Complications: Health Policy Unraveled

In mid-August, the Biden administration announced it had completed negotiations for the first 10 drugs in Medicare’s price program and that the new prices will be implemented in 2026. The achievement marks decades of effort and is a stellar achievement for the Democrats and the administration.

But Medicare already receives discounts and rebates on drugs, so it’s unclear what the savings will really be off the list price. And, as Stephanie Kennan points out, it is also unclear how much of any savings will filter through to patients because their costs will be determined by their insurance plans. Nor is it clear whether patients’ formularies will include the drugs whose prices were negotiated. Finally, Stephanie also describes how the Inflation Reduction Act fits into this landscape.

Name: Stephanie Kennan 

Title: Senior Vice President, Federal Public Affairs at McGuireWoods Consulting

Specialty: Stephanie Kennan helps clients navigate the legislative and executive branches of the federal government to solve problems involving a variety of healthcare policy issues. Her work focuses on providers, medical device manufacturers, drug manufacturers and associations concerned about Medicare and Medicaid reimbursement.

Connect: LinkedIn

[00:47] The administration claims the prices for the first 10 drugs negotiated under the Inflation Reduction Act will save taxpayers $6 billion and another $1.5 billion to seniors in out-of-pocket costs.

[01:54] The Centers for Medicare & Medicaid Services based its savings figures off the list priced for drugs, but many of the drugs are currently available to Medicare plans for discounts and rebates.

[02:18] Medicare recipients don’t usually pay the list price for drugs; they pay the price dictated by their insurance plans.

[02:44] Some members of Congress and patient advocacy groups worry there aren’t enough rules to guarantee that insurance plans will include the first 10 drugs, with newly negotiated prices, in patient formularies.

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Subscribe to Complications: Health Policy Unraveled in your preferred podcast app and never miss a healthcare update by subscribing to host and JD Supra’s #1 healthcare author Stephanie Kennan’s Washington Healthcare Update at www.mwcllc.com 

In an ironic move, it’s likely that Medicare Part D insurance premiums will rise next year even as a 2022 law sought to lower costs for patients,  but the administration is planning on implementing a program to stabilize the market.

Under the 2022 law, insurers must now make up the difference between costs formerly covered by patients and are raising drug premiums to compensate, explains host Stephanie Kennan. Join her as she explains the changes facing insurers and the efforts the government is making to stabilize the market during the transition brought about by the 2022 Inflation Reduction Act.

Name: Stephanie Kennan 

Title: Senior Vice President, Federal Public Affairs at McGuireWoods Consulting

Specialty: Stephanie Kennan helps clients navigate the legislative and executive branches of the federal government to solve problems involving a variety of healthcare policy issues. Her work focuses on providers, medical device manufacturers, drug manufacturers and associations concerned about Medicare and Medicaid reimbursement.

Connect: LinkedIn

[00:47] Insurers will be expected to make up the difference between what Medicare Part D patients used to pay and what they will pay beginning next year. The government will help defray the cost.

[01:22] The administration’s program designed to help defray costs is expected to cost $5 billion if all Medicare Part D plans participate, but enrollment is not yet certain.

[03:11] Under the Inflation Reduction Act, when patients meet a spending cap, plans will pay a higher percentage than before, and drug manufacturers will be required to provide a discount.

[05:01] A new Part D stabilization demonstration has three components for prescription drug plans that participate: lowering the base cost of the beneficiary premium; limiting Part D premium increases, and narrowing the upper threshold of risk corridors while increasing government risk-sharing. 

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Subscribe to Complications: Health Policy Unraveled in your preferred podcast app and never miss a healthcare update by subscribing to host and JD Supra’s #1 healthcare author Stephanie Kennan’s Washington Healthcare Update at www.mwcllc.com

A revolution in the use of psychedelic drugs to treat mental health issues experienced a setback in early August when the FDA declined to approve MMDA as a treatment for post-traumatic stress disorder.  

Host Stephanie Kennan provides important context to the FDA’s decision, which came as the agency has faced criticism for approving therapies without convincing evidence. She outlines the fallout, including a peer-reviewed journal’s decision to retract three papers about MMDA-assisted psychotherapy. She also looks ahead, explaining that, while this first attempt for MMDA stalled, other companies are working on their own applications.

