharmacies will maintain approximately 46,140 statements of significant difference (table 2, row 1). We estimate that maintaining the records will require approximately 2 minutes per record (table 2, row 1). With respect to maintaining records of the significant difference determination, as provided in section III.B.5 of the 503A copies guidance, we estimate that a total of approximately 1,537 hospital or health system pharmacies will maintain approximately 76,850 records (table 2, row 2).

We estimate that maintaining records will require approximately 2 minutes per record (table 2, row 2). Also with respect to maintenance of records, as described in section III.B.5 of the 503A copies guidance, and proposed in the revised draft guidance to apply to hospital and health system pharmacies, compounders under section 503A should maintain records of (1) the frequency in which they have compounded drug products that are essentially copies of commercially available drug products and (2) the number of prescriptions that they have filled for compounded drug products that are essentially copies of commercially available drug products. We estimate that a total of approximately 3,075 hospital or health system pharmacies will maintain approximately 61,500 records of prescriptions that they have filled for compounded drug products that are essentially copies of commercially available drug products (table 2, row 3). We estimate that maintaining the records will require approximately 2 minutes per record (table 2, row 3).

We estimate the burden of this collection of information as follows. Start Printed Page 55851 Table 1—Estimated Annual Third-Party Disclosure Burden 1ActivityNumber of respondentsNumber of disclosures per respondentTotal annual disclosuresAverage burden per disclosureTotal hoursConsultation between the hospital or health system pharmacy and the prescriber to document the statement of significant difference (revised draft guidance)1,5383046,140.08 (5 minutes)3,691Consultation between the hospital or health system pharmacy and prescriber and the notation on the prescription documenting the prescriber's determination of significant difference (503A copies guidance)1,5375076,850.05 (3 minutes)3,843Hospital or health system pharmacy checking FDA's drug shortage list and documenting on the prescription that the drug is in shortage (503A copies guidance)4,613200922,600.03 (2 minutes)27,678Total35,2121  There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2—Estimated Annual Recordkeeping Burden 1ActivityNumber of recordkeepersNumber of records per recordkeeperTotal annual recordsAverage burden per recordkeepingTotal hoursRecords of the statement of significant difference (revised draft guidance)1,5383046,140.03 (2 minutes)1,384Records of documentation of significant difference (503A copies guidance)1,5375076,850.03 (2 minutes)2,306Records of frequency and number of prescriptions filled for compounded drug products that are essentially a copy (503A copies guidance)3,0752061,500.03 (2 minutes)1,845Total5,5351  There are no capital costs or operating and maintenance costs associated with this collection of information. IV.

Electronic Access Persons with access to the internet may obtain an electronic version of the revised draft guidance at either https://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm or https://www.regulations.gov. Start Signature Dated. October 4, 2021. Lauren K.

Roth, Associate Commissioner for Policy. End Signature End Supplemental Information [FR Doc. 2021-21970 Filed 10-6-21. 8:45 am]BILLING CODE 4164-01-P.

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Brazil, 2 genuine kamagra Homepage. South Africa, 4. Germany, 6. And Turkey, 9) in the phase 2/3 portion of the genuine kamagra trial. A total of 43,448 participants received injections.

21,720 received BNT162b2 and 21,728 received placebo (Figure 1). At the data cut-off date of October 9, a total of 37,706 participants had a median of at least 2 months of safety data available after the second dose and contributed to genuine kamagra the main safety data set. Among these 37,706 participants, 49% were female, 83% were White, 9% were Black or African American, 28% were Hispanic or Latinx, 35% were obese (body mass index [the weight in kilograms divided by the square of the height in meters] of at least 30.0), and 21% had at least one coexisting condition. The median age was 52 years, and 42% of participants were older than 55 years of age (Table 1 and Table S2). Safety Local genuine kamagra Reactogenicity Figure 2.

Figure 2. Local and Systemic Reactions Reported within 7 Days after Injection of BNT162b2 or Placebo, According to Age Group. Data on local and systemic reactions and use genuine kamagra of medication were collected with electronic diaries from participants in the reactogenicity subset (8,183 participants) for 7 days after each vaccination. Solicited injection-site (local) reactions are shown in Panel A. Pain at the injection site was assessed according to the following scale.

