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This Week (December 11 - 15)

The House this week is scheduled to vote on the Lower Cost, More Transparency Act, the SUPPORT Act, and the PREEMIE Reauthorization Act of 2023.

Senate Health, Education, Labor & Pensions Committee will hold a hearing on "What is Fueling the Diabetes Epidemic?"

• Date: Thursday, December 14 at 10:00am ET
• More information available here.

House Energy & Commerce Committee will hold a hearing on "Leveraging Agency Expertise to Foster American AI Leadership and Innovation."

• Date: Wednesday, December 13 at 10:00am ET
• More information available here.

Senate Health, Education, Labor & Pensions Committee will hold a markup of health care legislation.

• Date: Tuesday, December 12 at 10:00am ET
• More information available here.

House Veterans' Affairs Subcommittee on Health Oversight will hold a hearing on "SSG Fox Suicide Prevention Grants: Saving Veterans' Lives Through Community Connection"

• Date: Tuesday, December 12 at 10:30am ET
• More information available here.

Last Week (December 4 - 8)

Health Care Highlights

FDA approves first CRISPR therapy. On Friday (December 8), the Food and Drug Administration (FDA) approved the first gene therapies to treat sickle cell disease, including the first cell-based gene therapy that uses CRISPR, a genome editing technology. The CRISPR-enabled therapy, Casgevy, is approved to treat sickle cell disease in patients ages 12 and older with recurrent vaso-occlusive crises. The other therapy, Lyfgenia uses a lentiviral vector for genetic modification and is approved to treat sickle cell disease in patients ages 12 and older with a history of vaso-occlusive events. A key unknown will be how the new treatments are priced and what the price point means for coverage and patient access.

Biden admin takes steps to address health care, drug costs. On Thursday (December 7), the Biden administration announced a slew of actions to promote competition in health care and lower health care and prescription drug costs:

• March-in rights. The Commerce Department unveiled a proposed framework outlining a series of questions federal agencies should consider when determining whether an innovation should be subject to the Bayh-Dole Act's march-in rights. The framework proposes a three-step process to determine whether one of the four statutory requirements for march-in rights apply and instructs agencies to consider whether a price is "extreme and unjustified," as well as the potential "chilling effect" on existing government relationships with industry. To date, no agency has exercised its right to march-in and re-allocate patent licenses for an innovation that was developed using taxpayer funding. However, the Biden administration with the new framework is signaling it will consider such tools for excessively priced drugs. White House National Economic Advisor Lael Brainard said, "When drug companies won't sell taxpayer funded drugs at reasonable prices, we will be prepared to allow other companies to provide those drugs for less." The proposal has drawn pushback from advocates who support and oppose the government's use of march-in rights, with those in support saying the "extreme" cost threshold is too restrictive and those opposed saying it will harm innovation. The proposal will be open for 60 days for comment and must undergo review by an inter-agency working group before being finalized.
• M&A activity: The Department of Justice (DOJ), the Federal Trade Commission (FTC), and the Department of Health and Human Services (HHS) issued a joint Request for Information to collect information on the impact private equity and "other corporations' increasing power and control of our health care" has on patients and to inform future rulemaking. The agencies, which are each working to address competition in health care, said they will work together and appoint health care competition officers to coordinate efforts and identify potentially anticompetitive transactions.
• Transparency: CMS published ownership data on Federal Qualified Health Centers and Rural Health Clinics. In addition, CMS will take additional steps to increase transparency into Medicare Advantage data by soliciting information from the public early next year on ways to strengthen CMS' data capabilities and Medicare Advantage transparency efforts.

Senate Finance Committee unveils legislative text on bipartisan package. On Thursday (December 7), the Senate Finance Committee reported legislative text on bipartisan policies that the Committee advanced last month. The Better Mental Health Care, Lower-Cost Drugs, and Extenders Act includes policies to expand Medicare and Medicaid beneficiaries' access to mental health care and substance use disorder services, address certain pharmacy benefit manager (PBM) practices to help lower out-of-pocket costs for seniors and support community pharmacies, extend expiring Medicare and Medicaid programs, and increase Medicare payments to providers. Click here for the legislative text. Click here for a section by section summary.

Senate Budget Committee launches inquiry into PE ownership of hospitals. On Thursday (December 7), the Senate Budget Committee launched a bipartisan investigation into private equity ownership of hospitals. Senators Whitehouse and Grassley sent letters to the chief executive officers (CEOs) of Leonard Green & Partners, Prospect Medical Holdings, Medical Properties Trust, Apollo Global Management, Lifepoint Health, and Ottumwa Regional Health Center, raising questions about the quality of patient care in hospitals owned by private equity.

HHS looks to improve cybersecurity protections. On Wednesday (December 6), HHS released a concept paper detailing the Department's health care cybersecurity strategy. The paper outlines four actions to help protect health care entities from cyberattacks: crafting voluntary performance goals working with Congress on needed authorities and resources; proposing enforceable cybersecurity standards to be incorporated into existing programs, including increasing civil monetary penalties for HIPAA violations; and enabling the Administration for Strategic Preparedness and Response's (ASPR) to serve as a coordinator for health care cybersecurity.

CMS' open enrollment data update. On Wednesday (December 6), CMS said nearly 7.3 million people have selected a 2024 health plan through the federally facilitated and state-based health insurance marketplaces from Nov. 1 through Dec. 2. CMS said about 23% of all plan selections were for new customers, while the rest were returning customers.

