Weekly Spotlight
Drugs Continue to Hold the Spotlight
More than a week ago, manufacturers of 10 widely prescribed drugs called out by CMS for being over-priced were to have received opening bids on the “maximum fair price” the Medicare program would pay for them. As yet, no reporting has offered any feedback from the manufacturer or CMS on the process. It is unlikely that details will be shared with the public as various aspects of the new drug pricing program are subject to ongoing litigation.
However, this did not stop Senate Health, Education, Labor, and Pensions Chair, Bernie Sanders, (D-VT) from calling three drug company CEOs to testify before his committee at a hearing titled “Why Does the United States Pay, by Far, the Highest Prices in the World for Prescription Drugs?” The event, which was billed as high drama, featured Johnson & Johnson CEO, Jaoquin Duato, Merck CEO, Robert Davis, and BMS CEO Chris Boerner, resulted in few notable takeaways and even fewer “gotcha” moments. The hearing’s second panel offered an opportunity to discus some of the issues underlying drug pricing challenges like impact on innovation and patient access as well as consideration of the roles PBMs play which is the topic of legislation currently advancing in Congress, but the Committee did not spend as much time with their testimony.
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
CMS Publishes ACA Advancing Interoperability and Improving Prior Authorization Processes Final Rule
This final rule will improve the electronic exchange of health care data and streamline processes related to prior authorization through new requirements for Medicare Advantage (MA) organizations, state Medicaid fee-for-service (FFS) programs, state Children’s Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs). This final rule will also add new measures for eligible hospitals and critical access hospitals (CAHs) to report under the Medicare Promoting Interoperability Program and for MIPS eligible clinicians to report under the Promoting Interoperability performance category of the Merit-based Incentive Payment System (MIPS). These policies, taken together, will reduce overall payer and provider burden and improve patient access to health information while continuing CMS’s drive toward interoperability in the health care market.
Medicare Shared Savings Program: Application Deadlines for a January 1, 2025, Start Date
CMS will accept applications starting May 20 and encourages health care providers in rural and under-served areas to join together as ACOs. Providers can learn about advance shared savings payments to build infrastructure, hire staff, and provide services and roles for community-based organizations.
More Information:
Register for 2024 MIPS Annual Call for Quality and Cost Measures Overview Webinar on February 22
On Thursday, February 22, 2024, at 3 p.m. ET, the Centers for Medicare & Medicaid Services (CMS) will host a webinar to provide an overview of the development, criteria, and evaluation of Merit-based Incentive Payment System (MIPS) quality and cost measures that align with CMS priorities. The webinar will provide an overview of the following topics:
- 2024 MIPS Annual Call for Quality and Cost Measures (opened on January 31, 2024, and closes on May 10, 2024);
- Requirements for Successful Submission;
- Measure Evaluation Considerations; and
- Specialty or Clinical Topic Gap Areas.
Participants will have an opportunity to ask questions related to the presentation.
This webinar is intended to assist with the development of quality and cost measures for future MIPS performance periods.
Webinar Information
Further Analysis of Medicare Advantage Rule Shows Insurers Face Slight Proposed Cut to 2025 Payments
The federal government is cutting the average benchmark payments for 2025 Medicare Advantage plans by 0.2%. The proposed rule pegged per capita cost increases at 2.44% (although it is almost always increased in the final rule). However, the MA coding system will decrease payments by 2.45%, resulting in a net loss. Notably, CMS refrained from making changes to MA coding intensity which MedPAC has cited as one of the reasons for the program’s increasing price tag.
Food and Drug Administration (FDA)
FDA CBER Webinar: Considerations for the Development of CAR T Cell Products
The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual public webinar on Thursday, March 7 at 1:00 p.m. to discuss a recently finalized guidance document on considerations for the development of Chimeric Antigen Receptor (CAR) T cell products. This guidance is intended to assist industry and academic sponsors that are developing ex vivo-manufactured CAR T cell products.
FDA to Help Patients and Doctors Push Back Against Drugs’ Harsh Side Effects
Through a program called Project Optimus, the FDA is pushing drugmakers to include more patients in early dose-finding trials to get better data on when lower doses can work. Answering calls from patients and advocates that cancer drugs be made more tolerable.
