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 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:
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:
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.”
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.
For more information, contact Debra Curtis, Kristen O’Brien, Priya Rathakrishnan or Erica Stocker.
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