NIH expands Home Test to Treat program. On Wednesday (December 6), the National Institutes of Health announced it will expand the Home Test to Treat pilot program nationally, enabling patients who test positive test for COVID-19 or the flu to receive no-cost testing and treatment via telehealth at no out-of-pocket cost.

CMS publishes interim final rule on Medicaid redetermination enforcement authorities. On Wednesday (December 6), CMS published an interim final rule with request for comments that implements new reporting requirements and enforcement authorities under the Consolidated Appropriations Act, 2023 (CAA, 2023) related to the Medicaid redetermination process. The new enforcement authorities for states that fail to comply include requiring states to submit a corrective action plan, suspending dis-enrollments from Medicaid for procedural reasons, and imposing civil money penalties, as well as reducing the state's Federal Medical Assistance Percentage (FMAP) for failure to meet reporting requirements. The rule is effective as of December 6.

Biden Administration publishes Fall 2023 Unified Agenda. On Wednesday (December 6), the Biden administration published the unified agenda on the Office of Management and Budget, which includes agency rule lists for all federal departments. In addition, the HHS fall 2023 list, unified agenda includes several highly anticipated rules impacting health care from the Department of Justice and the Department of Labor.

Joint Commission launches new certification program. On Wednesday (December 6), the Joint Commission announced it plans to launch a new certification program on the Responsible Use of Health Data for U.S. hospitals and critical access hospitals in 2024. The certification's requirements cover the de-identification process, data controls, limitations on use, algorithm validation, patient transparency, and oversight structure.

Hearings, Markups, and Other Committee Action

Senate Finance Committee held a hearing on "Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective." On Tuesday (December 5), the Senate Finance Committee held a hearing focused on addressing existing and preventing future drug shortages, which often impact low-cost generics, such as generic sterile injectable (GSI) drugs. During the hearing, lawmakers heard from a panel of witnesses representing pharmacists, economists, novel generic drug manufacturers, and doctors all of whom said addressing existing and future drug shortages will require new investments in generics. Specifically, several witnesses spoke about the importance of creating financial incentives for purchasers, such as group purchasing organizations (GPOs) or health systems, to contract with generic drug manufacturers who have made investments in quality manufacturing, as opposed to those who simply have the lowest-priced generic drug. The witnesses and several lawmakers raised concerns that this "race to the bottom" occurring in generic drug pricing is a primary driver of the current shortages.

• More information available here.

House Energy & Commerce Committee held a mark up of 44 bills, including 19 health care bills. On Wednesday (November 29), the Committee advanced to the full House 19 health care bills:

• H.R. 5372, Expanding Seniors' Access to Lower Cost Medicines Act of 2023, was reported, as amended, by a roll call vote of 48-0.
• H.R. 2880, Protecting Patients Against PBM Abuses Act, was reported, as amended, by a roll call vote of 46-0.
• H.R. 5393, To amend title XVIII of the Social Security Act to ensure fair assessment of pharmacy performance and quality under Medicare part D, and for other purposes, was reported by a roll call vote of 44-0.
• H.R. 5385, Medicare PBM Accountability Act, was reported, as amended, by a roll call vote of 44-0.
• H.R. 5386, Cutting Copays Act, was reported, as amended, by a roll call vote of 41-1.
• H.R. 4881, To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program, was reported, as amended, by a roll call vote of 45-0.
• H.R. 5389, National Coverage Determination Transparency Act, was reported, as amended, by a roll call vote of 46-0.
• H.R. 133, Mandating Exclusive Review of Individual Treatments (MERIT) Act, was reported, as amended, by a roll call vote of 42-0.
• H.R. 5396, Coverage Determination Clarity Act of 2023, was reported, as amended, by a roll call vote of 44-0.
• H.R. 5371, Choices for Increased Mobility Act of 2023, was reported, as amended, by a roll call vote of 41-0.
• H.R. 5388, Supporting Innovation for Seniors Act, was reported, as amended, by a roll call vote of 43-0.
• H.R. 5380, To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage, was reported, as amended, by a roll call vote of 43-0.
• H.R. 3842, Expanding Access to Diabetes Self-Management Training Act of 2023, was reported, as amended, by a roll call vote of 44-0.
• H.R. 5397, Joe Fiandra Access to Home Infusion Act of 2023, was reported, as amended, by a roll call vote of 46-0.
• H.R. 5555, DMEPOS Relief Act of 2023, was reported, as amended, by a voice vote.
• H.R. 2365, National Plan to End Parkinson's Act, was reported, as amended, by a roll call vote of 47-0.
• H.R. 6545, Physician Fee Schedule Update and Improvements Act, was reported, as amended, by a roll call vote of 46-0.
• H.R. 6364, Medicare Telehealth Privacy Act of 2023, was reported, as amended, by a roll call vote of 44-0.
• H.R. 1352, Increasing Access to Biosimilars Act of 2023, was reported, as amended, by a roll call vote of 44-0s.

• More information available here.

Reports, Studies, and Journals

JAMA: Reimbursement to Pharmacies for Generic Drugs by Medicare Part D Sponsors. The study found that Medicare Part D sponsors provided excessive point-of-sale reimbursements, a mean of 5.4 times, to pharmacies for certain generic drugs compared with acquisition costs.

Health Affairs: A National Overview of Nonprofit Hospital Community Benefit Programs to Address the Social Determinants of Health. A study provides an overview to better understand the extent to which US nonprofit hospitals invest in social determinants of health at either the community or individual patient level and to provide examples of programs in each area.

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