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MCDERMOTT PLUS CHECK-UP: November 22, 2019

This Week’s Dose

Impeachment continued to dominate the news, Congress averted a government shutdown, and federal vaping regulation stalled.  

Congress

  • Congress Agreed to Funding Deal. Lawmakers reached a deal on a continuing resolution (CR) to fund the government through December 20, 2019. The new CR maintains funding for several expiring healthcare programs (the so-called extenders), including:

    • Community health centers;

    • Medicaid in Puerto Rico and other territories;

    • The Certified Community Behavioral Health Clinic demonstration;

    • The National Health Service Corps;

    • Teaching health centers’ graduate medical education programs;

    • The Special Diabetes Program; and

    • The Special Diabetes Program for Indians.

The deal also includes an extended delay of the disproportionate share hospital (DSH) payment cuts through December 20. Congress will now work to reach a deal on the final fiscal year 2020 spending package that will likely include longer-term funding for the extenders and further delay or repeal the DSH cuts.

  • Lawmakers Requested Information on Efforts to Address Maternal Mortality. Eight Democratic members of Congress led by Senator Elizabeth Warren (D-MA) and Representative Lisa Blunt Rochester (D-DE) sent a letter requesting information on the Center for Medicare and Medicaid Innovation’s (CMMI) efforts to address the maternal mortality crisis in the US. The letter cites several reports that point to significant racial disparities in maternal health outcomes and limited access to maternal care in rural and other underserved areas. The letter requests information on how alternative payment models could be used to test innovative ways of delivering maternal healthcare. The lawmakers request that CMMI respond to the inquiry by December 6, 2019. This comes on the heels of additional legislative action on maternal health programs in the Energy and Commerce Committee (see our Quick Hits).

Administration

  • Future of E-Cigarette Regulation Unknown. A Food and Drug Administration (FDA) regulation that was expected to implement a ban on flavored tobacco products cleared review at the Office of Management and Budget (OMB) on November 4, but has yet to be published. House Oversight and Reform Subcommittee on Economic and Consumer Policy Chairman Rep. Raja Krishnamoorthi (D-IL) sent a letter to the White House and FDA demanding to know the status of the rule, and six major healthcare organizations published an op-ed urging the Administration to move forward with the flavor ban. Also this week, the House Energy and Commerce Committee advanced a bill that would go even further than the Administration’s initial proposal, banning all flavored tobacco products, raising the tobacco purchasing age to 21 and banning all online tobacco sales. While the bill could pass the House, it is not expected to be considered in the Senate, where Republicans have voiced concerns that a flavor ban goes too far. President Trump’s position has been difficult to discern, though Joe Grogan, the head of the Domestic Policy Council, recently called regulating tobacco a “huge waste of time.” The Administration has not indicated whether it will backtrack completely on the flavor ban or attempt a different compromise.

Courts

  • A Third Judge Blocked the Administration’s “Conscience Rule.” A federal judge in San Francisco ruled against a Trump Administration rule that would have allowed healthcare providers to refuse to offer certain healthcare services that they disagree with on religious or moral grounds. The policy had been scheduled to take effect on November 22, 2019. The ruling follows similar decisions by federal district courts in New York and Washington State, holding that the Department of Health and Human Services (HHS) overstepped its authority in issuing the rule. The Administration has not said whether it plans to appeal, though it has repeatedly been willing to engage in prolonged court battles over its policies.

States

  • Tennessee Submitted Block Grant Waiver to CMS. Tennessee’s proposal would establish a cap on federal funds in exchange for new program flexibility. The waiver comes after the Centers for Medicare and Medicaid Services (CMS) withdrew from OMB review a proposed guidance letter, which was expected to encourage states to convert their Medicaid programs to block grant systems. The withdrawal was unexpected, though CMS reiterated that it would soon release new Medicaid funding guidance. Tennessee has responded to critics who argue that a block grant system would result in reduced services, saying that it will use its new flexibility to add coverage and will not make changes to preventative service benefits for individuals under 21. Many legal scholars have questioned whether CMS has the authority to implement block grants. If CMS approves the Tennessee waiver, it is almost certain to be challenged in court.

  • Massachusetts Advanced Strict Vaping Ban. The state Senate approved a measure that would ban flavored tobacco products, including menthol flavors, place a new excise tax on vaping products, and require health insurers to cover FDA-approved smoking cessation products and counseling with no copays. The bill now heads to the state House, which passed a similar measure earlier this month. Governor Charlie Baker (R) has not said whether he would sign the legislation. If enacted, the Massachusetts plan would be the strictest statewide vaping restriction to emerge thus far amid rising concern over teen vaping and vaping-related lung illnesses. Given the recent uncertainty surrounding a flavor ban at the federal level, more states may follow Massachusetts’s lead and pursue restrictions of their own.

Quick Hits

  • The House Energy and Commerce Committee advanced several pieces of legislation, including a bill to raise the tobacco purchasing age to 21 and a bill to create maternal health programs with an emphasis on quality, rural areas, and addressing racial and ethnic disparities.

  • Senators pressed Stephen Hahn on the teen vaping epidemic during his confirmation hearing to be FDA commissioner.

  • A Finance Committee hearing examined barriers to Alzheimer’s diagnosis, treatment and care coordination. Read our summary here.

  • Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) released a framework and request for feedback on policy areas for “Cures 2.0.” It includes a focus on areas such as digital health, Medicare coverage of new drugs and devices, harnessing patient data to improve treatments and cures, and supporting families and caregivers. They are asking for comments on these issue areas by December 16, 2019.

  • HHS indicated its plan to propose the International Pricing Index demonstration this month, according to the fall regulatory agenda.

  • Last week, HHS issued the Transparency in Coverage proposed rule, which outlines new reporting requirements for group health plans and issuers in the individual and group markets regarding beneficiary cost sharing, in-network provider negotiated rates and historical out-of-network allowed amounts. Read our summary of the rule here.

© 2019 McDermott Will & Emery

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About this Author

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...

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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 became an authoritative source on a variety of legislative approaches, especially related to veterans’ health.

Prior to that role, Rachel was lead legislative liaison at the US Department of Health and Human Services’ Office of the National Coordinator for Health IT (ONC) where she was instrumental in providing research, analysis and feedback to Members of Congress and staff on the 21st Century Cures legislation, among other relevant policies. Rachel also created short- and long-term strategic outreach plans that increased ONC’s visibility and profile.

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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.

Emma graduated...

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