August 9, 2022

Volume XII, Number 221

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August 08, 2022

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McDermottPlus Check-Up: June 24, 2022

This Week’s Dose

It was a busy week in Washington, as Congress wrapped up its final week of legislative business before the Independence Day recess.  In the Senate, the bipartisan group of Senators working on a gun violence prevention compromise released legislative text and quickly brought the bill to the Senate floor, where it was approved by a wide margin. The House quickly followed suit, sending the bill to the President’s desk to be signed into law. The House also passed mental health and ARPA-H legislation, while at the committee level, consideration of FY 2023 appropriations bills continued.  The Supreme Court also formally issued its previously-leaked ruling overturning Roe v. Wade

Congress

Gun Violence Prevention Bill Advanced.  On June 21, a group of 10 Democrats and 10 Republicans released the Bipartisan Safer Communities Act—marking Congress’ most significant step forward on gun violence prevention legislation in the last 30 years.

The bill includes support for state crisis intervention orders, protections for victims of domestic violence, clarity on the definition of “federally licensed firearms dealer,” an enhanced review process for those under 21 years of age, penalties for “straw purchasing,” support for community-based violence prevention initiatives, investments in children and family mental health services, and increased funding for school safety. A summary of the bill can be found here.

The bill also includes notable health-related provisions:

  • Supports national expansion of the Medicaid community behavioral health center model;

  • Requires the Secretaries of Health and Human Services (HHS) and Education to provide guidance to the Medicaid agencies and schools on the provision of mental health services in schools;

  • Requires the HHS Secretary to provide guidance to Medicaid agencies on providing telehealth services;

  • Provides investments through HHS to programs for provider training in mental health, suicide prevention, crisis and trauma intervention and recovery;

  • Appropriates $150 million to support implementation of the 9-8-8 National Suicide Prevention hotline;

  • Invests in programs to expand mental health and supportive services in schools, including early identification and intervention programs, school-based mental health and wrap-around services, improvements to school-wide learning conditions, and school safety; and

  • Requires the Secretary of HHS to review Early and Periodic Screening, Diagnostic and Treatment (EPSDT) services in Medicaid programs, provide technical assistance on deficiencies, and provide guidance on providing mental health services to children, and requires a GAO report and a report from the Secretary on EPSDT.

To pay for the legislation, the bill delays by one-year implementation of the rule addressing safe harbor protection for prescription drug rebates. This rule, proposed by the Trump Administration, has already been delayed until January 2026 by the Infrastructure Investment and Jobs Act. This new provision would delay implementation until 2027. Neither the Biden Administration nor Congress intend for this rule to ever become effective, and this further delay is less about a policy decision, and more about a convenient source for savings (read, accounting sleight of hand) to offset other costs in the gun bill.

The Senate approved the bill 65-33 the evening of June 23, and the House approved it 234-193 on June 24, sending the legislation to the President’s desk to be signed into law. 

Health Legislation Advances in House.  On June 22, the House passed the Restoring Hope for Mental Health and Well-Being Act (H.R. 7666) by a strong bipartisan vote of 402-20.  The legislation—which was authored by Energy and Commerce Committee Chairman Pallone (D-NJ) and Ranking Member Rodgers (R-WA)—reauthorizes key Substance Abuse and Mental Health Services Administration and Health Resources and Services Administration programs to address the national mental health and substance use disorder crises. Both the Senate Finance and HELP Committees are developing their own mental health bills as well.

The same day, the House also passed the Advanced Research Projects Agency-Health (ARPA-H) Act (H.R. 5585) by a vote of 336-85.  The bill—introduced by Energy and Commerce Health Subcommittee Chairwoman Eshoo (D-CA)—would establish ARPA-H as an independent agency within HHS to accelerate biomedical innovation. Before voting on final passage, the House also adopted an amendment removing the requirement that the ARPA-H Director be confirmed by the Senate.

The House bill’s approach differs from the approach preferred by Senate leaders and the Administration, who support the establishment of ARPA-H within the National Institutes of Health, not as an independent agency. In its Statement of Administration Policy on H.R. 5585, the Administration expressed support for House passage, but also stated that it “…supports an approach that provides the agency with flexibility to adapt to unforeseen circumstances and believes that leveraging the National Institutes of Health’s existing infrastructure would provide for the most efficient administration of the program’s goals. The Administration is concerned by the provision that would enable ARPA-H to bypass the process for ensuring that communications with Congress are accurate and reflect the views of the Executive Branch.

Administration

CMS Releases Proposed ESRD Rule.  On June 21, the Centers for Medicare & Medicaid Services (CMS) issued the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) proposed rule for CY 2023.

The proposed rule makes changes to the base payment rate, proposes updates to the ESRD Quality Incentive Program, includes proposed changes to the ESRD Treatment Choices Model, and contains several Requests for Information.  The proposed rule also considers applications for the Transitional Add-On Payment for New and Innovative Equipment and Supplies for three products. 

Overall, the proposed rule builds upon policies finalized in last year’s ESRD payment rule that sought to improve health equity and enhance access to treatment options, including home dialysis.  If finalized, the changes in the proposed rule would take effect January 1, 2023.  Comments on the proposed rule are due by August 22. A fact sheet from CMS provides additional details.

