THIS WEEK’S DOSE

• House Passes Legislation to Prohibit Use of QALYs: The Protecting Health Care for All Patients Act would prohibit the use of quality-adjusted life years (QALYs) and similar measures in all federal programs.
• House Hearing Examines Chronic Drug Shortages: The House Ways and Means Committee held a hearing to discuss chronic drug shortages.
• Senate Hearings Focus on AI, Prescription Drug Prices: The Senate Finance Committee held a hearing to discuss artificial intelligence (AI) in healthcare, and the Senate Health, Education, Labor & Pensions (HELP) Committee held a hearing to discuss US prescription drug costs.
• Administration Releases 42 CFR Part 2 Final Rule: The Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office for Civil Rights (OCR) finalized modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR Part 2.
• Administration Launches Behavioral Health IT Initiative: SAMHSA and the Office of the National Coordinator for Health Information Technology (ONC) announced the Behavioral Health Information Technology (IT) Initiative.
• HRSA Announces OPTN Updates: The Health Resources and Services Administration (HRSA) announced updates related to its Organ Procurement and Transplantation Network (OPTN) Modernization Initiative.

CONGRESS

House Passes Legislation to Prohibit Use of QALYs in All Federal Health Programs. The House passed H.R. 485, the Protecting Health Care for All Patients Act of 2023, a bill designed to prohibit the use of QALYs and similar measures in all federal programs. Despite attempts at the committee level to achieve bipartisan support, an agreement was never reached and Democrats remained in opposition on the House floor, where the bill was approved in a party line vote of 211 – 208.

House Energy and Commerce Committee Chair Rodgers (R-WA) and others supporting the legislation have noted that QALYs discriminate against people with disabilities by underestimating how much treatments benefit them. On the other hand, Energy and Commerce Committee Ranking Member Pallone (D-NJ) has stated that even though he has no problem banning QALYs, the language in the bill is too vague and could allow pharmaceutical companies to charge more for drugs.

House Ways and Means Committee Holds Hearing on Chronic Drug Shortages. The hearing included discussion on the pervasive problem of drug shortages and their harmful impact on patient access to care. Republicans stated that the root cause of drug shortages is overregulation by the government. Many members highlighted the need to take domestic control over production of active pharmaceutical ingredients. Some members expressed concern with China and India’s involvement in producing these ingredients. Many members noted the disparities in how drug shortages affect rural Americans compared to their urban counterparts.

Senate Finance Committee Holds Hearing on AI. The hearing included discussion on the use of algorithms and AI systems in federal healthcare programs. Witnesses shared the potential benefits and harms of using AI in healthcare decisions and called for increased regulation of AI that still allows for innovation. They noted the need for the government to establish standards for organizational readiness and responsibility in using healthcare AI tools. They also highlighted disparities that exist within AI models. Many senators expressed concern that AI could exacerbate these disparities and emphasized the need to address them. Some senators emphasized the need to make sure that doctors are able to supplement their care with AI but still make their own decisions.

Senate HELP Committee Holds Hearing on US Prescription Drug Costs. The hearing witnesses included pharmaceutical executives, and the committee discussed the question of why the US has higher drug prices than its global peers, as well as what steps are needed to reduce prices and encourage competition. There was bipartisan concern about the high cost of prescription drugs and recognition of the need to balance cost with innovation. Witnesses and some Republican committee members noted the existence of improved access to and options for innovative drugs. Democratic committee members expressed concern about high levels of spending on stock buybacks, dividends, executive compensation, and marketing and advertising compared to research and development. There was bipartisan concern about the corruption of the patent system and anticompetitive behavior by the pharmaceutical industry.

ADMINISTRATION

Administration Releases 42 CFR Part 2 Final Rule. The final rule pertains to regulations that protect the privacy of patients’ SUD treatment records. The rule contains provisions intended to increase coordination among providers treating patients for SUDs, strengthen confidentiality protections through civil enforcement and enhance integration of behavioral health information with other medical records to improve patient health outcomes.

The final rule includes the following modifications to 42 CFR 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 healthcare operations.
• Permits redisclosure of Part 2 records by Health Insurance Portability and Accountability Act (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 the US Department of Health and Human Services (HHS) with 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.

Read the HHS press release here and the fact sheet here.

SAMHSA and ONC Launch Behavioral Health IT Initiative. The initiative will invest more than $20 million over three years in an effort to identify and pilot a set of behavioral-health-specific data elements with SAMHSA’s Substance Use Prevention, Treatment, and Recovery Services Block Grant and Community Mental Health Services Block Grant grantees.

