HealthCare Roundtable e-News – July 24, 2023

 

Roundtable Activity

The Roundtable is pleased to welcome The Texas A&M University System as our newest member.

The Texas A&M University System, a state governmental employer, currently sponsors a self-funded, non-ERISA group health plan, The Texas A&M University System Group Health Program (the “A&M Care Plan”), comprised of three plans: the A&M Care Plan, the A&M Care 65 Plus Plan, and the A&M Care J Plan. The A&M Care plan is a preferred provider organization (“PPO”) offered to all benefits-eligible employees and retirees regardless of where they live or work. The A&M System currently contracts with Blue Cross and Blue Shield of Texas for the administration of the A&M Care Plan and Express Scripts as the Pharmacy Benefit Manager (PBM). The A&M System has approximately 32,000 benefits-eligible employees and retirees enrolled in the self-insured A&M Care plans, with approximately 58,000 covered lives.

For more information, visit The Texas A&M University System.


Top News

House Republicans Request Greater Transparency in Medicare National Coverage Determinations

Last week, a group of House Republicans led by Energy and Commerce Committee Chair Rep. McMorris Rodgers (R-WA) and Ways and Means Committee Chair Rep. Smith (R-MO) submitted a letter to the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) requesting they provide greater transparency and visibility into the Medicare National Coverage Determination (NCD) process. Their letter states that there is an unknown number of NCD requests pending CMS review and the agency’s “uncertain timelines and opaque methodologies” stifle medical innovation and beneficiaries’ access to care. To foster greater transparency, the Representatives request that the agency provide the committees with updated data on the outstanding NCD requests and a plan to update the public NCD dashboard.

The letter comes as CMS has recently introduced a proposed rule to institute a pathway to provide Transitional Coverage of Emerging Technologies (TCET), to address concerns that the traditional NCD process fails to keep pace with emerging products approved by the Federal Food and Drug Administration (FDA). For example, CMS was widely criticized for limiting coverage of the recently FDA-approved Alzheimer’s Disease treatment, Leqembi. The House Republicans also cite this example in their letter and call upon CMS to reconsider expanding Medicare coverage for this class of treatments.

 

House Energy and Commerce Health Subcommittee Holds Hearing on Medicare Coverage Pathways for Innovative Drugs, Medical Devices, and Technology

On Tuesday, the House Energy and Commerce Health Subcommittee held a hearing titled, “Innovation Saves Lives: Evaluating Medicare Coverage Pathways for Innovative Drugs, Medical Devices, and Technology.” Chairman Guthrie (R-KY) provided opening remarks explaining that it is imperative for policymakers to ensure that there is a balance between rewarding innovation and providing quality care in reference to Alzheimer’s disease, diabetes, and similar complex conditions. Ranking Member Eshoo (D-CA) added that moving forward, CMS will need effective resources and expert staff to make Medicare coverage decisions by utilizing comprehensive data collection and analysis techniques. Chair Rodgers (R-WA) and Ranking Member Pallone (D-NJ) further spoke about the importance of the U.S. maintaining a competitive edge within clinical trials to develop effective breakthrough treatments. The witnesses present during this hearing represented the American Academy of Neurology, the Society of Thoracic Surgeons, PAVmed, Edwards Lifesciences, the Alzheimer’s Association, and Johns Hopkins University School of Medicine.

 

FTC Votes to Issue Statement Withdrawing PBM Advocacy Documents

On Thursday, the Federal Trade Commission (FTC) voted 3-0 to issue a statement cautioning against the reliance on prior advocacy statements and studies related to pharmacy benefit mangers (PBMs) that no longer reflect current market realities. The FTC notes that the PBM industry has changed significantly over the last two decades, and that it is currently engaged in a major study to update its understanding of the industry and its practices. Specifically, the FTC warns against relying on eleven advocacy letters and reports released between 2004 and 2014 that advocated against proposals to increase regulatory oversight and transparency of PBMs

Administrative Action

On Thursday, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced grants totaling $47.8 million for five programs aimed at addressing substance misuse and the nation’s overdose epidemic. The focus is on improving access to evidence-based treatment and supporting efforts to prevent and treat addiction. The grants align with provisions in the Consolidated Appropriations Act of 2023, which expanded the number of providers able to prescribe medication for opioid use disorder such as buprenorphine, making treatment more accessible for patients in need. The five grant programs receiving funding are: Medication-Assisted Treatment-Prescription Drug and Opioid Addition (MAT-PDOA); Emergency Department Alternatives to Opioids Demonstration Program; Sober Truth on Preventing Underage Drinking Act (STOP Act); Adult Reentry Program; and the State Pilot Grant Program for Treatment for Pregnant and Postpartum Women.

Congressional Action

  • On Tuesday, U.S. Senator Murphy (D-CN) introduced the National Strategy for Social Connection Act (one-pager), which serves as a roadmap to begin addressing the epidemic of social isolation and loneliness by naming the problem, developing solutions, educating the public about best practices, and enhancing data collection regarding the scope of the problem. The bill includes provisions to requiring a national strategy on social connection and establishing an office within the Executive Office of the President to combat loneliness and strengthen communities. Additionally, an annual budget of $5 million would be allocated to the Centers for Disease Control and Prevention (CDC) for conducting and supporting research on loneliness and social connection. The bill also establishes an Advisory Council with membership across federal agencies along with non-federal stakeholders.
  • On Wednesday, the House Committee on Education & the Workforce Ranking Member Robert Scott (D-VA), Rep. Susan Wild (D-PA), and Rep. Susie Lee (D-NV) reintroduced the Direct Creation, Advancement, and Retention of Employment (CARE) Opportunity Act of 2023. This legislation invests over $1.8 billion over five years in training and increasing opportunities for direct care workers. The bill includes provisions to invest in bolstering the direct care workforce pipeline, encourage retention and career advancement in the direct care field, respond to the needs of a growing aging population, and support the health and wellbeing of those who need on direct care services. The Direct CARE Opportunity Act was originally introduced by the House Committee on Education and the Workforce in 2017. It comes as the direct care workforce faces predictions of job growth despite continued low wages and unstable working conditions.
  • Senator Bernie Sanders (I-VT), Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, announced that the HELP Committee will consider a large legislative package put forth by the Senator on July 26. The bill would significantly increase funding towards healthcare services and support the provider workforce. The package is notably larger than a similar bill in the House, which has garnered bipartisan support. The bill budgets $86.5 billion over five years with the majority of the spending = directed towards community health centers, which rely on federal dollars to operate. $10.2 billion will be allocated for fiscal year 2024, with an increase in funding for fiscal year 2028, totaling $65.5 billion over five years. $8.3 billion is allotted to fund the National Health Service Corps over 5 years.

Regulatory Action

Last Friday, the Federal Trade Commission (FTC) announced the withdrawal of two major policy statements related to the enforcement of antitrust in health care markets. The Statements of Antitrust Enforcement Policy in Health Care, published in August 1996, and Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program, published in October 2011, have acted as guidance for antitrust enforcers on anti-competitive behavior for years. The statements explained how members of the health care industry could share data under certain narrow conditions, called “safety zones,” without triggering regulatory concerns. Citing profound changes in health care markets over the last 30 years, the FTC made the decision to withdraw both these statements and instead will rely on general antitrust principles moving forward. The withdrawal follows the Department of Justice’s decision to rescind the same statements back in February 2023.