Name: Stephanie Kennan 

Title: Senior Vice President, Federal Public Affairs at McGuireWoods Consulting

Specialty: Stephanie Kennan helps clients navigate the legislative and executive branches of the federal government to solve problems involving a variety of healthcare policy issues. Her work focuses on providers, medical device manufacturers, drug manufacturers and associations concerned about Medicare and Medicaid reimbursement.

Connect: LinkedIn

[00:40] On August 9, the FDA announced it would not approve an application for MMDA-assisted psychotherapy to treat post-traumatic stress disorder.

[01:18] MMDA would have been the first psychedelic drug approved by the FDA, but the government’s rejection was not unexpected, as an advisory panel had voted not to approve earlier this summer.

[01:50] In addition to denying approval, the FDA also said it would withdraw a planned study on people who buy psychedelic drugs.

[02:16] The FDA’s decision comes at a time when it has been criticized for approving therapies without convincing evidence.

[02:25] Fallout from the FDA’s decision includes the “Journal of Psychopharmacology’s” retraction of three papers about MMDA-assisted psychotherapy due to violations of protocol.

[02:47] Meanwhile, the company that sought approval is raising concerns about the composition and conduct of the FDA’s advisory committee meeting.

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Subscribe to Complications: Health Policy Unraveled in your preferred podcast app and never miss a healthcare update by subscribing to host and JD Supra’s #1 healthcare author Stephanie Kennan’s Washington Healthcare Update at www.mwcllc.com 

Congress is teeing up discussions on a controversial issue that strikes at the heart of the Medicare system: how physicians are paid.

Lawmakers are weighing changes to the Medicare Physician Fee Schedule for the first time since 2015, and host Stephanie Kennan lays out the landscape. She provides background on the pay schedule, describes reforms under consideration, and explains why physicians and other stakeholders are warning about a gap between rising costs and physician payments – which could impact care.

Name: Stephanie Kennan 

Title: Senior Vice President, Federal Public Affairs at McGuireWoods Consulting

Specialty: Stephanie Kennan helps clients navigate the legislative and executive branches of the federal government to solve problems involving a variety of healthcare policy issues. Her work focuses on providers, medical device manufacturers, drug manufacturers, and associations concerned about Medicare and Medicaid reimbursement.

Connect: LinkedIn

[00:51] For the first time since 2015, Congress is weighing potential changes to the Medicare Physician Fee Schedule.

[01:03] Reform is driven by the proposed 2025 Medicare Physician Fee Schedule, which would cut physicians’ pay rate by 2.8 percent.

[01:50] Doctors aren’t the only ones concerned about the projected payment schedule; Medicare trustees have issued warnings of their own.

[02:34] How the physician fee schedule works.

[03:16] The Medicare Economic Index, or MEI, figures prominently in payment reform discussions. Here’s what to know about it.

[05:17] An overview of the white paper, released in May by the Senate Finance Committee, proposing that Medicare adjust payments to account for inflation.

[05:38] The white paper outlines opportunities for reform, among them: creating sustainable payment updates to ensure clinicians can own and operate their practices and incentivizing alternative payment models that reward providing better care at lower cost.

[07:16] A bipartisan duo of lawmakers has proposed legislation that, they say, would better support and improve pay for high-quality primary care providers.

[08:05] Their proposal represents a marker for discussions on primary care, and lawmakers have teed up this difficult and controversial issue.

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Subscribe to Complications: Health Policy Unraveled in your preferred podcast app and never miss a healthcare update by subscribing to host and JD Supra’s #1 healthcare author Stephanie Kennan’s Washington Healthcare Update at www.mwcllc.com

“Site-neutral” is a short name for a proposal that has bipartisan interest in Congress, but is being fiercely fought by hospitals. 

Host Stephanie Kennan explores the divisive issue of site-neutral payment reform, an approach to healthcare spending that would align Medicare payments for outpatient services across care settings. Amid growing bipartisan interest and pressure to rein in healthcare costs, Congress has proposed reforms such as the Medicare Patient Access to Cancer Treatment Act. But hospitals are fighting it because of the potential to reduce revenue and, they worry, decrease healthcare access in rural and low-income communities. 

Tune in as Stephanie outlines arguments on both sides of the debate and updates listeners on the status of this controversial approach.

