HealthCare Roundtable e-News – March 20, 2023

 

Registration Now Open

Webinar – March 28, 2023 – 2:00 PM (EST) – The Cost of the Pharmaceutical Industries’ Anticompetitive Practices and its Impact on Public Sector Purchasers

To protect profits and delay competition, pharmaceutical companies often abuse patent thickets, the accumulation of an overlapping set of patents, and other anti-competitive practices which leads to higher costs for Roundtable members and the public sector purchasers they serve. A recent Matrix Global Advisors (MAG) report highlights the cost of these practices, finding that abuse of patent thickets results in certain drugs costing patients and the healthcare system an estimated $1.8 billion to $7.6 billion per year.

Join us for a discussion with the Public Sector HealthCare Roundtable senior policy team and the report’s authors on the cost of anti-competitive practices by the pharmaceutical industry and policymakers’ efforts to enact legislative and regulatory reform.

Register here.

About the Speaker

ALEX BRILL, CEO

Matrix Global Advisors (MGA)

Prior to founding MGA, Alex was the policy director and chief economist for the House Committee on Ways and Means, where he worked from 2002 to 2007. At Ways and Means, Alex directed policy development and led negotiations on a variety of tax, health, pension, and trade matters.

Alex has testified numerous times before Congress on tax policy, labor markets, unemployment insurance, Social Security reform, fiscal stimulus, the manufacturing sector, and biological drug competition. He has served as an expert witness and litigation consultant in both tax and pharmaceutical patent litigations.

In addition, Alex served as a tax policy advisor to the National Commission on Fiscal Responsibility and Reform, coauthored the book The Real Tax Burden: More Than Dollars and Cents with Alan D. Viard, and is currently a senior fellow at the American Enterprise Institute.

Top News

HHS Releases Initial Guidance for IRA Medicare Drug Pricing Negotiation Program

On Wednesday, March 15th, the Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), issued initial guidance detailing the requirements and parameters—including requests for public comment—on key elements of the new Medicare Drug Price Negotiation Program beginning in 2026 (fact sheet here). The Inflation Reduction Act (IRA) authorizes Medicare to directly negotiate drug prices for certain high-expenditure, single-source Medicare Part B or Part D drugs, meaning only those drugs for which there is no generic or biosimilar competition.

By September 1, 2023, CMS will publish the first 10 Medicare Part D drugs selected for price negotiations starting in 2026. The initial guidance details how CMS intends to identify selected drugs, conduct the negotiation process, and establish requirements for manufacturers of selected drugs. The negotiation criteria include a variety of factors, such as annual revenue, sales volume, and research and development costs.

CMS is seeking comment on the key elements of the guidance, including the terms and conditions in the manufacturer agreement, the method for applying the maximum fair price, the process for the offer and counteroffer exchange, and the dispute resolution process. Comments can be submitted via email to IRARebateandNegotiation@cms.hhs.gov and are due by April 14, 2023. CMS expects to issue revised guidance for the first year of negotiation in the Summer of 2023.

 

HHS Finds Significant Medicare Beneficiary Savings from Elimination of Vaccine Cost-Sharing

Last week, the Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) published a report on Medicare Part D enrollee savings from the elimination of vaccine cost-sharing. On January 1, 2023, the Inflation Reduction Act (IRA) eliminated enrollee cost-sharing for recommended vaccines covered under Medicare Part D. In 2021, 3.4 million people received vaccines under Part D with an annual out-of-pocket cost of $234. According to the report, this translates to nearly $70 in out-of-pocket savings per enrollee receiving a Part D vaccine if the IRA had been in effect in 2021.

 

Urban Institute Brief Finds Most Adults With Past-Due Medical Debt Owe Money to Hospitals

Last week, the Urban Institute published a brief that found most adults with past-due medical debt owe money to hospitals. According to the brief, over 15% of American adults report past-due medical debt, and nearly 73% of those individuals owe some or all of their debt to hospitals. Adults with disabilities and Black and Latino adults were more likely to report past-due medical debt. Individuals with incomes below 250% of the Federal Poverty Level (FPL) were no more likely to avoid being referred to debt collection or receive discounted care when compared to higher-income earners. The brief concludes that greater standards and consumer protections are necessary to alleviate debt burdens and improve access to affordable care.