Patient
FDA Extends Comment Period for Advance Manufacturing Tech Designation Program Guidance
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability entitled “Advanced Manufacturing Technologies Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request” that appeared in the Federal Register of December 13, 2023. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
The National Press Club to Hold Discussion with FDA Commissioner Robert Califf on “Communication and its Link to Health Outcomes”
The National Press Club will hold a discussion with FDA Commissioner Robert Califf on “communication and its link to health outcomes,” part of its “NPC Headliners” series.
Hill Happenings
The Budget and Economic Outlook for 2024 to 2034: Press Briefing Slides from Congressional Budget Office
According to CBO projections, federal budget deficits total $20 trillion over the 2025–2034 period and federal debt held by the public reaches 116 percent of GDP. Economic growth slows to 1.5 percent in 2024 and then continues at a moderate pace. Spending on Medicare will increase by about $65 billion in 2024 due to larger payments to Medicare Advantage and Part D payments, the Congressional Budget Office says, while Medicaid expenditures will decrease by $58 billion, or 9%, because of post-COVID Medicaid unwinding.
CMR to Retire
After winning the leadership post this Congress in a tightly contested battle, Energy and Commerce Committee Chair Cathy McMorris Rodgers has announced that she will retire from Congress. Rep. Brett Guthrie (R-Ky.), the current chair of the Health Subcommittee has indicated he will run to replace her along with Rep. Bob Latta of Ohio, who will be the most senior Republican on the E&C Committee next Congress. Rep. Richard Hudson of North Carolina, chair of the National Republican Congressional Committee, has also been encouraged to run. Politico
Bill Gives Small-Molecule Drugs More Time On Market Before Negotiation
E&C Health Subcommittee Chair Rep. Brett Guthrie (R-KY_ joined Reps Greg Murphy (R-NC) and Don Davis (D-NC) in introducing legislation to address the “pill penalty” imposed by the Inflation Reduction Act (IRA) last year. Currently, the IRA states that small molecule drugs are eligible for drug price negotiation in Medicare seven years after a drug is granted FDA approval. A two-year negotiation period would follow, and the drug’s new maximum fair price would take effect in the ninth year since the drug’s approval. Biologics, or large molecule drugs, have until 11 years after they receive FDA approval before being considered for price negotiation and the final negotiated prices become effective during the 13th year after the approval date.The Ensuring Pathways to Innovative Cures (EPIC) Act aims to balance the scale between small and large molecule drugs by aligning the statutory timelines so negotiation eligibility kicks in 11 years after a drug of either type is approved by FDA.
Drug
Senate 340B Workgroup Releases Discussion Draft
U.S. Sens. John Thune (R-S.D.), Debbie Stabenow (D-Mich.), Shelley Moore Capito (R-W.Va.), Tammy Baldwin (D-Wis.), Jerry Moran (R-Kan.), and Ben Cardin (D-Md.), all members of the Senate 340B bipartisan working group, released a legislative discussion draft that would make updates to the 340B program. Last year, the Senate 340B working group sought input on bipartisan policy solutions that would provide stability and transparency to the 340B program to ensure the program can continue to achieve its original intent of supporting entities serving eligible patients. In a letter sent to stakeholders today, the senators note that passing legislation in the 118th Congress remains a top priority for the working group.
House narrowly passes ban on quality-of-life metric
The House voted to pass legislation banning the use of quality-adjusted life years in federal programs. Authored by Energy and Commerce Committee Chair, Cathy McMorris Rodgers, the Protecting Healthcare for All Patients Act of 2023 would prohibit any federal program from evaluating an intervention’s impact by assigning it a value that many advocates say under-values how much a treatment or intervention will benefit someone who is sick or has a disability. The bill received significant push back from House Democratic leadership and is not expected to pass in the Senate.
Notable Notes
Washington Post Live to Hold a Virtual Discussion on “Improving Women’s Heart Health and Cardiovascular Care.”
Washington Post Live
Jennifer Ellis, Cardiac surgeon
Alicia Chong Rodriguez, Founder and CEO of Bloomer Tech
Janet Wright, Director of the Centers for Disease Control and Prevention’s Division for Heart Disease and Stroke Prevention
Alexandra Lansky, Professor of medicine at Yale School of Medicine
Martha Gulati, Director of preventive cardiology at Cedars-Sinai Medical Center’s Smidt Heart Institute
Jennifer Ellis was a member of the STS Workforce on Health Policy and was a leader with the Association of Black Cardiologists.