Name: Stephanie Kennan 

Title: Senior Vice President, Federal Public Affairs at McGuireWoods Consulting

Specialty: Stephanie Kennan helps clients navigate the legislative and executive branches of the federal government to solve problems involving a variety of healthcare policy issues. Her work focuses on providers, medical device manufacturers, drug manufacturers and associations concerned about Medicare and Medicaid reimbursement.

Connect: LinkedIn

[00:32] “Site-neutral payments” is shorthand for a reform that would align Medicare payments for outpatient services across settings. Hospitals are anything but neutral about this approach – they’re fighting it fiercely.

[00:59] The goal of this approach is for Medicare to pay the same rate for the same service, regardless of what type of facility – outpatient department, surgical center, or freestanding physician’s office – provides it.

[01:37] Last year, a congressional advisory committee on Medicare payments called MedPAC identified potential services that could be appropriate for site-neutral payments.

[02:34] Congress has been focusing on site-neutral payment reform because of concerns about healthcare costs and the rapid pace of consolidation.

[03:56] Opponents argue that this approach would adversely affect patient access to services by reducing hospital venues, particularly in rural and low-income communities.

[05:07] An overview of the various proposals in Congress related to site-neutral payment reform and how hospitals could be affected.

[06:15] Is the fight only about the money? Hospitals point to other concerns, including that this reform could potentially decrease overall healthcare spending.

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Subscribe to Complications: Health Policy Unraveled in your preferred podcast app and never miss a healthcare update by subscribing to host and JD Supra’s #1 healthcare author Stephanie Kennan’s Washington Healthcare Update at www.mwcllc.com 

The National Institutes of Health (NIH) has been under scrutiny since COVID-19, so it is not surprising that members of Congress have released NIH reform initiatives.

In this episode of Complications: Health Policy Unraveled, host Stephanie Kennan provides a summary of NIH reform recommendations, starting with the white paper released by Republican Senator Bill Cassidy, which suggests reform priorities around transparency and research grants. Stephanie also breaks down the broader NIH Energy and Commerce Framework released by House Energy and Commerce Chair Kathy McMorris, which recommended comprehensive NIH reform in several areas, including mission and leadership, financial disclosure and transparency requirements, misconduct and expert accountability, and funding and grant reform. 

Tune in to learn more about the congressional NIH reform recommendations and why it is important to help shape the conversation about NIH reform even if it is unlikely that reform legislation would pass this year. 

Name: Stephanie Kennan 

Title: Senior Vice President, Federal Public Affairs at McGuireWoods Consulting

Specialty: Stephanie Kennan helps clients navigate the legislative and executive branches of the federal government to solve problems involving a variety of healthcare policy issues. Her work focuses on providers, medical device manufacturers, drug manufacturers and associations concerned about Medicare and Medicaid reimbursement.

Connect: LinkedIn

[01:04] The white paper released by Senator Bill Cassidy, the ranking Republican on the Senate HELP Committee, recommends that NIH maintain a balanced research portfolio, streamline the peer review process, address recruiting and biomedical workforce retention problems, and collaborate with public health agencies, healthcare systems, and the private sector. 

[01:34] The NIH Energy and Commerce Framework released by House Energy and Commerce Chair Kathy McMorris Rogers is much broader than Senator Cassidy’s white paper and contains far more recommendations and comprehensive reform recommendations.

[02:34] Driving this reform is the narrative that NIH lost public trust because of COVID-19, issues related to gain of function research, and a sense that NIH leadership stays on too long.

[01:58] Representative McMorris Rogers wrote in an op-ed that NIH has granted approval for dangerous experiments with little oversight, and in some instances, has been intentionally deceptive about research paid for with taxpayer dollars.

[03:24] For an agency that once had strong bipartisan support, the NIH now faces “crunch time” to ensure it has funding for projects. 

[07:48] Representative McMorris Rogers recommends restoring Congress’ role in directing NIH funding, as well as demanding transparency for indirect costs, preventing waste, and ensuring NIH is accounting for taxpayer dollars spent.  

[08:48] The Framework’s section on grants discusses instances of missteps in NIH grant review that have prevented successful research outcomes, and makes lengthy recommendations on grant reform. 

