Complications: Health Policy Unraveled

Understanding Medicare’s Negotiated Drug Prices: What Are The Real Savings?

Thu, 12 Sep 2024 03:00:00 -0500

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.

Meet Your Host

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

Episode Highlights

[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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How the Inflation Reduction Act Is Affecting Medicare Part D Drug Costs

Thu, 05 Sep 2024 03:00:00 -0500

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.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[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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Rejecting a Psychedelic Drug for PTSD Treatment: Why and What’s Next

Thu, 29 Aug 2024 03:00:00 -0500

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.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[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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Reforming the Medicare Physician Fee Schedule: Controversy and Urgency

Thu, 15 Aug 2024 03:00:00 -0500

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.

Meet Your Host

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

Episode Highlights

[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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How Site-Neutral Payment Reform Divides Policymakers and Hospitals

Fri, 02 Aug 2024 03:00:00 -0500

“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.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[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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A Closer Look: NIH Reform Recommendations In Congress

Fri, 05 Jul 2024 03:00:00 -0500

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.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[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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340B ACCESS Act Aims to Clarify Contract Pharmacy Role in Drug Discount Program

Fri, 28 Jun 2024 03:00:00 -0500

“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.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[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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Supreme Court to Hear Arguments on Medicare’s Disproportionate Share Hospital Payments

Thu, 20 Jun 2024 03:00:00 -0500

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.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[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

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New Medicaid Rule Promotes Transparency and Should Improve Quality of Care

Thu, 23 May 2024 03:00:00 -0500

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.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[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.

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New CMS Guidelines for Drug Price Negotiation

Thu, 16 May 2024 03:00:00 -0500

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.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[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

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Switcheroo Scams: Stopping Unauthorized Health Plan Switching

Thu, 02 May 2024 03:00:00 -0500

Recently, some consumers have found that their health plans had been changed without their knowledge, impacting their coverage and their finances.

In this episode of Complications: Health Policy Unraveled, host Stephanie Kennan explores unauthorized plan switching related to Affordable Care Act health plans. Consumers are being unknowingly switched to different health plans, resulting in coverage disruptions, financial losses, and even loss of access to care. Misleading ads and unethical practices by some call centers combined with changes in enrollment periods are exacerbating the issue, leading to lawsuits and regulatory concerns. Despite efforts by federal and state regulators, challenges remain in detecting and addressing these unauthorized switches effectively. Tune in to learn more about the latest scam targeting low income individuals seeking medical coverage.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[0:40] A recent Kaiser Family Foundation report identified incidents in which consumers learned that their health plans had unknowingly been changed, affecting their health coverage and finances.

[1:12] A lawsuit has been filed in the Southern District of Florida against call centers who allegedly paid for individuals’ information and then switched their health insurance policies without their knowledge, resulting in additional costs or coverage issues for consumers.

[2:44] It appears this scam began as a way to target those seeking coverage during a special enrollment period for low income individuals.

[3:16] It is currently unknown how many complaints have been filed with CMS, but the issue has certainly ramped up in the last year and is mostly concentrated on the federal healthcare.gov website.

[4:08] Enrollment has been a top priority for the health insurance marketplace, so finding a way to stop bad actors while still encouraging new consumers presents a challenge.

[4:28] The complaint process, which would initiate an investigation, is cumbersome, not centralized between state and federal agencies, and confusing for many.

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“Looking Back” on the CRA’s Impact on Healthcare Rules

Fri, 26 Apr 2024 03:00:00 -0500

The Congressional Review Act has been used to overturn 20 rules since it was enacted. Will a Biden administration healthcare rule be next?

In this episode of Complications: Health Policy Unraveled, host Stephanie Kennan explores the intricacies of the Congressional Review Act (CRA) and its significance for healthcare policy. She explains how the CRA empowers Congress to review and potentially overturn federal agency rules through its “lookback” provision, particularly during administration transitions. Through a detailed examination of the CRA's complex mechanisms and timelines, Stephanie provides listeners with valuable insights into navigating the intricacies of healthcare policy amidst legislative challenges and regulatory changes.

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Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[0:32] Because of the Congressional Review Act’s “lookback” provision, certain healthcare-related rules may soon face being overturned.

[1:11] The CRA was enacted in 1996 to prevent “midnight rulemaking,” when presidential administrations enact rules late in their term or as they’re leaving office.

