The Families First Coronavirus Response Act (FFCRA) was enacted on March 18, 2020. The sweeping federal legislation provides emergency paid sick leave (EPSL) and expanded paid Family and Medical Leave (EFML) to certain covered workers impacted by the COVID-19 pandemic. On April 1, 2020, the U.S. Department of Labor (DOL) issued regulations implementing the FFCRA and answering, at least in part, some questions related to coverage, eligibility, use, and job restoration. You can read our updates to this subject here on our Employment Law Worldview site.
UK End of Transition – Moves to Provide Clarity for Industry
The work of UK health and regulatory authorities has mainly been targeted on COVID-19 work over recent months but there has been an increasing focus on End of Transition work in recent week’s and given that the Brexit transition period ends at 11pm on 31st December 2020 (GMT). As part of this work, UK MHRA has started to issue multiple separate pieces of guidance for the UK Life Science industry that covers many areas including clinical trials, medical devices, marketing authorisations, pharmacovigilance and manufacture and supply. These are to apply from the start of 2021 and 31 separate pieces of guidance were issued on 1 September with more to follow soon.
The guidance recognises that Northern Ireland will continue to apply EU rules in respect of medicines and device law and will be subject to the EU acquis under the Northern Ireland Protocol. Great Britain will be subject to UK law and guidance seeks to explain how this will fit together in terms of ability to market and supply and comply with a jigsaw of obligations going forward.
One emerging major question that arises in relation to the new guidance is how this might fit with powers that could be exercised under the new United Kingdom Internal Markets Bill, if enacted and published this week. The Bill contains powers that could seek to override differences in regulatory requirements across the UK from 2021. Finally, it is also noted that the ongoing aim of a UK-EU FTA and guidance that may emerge from committees tasked with applying the Northern Ireland Protocol could also impact on how the UK Life Science industry should operate after the end of this year.
There are clearly many moving parts still and scope for significant shifts in the regulatory landscape in coming weeks.
HHS Eases Federal Substance Use Disorder Confidentiality Rules
Last month the Substance Abuse and Mental Health Services Administration (“SAMHSA”) finalized amendments to the federal Confidentiality of Substance Use Disorder Patient Records regulation, 42 C.F.R. Part 2 (“Part 2”). The changes purport to better facilitate substance use disorder (“SUD”) care coordination and treatment by loosening technical consent requirements, clarifying permissible disclosures, and providing other guidance. Notably, these changes do not address changes required under the COVID-19-related CARES Act, which will require aligning Part 2’s consent requirements more closely to HIPAA. More information about these changes are summarized below:
- Modification of Authorization Requirements: Part 2 previously required naming specific individuals to receive SUD records in authorization forms (except in very limited circumstances). This functioned as a major barrier to effective data sharing because patients often did not know a specific person’s name at a recipient organization. The modified authorization rules now more closely align with HIPAA by permitting organizations (instead of specific persons) to be named in authorization forms.
- Permissible Disclosures for Payment and Health Care Operations Permitted with Written Consent: Part 2 previously left some ambiguity about the types of purposes for which SUD information could be disclosed with patient consent. The modifications now permit disclosures with consent that align to the HIPAA definitions of “Payment” and “Health Care Operations” and include “care coordination and case management.”
- Disclosures for Research: The modifications also align the Part 2 “research” disclosure rules much more closely with HIPAA and the federal “Common Rule” regarding human subject research.
- Permissible Disclosures for Audit and Program Evaluation: The regulation also clarifies specific situations that fall within the scope of permissible disclosures for audits and/or program evaluation purposes. Federal, state and local governmental agencies and third-party payers may conduct audits and evaluations to identify needed actions at the agency or payer level to improve care. Additionally, audits and evaluations may include reviews of appropriateness of medical care, medical necessity, and utilization of services.
- Regulation Scope and Re-Disclosure: Treatment records created by non-Part 2 providers based on their own patient encounter(s) are explicitly not covered by Part 2, unless the provider incorporates SUD records received from a Program into the provider’s records. Otherwise, providers (and the EHRs they use) can avoid Part 2 applicability by segmenting data obtained from Part 2 records from the rest of the provider’s records.
Critical features of Part 2 remain unchanged, however, including:
- Most data uses and disclosures still require patient authorization. However, Part 2 changes are coming up under the CARES Act that will make it substantially easier for entities subject to HIPAA to share information after obtaining an initial authorization.
- Part 2 continues to prohibit law enforcement’s use of SUD patient records in criminal prosecutions against patients in the absence of a court order.
This development will have wide-ranging implications for Part 2 programs, which will benefit from the additional flexibility. The area of healthcare data privacy is constantly evolving and it can be difficult to navigate changes in the law. Please contact the authors of this post or your regular SPB contact if you have any questions.
Kamala Harris – Where the Vice Presidential Nominee Stands on Key Healthcare Issues
On Tuesday, August 11, 2020, presumptive Democratic presidential nominee Joe Biden announced Sen. Kamala Harris (D-CA) as his vice presidential running mate. Since joining Congress in 2017, Sen. Harris has largely served as a bridge between progressive and moderate Democratic positions and policies. She has made immigration, equal pay and reproductive health rights core planks of her policy proposals. Her current congressional committee assignments include Senate Judiciary, Homeland Security and Governmental Affairs, Intelligence and Budget.
Healthcare consistently ranks as a top priority for voters, and in the midst of an infectious disease pandemic we expect the focus on healthcare to intensify over the coming months. Healthcare also served as a differentiator in the crowded Democratic presidential primary; while all of the candidates supported universal access to health insurance coverage, policy solutions to achieve that goal ranged from creating a single-payer system to maintaining the current employer-based approach while providing a robust public option. As a candidate for president, Sen. Harris’s proposal embraced an eventual “Medicare-for-All” system buoyed by private insurance options and instituted over a 10-year transition period. Vice President Biden’s healthcare plan builds on the Affordable Care Act (ACA) by making current premium tax credits more generous and creating a public insurance option available to all Americans.
Although Sen. Harris will ultimately support Vice President Biden’s policies, her record as a prosecutor, the Attorney General of California and as a senator will influence the campaign and decisions made in the White House, if elected on November 3, 2020. Continue Reading
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:
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- The U.S. pharmaceutical supply chain “and the effect of concentration and reliance on foreign manufacturing within that industry,”
- The U.S. pharmaceutical supply chain “and the effect of concentration and reliance on foreign manufacturing within that industry,”
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- How foreign investment impacts U.S. “domestic capacity to produce drugs and active and inactive ingredients of drugs,”
- How foreign investment impacts U.S. “domestic capacity to produce drugs and active and inactive ingredients of drugs,”
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- Whether foreign investment in U.S. genome sequencing technology affects “the capacity to sequence or store DNA in the United States,” and
- Whether foreign investment in U.S. genome sequencing technology affects “the capacity to sequence or store DNA in the United States,” and
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- An accounting of CFIUS reviews over the past ten years of foreign investment in the pharmaceutical and genome sequencing industries.
- 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.
