On August 20, 2020 the Department of Health and Human Services (HHS) published a notice of proposed rulemaking (85 Fed. Reg. 51397) on good practices for the release and maintenance of agency guidance documents. Comments must be posted by 11:59 pm on September 16, 2020.

As instructed in the October 9, 2019 Executive Order 13891 (EO), titled ‘‘Promoting the Rule of Law Through Improved Agency Guidance Documents (84 FR 55235 (Oct. 15, 2019)), HHS proposes to issue regulations to ensure (i) there is proper notice of any new guidance, and (ii) that the guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations.

This proposed rule appears to follow the Office of Management and Budget, “Final Bulletin for Agency Good Guidance Practices,” issued on January 25, 2007 (72 Fed. Reg. 3432) with respect to the significant guidance document that may, for example “adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities” or “materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof” and generally requires a 30 day notice and comment period.

Background

Continue Reading HHS Proposes a New Rule to Govern Release and Maintenance of Agency’s Guidance Documents

Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. In this episode, hosts Payal Nanavati and Joe Records sit down with Todd Rosenberg and Samuel Krause to discuss ERISA preemption of state regulation of pharmacy benefit managers (PBMs) in light of the upcoming U.S. Supreme Court hearing in Rutledge v. Pharmaceutical Care Management Association.

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On July 17th, the California Office of Administrative Law (“OAL”) approved an emergency regulation (effective until January 14, 2021) from the California Department of Managed Health Care (“DMHC”) that specifies COVID-19 diagnostic testing coverage requirements for California health care service plans. Medi-Cal managed care plans, Medicare Advantage plans, and specialized health plans are not subject to the regulation. The DMHC provided additional context to the emergency regulation in an all plan letter issued on July 23rd.

The regulation deems COVID-19 testing to be an urgent health care service during the California state of emergency. It also states that COVID-19 diagnostic testing is a medically necessary basic health care service for enrollees who are essential workers, regardless of whether the enrollee has symptoms of COVID-19 or a known or suspected exposure to a person with COVID-19. Essential workers are defined in the regulation to include a broad range of individuals working in the health care, emergency services, public transportation, congregate care, correctional, food service, and education sectors. Additionally, they include individuals who work in retail, manufacturing, agriculture, and food manufacturing that either have frequent interactions with the public or cannot regularly maintain at least six feet of space from other workers.

Between the regulation, all plan letter, and other applicable federal law, California health plans will need to comply with the following requirements for enrollees seeking COVID-19 testing:

Continue Reading Required Coverage of COVID-19 Testing for Essential Workers in California

On July 17, 2020, in a 2-1 decision, the  U.S. Court of Appeals for the D.C. Circuit upheld a Trump Administration rule that expands the scope of short-term limited duration insurance (STLDI) plans, affirming the lower court’s opinion that STLDI plans do not violate the Affordable Care Act. Ass’n for Cmty. Affiliated Plans v. U.S. Dep’t of Treasury , D.C. Cir. App., No. 19-05212 (July 17, 2020).

The rule’s genesis can be traced to an Executive Order issued in October 2017, which aimed to expand the availability of STLDI plans, seen by the Administration as more “appealing and affordable” than plans mandated by the ACA. The order tasked the Departments of Treasury, Labor, and Health and Human Services with expanding the duration of STLDI plans from three months to twelve. The changes also provide for renewals of those plans, which can amount to continuous coverage for up to three years.

Continue Reading Appeals Court Upholds Trump Administration’s Short-term, Limited Duration Insurance Policy Rule

On April 30, 2020, the Centers for Medicare and Medicaid Services (CMS) announced a second round of regulatory waivers and rule changes in an interim final rule with comment (IFC) that added significant flexibilities for the coverage of telehealth services furnished by a broader set of eligible clinicians and in nontraditional health settings during the COVID-19 public health emergency. These additional changes further demonstrate CMS’s commitment to using telehealth to mitigate COVID-19 exposure risks to Medicare beneficiaries and its response to feedback regarding gaps in existing telehealth coverage and reimbursement rules.

Please click here to read the full alert, including our insights on whether these changes will remain after the COVID-19 emergency.

