HealthCare Roundtable e-News – February 12, 2024

 

Top News

House Passes Bill to Ban QALYs and Related Measures in Federal Programs

The House passed H.R.485, Protecting Health Care for All Patients Act, which prohibits federal health care programs from utilizing quality-adjusted life years (QALYs) to determine relevant thresholds for coverage, reimbursements, or incentive programs. QALYs are metrics utilized to evaluate a drug’s effects on health outcomes and quality of life. Introduced by the House Energy and Commerce Chair Representative Cathy McMorris Rodgers (R-WA), this legislation would ban Medicaid, the VA, and other programs from using QALYs and similar measures. Previously, the Affordable Care Act prohibited the use of QALYs as a standard in determining health care coverage within Medicare. Advocates of the bill note that QALYs are discriminatory measures against individuals with disabilities because they contribute to underestimates of the benefits of treatments. Members of Congress, such as Representative Frank Pallone (D-NJ) raised concerns about the bill’s vague language and potential issues related to lowering drug costs. Democratic leaders cited that the bill could weaken Inflation Reduction Act Medicare drug price negotiation provisions.

 

House Committee on Oversight and Accountability Holds Markup on PBM Bill

The House of Representatives Committee on Oversight and Accountability held a markup on six bills including H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act. This bipartisan, bicameral act would prohibit Pharmacy Benefit Managers (PBMs) from making higher profits on expensive drugs than they do from lower-cost drugs to even the playing field for patients. During the markup, Committee members proposed amendments to the bill surrounding transparency and oversight of PBMs. The bill was agreed to with 29 in favor and 11 opposed with one member voting present. Healthsperien covered the markup and detailed notes can be found HERE.

 

Senate 340B Bipartisan Working Group Releases Legislative Discussion Draft

Members of the Senate 340B bipartisan working group released a legislative discussion draft that would make updates to the 340B program. The 340B program requires that drug manufacturers participating in Medicaid and Medicare provide certain non-profit health care providers, hospitals, and clinics a discount on outpatient drugs. In a letter sent to 340B stakeholders, members of the working group note that passing legislation in the 118th Congress is their top priority. This draft discussion is in response to the Request for Information the working group issued in June of 2023. However, the working group is seeking additional information on various aspects, including patient definition, child sites, and contract pharmacy arrangements. The comment period will be open from now until April 1, 2024.

Regulatory Action

  • The Administration for Community Living (ACL) released a final rule (overview) to update the regulations implementing its Older Americans Act (OAA) programs. The new regulations will take effect on March 15, 2024, but regulated entities have until October 1, 2025, to comply. The OAA authorizes programs and services that help older adults age in place, ombudsman services that support older adults who live in long-term care facilities, and additional services for caregivers and older adults. The release of the final rule reflects input received through a request for information, a series of listening sessions, and more than 750 comments received in response to the June 2023 Notice of Proposed Rule Making (NPRM) from a range of stakeholders.

Key provisions of the final rule include:

    • Providing more information about implementing the definition of “greatest social need” in State and area plans, in particular permitting State agencies and AAAs to further refine specific target populations of greatest social need based on local and individual factors.
    • Incorporating guidance for the National Family Caregiver Support Program and the Native American Caregiver Support Program, which were authorized since the last update to the OAA regulations.
    • Establishing expectations for legal assistance and activities to prevent elder abuse.
    • Updating definitions, modernizing requirements, and clarifying flexibilities within the senior nutrition programs, in particular increasing the amount of funds used for shelf-stable, pick-up, drive through meals.

In the coming months, ACL will share resources and provide technical assistance to support states, tribes and tribal organizations, area agencies on aging, and others in the aging network in meeting the requirements of the new regulations.

 

  • The Substance Abuse and Mental Health Services Administration (SAMHSA) released a final rule that finalizes modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations, which protect the privacy of patients’ SUD treatment records. The rule was informed by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that, among other things, required HHS to bring the Part 2 program into closer alignment with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Breach Notification, and Enforcement Rules. The final rule includes the following modifications to Part 2:
    • Permits use and disclosure of Part 2 records based on a single patient consent given once for all future uses and disclosures for treatment, payment, and health care operations.
    • Permits redisclosure of Part 2 records by HIPAA covered entities and business associates in accordance with the HIPAA Privacy Rule, with certain exceptions.
    • Provides new rights for patients under Part 2 to obtain an accounting of disclosures and to request restrictions on certain disclosures, as also granted by the HIPAA Privacy Rule.
    • Expands prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative, and legislative proceedings.
    • Provides HHS enforcement authority, including the potential imposition of civil money penalties for violations of Part 2.
    • Outlines new breach notification requirements applying to Part 2 records.

Congressional Action

U.S. Senators Marco Rubio (R-FL) and Tom Carper (D-DE) recently introduced the At Home Observation and Medical Evaluation (HOME) Services Act (press release). The HOME Act would establish a pilot program that will test expanding the acute hospital-at-home program to include observation status patients with the goal of opening hospital beds for patients needing more support. The current hospital-at-home program only covers acute patients, not observation status patients. The hospital-at-home program has proven vital in providing care during periods of high demand on hospital resources, particularly during the COVID-19 public health emergency. The HOME Act aims to expand the services of this program to better prepare hospitals for the next public health crisis. Senator Marsha Blackburn (R-TN) is an original cosponsor of the HOME Act, indicating bipartisan support of the legislation.


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