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This Week (June 27-July 1)

The House Energy and Commerce Health Subcommittee holds a hearing on "Protecting America's Seniors: Oversight of Private Sector Medicare Advantage Plans."

• Details: 11:00 AM EDT on 06/28/2022, 2123 Rayburn House Office Building
• More information available here.

The House Energy and Commerce Health Subcommittee holds a hearing on "Investing in Public Health: Legislation to Support Patients, Workers, and Research."

• Details: 11:00 AM EDT on 06/29/2022, 2123 Rayburn House Office Building
• More information available here.

Last Week (June 20-24)

Health Care Highlights

Supreme Court overturns Roe v. Wade; White House responds. On Friday (June 24), in one of the most anticipated rulings in decades, the Supreme Court voted 5-4 to overturn Roe v. Wade, which first declared a constitutional right to abortion in 1973, and Planned Parenthood v. Casey, which re-affirmed that right in 1992. President Joe Biden along with other Biden Administration officials immediately condemned the ruling, saying that the justices took away a fundamental right that had been in place for decades. The White House also announced on Friday actions they were taking in response to the ruling along with releasing the Biden-Harris Blueprint for Addressing the Maternal Health Crisis. The Blueprint outlines five priorities to improve maternal health and outcomes in the United States:

• Increasing access to and coverage of comprehensive high-quality maternal health services, including behavioral health services
• Ensuring women giving birth are heard and are decisionmakers in accountable systems of care
• Advancing data collection, standardization, harmonization, transparency, and research
• Expanding and diversifying the perinatal workforce
• Strengthening economic and social supports for people before, during, and after pregnancy.

CMS Administrator Chiquita Brooks-LaSure also issued a statement, saying "I will do everything in my authority to ensure that people have the choice of when and how to start a family … CMS will continue working to maintain and expand access to the full range of reproductive health care services across the lifespan — that includes IUDs, emergency contraception, oral contraception, other forms of contraception, and abortion care within our legal authority."

Congress sends gun safety bill with mental health investments to Biden's desk. On Friday (June 24), the House passed 234-193 a bipartisan gun safety bill, following a 65-33 Senate vote on Thursday (June 23), sending it to President Biden for his signature. The bill, called the "Bipartisan Safer Communities Act," would close the so-called "boyfriend loophole," impose a de facto waiting period for firearm purchasers under the age of 21, and incentivize states to enact red flag laws. The bill also contains billions of dollars aimed at addressing mental health and substance use disorder. One of the most significant components of the package would expand the federal Certified Community Behavioral Health Clinics (CCBHCs) demonstration program, currently in a limited number of states, to nationwide. The legislation also requires the Secretaries of Health and Human Services (HHS) and Education to provide guidance to Medicaid agencies and schools on the provisions of mental health services in school; requires the HHS Secretary to provide guidance to Medicaid agencies on providing telehealth services; among other mental health investments.

House passes mental health and ARPA-H legislation. The House this week also passed two health care bills of note on a strong bipartisan basis: the Restoring Hope for Mental Health and Well-Being Act (H.R. 7666) and the Advanced Research Projects Agency-Health (ARPA-H) Act (H.R. 5585). H.R. 7666 would reauthorize mental health and substance use disorder block grants and related programs administered by the Substance Abuse and Mental Health Services Administration (SAMHSA) and Health Resources and Services Administration (HRSA), along with a variety of other items. Among those, the bill would require all nonfederal governmental health plans to comply with mental health insurance parity rules, eliminate the need for doctors to obtain waivers to prescribe detoxification treatment, add reporting requirements for insurers regarding pharmacy benefit managers (PBMs), and extend Medicaid and CHIP benefits to institutionalized juveniles, among other items. H.R. 5585 would formally establish ARPA-H as part of HHS and authorize $500 million annually from fiscal 2023 through 2027 for the office. The pieces of legislation have uncertain futures, however, as the Senate Finance committee is crafting its own bipartisan mental health package and has an alternate bill regarding the creation of ARPA-H.