[1:32] Agencies must report new rules to Congress who, with a joint resolution of disapproval, can overturn the rule or prevent it from ever going into effect. This process has been used to overturn 20 rules since its enactment.

[2:15] The CRA applies to final rules, including major and non-major rules, and could potentially be used for agency actions not typically subject to notice-and-comment rulemaking.

[2:29] Agencies must submit their rules to the GAO, which frequently helps clarify when agency actions meet the CRA definition of a rule, though these opinions can subject even unsubmitted agency action to a possible joint resolution of disapproval.

[4:04] A joint resolution of disapproval can only be used to invalidate one rule at a time and must be introduced within 60 days of when Congress receives the rule, which can lead to confusion as to when the period actually expires.

[5:01] While the lookback provision is intended to ensure Congress will have a full period to consider each agency action, in practice, the specifications as to committee votes, motions, and timing can create a headache.

[6:34] A rule subject to an enacted joint resolution of disapproval cannot later be reissued in “substantially the same form,” though that phrase is left undefined.

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What's Left on Congress' Healthcare To-Do List

Thu, 04 Apr 2024 03:00:00 -0500

Congress has a number of important healthcare issues currently pending, but whether any get resolved before the end of the term is still to be seen.

In this episode of Complications: Health Policy Unraveled, Stephanie Kennan explores key healthcare policy issues before Congress, including PBM reform, healthcare transparency, cybersecurity, insulin pricing, protection of health data, and budget appropriations.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[0:36] Though both the House and Senate have been working on PBM reform for years, including pushing legislation through committees, it continues to be excluded from any healthcare packages.

[1:50] In attempts to increase healthcare transparency, Congress now requires insurers to publish price lists but legislation aimed at improving upon these measures have been stalled.

[3:15] The newly introduced Healthcare Cybersecurity Improvement Act would provide accelerated payments to healthcare providers in the event of a cyber breach so long as they meet cybersecurity standards.

[5:13] Biden’s 2022 Inflation Reduction Act lowered the cost of insulin, but Congress is poised to institute more sweeping reforms after manufacturers began capping costs and creating savings programs.

[5:51] Legislation is pending in both the House and the Senate that would prohibit the control of biotechnology by foreign adversaries so as to protect Americans’ genetic information.

[6:48] Budget and appropriations are also on the forefront of Congress’s mind at the moment and may involve healthcare ramifications, such as raising the age of Social Security and overhauling Medicare.

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Navigating AI in Healthcare: Legislative and Regulatory Updates

Thu, 21 Mar 2024 03:00:00 -0500

Artificial intelligence continues to be a focus for Congress and federal agencies. Are you keeping up with the latest developments that impact the healthcare sector?

In episode 22 of Complications: Health Policy Unraveled, host Stephanie Kennan provides updates on legislative and regulatory affairs concerning artificial intelligence. With the formation of the House Task Force on Artificial Intelligence, recent congressional hearings, and regulatory changes, the federal government is still dialed in on how to properly regulate and utilize artificial intelligence in a variety of sectors, including healthcare.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[00:39] In a bipartisan initiative, the House of Representatives has announced the formation of the Task Force on Artificial Intelligence which will be tasked with producing a report on guiding principles, risks and benefits of AI, and the effectiveness of current regulation.

[02:37] On February 8th, the Senate Finance Committee held a hearing on the potential applications of AI in healthcare, including ways to mitigate bias against certain patients by AI systems, though some senators worry legislation is being rushed.

[04:25] Representative Ted Lieu introduced the HEALTH AI Act which would require the NIH to establish a grant program to fund generative AI research, notably on how AI can reduce disparities in healthcare outcomes.

[05:15] DHHS recently made a technical correction to its previously proposed rule to enhance interoperability of electronic health information, HTI 1, causing new notice-and-comment period woes.

[06:20] In February, CMS issued an FAQ on Medicare Advantage Organizations and Medicaid Plans that addressed whether MA plans can use AI algorithms in making coverage decisions.

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Chevron, Abortion, and Misinformation: What’s On The SCOTUS Docket and Implications for the Healthcare Sector

Thu, 07 Mar 2024 03:00:00 -0500

What does fishing have to do with healthcare? Currently before SCOTUS is Loper Bright Enterprises, a case involving federal oversight of herring fishing which could impact the government's regulatory power broadly and thus, the healthcare sector.

