FDA Issued Enforcement Discretion Measures for Infant Formula

In recognition of the infant formula crisis facing the United States supply chain, the Food and Drug Administration (“FDA”) issued guidance on May 16, 2022 providing for enforcement discretion with respect to certain requirements for infant formulas that may not comply with certain statutory and regulatory requirements. The guidance remains in effect until November 14, 2022. Under this guidance, three categories of manufacturers may submit information to FDA:

  • Infant formula manufacturers who manufacture infant formula for export in domestic facilities;
  • Infant formula manufacturers who presently do not export infant formula manufactured in foreign facilities to the United States; and
  • Infant formula manufacturers who may be able to provide infant formula to help address shortages by changing production site(s), changing production practice(s), or making other changes to an existing infant formula.

Submissions should contain all the required information in Section III. D of the guidance and be submitted to Infant_formula_flexibility@fda.hhs.gov. FDA requests information including product specifications and labeling, current markets, inventory, manufacturing facilities, distribution plans to the retail level, full quantitative formulations, test results, and certifications for the manufacturing facility, as applicable. Upon receipt of the request, FDA will then consider “whether to exercise enforcement discretion and the extent of that enforcement discretion.”

                Generally, FDA requires persons responsible for infant formula manufacture or distribution to register with FDA and provide submissions for any new formulations or changes to existing formulations. There is a built-in timing delay, as manufactures may not market the new infant formula until 90 days after the filing date provided by FDA upon receipt of the submission. The submission package requires details including a description of the formula, quantitative formulation, compliance assurances, and quality assurance data, among other requirements. Regulated as a food, infant formula has its own statutory and regulatory requirements located in 21 CFR Parts 106 and 107 that manufacturers need to follow. This includes minimum amounts for thirty nutrients and maximum amounts for ten of them. See 21 CFR § 107.100. FDA has explained in guidance that infant formula not meeting these designated levels are considered adulterated. The guidance provides an important pathway for manufacturers who may presently meet FDA requirements to assist in alleviating the domestic shortage of infant formula.

Ohio Expands Availability of Telehealth

Since the beginning of the COVID-19 pandemic, policymakers at both the federal and state level have worked to expand the availability of telehealth services. Since telehealth , in many cases, is viewed to provide a convenient, accessible and safe alternative to in-person visits with healthcare providers, it has been considered an effective tool to maintain access to healthcare services in light of the pandemic’s challenges. Consequently, many pre-pandemic regulatory limitations to telehealth were temporarily waived during the pandemic. Given this experience, and the generally favorable responses to expanded telehealth availability from patients and providers, many policymakers are now working to make this temporary expansion permanent.

Consistent with this trend, last year the Ohio legislature passed House Bill 122, which was signed into law by Governor DeWine on December 22, 2021. HB 122 helps expand telehealth availability through two primary mechanisms: (i) requiring health plans to reimburse healthcare professionals for providing covered telehealth services, and (ii) expanding the classes of health care providers who are authorized to provide telehealth services. Continue Reading

Government Continues Aggressive Antitrust Enforcement in the Healthcare Space

On February 24, 2022, the U.S. Department of Justice (“DOJ”) filed suit to block UnitedHealth’s proposed acquisition of Change Healthcare. UnitedHealth owns the largest health insurer in the U.S., while Change Healthcare is a data company whose software is the largest processor of health insurance claims in the U.S. The DOJ alleges that the acquisition, if allowed to proceed, would give UnitedHealth unfettered access to rival health insurers’ competitively sensitive information, including health insurance pricing. According to the complaint, this would lessen competition and “result in higher cost, lower quality, and less innovative commercial health insurance for employers, employees, and their families.”

The DOJ’s challenge continues a recent trend of aggressive enforcement involving vertical mergers (i.e. transactions between firms at different levels of the supply chain), with the Federal Trade Commission challenging three vertical mergers in the last year alone. These enforcement efforts represent a material shift from the prior enforcement attitude, which often allowed parties to resolve competition concerns raised by vertical mergers through conduct remedies such as information firewalls or supply commitments. The DOJ’s decision to forego such a remedy (assuming one was proposed) signals the government’s intent to take a tougher stance on mergers in the healthcare space. President Joe Biden previously listed prescription drugs and healthcare services as an antitrust priority area in his July 9, 2021 executive order.

The complaint was filed in the District Court for the District of Columbia and can be accessed here: https://www.justice.gov/opa/press-release/file/1476676/download.

Judge Strikes Down Part Of Administration’s Surprise Billing Rules In Win For Physicians

The Biden Administration’s Interim Final Rule implementing provisions of the No Surprises Act suffered its first major legal setback yesterday.  Judge Kernodle of the Eastern District of Texas issued a decision vacating portions of the Rule relating to the independent dispute resolution (“IDR”) process that the Act creates.