Administrative Action

  • Last Friday, the U.S. Department of Health and Human Services (HHS), through the Health Resources (HRSA), announced the availability of approximately $25 million to expand primary care, including mental health services, in schools. For the first time, applicants are required to add or expand mental health services to receive school-based funding. The new opportunity builds on the $30 million HRSA has awarded since September 2021 to increase access to health center services in schools. The $25 million funding opportunity supports the mental health pillar of President Joe Biden’s Unity Agenda and the Administration’s strategy to address the mental health crisis. 

  • On Monday, Eisai announced that the U.S. Veterans’ Health Administration (VHA) will provide coverage of Leqembi, Biogen’s new treatment for Alzheimer’s disease. Eisai noted in their announcement that the VHA plans to allow coverage of the treatment to any veteran who meets the eligibility criteria indicating they have mild Alzheimer’s dementia. In 2022, an estimated 167,954 Veteran’s Administration patients were diagnosed with Alzheimer’s dementia, although it is not yet known how many would be eligible to receive this treatment. This announcement comes after the Centers for Medicare and Medicaid Services (CMS) recently declined to cover the drug outside of clinical trials, which has only achieved accelerated approval from the Food and Drug Administration (FDA).

  • Recently, the U.S. Food and Drug Administration (FDA) released its FY 2024 Budget Justification for its proposed $7.2 billion total budget for the fiscal year (fact sheet here). The budget is an increase of $372 million, or 10 percent, over its FY 2023 funding level and includes $3.3 billion in user feeds. The budget makes significant investments to enhance food safety, advance medical product safety, strengthen its public health capacity, and modernize its facilities.  

Congressional Action

  • Last week, the U.S. Senate Special Committee on Aging held a hearing to discuss current and future struggles facing the caregiving workforce in the United States as well as the social and economic benefits that could come from increasing wages for home and community-based services (HCBS). Chairman Casey introduced a new bill, the HCBS Access Act, which would aim to eliminate, over time, lengthy waiting lists for home care services. The committee also discussed the Better Care for Better Jobs Act, which would enhance Medicaid funding for home care services and strengthen the caregiving workforce. The hearing summary can be found here.  

  • Last week, U.S. Senators Shelley Moore Capito (R-WV) and Jeanne Shaheen (D-NH), along with U.S. Representatives Kevin Hern (R-OK) and Mike Thompson (D-CA), reintroduced the Access to Prescription Digital Therapeutics Act of 2023. This bipartisan, bicameral legislation aims to increase access to Prescription Digital Therapeutics (PDTs) and expand Medicare coverage to include PDTs. PDTs are products, devices, or applications that primarily use software and have a cleared or approved indication for the prevention, management or treatment of a medical disease, condition or disorder. The treatments are tested for safety and efficacy in randomized clinical trials, evaluated by the U.S. Food and Drug Administration (FDA), and prescribed by health care providers. 

  • Recently, the Senate Health, Education, Labor, and Pensions (HELP) Committee released a Request for Information (RFI) on the Pandemic and All-Hazards Preparedness Act (PAHPA), which is up for reauthorization this year. PAHPA funds programs that enable the federal government to respond to natural disasters and threats from emerging infectious diseases and chemical or biological agents. It must be reauthorized every five years and is set to expire on September 30, the end of fiscal year 2023. Comments can be submitted via email to PAHPA2023Comments@help.senate.gov and are due by close of business Wednesday, March 29, 2023. 

Medicare

  • On Wednesday, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced 27 prescription drugs for which Part B beneficiary coinsurances may be lower from April 1 – June 30, 2023. As a result of the Inflation Reduction Act’s (IRA) inflation rebate provisions, Medicare beneficiaries who take these drugs may save between $2 and $390 per average dose starting April 1, depending on their coverage. The beneficiary coinsurance will be 20 percent of the inflation-adjusted payment amount.

  • The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), issued initial guidance detailing the requirements and parameters—including requests for public comment—on key elements of the new Medicare Drug Price Negotiation Program beginning in 2026 (fact sheet here). The Inflation Reduction Act (IRA) authorizes Medicare to directly negotiate drug prices for certain high-expenditure, single-source Medicare Part B or Part D drugs, meaning only those drugs for which there is no generic or biosimilar competition. Comments can be submitted via email to IRARebateandNegotiation@cms.hhs.gov and are due by April 14, 2023.