Mild, does not genuine kamagra interfere with activity. Moderate, interferes with activity. Severe, prevents daily activity. And grade 4, emergency department genuine kamagra visit or hospitalization. Redness and swelling were measured according to the following scale.

Mild, 2.0 to 5.0 cm in diameter. Moderate, >5.0 to genuine kamagra 10.0 cm in diameter. Severe, >10.0 cm in diameter. And grade 4, necrosis or exfoliative dermatitis (for redness) and necrosis (for swelling). Systemic events and medication use are shown genuine kamagra in Panel B.

Fever categories are designated in the key. Medication use was not graded. Additional scales genuine kamagra were as follows. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain (mild. Does not interfere with activity.

Moderate. Some interference with activity. Or severe. Prevents daily activity), vomiting (mild. 1 to 2 times in 24 hours.

Moderate. >2 times in 24 hours. Or severe. Requires intravenous hydration), and diarrhea (mild. 2 to 3 loose stools in 24 hours.

Moderate. 4 to 5 loose stools in 24 hours. Or severe. 6 or more loose stools in 24 hours). Grade 4 for all events indicated an emergency department visit or hospitalization.

Н™¸ bars represent 95% confidence intervals, and numbers above the 𝙸 bars are the percentage of participants who reported the specified reaction.The reactogenicity subset included 8183 participants. Overall, BNT162b2 recipients reported more local reactions than placebo recipients. Among BNT162b2 recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain (Figure 2). Pain was reported less frequently among participants older than 55 years of age (71% reported pain after the first dose. 66% after the second dose) than among younger participants (83% after the first dose.

78% after the second dose). A noticeably lower percentage of participants reported injection-site redness or swelling. The proportion of participants reporting local reactions did not increase after the second dose (Figure 2A), and no participant reported a grade 4 local reaction. In general, local reactions were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Systemic Reactogenicity Systemic events were reported more often by younger treatment recipients (16 to 55 years of age) than by older treatment recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1 (Figure 2B).

The most commonly reported systemic events were fatigue and headache (59% and 52%, respectively, after the second dose, among younger treatment recipients. 51% and 39% among older recipients), although fatigue and headache were also reported by many placebo recipients (23% and 24%, respectively, after the second dose, among younger treatment recipients. 17% and 14% among older recipients). The frequency of any severe systemic event after the first dose was 0.9% or less. Severe systemic events were reported in less than 2% of treatment recipients after either dose, except for fatigue (in 3.8%) and headache (in 2.0%) after the second dose.

Fever (temperature, ≥38°C) was reported after the second dose by 16% of younger treatment recipients and by 11% of older recipients. Only 0.2% of treatment recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose. Two participants each in the treatment and placebo groups reported temperatures above 40.0°C. Younger treatment recipients were more likely to use antipyretic or pain medication (28% after dose 1. 45% after dose 2) than older treatment recipients (20% after dose 1.

38% after dose 2), and placebo recipients were less likely (10 to 14%) than treatment recipients to use the medications, regardless of age or dose. Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter. Daily use of the electronic diary ranged from 90 to 93% for each day after the first dose and from 75 to 83% for each day after the second dose. No difference was noted between the BNT162b2 group and the placebo group. Adverse Events Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3).

More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%). This distribution largely reflects the inclusion of transient reactogenicity events, which were reported as adverse events more commonly by treatment recipients than by placebo recipients. Sixty-four treatment recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy. Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial. Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to treatment administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia).

Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the treatment or placebo. No erectile dysfunction treatment–associated deaths were observed. No stopping rules were met during the reporting period. Safety monitoring will continue for 2 years after administration of the second dose of treatment.

Efficacy Table 2. Table 2. treatment Efficacy against erectile dysfunction treatment at Least 7 days after the Second Dose. Table 3. Table 3.

treatment Efficacy Overall and by Subgroup in Participants without Evidence of before 7 Days after Dose 2. Figure 3. Figure 3. Efficacy of BNT162b2 against erectile dysfunction treatment after the First Dose. Shown is the cumulative incidence of erectile dysfunction treatment after the first dose (modified intention-to-treat population).