Potentially overlooked between the enactment of the Families First Coronavirus Response Act (the FFCRA) on March 18 and the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act) on March 27, the U.S. Court of Appeals for the District of Columbia Circuit heard oral argument via teleconference on March 20 in Ass’n for Cmty. Affiliated Plans v. U.S. Dep’t of Treasury, No. 19-05212 (D.C. Cir. July 30, 2019). At issue in that case is the fate of a Trump Administration rulemaking expanding the scope of non-ACA compliant short-term limited duration insurance (STLDI) plans. Already controversial—with some arguing that STLDI plans increase access to health care, while others decry them as misleading consumers and destabilizing the individual insurance market—STLDI plans are of particular import given the COVID-19 pandemic.

As millions face unemployment, lose access to employer-sponsored health insurance coverage, and qualify to seek coverage via a special enrollment period, others may look to STLDI policies to obtain at least some coverage in the wake of COVID-19. But, as with ACA requirements such as essential health benefits and community rating, STLDI plans are not subject to the recently enacted zero-dollar cost-sharing and other coverage requirements for COVID-19 diagnostic testing.

Continue Reading Appeals Court Hears Argument on Short-term, Limited Duration Insurance Plan Rule; STLDI Plans are not Required to Provide $0 Cost-share of COVID-19 Diagnostic Testing

This week CMS continued its rapid response—average approval takes less than a week—to review and approve Social Security Act Section 1115(c) Appendix K and Section 1135 waivers to facilitate state Medicaid programs’ efforts to address the COVID-19 pandemic. CMS approved waiver applications from Colorado, Connecticut, Delaware, Hawaii, Idaho, Indiana, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New York, Oregon, Pennsylvania, Rhode Island, and Wyoming. As-of this posting, 34 states have sought and received waivers allowing increased flexibility to cope with COVID-19. Many of the waivers temporarily lift prior authorization requirements, permit use of alternative care settings and ease provider enrollment requirements to facilitate beneficiaries’ access to care, and relax timelines for fair hearings and other requirements. CMS is posting the waiver approval letters here.

New York State is now considered the nation’s epicenter of the coronavirus outbreak, far surpassing all other states in confirmed COVID-19 cases.  Managed long-term care plans (“MLTCPs”) and other Medicaid managed care organizations (“MCOs”) are facing unprecedented financial and other challenges addressing the care needs of their members as COVID-19 continues to ravage more and more New Yorkers.  Earlier this week, the New York State Department of Health (“DOH”) acted to secure regulatory relief from the federal government for MLTCPs and MCOs as well as Programs of All-Inclusive Care to the Elderly (“PACE”) Organizations from the growing financial stress brought about by the coronavirus outbreak.

In recognition of the challenges faced by health care providers and payors alike, on March 13, 2020, the Secretary of Health and Human Services, invoking Section 1135 of the Social Security Act authorized the Centers for Medicare and Medicaid Services (“CMS”) to waive application of certain federal laws to ensure that sufficient health care items and services are available to meet the needs of Medicaid patients and plan members during the coronavirus public health emergency.  On March 23, 2020, DOH requested additional waivers from federal regulations under Section 1135 that impact among others, MCOs and MLTCPs, including:

Continue Reading New York State Department of Health Seeks Additional 1135 Waivers From CMS To Alleviate Strain On Medicaid Managed Long-Term Care Plans and Other MCOs As Well As PACE Organizations Amidst Coronavirus Outbreak

In part two of this two-part series on what providers should know about COVID-19, hosts Payal Nanavati and Joe Records talk with Brian McGovern about guidance from state and federal health care regulators. This episode touches on how state agencies, CMS, CDC, and other regulatory bodies have instructed providers—especially nursing homes—on how to handle this pandemic.

If you missed it, check out Part 1 of this series, released on March 26, when we spoke with Eric Su about the labor and employment issues facing providers during the outbreak.

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Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. In part one of this two-part series on what providers should know about COVID-19, hosts Payal Nanavati and Joe Records discuss labor and employment issues with Eric Su. This episode touches on long term care and other health care providers’ obligations as employers and some best practices for handling this pandemic.

Stay tuned for tomorrow’s release of Part 2 with Brian McGovern on Federal and State Guidance.

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