  • On Thursday, the Medicare Payment Advisory Commission (MedPAC) released its March 2023 report covering Medicare payment policy to Congress. The 12-chapter report evaluates Medicare payment issues and recommendations from Congress. Notably, MedPAC shared a comparison of per-enrollee spending in the Medicare Advantage (MA) program to traditional fee-for-service Medicare. The report highlighted the following key areas: 1) Increased payments to MA due to coding differences. 2) The need for additional support for safety net providers. 3) Recommendations for increasing physician payment. 4) The growth of drug prices in Medicare Part D.    

Medicaid

  • On Tuesday, CMS shared the Fiscal Year (FY) 2024 Justification of Estimates for the Appropriations Committees. CMS notes that the FY 2024 budget request reflects a level of funding that allows CMS to focus on base operations, as well as improve its traditional activities throughout its various programs, including program operations, federal administration, survey and certification, and research. In addition, the FY 2024 budget request reflects CMS’s key initiatives related to ending the opioid epidemic, advancing health equity, and ensuring nursing home safety, quality, and transparency. CMS requests funding for its annually appropriated accounts, including Program Management (PM), discretionary Health Care Fraud and Abuse Control (HCFAC), Grants to States for Medicaid, and Payments to the Health Care Trust Funds. 

  • On Wednesday, the Medicaid and CHIP Payment and Access Commission (MACPAC) published its March 2023 Report to Congress on Medicaid and CHIP. MACPAC is statutorily bound to submit reports to Congress by March 15 and June 15 of each year. The report contains four chapters of interest to Congress: (1) Medicaid race and ethnicity data collection and reporting, (2) principles for assessing Medicaid nursing facility payment programs, (3) strengthening evidence under Medicaid drug coverage, and (4) MACPAC’s statutorily required review of hospital payment policy for the nation’s safety-net hospitals.

Research

  • The Institute for Clinical and Economic Review (ICER) published a White Paper titled “Advancing Health Technology Assessment Methods that Support Health Equity.” The white paper recommends methods for health technology assessment (HTA) in the United States to improve health equity for racial, ethnic, and other socially disadvantaged groups. The paper presents several key recommendations, including: 1) Selecting health care technology interventions for assessment 2) Engaging patients and patient groups in the HTA process 3) Evaluating the diversity of participants in clinical trials, among other recommendations. 

  • The Coalition to End Social Isolation and Loneliness released their 2023-2024 Policy Priorities. The Priorities reflect the work of the Foundation for Social Connection’s Scientific Advisory Council (SAC)— notably the Systems approach of Cross-sector Integration and Action across the Lifespan (SOCIAL) Framework. The overarching Policy Priorities are: 1) Increasing public awareness regarding social isolation and loneliness and their effect on health, belonging, well-being, and resilience. 2) Enhancing social services and supports to address social isolation and loneliness and promote social connection. 3) Advancing health services and supports to address social isolation and loneliness and promote social connection. 4) Leveraging innovative solutions that foster connection and social integration. 5) Advancing research to establish the prevalence of social isolation, loneliness, and connection.  

  • Recently, FAIR Health released a report titled “A Window into Primary Care: An Analysis of Private Healthcare Claims,” which analyzes primary care utilization patterns by geography and compares differences in physician versus non-physician care, allowed amounts, telehealth utilization, and behavioral health utilization. The study highlights regional gaps in primary care usage and how this can lead to worse patient health outcomes. Notably, the analysis found that nearly 30% of all patients receiving medical services between 2016 and 2022 did not see a primary care physician (PCP). The study also found that non-physicians treated greater percentages of patients with diagnoses related to mental health or acute respiratory diseases than physicians did.

Mark Your Calendar for Upcoming Roundtable Events

Webinar – May 9, 2023 – 2:00 PM (EST) – Drivers of Health Care Costs: Hospital Consolidation and Lack of Price Transparency

With healthcare costs growing at an unsustainable rate, employers, taxpayers, and patients have to pay more for the same quality of care. Hospitals are one of the top drivers of rising healthcare costs due to the lack of market competition. Join us to hear from the Public Sector HealthCare Roundtable senior policy team and our group of experts on the impact of hospital consolidation, anti-competitive practices, and the lack of price transparency on patients and market-based solutions to increase hospital competition and reduce healthcare costs.

 

19th Annual Conference – November 1-3, 2023