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This week (Feb. 20-24)

Congress will be on recess until the week of February 27. As such, This Week in Health Policy will be on hiatus until Friday, March 3.

Last week (Feb. 13-17)

Health Care Highlights

CMS announces three new innovation models on drug pricing. On Tuesday (Feb. 14), the Centers for Medicare and Medicaid (CMS) announced that the Center for Medicare & Medicaid Innovation (CMMI) will test three new models targeting prescription drug prices. The three models selected by the Department of Health and Human Services (HHS) Secretary for testing are:

• The Medicare High-Value Drug List Model is a voluntary model that CMS said is designed to encourage Part D plans to offer "a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions." Under the proposal, Part D plans would be encouraged to set maximum monthly co-payments at $2 for about 150 high-value generic drugs. The HHS secretary directed CMS to collect input from stakeholders and announce model specifications as soon as possible.
• The Cell and Gene Therapy Access Model is a voluntary model under which state Medicaid agencies would partner with CMS, which would be tasked with coordinating and administering multi-state outcomes-based agreements with manufacturers of certain cell and gene therapies. The HHS Secretary suggested CMS could launch the model test as early as 2026.
• The Accelerating Clinical Evidence Model is a mandatory model that would adjust Medicare Part B fee-for-service providers' payments for Accelerated Approval Program (AAP) drugs to give manufacturers an incentive to expedite and complete confirmatory clinical trials. The HHS Secretary did not specify a timeline for the model, noting the model is likely to be "difficult to implement."

CMS published a fact sheet and HHS issued a report with additional details on the proposed models.

Biden signs EO to strengthen racial equity and underserved communities. On Thursday (Feb. 16), President Biden signed an executive order (EO) that directs federal agencies to produce annual public Equity Action Plans to address the barriers underserved communities may face in accessing and benefitting from the agency's policies, programs, and activities and improve community engagement, particularly with underserved communities. The EO also includes provisions to invest in underserved communities and improve data equity and transparency.

CMS proposed rule on nursing home ownership data reporting. On Monday (Feb. 13), CMS issued a proposed rule implementing portions of Section 6101 of the Affordable Care Act, which require Medicare skilled nursing facilities and Medicaid nursing facilities to disclose certain ownership, managerial, and other information, particularly related to private equity companies and real estate investment trusts. The rule received pushback from the nursing home industry. Mark Parkinson, president and CEO of the American Health Care Association and National Center for Assisted Living, said in a statement, "This has become a distraction from the real issues that impact the majority of providers, like Medicaid underfunding and workforce shortages."

CMS proposes Medicare coverage for power seat evaluation equipment. On Wednesday (Feb. 15), CMS released a proposed National Coverage Determination (NCD) decision that would expand coverage for power seat evaluation equipment on certain power wheelchairs for Medicare beneficiaries. The proposed NCD is open for a 30-day comment period.

ONC announces the first Qualified Health Information Networks. On Monday (Feb. 13), the Office of the National Coordinator for Health IT (ONC) and the Trusted Exchange Framework and Common Agreement (TEFCA) unveiled the first six organizations to be approved as prospective Qualified Health Information Networks to facilitate nationwide health information exchange. The Networks will be tasked with implementing TEFCA's eligibility requirements and terms and commitments, as well as a commitment to launch in 12 months.

Hearings and Markups

Senate Health, Education, Labor Pensions (HELP) Committee held a hearing on "Examining Health Care Workforce Shortages: Where Do We Go From Here": On Thursday (February 16), the Senate Health, Education, Labor Pensions (HELP) Committee held its first hearing of the year. During the hearing, committee members heard testimony from a panel of health care providers who offered solutions to the nation's current and future shortage of health care workers. Many of the proposals discussed focused on addressing underserved and rural areas, such as through loan repayment programs for providers who work in rural areas, and ways to fill workforce gaps. Lawmakers and panelists discussed improving reimbursement, expanding residency programs, and immigration and other solutions to increase the diversity of the health care workforce. Senate HELP Committee Chair Bernie Sanders (I-VT) began and closed the hearing with a promise to soon introduce legislation to address the workforce shortage..