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Subscribe to Complications: Health Policy Unraveled in your preferred podcast app and never miss a healthcare update by subscribing to host and JD Supra’s #1 healthcare author Stephanie Kennan’s Washington Healthcare Update at www.mwcllc.com 

“The 340B Drug Discount Program is the second largest government pharmaceutical program based on net drug spending and is only behind Medicare Part D.  It's been the subject of a lot of legislation and hearings in Congress because of its growth and because of the confusion over contract pharmacies.”

In this episode of Complications: Health Policy Unraveled, host Stephanie Kennan discusses the latest on the 340B Drug Discount Program, which since 1992 has provided low income and uninsured patients increased access to drugs by requiring manufacturers to provide outpatient drugs to eligible healthcare organizations at a discount. 

Tune in to learn about 340B ACCESS Act, the latest bill introduced in the House attempting to clarify the intent and operations of the 340B Drug Discount Program and hear about how the controversy over the use of contract pharmacies in the 340B Drug Discount Program has played out in the courts and state legislatures. 

Name: Stephanie Kennan 

Title: Senior Vice President, Federal Public Affairs at McGuireWoods Consulting

Specialty: Stephanie Kennan helps clients navigate the legislative and executive branches of the federal government to solve problems involving a variety of healthcare policy issues. Her work focuses on providers, medical device manufacturers, drug manufacturers and associations concerned about Medicare and Medicaid reimbursement.

Connect: LinkedIn

[00:33] The 340B ACCESS Act is the latest bill introduced in the House attempting to clarify the intent and operations of the 340B Drug Discount Program administered by the Health Resources Services Administration.

[02:54] The 340B Drug Discount Program requires drug manufacturers to provide outpatient drugs to eligible healthcare organizations at discounted prices in order to remain eligible for reimbursement through Medicaid.

[04:04] The use of contract pharmacies has become controversial as covered entities have increased their use of contract pharmacies. In the summer of 2020, some drug manufacturers began announcing restrictions on 340B covered entities that distribute 340B drugs using contract pharmacies.  

[04:34] Manufacturers argue that the restrictions are necessary to prevent duplicate discounting and unlawful distribution of 340B drugs to non-patients, while covered entities argue that they are paying more for certain 340B drugs and can’t generate savings from them.

[05:02] Health Resources Services Administration (HRSA) responded to the restrictions in 2021 by issuing violation letters to manufacturers. Several manufacturers then sued the HRSA. One of the cases is still pending.  

[05:40] Contemporaneously, several states began considering legislation to make it unlawful for drug manufacturers to restrict contract pharmacy use by covered entities within their states. In one case Pharma sued the state of Arkansas, and lost. 

[07:02] It’s now up to Congress to clarify the appropriate role of contract pharmacies in the 340B program. 

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Subscribe to Complications: Health Policy Unraveled in your preferred podcast app and never miss a healthcare update by subscribing to host and JD Supra’s #1 healthcare author Stephanie Kennan’s Washington Healthcare Update at www.mwcllc.com 

In 2022, the Supreme Court of the United States heard arguments related to Medicare’s Disproportionate Share Hospital Payments. Now that issue is before the court again.

In this episode of Complications: Health Policy Unraveled, host Stephanie Kennan discusses an upcoming SCOTUS case involving hospitals and the Department of Health and Human Services (HHS). The hospitals argue that HHS in not following  the 2022 SCOTUS decision related to how patients receiving SSI are counted. The hospitals argue that the manner in which HHS counts patients has resulted in funding cuts and puts some hospitals in jeopardy of not being eligible for other programs including the 340B program. HHS argued that the case should be dismissed and that amending the 2022 ruling would allow abuse of DSH payments. Stay tuned to Complications for updates as arguments are heard and a ruling is made.

Name: Stephanie Kennan 

Title: Senior Vice President, Federal Public Affairs at McGuireWoods Consulting

Specialty: Stephanie Kennan helps clients navigate the legislative and executive branches of the federal government to solve problems involving a variety of healthcare policy issues. Her work focuses on providers, medical device manufacturers, drug manufacturers and associations concerned about Medicare and Medicaid reimbursement.