In episode 21 of Complications: Health Policy Unraveled, host Stephanie Kennan explores Loper Bright Enterprises and other cases before the U.S. Supreme Court with wide-ranging implications for healthcare policy. From challenges to regulatory power and abortion laws, to debates over the FDA's actions and free speech on COVID-19, this episode delves into cases raising complex legal issues that will shape the future of healthcare.

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Name: Stephanie Kennan

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

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Episode Highlights

[00:35] If the Supreme Court were to overturn the Chevron deference doctrine in the Loper Bright Enterprises case regarding herring fishing, the regulatory power of government agencies, including those in healthcare, will be significantly impacted.

[01:32] Two cases currently before the Court address Idaho’s abortion law, which only permits abortions when necessary to save the patient’s life, and its interaction with federal healthcare law.

[03:28] In Alliance for Hippocratic Medicine vs. FDA, the Court will decide if the FDA overstepped its regulatory authority when it expanded access to Mifepristone, the over-the-counter abortion pill, which could have long-reaching effects on other medications and abortion regulations.

[06:01] In Murthy v. Missouri, the Court will determine whether Covid-19 misinformation is protected free speech. If it is protected, federal health agencies may face an uphill battle trying to effectively communicate health initiatives to the public.

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AI Dilemmas: Congress’s Proposed Legislation and the Future of AI Governance

Wed, 31 Jan 2024 03:00:00 -0500

AI is dividing members of Congress based on how they feel it should be regulated. As a result, Congress may concede regulatory power to the Biden Administration, which has proven more efficient in developing regulatory framework for AI.

In episode 20 of Complications: Health Policy Unraveled, host Stephanie Kennan discusses AI-related congressional actions from last year and what’s on the horizon for this year. Walking through proposed pieces of legislation in both the House and the Senate, Stephanie highlights areas of Congressional focus in the AI sphere. However, since it’s an election year, Congress will likely find it quite difficult to achieve all its ambitious AI-related goals. Tune in to this episode to learn more.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[1:20] In June 2023, Senate Majority Leader Chuck Schumer introduced the core principles of his SAFE Innovation framework for AI: security, accountability, foundation in democratic principles, explainability and US-led innovation.

[4:26] Stephanie walks through the numerous Senate bills concerning AI that have been recently proposed, which could update federal regulation to meet the needs of AI, expand access, update patent eligibility, and address public health threats posed by AI.

[6:56] In the House, proposed legislation would investigate the impact of AI on the job market, prohibit discrimination by AI algorithms, and create a new licensing framework.

[8:34] Senator Bill Cassidy published a white paper in September to gather feedback on how Congress can effectively mitigate risk and leverage benefits of AI as it relates to health, education and workforce sectors.

[9:35] For now, it seems Congress is divided in how it wants to approach AI regulation, but with the election fast-approaching, there may not be enough time to get proposed bills passed.

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Regulating Artificial Intelligence: Transparency, Safety, and Equity

Mon, 15 Jan 2024 03:00:00 -0500

With the recent exponential growth of artificial intelligence technologies, the Biden administration is trying to help guide the nation in the development and deployment of safe, secure, and transparent AI technologies across all sectors, including healthcare.

In episode 19 of Complications: Health Policy Unraveled, host Stephanie Kennan explores the recent regulatory activity related to artificial intelligence. In October 2023, President Biden issued an executive order on the safe, secure, and trustworthy development and use of AI, which would establish a coordinated approach to its implementation in the federal government. Likewise, in December 2023, HHS released its first rule related to AI, called the HTI-1 Final Rule, which will increase transparency, promote coordination among agencies, and promote equity.

Tune in to hear how the Biden administration and HHS plan to regulate AI at the federal level.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[0:58] President Biden issued an executive order on safe, secure, and trustworthy development and use of AI.

[1:47] Overview of the executive order, which has eight key directives.

[6:00] The executive order would also require HHS to appoint a Chief AI Officer and create an AI task force to oversee the strategic plan for safe use of artificial intelligence in the healthcare sector.

[7:21] Additionally, HHS will need to develop an AI Assurance Policy and AI Safety Program to ensure the safety of AI in the healthcare sector and identify clinical errors as they arise.

[8:16] The executive order also directs HHS to develop a regulatory strategy for the use of AI in drug development.