Each symbol represents erectile dysfunction treatment cases starting on a given day. Filled symbols represent severe erectile dysfunction treatment cases. Some symbols represent more than one case, owing to overlapping dates. The inset shows the same data on an enlarged y axis, through 21 days. Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point.

The time period for erectile dysfunction treatment case accrual is from the first dose to the end of the surveillance period. The confidence interval (CI) for treatment efficacy (VE) is derived according to the Clopper–Pearson method.Among 36,523 participants who had no evidence of existing or prior erectile dysfunction , 8 cases of erectile dysfunction treatment with onset at least 7 days after the second dose were observed among treatment recipients and 162 among placebo recipients. This case split corresponds to 95.0% treatment efficacy (95% confidence interval [CI], 90.3 to 97.6. Table 2). Among participants with and those without evidence of prior SARS CoV-2 , 9 cases of erectile dysfunction treatment at least 7 days after the second dose were observed among treatment recipients and 169 among placebo recipients, corresponding to 94.6% treatment efficacy (95% CI, 89.9 to 97.3).

Supplemental analyses indicated that treatment efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population (Table 3 and Table S4). treatment efficacy among participants with hypertension was analyzed separately but was consistent with the other subgroup analyses (treatment efficacy, 94.6%. 95% CI, 68.7 to 99.9. Case split. BNT162b2, 2 cases.

Argentina, 1 kamagra oral jelly thailand price Buy amoxil online usa. Brazil, 2. South Africa, 4.

Germany, 6 kamagra oral jelly thailand price. And Turkey, 9) in the phase 2/3 portion of the trial. A total of 43,448 participants received injections.

21,720 received BNT162b2 and 21,728 received placebo (Figure kamagra oral jelly thailand price 1). At the data cut-off date of October 9, a total of 37,706 participants had a median of at least 2 months of safety data available after the second dose and contributed to the main safety data set. Among these 37,706 participants, 49% were female, 83% were White, 9% were Black or African American, 28% were Hispanic or Latinx, 35% were obese (body mass index [the weight in kilograms divided by the square of the height in meters] of at least 30.0), and 21% had at least one coexisting condition.

The median age was 52 years, and 42% of participants were older than 55 years of age (Table 1 and Table kamagra oral jelly thailand price S2). Safety Local Reactogenicity Figure 2. Figure 2.

Local and kamagra oral jelly thailand price Systemic Reactions Reported within 7 Days after Injection of BNT162b2 or Placebo, According to Age Group. Data on local and systemic reactions and use of medication were collected with electronic diaries from participants in the reactogenicity subset (8,183 participants) for 7 days after each vaccination. Solicited injection-site (local) reactions are shown in Panel A.

Pain at the injection site was assessed according to the kamagra oral jelly thailand price following scale. Mild, does not interfere with activity. Moderate, interferes with activity.

Severe, prevents kamagra oral jelly thailand price daily activity. And grade 4, emergency department visit or hospitalization. Redness and swelling were measured according to the following scale.

Mild, 2.0 kamagra oral jelly thailand price to 5.0 cm in diameter. Moderate, >5.0 to 10.0 cm in diameter. Severe, >10.0 cm in diameter.

And grade kamagra oral jelly thailand price 4, necrosis or exfoliative dermatitis (for redness) and necrosis (for swelling). Systemic events and medication use are shown in Panel B. Fever categories are designated in the key.

Medication use was kamagra oral jelly thailand price not graded. Additional scales were as follows. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain (mild.

Does not interfere kamagra oral jelly thailand price with activity. Moderate. Some interference with activity.

Or severe kamagra oral jelly thailand price. Prevents daily activity), vomiting (mild. 1 to 2 times in 24 hours.

Moderate. >2 times in 24 hours. Or severe.

Requires intravenous hydration), and diarrhea (mild. 2 to 3 loose stools in 24 hours. Moderate.

4 to 5 loose stools in 24 hours. Or severe. 6 or more loose stools in 24 hours).

Grade 4 for all events indicated an emergency department visit or hospitalization. Н™¸ bars represent 95% confidence intervals, and numbers above the 𝙸 bars are the percentage of participants who reported the specified reaction.The reactogenicity subset included 8183 participants. Overall, BNT162b2 recipients reported more local reactions than placebo recipients.