Connect: LinkedIn

[00:32] The Supreme Court of the United States (SCOTUS) will hear arguments on a suit between hospital groups and the Department of Health and Human Services (HHS) related to Medicare’s disproportionate share of hospital payments (DSH)

[00:55] Facts and ruling of 2022 SCOTUS case about DSH

[01:42] Basis of the current SCOTUS DSH case

[02:48] Hospital groups’ arguments for why SCOTUS should resolve DSH issues not considered in the 2022 ruling

[03:47] HHS’s arguments for why SCOTUS should dismiss the current DSH suit

[04:45] Stay tuned to Complications for analysis of SCOTUS’s ruling on this case

Connect with us on Facebook, Twitter, LinkedIn, YouTube.

Subscribe to Complications: Health Policy Unraveled in your preferred podcast app and never miss a healthcare update by subscribing to host and JD Supra’s #1 healthcare author Stephanie Kennan’s Washington Healthcare Update at www.mwcllc.com

Medicaid is complicated.

In this episode of Complications: Health Policy Unraveled, host Stephanie Kennan discusses the newly finalized regulations concerning Medicaid, specifically as they pertain to the Managed Care Rule. These new regulations aim to increase transparency and improve access in states' Medicaid programs. Key points discussed include: changes in state-directed payments to ensure they are reasonable, enhanced requirements for reporting and evaluation, alterations in the medical loss ratio, imposition of enrollee protections, and improvements in the quality of care through careful evaluation and public comments.

Tune in as Stephanie helps simplify the complexities of the new Medicaid rules.

Name: Stephanie Kennan 

Title: Senior Vice President, Federal Public Affairs at McGuireWoods Consulting

Specialty: Stephanie Kennan helps clients navigate the legislative and executive branches of the federal government to solve problems involving a variety of healthcare policy issues. Her work focuses on providers, medical device manufacturers, drug manufacturers and associations concerned about Medicare and Medicaid reimbursement.

Connect: LinkedIn

[0:24] Broad overview of new “Managed Care Rule”

[2:17] New Rule implements transparency measures related to state-directed Medicaid payments

[4:20] States must report more specific data related to medical loss ratio

[5:07] Medicaid enrollees will receive more protections, including reduced appointment wait times and secret-shopper surveys of Medicaid services

[6:37] New Rule seeks to improve quality of care by requiring public comment on rule changes and external quality of care reports.

Connect with us on Facebook, Twitter, LinkedIn, YouTube.

Subscribe to Complications: Health Policy Unraveled in your preferred podcast app and never miss a healthcare update by subscribing to host and JD Supra’s #1 healthcare author Stephanie Kennan’s Washington Healthcare Update at www.mwcllc.com

The Center for Medicaid & Medicare Services (CMS) recently released new guidelines that will affect the Medicare drug price negotiation process beginning in 2026.

In this episode of Complications: Health Policy Unraveled, host Stephanie Kennan provides a summary of the new CMS guidelines, including the new requirements for drug manufacturers and Part D dispensing entities, the timeline for negotiating new drug prices, and some of the challenges in navigating these new guidelines. Tune in to learn more about these new CMS guidelines.

Name: Stephanie Kennan 

Title: Senior Vice President, Federal Public Affairs at McGuireWoods Consulting

Specialty: Stephanie Kennan helps clients navigate the legislative and executive branches of the federal government to solve problems involving a variety of healthcare policy issues. Her work focuses on providers, medical device manufacturers, drug manufacturers and associations concerned about Medicare and Medicaid reimbursement.

Connect: LinkedIn

[0:30] An overview of the new CMS drug price negotiation guidelines

[1:21] The limited effect of the Inflation Reduction Act on Medicare drug price negotiations

[1:39] The process of negotiating new maximum fair prices for drugs between Medicare and drug manufacturers.

[3:18] How the new guidelines mandate patient access to drugs

[5:28] Using a Medicare Transaction Facilitator to ensure the guidelines are followed by engaging in an exchange of information between drug manufacturers and CMS

[7:02] CMS’s procedures for receiving feedback on certain features of the new guidelines

Connect with us on Facebook, Twitter, LinkedIn, YouTube.

Subscribe to Complications: Health Policy Unraveled in your preferred podcast app and never miss a healthcare update by subscribing to host and JD Supra’s #1 healthcare author Stephanie Kennan’s Washington Healthcare Update at www.mwcllc.com