In a blog post announcing the initiative, SAMHSA and ONC noted that health IT adoption among behavioral health providers currently lags behind other providers. They also noted that lack of access to health IT and associated higher-level capabilities and efficiencies – such as notifications, clinical decision support, care planning, data exchange, analytics and reporting – impact behavioral health providers’ abilities to provide access to treatment through tools such as telehealth and limit integration of behavioral health data with primary care and other physical health entities.

The Behavioral Health IT Initiative aims to advance health IT in behavioral health broadly across HHS programs and beyond. SAMHSA and ONC intend to announce further updates on this initiative, along with opportunities to engage and help inform their work.

HRSA Announces OPTN Updates. HRSA released updates related to its OPTN Modernization Initiative. Announced in March 2023, the Modernization Initiative aims to strengthen the OPTN in five areas: technology, data transparency, governance, operations and quality improvement, and innovation. To support the initiative, Congress enacted legislation in September 2023 authorizing HRSA to expand competition for OPTN contracts and transform the system. While the legislation gave HRSA additional flexibility, Congress has not yet appropriated the additional funding necessary to accomplish HRSA’s modernization goals.

The most recent actions announced by HRSA include the following:

• Releasing a contract solicitation to create an independent OPTN board of directors, including supporting a special election to seat a new board within six months of contract award.
• Issuing a multi-vendor contract solicitation to support broad competition and best-in-class vendors for critical OPTN functions, to better serve the needs of patients, families and their care teams.
• Launching the discovery and development phase of the transition to a modernized OPTN IT matching system that leverages industry-leading IT standards and practices.
• Actions to address “pre-waitlist” inequities in the organ waitlist process and reduce variations in referrals to transplant and in organ procurement practices, including standardizing and updating data reporting on referrals, time-to-patient assessment, time-to-organ procurement and other data to allow for greater accountability across geography and populations and facilitate improved system performance.

In its press release, HRSA notes that the scope and scale of awards under the new solicitations will be contingent on final FY 2024 appropriations. HRSA’s FY 2024 budget proposed a $36 million increase to support modernization efforts. Final FY 2024 appropriations decisions are still being made in Congress, and the final amount may be well below that number.

For additional background and details on the OPTN and HRSA’s Modernization Initiative, please refer to our January +Insight, “Organ Procurement and Transplantation Network: What’s Next in Oversight and Reform.”

QUICK HITS

• HHS Releases Strategy to Combat Vector-Borne Diseases. HHS released the National Public Health Strategy to Prevent and Control Vector-Borne Diseases in People. This strategy represents the largest formal federal coordination effort focused on vector-borne disease (i.e., diseases from biting insects such as ticks, mosquitos, fleas and lice) prevention and control. Read more at this HHS press release.
• CMS Approves New Mexico’s Request for Community-Based Mobile Crisis Teams. The Centers for Medicare & Medicaid Services (CMS) approved a proposal from New Mexico for community-based mobile crisis intervention teams to provide Medicaid crisis services. With this approval, the state will be able to connect eligible individuals in crisis to a behavioral health provider 24 hours per day, 365 days a year.
• CMS Updates Medicare Current Beneficiary Survey Chartbook. Now updated with data for 2021, the chartbook is a resource for ready-made tables and graphs on four domains: Medicare Population Overview, Medicare Health and Well-Being, Health Care Access and Satisfaction, and Health Care Use and Expenditures.
• White House Holds IRA Briefing. CMS Administrator Brooks-LaSure emphasized the expanded eligibility for the Medicare Part D Extra Help program and the benefits available to seniors. HHS Secretary Becerra highlighted the historic change of Medicare’s new ability to negotiate with drug manufacturers to bring down costs for individuals and taxpayers. The Center for Medicare director, Dr. Seshamani, highlighted the impact that the cap on out-of-pocket drug costs in Part D is already having and noted that the impact will expand in 2025 when the cap drops to $2,000 annually.
• HRSA Releases Telehealth Funding Opportunity. HRSA released a new notice of funding opportunity to support innovative multi-state collaborations that will enable licensed healthcare professionals to provide physical health and behavioral health services through telehealth technology across states. HRSA will award approximately $500,000 to up to four eligible applicants annually over a period of five years. Applications are due by April 8, 2024. View the grant opportunity here, and join HRSA’s technical assistance webinar here on February 21, 2024, at 3:00 pm EST to learn more.

NEXT WEEK’S DIAGNOSIS

The Senate is scheduled to be in recess next week but Majority Leader Schumer (D-NY) has noted they will delay the recess until they complete consideration of the emergency supplemental bill that includes funding for Israel and Ukraine. The House is scheduled to be in session next week. Healthcare activity will occur at the committee level, including a House Energy and Commerce Committee legislative hearing on 19 public health bills.