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McDermottPlus Check-Up: January 24, 2020

This Week’s Dose: It was a relatively quiet week in Washington with the House of Representatives in recess and the Senate enmeshed in the impeachment trial. Activity is sure to pick up as soon as House members are back in town next week.

Congress

Senators Introduced E-Cigarette User Fee Bill. The bipartisan Resources to Prevent Youth Vaping Act led by Senators Jeanne Shaheen (D-NH) and Lisa Murkowski (R-AK) increases the total amount of user fees that the US Food and Drug Administration (FDA) collects from the tobacco industry by $100 million in fiscal year (FY) 2021 and removes the existing exclusion for e-cigarette manufacturers. The new fees collected from e-cigarette manufacturers will help fund industry oversight and increase public awareness of the negative effects of e-cigarettes. The Trump Administration included a similar e-cigarette user fee proposal in its FY 2020 budget. Combatting the epidemic of teen e-cigarette use has been a priority for many in Congress and the Administration. Earlier this month, FDA issued a partial ban on flavored e-cigarette products aimed at reducing their appeal to teens, but many in Congress said the guidance did not go far enough. Issues relating to flavored e-cigarettes and vaping products are likely to continue to play out throughout 2020.

Energy and Commerce Members Questioned FDA on Complex Generic Approval. A group of House lawmakers led by Energy and Commerce Committee Chairman Frank Pallone (D-NJ) and Ranking Member Greg Walden (R-OR) sent a letter to FDA Commissioner Stephen Hahn asking for details regarding the lag in development and approval of complex generic drugs. Complex drugs are often high-cost medications used to treat serious conditions, but FDA has been slow to approve generic versions, which are more affordable in many instances. According to the letter, “a primary purpose of this request is to determine whether additional authority is needed to improve the approval process for complex generic drugs to increase access and reduce costs.” Streamlining the development and approval of generic drugs is one of the few areas of broad bipartisan agreement in the drug pricing reform space. The lawmakers requested a response to their inquiry by January 31, 2020.

House Democrats Argued Against Public Charge Rule. A group of House Democrats, led by Speaker Nancy Pelosi (D-CA), submitted an amicus brief urging a federal appeals court to block the Trump Administration’s public charge rule. If implemented, the rule would allow immigration authorities to deny visas or green cards based on a person’s use of Medicaid or other public benefits, and has faced stiff opposition from immigrant rights groups. The US Department of Homeland Security issued the rule in August 2019, but it was quickly met with legal challenges. Three federal district courts issued injunctions preventing the rule from taking effect. In December 2019, a federal appeals court lifted two of the injunctions, and last week the Administration asked the US Supreme Court to lift the third nationwide injunction issued by a federal district court in New York. The Supreme Court has not yet responded to the request, and the injunction blocking the rule from taking effect remains in place.

Courts

US Supreme Court Will Not Expedite ACA Case. The Supreme Court rejected a request by Democratic attorneys general and the House of Representatives to expedite review of a case challenging the constitutionality of the Affordable Care Act (ACA). The request came after a federal appeals court declared the ACA’s individual mandate unconstitutional, but remanded the case to a federal district court in Texas to reevaluate whether the rest of the law can stand without the mandate in place. The Court’s order this week simply says that it will not expedite review of the case, which likely would have led to a decision prior to the 2020 election. This order does not indicate whether the Court will consider the case at a later date. The Supreme Court may decide to take up the case either before or after the district court in Texas issues a revised decision, though it is rare for the Court to intervene before a case is settled in the lower courts. The outcome is good news for the Trump Administration and Republicans, who argued against expedited review. Had the Supreme Court taken up the case before the 2020 election, Republicans would likely have been under significantly more pressure to present an alternative to the ACA in the event of a total repeal. While a decision for total repeal is not an immediate threat, healthcare is sure to remain a central issue on the campaign trail, and the prospect of sweeping repeal continues to linger.

States

Illinois Submitted a Waiver for Postpartum Medicaid Coverage. The Section 1115 waiver application would extend postpartum Medicaid coverage from the current 60 days to 12 months for beneficiaries at or below 213% of the federal poverty line. The waiver would also allow for continuous eligibility for mothers and babies for the entire 12-month postpartum period, and would allow beneficiaries to be reinstated in their previous Medicaid managed care organization if they submit renewal paperwork within 90 days of coverage termination (the current window is 60 days). It is not clear whether the Centers for Medicare and Medicaid Services (CMS) will approve the waiver. So far, the Administration has voiced narrower support for expanding postpartum coverage to mothers with substance use disorders. However, many lawmakers in both parties have expressed support for expanding postpartum Medicaid coverage, and the issue is likely to remain at the forefront for many maternal health advocates. CMS will accept comments on the proposal through February 13, 2020.