[9:44] In response to the executive order, HHS released the H2I-1 Final Rule in December 2023 which requires updated standards, specification and certification criteria for electronic health records and health IT modules, including transparency requirements. There are four key provisions to the rule.

[12:42] The Final Rule is particularly significant as it is the first time a final rule has addressed the use of artificial intelligence in healthcare, however, it is expected to cost developers upwards of $914 million.

[13:30] Overall, the Final Rule is meant to promote transparency in attempts to incentivize good AI practices, but allows leeway for clinicians to be trained on the material and to develop trust with the algorithms.

[16:01] Surveys indicate that HHS is one of the top users of AI in the government, ranking fourth among federal agencies.

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Overhauling Medicare Advantage: Proposed Changes for 2026

Tue, 02 Jan 2024 03:00:00 -0500

“Medicare Advantage has come under scrutiny related to mental health providers in their networks and related to broker's fees.” Proposed changes seek to remedy that.

In episode 18 of Complications: Health Policy Unraveled, host Stephanie Kennan details the changes to Medicare Advantage Plans recently proposed by the Senate Finance Committee and CMS. The Senate Finance Committee’s changes are aimed at ensuring accuracy among provider directories. CMS wishes to redefine “compensation” so as to ensure brokers are directing enrollees to the plan best-suited for the patient, not the plan that gives the broker the biggest bonus. The proposed changes would also promote greater access to behavioral health providers and supplemental benefits, especially for the chronically ill.

Tune in to hear about all the proposed changes that may be coming to Medicare Advantage plans.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[0:30] Senate Finance Committee and CMS have proposed changes to Medicare Advantage, including remedying the issue of “ghost networks” of mental health providers.

[2:14] Medicare Advantage will also be expected to submit annual reports of the accuracy of provider directories to the Secretary of HHS, who would then make the scores public.

[3:12] By 2031, GAO will need to report on in-network cost sharing applied to care by out-of-network providers based on inaccurate directories, provider response rates to outreach methods, and compliance with the duty to submit provider directory accuracy reports.

[4:06] CMS’s proposed changes focus on the use of agents and brokers to navigate the Medicare system, including updating the definition of compensation for such brokers.

[4:39] CMS is concerned that brokers are steering enrollees to plans based on their own compensation and bonus arrangements instead of the enrollee’s best interests.

[6:32] CMS also wants to add various behavioral health services, including mental health and addiction specialists, to one category–Outpatient Behavioral Health–for the purpose of setting adequacy standards.

[8:57] Medicare Advantage plans will be required to demonstrate that they provide research-backed supplemental benefits that have a reasonable expectation of improving the health or overall function of chronically ill enrollees.

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Standardize and Streamline: CMS Proposes Standards for Qualified Health Plans and the Exchanges

Mon, 18 Dec 2023 03:00:00 -0500

Change is on the horizon for the health plan marketplace.

In episode 17 of Complications: Health Policy Unraveled, host Stephanie Kennan describes the new standards proposed by the Centers for Medicare and Medicaid Services for qualified health plans in health insurance marketplaces. These changes include bringing state marketplaces in line with the federal health plan marketplace. Proposed changes are meant to increase eligibility, transparency and availability of services. Stephanie discusses the changes we can expect to come to the health insurance sector in 2025. Tune in to the episode to learn more.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[0:38] CMS recently proposed standards for qualified health plans offered through health insurance marketplaces.

[1:08] The proposed standards for states would include time and distance standards at least as stringent as those in the federal marketplace.

[2:11] CMS proposes that state marketplaces conduct network adequacy reviews similar to those performed in the federal marketplace.

[3:02] The proposal also includes changes to streamline marketplace operations to make eligibility requirements clearer and enrollment easier.

[4:45] The plan would also permit states to alter their eligibility requirements to expand Medicaid coverage.

[6:00] By removing the generosity standard, CMS wants states’ benchmark plans to provide a scope of benefits equal to that of a typical employer plan.

[7:21] In order to look more like the federal marketplace, CMS is proposing a requirement that states operate a centralized eligibility and enrollment platform on their marketplace websites.

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Unraveling End-of-Year Healthcare Policy: Congress' Agenda and Challenges

Mon, 04 Dec 2023 03:00:00 -0500

As we come to year-end, healthcare policy is in flux.

