Public Records Show Agencies Are Vigorously Enforcing New COVID-19 Requirements Against Healthcare Providers

Since the COVID-19 outbreak began, healthcare providers have faced a slew of new regulatory requirements. As many healthcare providers know, enforcement agencies have taken starkly different approaches in terms of how often, and how vigorously, they enforce these requirements. Recent reports show, however, that agencies are closely enforcing workplace safety requirements relating to COVID-19, especially as they pertain to healthcare providers. Within the past month, the U.S. Occupational Safety and Health Administration (OSHA) and its state counterparts have initiated thousands of enforcement actions regarding compliance with COVID-19 safety rules

For example, late last month, OSHA fined several nursing facilities, including three located in Ohio, after determining that they had not followed applicable workplace standards concerning COVID-19. OSHA determined that these nursing facilities had failed to implement appropriate respiratory protection programs, failed to evaluate employees’ abilities to use respirators when required, and failed to appropriately record their health and safety compliance activities. Altogether, OSHA has opened over 400 inspections thus far regarding compliance with COVID-19 safety requirements. Continue Reading

Supreme Court Ruling Limits Insurer and Employer Contraceptive Obligations

Earlier this month the Supreme Court of the United States upheld a regulation adopted under the Trump administration significantly cutting back the requirement that insurers and group health plans provide coverage for contraceptives without cost sharing under the Affordable Care Act (ACA).

Because of the ruling in Little Sisters of the Poor v. Pennsylvania, employers, including publicly traded companies, with religious or moral objections are not required to provide contraceptive coverage under the health plans offered to employees. Previously, only churches and religious orders were excepted from the contraceptive coverage requirement while nonprofit religious organizations and private for-profit entities that objected to contraception for religious reasons could opt out of the requirement. Now, all are excepted from the federal requirement based on religious or moral objections and insurers are relieved of their obligation, under the accommodation process, to provide contraceptive coverage to employees through an alternative health care plan. The ruling also means that colleges and universities with religious or moral objections need not provide contraceptive coverage in student health plans, and that individuals who object on religious or moral grounds may seek to obtain insurance coverage in the individual market without contraceptive benefits (except as may be required by state law).

You can read our analysis of this case in our recent client alert, available here.


For Your Eyes Only: Anticompetitive Collusion at a UK Hospital

Last week the UK Competition and Markets Authority (CMA) published its decision to fine Spire and 7 consultants ophthalmologists operating in its Macclesfield hospital for fixing “the level of the initial consultation fees charged by the Ophthalmologists at the Hospital” (para 3.34).

This is a classic ‘price-fixing’ decision against ophthalmologists who agreed to charge the same fee (£200) for an initial consultation. However, and more importantly, this decision comes as a stark reminder to Hospitals not to regulate the pricing policy of their external consultants – even if it is for selfless reasons! Indeed, although the CMA recognised that “Spire does not itself provide initial consultations in competition with the ophthalmologists”, Spire received the largest (by far!) fine of £1.2 million, whilst the individual fine for each consultant did not exceed £3,000. Continue Reading

Senators Announce Bipartisan Bill Requiring Pharmaceutical Supply Chain Report

U.S. Senators Marco Rubio (R-FL) and Elizabeth Warren (D-MA) recently announced plans to cosponsor S. 4191, the United States Pharmaceutical Supply Chain Review Act. According to bill text released by Senator Warren’s office, the bill directs the Federal Trade Commission (FTC) and the Secretary of the Treasury, in consultation with the Secretary of the Treasury, and acting through the Committee on Foreign Investment in the United States, to study the U.S. pharmaceutical supply chain. Specifically, within one year of enactment, the agencies identified would be required to study and submit an assessment of:

    • The U.S. pharmaceutical supply chain “and the effect of concentration and reliance on foreign manufacturing within that industry,”
    • How foreign investment impacts U.S. “domestic capacity to produce drugs and active and inactive ingredients of drugs,”
    • Whether foreign investment in U.S. genome sequencing technology affects “the capacity to sequence or store DNA in the United States,” and
    • An accounting of CFIUS reviews over the past ten years of foreign investment in the pharmaceutical and genome sequencing industries.