CMS approves Colorado Insurance Option. This week, the Biden administration approved Colorado's proposal to offer a state-run health insurance plan on the Affordable Care Act (ACA) exchanges next year, making it the first federally backed public option. The health plan is expected to lower premiums by an average of 22%, or about $132 monthly per person according to a CMS Press Release. According to a an accompanying Fact Sheet, the approved State Innovation Waiver will allow for the full implementation of the Colorado Option, "which is an innovative model for health insurance that promotes competition and health equity by combining several key components: standardized benefit plans; required premium reduction targets; regulatory and programmatic mechanisms as a backstop to ensure providers, hospitals, and issuers meet those targets; and state subsidies to lower out-of-pocket costs for individuals and families enrolling in coverage through the state's Exchange and for those not currently eligible for federal subsidies under the ACA."

CMS releases proposed Home Health and ESRD Rules. Late last week, CMS issued CY 2023 Home Health Prospective Payment System Rate Update proposed rule, which is projected to cut Medicare payments for such agencies by 4.2% next year, or $810 million compared to CY 2022. On Tuesday (June 21), CMS issued the End-Stage Renal Disease (ESRD) Prospective Payment System proposed rule for CY 2023. The ESRD rule is projected to lead to an overall 3.1% pay bump from last year for freestanding dialysis centers and a 3.7% boost for hospital-based facilities.

Bipartisan Senators release $35 insulin cap bill. Earlier this week, by Sens. Jeanne Shaheen (D-NH) and Susan Collins (R-ME) introduced legislation, the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act, designed to lower the costs of insulin. The bill is aimed at:

• Ensuring that insurance plans and PBMs cannot collect rebates on insulins that limit list price to the 2021 net prices for Medicare Part D or equivalent levels;
• Making such insulins eligible for cost-sharing protections, including waiver of any applicable deductible and limiting copays or coinsurance to no more than $35 per month or 25% of list price; and,
• Supporting patient access to such insulins by ensuring coverage and prior authorization, step therapy or other medical management requirements cannot be imposed to limit beneficiary use. .

Senate Majority Leader Chuck Schumer (D-NY) said he plans to hold a vote on the bill soon, however it is unclear if there are 10 Republican votes for the bill, which Democrats would need to avert a filibuster and pass the measure using the normal legislative process.

Biden administration action on e-cigarettes and nicotine. The FDA this week denied marketing authorization to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. The announcement comes after an FDA review of the company's premarket tobacco product applications (PMTAs), which the FDA determined "lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health." Juul is expected to appeal the decision. The FDA also announced this week plans to develop a proposed product standard that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products. "The goal of the potential rule would be to reduce youth use, addiction and death."

Reports, Studies, and Journals

Kaiser Family Foundation: The Last Major Phase of the COVID-19 Vaccination Roll-out: Children Under 5. This brief provides an overview of the characteristics of children under the age of 5 nationally and by state and discusses some of the particular issues to consider in rolling out vaccination to this age group.

The Commonwealth Fund: Meeting America's Public Health Challenge. Recommendations for Building a National Public Health System That Addresses Ongoing and Future Health Crises, Advances Equity, and Earns Trust

JAMA Network Open: Racial and Ethnic Disparities in Postpartum Care in the Greater Boston Area During the COVID-19 Pandemic. The study highlights racial and ethnic disparities in postpartum care access both before and after the onset of the pandemic, raising concerns about disparities in postpartum care-associated maternal and infant outcomes.

Medicaid and CHIP Payment and Access Commission: Directed Payments in Medicaid Managed Care. As of December 31, 2020, CMS had approved 201 distinct directed payment arrangements (excluding those related to COVID-19) in 37 states. This was a substantial increase over the 65 distinct arrangements approved in 23 states as of August 2018.

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