Courts

Supreme Court Rules on Abortion Case, Overturning Roe v. Wade.  On June 24, the U.S. Supreme Court issued a long-awaited ruling in Dobbs v. Jackson Women’s Health Organization.

The 6-3 decision overturned Roe v. Wade and Planned Parenthood v. Casey, eliminated the constitutional guarantees it provided, and determined that states are the venue to regulate abortion. This landmark decision will impact health policy on numerous levels, and additional details on these impacts will come into focus in the coming days and weeks:

  • Regulatory. We expect the Administration to use any and all regulatory avenues to provide access to abortion services in the short and long term. Ultimately, those avenues may be limited and subject to legal challenges, but the Administration will not react passively.

  • States. States will be very active with significant legislative action on both sides of the issue expected as states react to the new regime established by Dobbs. Stakeholders will have to respond to different regulatory regimes from state to state.

  • Legislative. We are in uncharted territory on the legislative front. Congress has operated under a status quo that allowed them to legislate while carefully keeping abortion policy sidelined. Dobbs should not prevent current, bipartisan legislation from moving forward, but 2023—as we move into a presidential cycle—is less clear. Will Congress be able to set aside abortion policy and move noncontroversial, bipartisan legislation? 

  • Electoral. The importance of abortion as a federal electoral issue has never been tested as it will be in these upcoming elections, as both sides seek to leverage the decision to drive turn out. Prevailing thinking about headwinds faced by Democrats may be altered.

In the coming days, our team will be providing additional analysis of the decision and what it means for health policy.

Quick Hits

  • CMS issued the CY 2023 Home Health Prospective Payment System Rate Update proposed rule, which would update Medicare payment policies and rates for home health agencies.  A CMS fact sheet can be found here.

  • The Centers for Disease Control and Prevention (CDC) announced its endorsement that all children 6 months through 5 years of age should receive a COVID-19 vaccine—expanding eligibility for vaccination to nearly 20 million additional children and making all Americans ages 6 months and older now eligible for vaccination.

  • The Sequoia Project—the nonprofit selected by the Office of the National Coordinator for Health IT as the Recognized Coordinating Entity to support the implementation of the Trusted Exchange Framework and Common Agreement—released additional standard operating procedures (SOP) and the Qualified Health Information Network fee schedule. Stakeholder feedback on the draft SOP is due by July 21.

  • HHS announced the approval of Colorado’s Section 1332 State Innovation Waiver amendment request to create the “Colorado Option”—a state-specific health coverage plan that seeks to expand coverage to nearly 10,000 Coloradans beginning in 2023.

  • The White House Office of National Drug Control Policy announced the release of a report on telehealth and substance use disorder (SUD), which found telehealth services can provide increased access to vulnerable individuals with SUD, decrease costs, and reduce spread of communicable diseases.  The report recommended expanding and making consistent current state and federal telehealth policies.

Hearings

  • The House Energy and Commerce Oversight and Investigations Subcommittee announced a June 28 hearing on Medicare Advantage plans use of prior authorization.

  • The House Energy and Commerce Health Subcommittee announced a June 29 legislative hearing on 11 public health bills.

Health Policy Breakroom Podcast

Last Wednesday, the Supreme Court issued its long-awaited decision on the Medicare 340B payment cut case (AHA v. Becerra). The Court found that HHS’s 340B drug payment cuts in 2018 and 2019 were unlawful and sent the case back to the D.C. District Court for further deliberations. Emily Cook and Rodney Whitlock visit this week to explain how this decision impacts 340B hospitals and what litigation remains surrounding the payment cut.

LISTEN 

Next Week’s Diagnosis

Congress will be in recess following the completion of the gun violence prevention bill, and the next votes in the House and Senate are scheduled to occur the week of July 11.  Next week the House will hold a committee work week, including two health-related hearings in the Energy and Commerce Committee and the scheduled conclusion of the House Appropriations Committee’s consideration of the 12 annual appropriations bills for FY 2023.  Both chambers will be in recess the week of July 4 for the Independence Day holiday.

© 2022 McDermott Will & EmeryNational Law Review, Volume XII, Number 175
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About this Author

Debra Curtis Health Policy Attorney Congress McDermott Will Emery

Debbie is a highly respected health policy authority who helps clients advance their missions in Congress and beyond. With more than three decades of experience working both on the Hill and with the health insurance exchange marketplace, she helps clients execute payment strategy, see around the corner on policy and regulatory changes, and pursue effective advocacy. In addition, Debbie has deep experience working closely with payers, industry stakeholders and government officials at the federal, state and local levels.

During her 24 years as a...

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Kristen O’Brien Healthcare Executive McDermott Consulting
Execusitve

Kristen O’Brien is an accomplished healthcare executive with a deep understanding of regulatory advocacy and healthcare policy efforts.

Kristen offers a strong background and a keen eye for solutions to barriers and challenges impacting healthcare clients. With more than 10 years of experience, her work focuses on implementing new laws through the rulemaking process, as well as working with relevant agency officials to develop and improve agency guidance.

Kristen recently served as Principal of the Health Industry Policy and Regulatory Practice Group at a law and lobbying...

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Professional Advisor

Erica Stocker is a professional advisor in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C., office. Erica focuses primarily on health care, including provider reimbursements, quality of care and patient safety.

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