As we’ve previously reported, the No Surprises Act tasks IDR entities with resolving disputes between providers and insurers over the appropriate rate of reimbursement for out-of-network services.  When a provider and an insurer are at an impasse in negotiations over a reimbursement dispute, the Act, if applicable, requires them to submit their offers to the IDR entity, which is supposed to select the most reasonable of the two offers.  In making that determination, the Act requires the IDR entity to consider an express list of statutory factors, such as the median in-network rate for the services, information relating to the training and experience of the provider, and the market share of the parties.  On September 30, 2021, the government promulgated the interim Rule, which requires IDR entities to “select the offer closest to the” median in-network rate “unless the certified IDR entity determines that credible information submitted by either party [regarding the other statutory factors] clearly demonstrates that the” median in-network rate “is materially different from the appropriate out-of-network rate.”  In those instances, the IDR entity must select the offer that “best represents the value of the” services rendered. Continue Reading

Highest French Administrative Court Freezes Ban on CBD Flowers and Leaves

The regulation of CBD/Hemp products has been a very hot topic in France these past months since the “Kanavape” ruling. In Kanavape, the CJEU asked France to review its very strict CBD regulations, more specifically its Regulation (arrêté) of 22 August 1990 (CJEU, 19 November 2020, C-663/18) in light of the free movement of goods principle. In the European Union, France has one of the toughest laws against cannabis but the highest rate of cannabis use.

After the Kanavape ruling, the debate took a political dimension: France had to submit a new draft Regulation to the European Commission and French courts have been giving effect to the European ruling directly, despite the legal uncertainty created by this situation.

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Italian Ministers Announce Timetable for Investment in Digital Health

On January 8, 2022, Minister of Health Roberto Speranza and Minister for Technological Innovation and Digital Transition Vittorio Colao, in an article published in the Italian press, made a number of announcements about the timing of the Italian government’s intended investment in digital health. This investment forms part of the Italian Recovery and Resilience Plan (RRP).

On July 13, 2021, the European Council approved the final version of the RRP. The RRP is part of the EU Next Generation program (NGEU), namely the €750 billion package of which €222 billion has been allocated to Italy.

Through the RRP, the Italian government intends to invest €15.63 billion in the healthcare sector. Specifically, it intends to invest more than €2 billion in healthcare digitalization.

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AMA and AHA Challenge IDR Process under the No Surprises Act

The American Medical Association and the American Hospital Association filed suit under the Administrative Procedure Act in the District of Columbia District Court challenging portions of the interim final rule (the “Rule”) issued by the Department of Health and Human Services, the Department of Labor, the Department of the Treasury, and the Office of Personnel Management relating to the dispute resolution process under the No Surprises Act.  They are joined in the suit by two healthcare systems and two individual physicians.

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Judge Blocks Portions of Centers for Medicare and Medicaid Services (CMS) Vaccine Mandate (US)

A federal court decision has created a new wrinkle for healthcare employers that are preparing to comply with the new vaccine mandate from the Centers for Medicare and Medicare Services (CMS).  On November 29, 2021, Judge Matthew Schelp of the Eastern District of Missouri issued an order blocking the implementation of the CMS vaccine mandate in ten states where the state Attorneys General had challenged the mandate.  While this decision does not conclusively resolve the legal challenges to the CMS mandate, it may shed light on how higher courts will view the questions surrounding the mandate’s enforceability, and it constitutes an important consideration for organizations otherwise covered by the CMS mandate.  For additional information about this development, please see our Employment Law Worldview blog where this decision is discussed in further detail. 

Healthcare Research: A Transatlantic and Trans-European Dialogue Seminar

On November 23rd, Squire Patton Boggs partner Elliot Golding will lead a panel of industry thought leaders in a discussion of transcontinental health research and data issues.  Topics to be explored include:

  • What are the challenges that companies need to face in order to promote research with health data?
  • What should evolve in the legal framework to promote data-driven research in this area?
  • How can we give patients trust in the use of their personal data in health research?  What benefits would arise for patients themselves and for society?

Presenters include:

  • Dr. Hans Hofstratt, Vice-President at Philips Research, Royal Philips
  • Mr. Alexandre Entraygues, Head Data Privacy Europe at Novartis
  • Dr. Geff Brown, Associate General Counsel at Microsoft.

The discussion will take place 10:15-11:00 am Eastern Standard Time.  If interested, you may find more information here.

COVID-19 Vaccine Mandate Fundamentals for Healthcare Employers

Now that OSHA has issued its emergency temporary standard and CMS has issued its own emergency rule, the landscape has changed once again for healthcare employers in terms of addressing employees’ vaccination status.  Fortunately, they now have much more certainty, which allows for more specific and detailed planning to address the myriad vaccination-related requirements that apply for healthcare entities.  The following sets forth key details that healthcare employers should understand as they are establishing their compliance strategies for these obligations. Continue Reading

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