The bill was introduced by Senator Warren and referred to the Senate Committee on Banking, Housing, and Urban Affairs. It appears the senators are still working to gather cosponsors for the bill.

Senators Rubio and Warren also released a one-page summary of the bill. The summary cites a 2019 annual report conducted by the U.S.-China Economic Security Review Commission that found nearly 80 percent of active pharmaceutical ingredients (APIs) are imported from abroad. The Senators conclude that an “overreliance [on APIs] leaves our supply chain of critical drugs used by millions of Americans vulnerable to disruption – whether by accident or by design.”

Recent Supreme Court Decision Creates Basis For Challenge To HHS’s Rescission Of Anti-Discrimination Protections

Most readers are likely familiar with the landmark decision issued by the U.S. Supreme Court last week, in which the Court held that Title VII prohibits discrimination on the basis of sexual orientation and transgender status. (Read more about this decision here.) That decision not only provided important clarification to the scope of protections for the LGBT community, but it may also create a basis for challenges to a recent rule by the Trump administration’s Department of Health and Human Services (HHS).

As background, shortly after the Patient Protection and Affordable Care Act (ACA) became law, the Obama HHS issued a rule clarifying that the ACA prohibits discrimination on the basis of gender identity and transgender status. Then, earlier this month, the Trump HHS published its own rule that, once effective, would remove those anti-discrimination provisions. Three days later, the Supreme Court issued the above-referenced decision, and explicitly held that Title VII prohibits discrimination on the basis of transgender status.

This decision leaves the HHS’s new rule vulnerable to challenge. Several groups already have filed legal actions seeking to block the HHS from removing those bars on discrimination. The HHS has not yet changed course, and is asserting that the ACA’s specific language and applicability to healthcare render it distinguishable from the cases at issue before the Supreme Court (which involved Title VII and its applicability in the context of employment). Nevertheless, the language of the Supreme Court’s decision, and the Supreme Court’s opinion that “sex” discrimination includes discrimination on the basis of transgender status, create a significant reason to believe that the HHS rule will be overturned. The outcome of this litigation will have important consequences for healthcare organizations, insurers, and patients, and it may ultimately clarify protections that exist in other settings as well.

Growing Bullseye on Skilled Nursing Facilities

Although nursing homes appreciate the recent release of $4.9 billion in financial assistance, the bullseye on them continues growing.  Troubles that preceded the COVID-19 crisis have gotten worse for facilities caring for high risk seniors.  They face scrutiny over death rates from COVID-19, as well as how they will use relief money.

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Redefined by COVID-19 and Shaped by Current Events: What’s Ahead for US Federal Appropriations

Attention in Congress will soon turn to the annual appropriations process and passage of fiscal year 2021 spending bills.  In addition to funding the entire US government each year, the 12 Appropriations Committee bills in the House and Senate shape federal public policy that touches every person and business in the United States.  The new fiscal year begins on October 1.

In the coming weeks and months, standing committees in the House and Senate will be focused on must-pass legislation including the National Defense Authorization Act, the Water Resources Development Act, a surface transportation bill, and passage of appropriations bills for fiscal year 2021.

New COVID-19 health and safety protocols on Capitol Hill are presenting Congress with a series of unique challenges.  The legislative process is going to look very different as compared to even several months ago.  See a discussion here on our Capital Thinking Blog.

CARES Act Medicare Money – View From Former Prosecutors

The CARES Act requires Medicare providers to attest to multiple certifications.  Former prosecutors examine how law enforcement may scrutinize these certifications. Marisa Darden, David Maria, and Thomas Zeno also offer tips on how providers who receive CARES Act funds can insulate themselves from scrutiny.  Their article can be found here.