In episode 16 of Complications: Health Policy Unraveled, host Stephanie Kennan discusses the possible absence of an end-of-year healthcare package due to the appropriations process deadlines. She also discusses some of the initiatives Congress wants to do when they can do a healthcare package. Bills that could reshape the PBM industry significantly are stalled, and other issues that need to be addressed include site-neutral payment reforms, pending physician fee cuts, and behavioral health reforms. The episode wraps up with the announcement of several Congressional retirements affecting the healthcare policy landscape.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[00:42] An end-of-year healthcare package may not pass due to the appropriations process

[03:02] Healthcare legislation, such as legislation affecting PBMs, is awaiting action from Congress

[06:36] Site neutral payment reforms in Medicare are unclear

[08:06] Another issue in Medicare payment that needs to be addressed is physician fee cuts

[09:40] Congress has been working on several behavioral health reforms

[10:56] Congressional retirements have been announced that will impact health policy

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Supporting Healthcare for Homeless: CMS Allows Reimbursement for “Street” Medicine

Mon, 20 Nov 2023 03:00:00 -0500

The Centers for Medicare & Medicaid Services (CMS) has made a small change that has a large impact.

In episode 15 of Complications: Health Policy Unraveled, host Stephanie Kennan discusses the updated CMS billing policy, which now allows insurers to pay street medicine providers for their services. This move gives providers the flexibility to see homeless patients outside a traditional facility and seeks to address the healthcare needs of the ever-increasing number of homeless people across the country. Currently pending in the House is a bipartisan bill that would expand access to street medicine for homeless individuals across the country. Tune in to learn more about the expansion of street medicine and reimbursements to providers.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[0:40] CMS will now reimburse those providing medical services to homeless people outside traditional medical facilities

[1:24] States are beginning to approve billing for treatment of homeless people outside traditional medical facilities

[2:00] This change in federal billing was prompted by street medicine providers in 2022

[2:24] Pending bipartisan legislation in Congress, Direct Care for the Homeless Act, would expand access to street care and reimburse more street medicine providers

[3:33] The bill has been referred to House committees for consideration, meanwhile there is no similar legislation in the Senate yet

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Medicare Premium Increases: What to Expect for 2024

Mon, 06 Nov 2023 03:00:00 -0500

The Centers for Medicare & Medicaid Services (CMS) has announced that Medicare premiums are expected to increase in 2024.

In episode 14 of Complications: Health Policy Unraveled, host Stephanie Kennan breaks down all the expected Medicare premium increases and what’s behind these rate hikes. Because the Supreme Court held that cuts to drug reimbursements to 340B Hospitals are unlawful, CMS now plans to repay the $9 billion to these hospitals, raising premium rates. The increases can also be attributed to expected expansions in access to Alzheimer’s care. Tune in to this episode to learn how your insurance premiums may be affected.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[0:33] CMS announces that Medicare premiums are expected to increase in 2024.

[0:57] Increases to Medicare Part B standard monthly premiums and annual deductibles

[2:54] Projected costs for Medicare Part B are still quite uncertain.

[3:46] Medicare Part A inpatient hospital deductions are also increasing, including a $32 increase in the deductible for the first 60 days of coverage.

[4:13] The per day costs of lifetime reserve days is up to $816 in 2024, and the daily co-insurance for extended care services have also gone up.

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DEA Extends Telehealth Prescribing Flexibilities for Controlled Substances

Mon, 23 Oct 2023 03:00:00 -0500

The regulatory landscape for telehealth prescribing of controlled substances is evolving.

In episode 13 of Complications: Health Policy Unraveled, host Stephanie Kennan covers the DEA's recent extension of pandemic-era telehealth prescribing flexibilities for controlled substances through 2024, marking the second extension. Originally set to expire in May, these extensions followed extensive public input, including 38,000 comments and two telemedicine listening sessions. Advocates, including healthcare organizations and Congress members, stress the importance of telehealth for addressing issues like opioid use disorders. The DEA is currently reviewing feedback, leaving the final rules to be determined. Stay tuned for updates on this dynamic policy landscape.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[00:39] DEA and HHS announced they would extend the pandemic-era telehealth prescribing flexibilities for controlled substances through 2024

[01:46] Overview of what lead to the first temporary rule extension

[02:47] Overview of what lead to the second temporary rule extension

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Navigating the No Surprises Act: Challenges and Controversies

Mon, 09 Oct 2023 03:00:00 -0500

The No Surprises Act has had some difficulties in the implementation process, and those difficulties are raising issues.