Quick Hits  

  • CMS is seeking feedback on ways to better coordinate care from out-of-state providers for Medicaid-eligible children with medically complex conditions. Comments are due March 23, 2020.

  • CMS released a new data highlight on the reporting of social determinants of health for Medicare fee-for-service beneficiaries.

  • The US Government Accountability Office issued a report on artificial intelligence in healthcare.

  • The Medicaid and CHIP Payment and Access Commission held its January Commission meeting. Find the agenda here.

M+ Resources

  • The Senate began President Trump’s impeachment trial this week. Here is what you need to know about what comes next.

  • The latest episode of the Health Policy Breakroom offers a deep dive into what 2020 has in store for Medicaid reform.

  • For all our latest predictions on the 2020 landscape, be sure to follow our Policy Forecast page.

Next Week’s Diagnosis: House lawmakers return as the impeachment trial continues in the Senate.

© 2020 McDermott Will & EmeryNational Law Review, Volume X, Number 24

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McDermott + Consulting, McDermott Law Firm

McDermott+Consulting serves health industry clients with one-stop lobbying services, data analytics and modeling, and policy advice.

When clients are faced with legislative and regulatory obstacles that challenge business operations and opportunities, they turn to us for solutions.  In providing these services, McDermottPlus has access to the resources and talent of McDermott Will & Emery LLP, including its most accomplished and renowned health law practice.

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Mara McDermott, McDermott Law Firm, Washington DC, HealthCare Law Executive

Mara is an accomplished health care executive with a deep understanding of federal health care law and policy, including delivery system reform, physician payment and Medicare payment models.

Most recently Mara served as the senior vice president of federal affairs at America’s Physician Groups (formerly the California Association of Physician Groups, CAPG), a professional association representing medical groups and independent practice associations practicing in capitated, coordinated care models. As head of the Washington, DC, office, Mara worked on behalf of the association’s member organizations to advance policies that promoted coordinated care, including working with members of Congress and their staffs, the administration, health policy stakeholders and coalitions to advance alternative payment models. Mara’s work covered a wide variety of issue areas, including implementation of the Medicare Access and CHIP Reauthorization Act (MACRA) and Medicare Advantage policy, as well as issues related to the Medicare physician fee schedule and Medicare accountable care organizations.

Previously, Mara was counsel in the health industry practice at a law firm in Washington, DC. In that role, she focused on a variety of issues affecting health industry clients, with a particular emphasis on health policy and regulatory issues facing physician organizations, hospitals, pharmaceutical companies and academic medical institutions.

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Rachel Stauffer, McDermott Law Firm, Washington DC, Health Policy Consultant

Rachel is a highly experienced government relations and legislative affairs strategist and advocate who is informed by a solid foundation of health policy knowledge.

Prior to joining McDermottPlus, Rachel served as the director of policy and government relations for a health IT contractor, where she developed the company’s first strategic plan for government relations. She grew the company’s profile on Capitol Hill by establishing new relationships with key leaders in the federal, state and military health program space. As a result, the company...

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Katie Waldo Healthcare Attorney

Katie is an experienced government relations strategist who helps clients navigate the complex issues surrounding Medicare, Medicaid and the healthcare marketplace.

Katie works with clients to represent their needs before the US Congress and the US Department of Health and Human Services (HHS) and its agencies by relying on extensive experience as a policy advisor on the Medicaid and Medicare programs, as well as the 340B program and other aspects of the Public Health Service Act. She anticipates the effects of state and federal policymaking on issues impacting their businesses and...

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Government Relations Professional and Registered Lobbyist

Emma is a government relations professional and registered lobbyist who supports clients on a range of health policy issues.

As a policy consultant, Emma lobbies and consults with legislators and congressional staff on issues relating to Medicare, Medicaid payment and regulation, and the 340B Drug Pricing Program. She provides analysis of the federal political and regulatory environment, and routinely monitors pertinent Hill activities including congressional hearings, bill markups and think tank events.

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