Regulatory Digest – Week of February 26, 2024

Introduction
This week all eyes have been on Congress and their efforts to avert a partial (or total) government shutdown. Meanwhile, the EtO final rule (expected today) is still pending but the MA final rule is at OMB.

Weekly Spotlight

Congress has spared no theatrics this year, punting FY 2024 spending bills once again in hopes that they can reach a final deal on last year’s work before the middle of next month. The Leap Day votes thwarted a partial government shutdown on Saturday.

Congress now has until March 8 to pass six bills that have largely been agreed-to and until March 22 to pass the rest. FDA funding is included in the March 8th bunch while the rest of the Department of Health and Human Services funding is in the package now expiring on March 22. Advocates are still watching the March 22 bills for news on a number of programs that still need to be reauthorized including the global HIV/AIDS program, PEPFAR; the SUPPORT Act, which tackles the opioid epidemic; and the Pandemic and All-Hazards Preparedness Act. The negotiated bills also do not include any movement on proposals to reform the practices of pharmacy benefit managers.

Lastly, physicians still hoping for a “doc fix” (a patch to make up for a 3.4% pay cut in 2024 due to a reduction in the conversion factor in the Medicare physician fee schedule) have reason to be cautiously optimistic that they will get some relief. And something is probably better than nothing: Congress is rumored to be considering a 1.75% prospective conversion factor bump. This would leave a 1.63% conversion factor cut in place for the rest of the year. Net of the first 3 months of 2024 at -3.4%, doctors will have achieved a 1.25% fix annualized over the year. This fix is likely to be offset with the Medicare Improvement Fund or an extension of the Medicare sequester.

Meanwhile, President Biden will present his State of the Union address March 7 and is expected to release his budget proposal for FY 2025 on March 11. Check out my blog for more of my musings on the absurdity of appropriations brinksmanship and all things doc pay.

#All

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

MA and Part D Rule at OMB

The Medicare Advantage and Medicare Part D final rule is at the Office of Management and Budget for final review before publication.

#All

White House to hold a listening session on reforming pharmacy benefit managers

The White House will hold a listening session on Monday to hear ideas on ways to reform the role of pharmacy benefit managers, STAT reports. The list of attendees includes representatives from the federal government and industry, who are expected to provide insights into how the largest pharmacy benefit managers determine which medicines are covered by insurers and employers, as well as prices that are paid at pharmacy counters. Among those invited is Mark Cuban, whose Cost Plus Drug Company is trying to transform the marketplace by avoiding the largest middlemen when reaching benefits agreements with employers.

#Drug, #Hospital, #Patient, #Payer, #Provider

CMS Finalizes Part 1 Guidance on Part D Cap and Smoothing

CMS released the final part one guidance for the new Medicare Prescription Payment Plan to  ensure that Medicare Part D plan sponsors can effectively build the necessary infrastructure to provide a seamless experience for people enrolled in a Medicare Part D prescription drug plan, including those changes included in the Inflation Reduction Act.

#Drug, #Hospital, #Patient, #Payer, #Provider

CMS Call for Clinical Improvement Activity Measures

CMS is soliciting ideas for clinical practice improvement activities for consideration for future years of the Merit-based Incentive Payment System (MIPS). The MIPS Annual Call for Improvement Activities process allows clinicians, professional associations and medical societies that represent clinicians, researchers, consumer groups, and others to identify and submit activities.

#Provider

CMS Publishes 2024 National Impact Assessment of Quality Measures Report

The National Impact Assessment of the Centers for Medicare & Medicaid Services (CMS) Quality Measures Reports (Impact Assessment Reports) examine data-driven results that support progress toward CMS objectives to improve public health, implement measures meaningful to patients and providers, minimize provider burden, focus on outcomes whenever possible, identify significant opportunities for improvement, and support a transition to population-based payment models.

#Provider, #Hospital, #Patient

Food and Drug Administration (FDA)

EtO Rule Update

FDA hosted another in a series of Medical Device Sterilization Town Halls on February 29th, one day before the expected publication of a final regulation governing the use of ethylene oxide (Eto) for medical device sterilization. Kaiser Family Foundation also took a look behind the scenes at FDA and the EPA to understand their efforts to limit the risks associated with the use of EtO.

#Device

2023 FDA Oncology Center of Excellence (OCE) Annual Report

The 2023 report highlights three new OCE projects aimed at achieving better outcomes for patients with cancer.

  • Project ASIATICA is bringing together advocacy, research, and policy regarding Asian American, Native Hawaiian, and other Pacific Islander patients with cancer.
  • Project Endpoint is working to enhance the development of endpoints in oncology drug development and foster engagement with the broader community to advance our understanding of and explore potential uses for early, novel endpoints that will ultimately improve outcomes for patients.
  • Project Pragmatica provided feedback and interaction with the National Cancer Institute to develop the Pragmatica-Lung Study, a randomized phase 3 trial of a two-drug combination in lung cancer, launched in April 2023. The trial encourages streamlined eligibility criteria and safety data collection, and specific community recruitment efforts aimed at inclusive populations.

#Drug, #Hospital, #Patient, #Payer, #Provider

Hill Happenings

CBO’s Waterfall Model for Projecting Discretionary Spending, February 2024

A new interactive tool from CBO allows users to simulate the agency’s process for projecting discretionary budget authority and outlays for different types of spending over the course of 10 years.

#All

Notable Notes

GCOA Announces Healthy Ageing Innovation Prize

More information.

#Drug, #Device

States Guard Drug Discount Program as Pharma Wages Legal Battles

Bloomberg reports state legislation aiming to block discriminatory practices used against pharmacies in the federal 340B Drug Discount Program is ramping up this year despite legal challenges from the pharmaceutical industry, Bloomberg Law explains. The program has faced challenges over how discounts are used or where they are provided, while some drug makers have restricted discounts to contract pharmacies. At least a dozen states have introduced 340B contract pharmacy arrangement protection laws to combat the restrictions, but states that passed legislation are currently defending provisions in court. But several other states are still taking their chances introducing laws to protect the federal scheme.

#Drug, #Hospital, #Patient

NMQF to Host Webinar on Cardiovascular Health Equity

More information.

#Patient, #Provider

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