In episode 12 of Complications: Health Policy Unraveled, host Stephanie Kennan provides an update on the No Surprises Act, a law passed by Congress in December 2020 to protect patients from excessive surprise medical bills. The law partially went into effect in the beginning of 2022 for those in individual and group health plans. Stephanie discusses the challenges and issues faced during its implementation, including legal battles, concerns about the arbitration process, and the impact on small medical practices. The debate over including ground ambulances in the legislation is also covered.

Tune in to this episode to learn more.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[00:53] No Surprises Act addresses surprise bills for medical care in three circumstances

[01:20] Difficulties in implementation

[01:56] Court rulings have also hampered implementation

[05:00] September 21, 2023 hearing at the House Ways and Means Committee examined the effect of the No Surprises Act on providers

[06:36] Committee members disagreed over whether ground ambulances should be included in the legislation

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Prescription Drug Costs in Focus: PBM Reform on the Horizon

Mon, 25 Sep 2023 03:00:00 -0500

Pharmacy benefit managers (PBMs) continue to be a topic which causes angst in Congress. However, PBM reform is not far off, and is likely to come before the end of the year.

In episode 11 of Complications: Health Policy Unraveled, host Stephanie Kennan discusses the bipartisan introduction of the Patients Before Middlemen Act in the Senate, which is aimed at realigning incentives that help lower prescription drug costs for Medicare Part D beneficiaries. Additionally, this episode highlights the broader legislative efforts to address drug pricing issues. Tune in to this episode to learn more.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[00:45] Senate introduces the Patients Before Middlemen Act

[01:37] The impact of the Patients Before Middlemen Act on PBM compensation

[02:05] Other legislative efforts to address prescription drug pricing issues

[03:55] PBM reform is not far off

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DEA’s Telehealth Proposed Rules: Expanding Access & Preventing Medication Misuse, or Not?

Mon, 11 Sep 2023 03:00:00 -0500

“The initial reaction to the rules is that they are much more restrictive than necessary and impose concerning limitations and burdens on clinicians and the patients they treat.”

In episode 10 of Complications: Health Policy Unraveled, host Stephanie Kennan discusses the Drug Enforcement Agency’s telehealth proposed rules which could impact how patients gain access to certain medications. The DEA received 38,000 comments on the proposed changes, a record amount of feedback.

It is likely that when finalized, the rule will contain many of the elements of the proposed rule, which will add complexity for patients and providers. The rule is expected in late fall.

Meet Your Host

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

Episode Highlights

[00:31] DEA’s proposed telehealth rules.

[01:19] DEA received a record number of comments on the proposed rules.

[01:47] DEA proposed creating two new limited options for the telemedicine prescribing of controlled substances without a prior in-person exam.

[02:48] Feedback from supporters and opponents of the proposed rules.

[03:39] Special allowance and exemptions.

[05:12] Overview of the Ryan Haight Act.

[08:27] Many public comments focus on the importance of telehealth-based Buprenorphine treatments in rural areas.

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Who Has Access to Our Health Data? Understanding the ADPPA

Mon, 28 Aug 2023 03:00:00 -0500

The concept of a federal consumer privacy framework is something that Congress has worked on for several years in both the House and Senate, but it's never come to fruition.

In episode 9 of Complications: Health Policy Unraveled, host Stephanie Kennan discusses the American Data Privacy and Protection Act (ADPPA), which would, if passed, create a comprehensive federal consumer privacy framework. The goal of the legislation would be to protect consumers from discriminatory use of their data and require entities to use more stringent security measures. Though the House Energy and Commerce Committee is currently revamping legislation, the path to becoming a law is unclear.

Meet Your Host

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 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

Episode Highlights

[1:00] The House Energy and Commerce Committee is revamping legislation to standardize protections of consumer data usage, including requiring reasonable data security measures.

[2:07] While the ADPPA would not cover certain health data already covered by HIPAA or “High Tech”, it would cover a variety of sensitive information such as geolocation data, login credentials, private communications, or healthcare data related to diagnosis or treatment.

[2:46] More and more non-HIPAA covered entities are gaining access to health data all the time, but the ADPPA would regulate the amount of data they can collect on individuals and require explanations for data collection.

[3:14] A recent study identified third-party tracking tools on 99% of abortion clinic websites. Another study found that three-quarters of patients have significant health data and privacy concerns.