• More information available here.

Senate Commerce, Science, & Transportation Committee held a hearing on "Bringing Transparency and Accountability to Pharmacy Benefit Managers." On Thursday (February 16), the Senate Commerce, Science, & Transportation Committee held a hearing entitled, "Bringing Transparency and Accountability to Pharmacy Benefit Managers." The hearing centered on the bipartisan Pharmacy Benefit Manager Transparency Act (S. 127) reintroduced by Committee Chair Maria Cantwell (D-WA) and Sen. Chuck Grassley (R-IA). During the hearing, both Democrats and Republicans cited a need for additional transparency to better understand how money flows through PBMs and the role PBMs play in patients' out-of-pocket drug costs. However, some Republicans, including ranking member Ted Cruz (R-TX), raised concerns about the bill's provisions related to the FTC and the potential for the FTC to assume new authorities at a time when there are no Republican commissioners. The panel heard from two panels of witnesses. First, Sen. Grassley, and next from a panel of experts, including a pharmacist, an oncology, and two economists. While most of the panelists spoke in favor of increasing PBM transparency, Casey Mulligan, a professor in economics at the University of Chicago, warned about the potential downfalls of increased PBM regulation.

• More information available here.

The Senate Veterans' Affairs Committee held a hearing to consider the nomination of Joshua D. Jacobs to be undersecretary for benefits for the Department of Veterans Affairs: On Thursday (Feb. 16), the Senate Veterans' Affairs Committee held a hearing to consider Joshua Jacobs' nomination for undersecretary for benefits for the Department of Veterans Affairs. Jacobs received little opposition during the hearing and fielded comments on how he would implement the Promise to Address Comprehensive Toxics (PACT) Act. Jacobs is expected to be confirmed in the coming weeks.

• More information available here.

Senate Foreign Relations Committee held a hearing on "Countering Illicit Fentanyl Trafficking": On Wednesday (Feb. 15), the Senate Foreign Relations Committee held a hearing on illicit fentanyl trafficking. The committee heard from a panel of federal government representatives including Drug Enforcement Administration Administrator Anne Milgram, Assistant Secretary of State Bureau of International Narcotics and Law Enforcement Affairs Todd Robinson, and Office of National Drug Control Policy Director Rahul Gupta. During the hearing, lawmakers and panelists discussed policy solutions to reduce the amount of illicit fentanyl entering the Untied States, including those targeting ports of entry, social media, and role of drug cartels.

• More information available here.

Senate Judiciary Committee held a hearing on "Protecting Our Children Online": On Tuesday (Feb. 14), the Senate Judiciary Committee held a hearing on data privacy for children. The committee heard from a panel of the committee heard testimony from a panel of child safety advocates and industry leaders. During the hearing, lawmakers discussed several bills on the topic, including the Kids' Online Safety Act, the Earn It Act, the Children and Teens Online Privacy Protection Act, Platform Accountability and Transparency Act, and others, with lawmakers from both sides of aisle expressing a desire to strengthen online privacy protections for children.

• More information available here.

Reports, Studies, and Journals

Congressional Budget Office: The Budget and Economic Outlook: 2023 to 2033. The CBO's latest 10-year outlook projects the federal deficit for 2023 will be $0.4 trillion, and the cumulative deficit from 2023 to 2033 will be $3.1 trillion. CBO projected the deadline to address the debt limit will occur between July and September 2023.

Food and Drug Administration: External Review of FDA Regulation of Opioid Analgesics Final Report. The report details the FDA's independent external opioid-related activities review and recommends three ways the FDA can improve its drug overdose response efforts, including proposals to ask Congress for authorities to strengthen oversight of prescription opioid analgesics. Health Affairs: Hospital Price Transparency: Progress And Commitment To Achieving Its Potential. In the article, Centers for Medicare & Medicaid Services leaders share results of a study that found 70% of hospitals are in compliance with the Hospital Price Transparency Rule's requirements to publicly post a machine-readable file that contains payment information, as well as a consumer-friendly display of at least 300 shoppable services. CMS said this is up from 27% compliance in 2021.

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