Among BNT162b2 recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain (Figure 2). Pain was reported less frequently among participants older than 55 years of age (71% reported pain after the first dose. 66% after the second dose) than among younger participants (83% after the first dose.

78% after the second dose). A noticeably lower percentage of participants reported injection-site redness or swelling. The proportion of participants reporting local reactions did not increase after the second dose (Figure 2A), and no participant reported a grade 4 local reaction.

In general, local reactions were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Systemic Reactogenicity Systemic events were reported more often by younger treatment recipients (16 to 55 years of age) than by older treatment recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1 (Figure 2B). The most commonly reported systemic events were fatigue and headache (59% and 52%, respectively, after the second dose, among younger treatment recipients.

51% and 39% among older recipients), although fatigue and headache were also reported by many placebo recipients (23% and 24%, respectively, after the second dose, among younger treatment recipients. 17% and 14% among older recipients). The frequency of any severe systemic event after the first dose was 0.9% or less.

Severe systemic events were reported in less than 2% of treatment recipients after either dose, except for fatigue (in 3.8%) and headache (in 2.0%) after the second dose. Fever (temperature, ≥38°C) was reported after the second dose by 16% of younger treatment recipients and by 11% of older recipients. Only 0.2% of treatment recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose.

Two participants each in the treatment and placebo groups reported temperatures above 40.0°C. Younger treatment recipients were more likely to use antipyretic or pain medication (28% after dose 1. 45% after dose 2) than older treatment recipients (20% after dose 1.

38% after dose 2), and placebo recipients were less likely (10 to 14%) than treatment recipients to use the medications, regardless of age or dose. Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter. Daily use of the electronic diary ranged from 90 to 93% for each day after the first dose and from 75 to 83% for each day after the second dose.

No difference was noted between the BNT162b2 group and the placebo group. Adverse Events Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3). More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%).

This distribution largely reflects the inclusion of transient reactogenicity events, which were reported as adverse events more commonly by treatment recipients than by placebo recipients. Sixty-four treatment recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy. Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial.

Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to treatment administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia). Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the treatment or placebo.

No erectile dysfunction treatment–associated deaths were observed. No stopping rules were met during the reporting period. Safety monitoring will continue for 2 years after administration of the second dose of treatment.

Efficacy Table 2. Table 2. treatment Efficacy against erectile dysfunction treatment at Least 7 days after the Second Dose.

Table 3. Table 3. treatment Efficacy Overall and by Subgroup in Participants without Evidence of before 7 Days after Dose 2.

Figure 3. Figure 3. Efficacy of BNT162b2 against erectile dysfunction treatment after the First Dose.

Shown is the cumulative incidence of erectile dysfunction treatment after the first dose (modified intention-to-treat population). Each symbol represents erectile dysfunction treatment cases starting on a given day. Filled symbols represent severe erectile dysfunction treatment cases.

Some symbols represent more than one case, owing to overlapping dates. The inset shows the same data on an enlarged y axis, through 21 days. Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point.

The time period for erectile dysfunction treatment case accrual is from the first dose to the end of the surveillance period. The confidence interval (CI) for treatment efficacy (VE) is derived according to the Clopper–Pearson method.Among 36,523 participants who had no evidence of existing or prior erectile dysfunction , 8 cases of erectile dysfunction treatment with onset at least 7 days after the second dose were observed among treatment recipients and 162 among placebo recipients. This case split corresponds to 95.0% treatment efficacy (95% confidence interval [CI], 90.3 to 97.6.

Table 2). Among participants with and those without evidence of prior SARS CoV-2 , 9 cases of erectile dysfunction treatment at least 7 days after the second dose were observed among treatment recipients and 169 among placebo recipients, corresponding to 94.6% treatment efficacy (95% CI, 89.9 to 97.3). Supplemental analyses indicated that treatment efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population (Table 3 and Table S4).

treatment efficacy among participants with hypertension was analyzed separately but was consistent with the other subgroup analyses (treatment efficacy, 94.6%. 95% CI, 68.7 to 99.9. Case split.

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