[3:40] The ADPPA would charge the FTC with enforcement of its new standards, an agency that has already expressed interest in regulating companies using health data improperly.

[4:35] There is some concern related to a possible conflict between HIPAA’s de-identified data standard and those in the ADPPA. Another concern is the preemption of state laws that already address privacy concerns.

[5:06] Although the House Energy and Commerce Committee has started revisiting the issue and there is support for greater regulation of consumer health data usage, whether the legislation will move forward is still unclear.

[5:35] While Congress considers the ADPPA, the FTC wants to update the health breach notification rule to include digital health apps.

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The “Ghosts’ of Mental Healthcare: Democratic Staff of the Senate Finance Committee Release Report Concerning Medicare Advantage Plans

Mon, 14 Aug 2023 03:00:00 -0500

“More than 80% of the listed in-network mental health providers [that] staff tried to contact were ‘ghosts’ as they were either unreachable, not accepting new patients, or not a network.”

In this episode of Complications: Health Policy Unraveled, host Stephanie Kennan discusses “ghost networks” and Medicare Advantage plans. Based on a recent Senate Finance Committee study, Medicare Advantage provider directories are littered with inaccurate or unreachable listings for mental health services. Stephanie discusses the Committee’s recent recommendations on how to rectify “haunted” provider lists.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[0:41] An explanation of “Ghost Networks”.

[1:04] Staff of the Senate Committee on Finance conducted a “secret shopper” study to determine how pervasive mental health provider ghost networks are in the Medicare Advantage Program.

[1:15] Study Results.

[2:18] The Centers for Medicare and Medicaid Services (CMS) require Medicare Advantage plans to keep their provider lists up to date, but without an audit, inaccuracies might go unnoticed.

[2:35] Democratic Staff Report Recommendations.

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Unraveling the PBM Puzzle: Navigating Bipartisan Bills and Proposed Reforms

Fri, 28 Jul 2023 03:00:00 -0500

All this activity on PBM legislation ensures that something is likely to happen this year.

In this episode of Complications: Health Policy Unraveled, host Stephanie Kennan walks through legislation pending in both the House and Senate aimed at addressing the practices of Pharmacy Benefit Managers (PBMs), the drug pricing middlemen many blame for high drug costs and drug access issues.

Meet Your Host

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 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

Episode Highlights

[0:35] PBM legislation in the works as part of Senator Schumer’s plan for drug pricing package this year.

[1:15] Senate Proposal #1: Prescription Pricing for the People Act

[1:52] Senate Proposal #2: Pharmacy Benefit Manager Transparency Act

[2:20] Multiple Amendments offered

[4:50] House Proposal #1: Bill from the House Energy and Commerce Subcommittee on Health

[5:20] House Proposal #2: Pharmacy Benefits Manager Accountability Act

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Appropriations: Battle Expected at Year’s End (Again), Despite Promises Otherwise

Fri, 14 Jul 2023 03:00:00 -0500

Here we go again. A year-end appropriations showdown is likely, despite promises earlier this year to have the process work on time for a change.

In ep. 6 of Complications: Health Policy Unraveled, host Stephanie Kennan discusses the current appropriations battles, the timing of appropriations, and the process. You’ll learn about the hurdles in Congress to come to a consensus, and why you shouldn’t expect appropriations to be finished before Congress leaves for August recess.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[00:38] Expected timeline for discussions about appropriations in Congress.

[01:28] Disagreements about appropriations.

[03:25] Year-end budget fight.

[03:55] The “real deadline.”

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Nonprofit Hospitals and Tax Exemptions: What's at Stake

Mon, 03 Jul 2023 03:00:00 -0500

In this episode of Complications: Health Policy Unraveled, Stephanie Kennan discusses the tax exemption status of nonprofit hospitals, the legal requirements for tax exemption, and the recommendations made by the General Accounting Office regarding this issue. Despite the lack of clarity from Congress, scrutiny on tax exemption status may increase as the IRS responds to criticisms.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[00:45] The significant role of tax exemption.

[01:12] GAO made recommendations to Congress.

[01:26] Hospitals must satisfy three sets of requirements for non-for-profit tax exemption.

[01:40] IRS has identified six factors that demonstrate a community benefit.

[02:28] GAO’s most recent work updates a study that they did in 2020.

[03:28] Value of the tax exemption over the years.

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Physician-Owned Hospitals: Politics and Policy

Mon, 19 Jun 2023 03:00:00 -0500

The debate on physician-owned hospitals is beginning again. Or maybe it never really stopped.

In the latest episode of Complications: Health Policy Unraveled, host Stephanie Kennan shares the history behind the creation of physician-owned hospitals, and the current effort to loosen restrictions through legislation while the administration wants to continue restrictions.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[00:50] The history of physician-owned hospitals.

[01:05] Congress passed legislation concerning physician ownership and referral of services in the 1980’s, called “Stark Laws”.

[02:31] The Center for Medicare & Medicaid Services wants to restrict expansion of physician-owned hospitals designated as “high Medicaid facilities” and to set maximum limits on the expansion of those hospitals.

[03:42] What critics say about physician-owned hospitals.

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Closing the Gap: CMS Strengthens Enforcement of Hospital Price Transparency

Mon, 05 Jun 2023 03:00:00 -0500

Healthcare is moving towards a more transparent future.

In this episode of Complications: Health Policy Unraveled, host Stephanie Kennan explores the latest updates in hospital price transparency efforts. Delve into the strengthened enforcement process by CMS, exploring new requirements for corrective action plans, changes in the imposition of civil monetary penalties, and streamlined compliance procedures.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[00:33] Hearing on competition and transparency in the healthcare system.

[01:00] Change #1: Requiring corrective action plan completion deadlines.

[01:41] Change #2: Imposing civil monetary penalties earlier and automatically.

[02:45] Change #3: Streamlining the compliance process for non-compliant hospitals.

[03:14] How these enforcement updates will shorten the average time of compliance.

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The 340B Drug Discount Program: A Healthcare Soap Opera

Fri, 19 May 2023 03:00:00 -0500

In this episode of Complications: Health Policy Unraveled, host Stephanie Kennan clarifies the complexities of the 340B Drug Discount Program, discussing its history, ongoing litigation, challenges from drug manufacturers and Congress, and its impact on healthcare providers serving low-income and uninsured patients.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[00:35] Introduction to the 340B Drug Discount Program and its history.

[01:38] Expansion of the program in 2010 and the role of Disproportionate Share Hospitals (DSH).

[03:32] GAO recommendations for increased HRSA oversight.

[04:28] Recent litigation regarding Medicare Part B payment reductions.

[05:30] Drug companies limiting hospital access to contract pharmacies and subsequent legal challenges.

[07:32] HRSA's proposed rule and potential changes to the dispute resolution process.

[08:02] The Arkansas 340B Pricing Non-Discrimination Act and the ongoing legal battle.

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The Debt Ceiling Crisis: Unraveling Its Impact on Healthcare

Tue, 09 May 2023 03:00:00 -0500

In this inaugural episode of Complications: Health Policy Unraveled, host Stephanie Kennan discusses the federal debt ceiling and its potential impact on healthcare. As Congress battles over the debt ceiling, healthcare providers and investors hang in the balance, facing delayed payments and potential access issues, in a high-stakes political game with no clear path forward.

In this episode, we'll uncover the political dynamics surrounding the debt ceiling, evaluate competing budget cut proposals, and contemplate the possibility of a government default and its effects on healthcare services. Don't miss out on this crucial information as we navigate the uncertain path ahead.

Meet Your Host

Name: Stephanie Kennan

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

Connect: LinkedIn

Episode Highlights

[00:41] Competing debt ceiling bills in Congress and a call from the White House for negotiations

[01:55] Introduction to the debt ceiling debate and its relevance to healthcare

[04:31] Political challenges of the debt ceiling crisis and proposed bill, H.R. 187, the Default Prevention Act, and its five-tier payment structure.

[07:19] Adverse consequences for the U.S. economy and healthcare if Congress fails to raise debt ceiling.

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Welcome to Complications: Health Policy Unraveled

Mon, 08 May 2023 03:00:00 -0500

Tired of being baffled by healthcare policy? McGuireWoods Consulting presents Complications: Health Policy Unraveled, your solution to the policy puzzle. With our host, Stephanie Kennan, discover the ins and outs of healthcare policy and gain insights crucial for providers and investors. Let's simplify the complex together.

Follow us in your favorite 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 mwcllc.com.

And, if you found this podcast valuable, please share it with your colleagues and leave us a review. We always appreciate your feedback.