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Recent FDA Warning Letter to Amazon.com Suggests the Agency Is Getting Tired of the Whack-a-Mole Game
August 22, 2022 | Blog | By Joanne Hawana, Benjamin Zegarelli
Receiving a warning letter from the U.S. Food and Drug Administration (FDA) means that the agency has identified what it calls “violations of regulatory significance” and that you (as the recipient) need to take corrective actions or risk inviting some actual enforcement under the Food, Drug, and Cosmetic Act (FD&C Act), which could include injunctions, seizures, and criminal penalties. This post highlights what an FDA warning letter means for Amazon.com as well as potential implications for the retail giant.
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Eighth Circuit Adopts Stricter But-For Causation Standard for False Claims Act Claims based on Anti-Kickback Violations
August 18, 2022 | Blog | By Kevin McGinty, Rachel Yount
In a significant win for False Claims Act (FCA) defendants, the Eighth Circuit recently reversed a district court decision that defendants violated the FCA premised on violations of the Anti-Kickback Statute (AKS). The Eighth Circuit adopted a stricter but-for causation standard for FCA claims based on AKS violations, holding that, in order to prevail on these claims, the government must prove that FCA defendants would not have submitted claims for particular items or services to Medicare or Medicaid absent the illegal kickbacks.
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Senate Democrats Pass Long-Awaited Drug Pricing Reforms in Budget Reconciliation Bill
August 10, 2022 | Blog | By Bridgette Keller, Stephnie John
On August 7, 2022, after extensive deliberation, Senate Democrats passed their long-awaited reconciliation bill, the Inflation Reduction Act of 2022 (the Reconciliation Bill). In addition to climate and tax provisions, the Reconciliation Bill includes a revised drug pricing reform package that Democrats had approved last month. In this post, we review what passing the long-awaited drug pricing reforms means for Medicare recipients and for drug prices in the United States.
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PBM Regulatory Roundup (Summer 2022): States Continue PBM Oversight Activities
August 2, 2022 | Blog | By Bridgette Keller, Hassan Shaikh, Derek Flynn, Shaina Sikka
2022 continues to see a surge in state-led PBM enforcement efforts. This roundup provides a brief summary of Louisiana’s complaint against United Healthcare and OptumRx related to its Medicaid program and recent state legislative actions.
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PAMA Laboratory Reporting In Flux: ACLA Wins HHS Lawsuit and Congress Introduces PAMA Amendment Legislation
July 29, 2022 | Blog | By Karen Lovitch, Pat Ouellette
Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA) have recently occurred. As a result, the clinical laboratory industry is hopeful that Medicare cuts scheduled to resume in 2023 and other aspects of PAMA’s price reporting requirements will be reformed. This blogpost provides an analysis of the ACLA lawsuit and newly introduced legislation that amends PAMA.
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New York Office of Medicaid Inspector General Proposes Regulations on Medicaid Provider Compliance Programs
July 26, 2022 | Blog | By Jean D. Mancheno, Cody Keetch
The New York State Office of Medicaid Inspector General (OMIG) published proposed regulations in the July 13, 2022 issue of the New York State Register. The proposed regulations would repeal the current Part 521 - Provider Compliance Programs of Title 18 of the New York Codes, Rules and Regulations (NYCRR) in its entirety and establish new requirements for providers to detect and prevent fraud, waste and abuse in the Medicaid Program under a new Part 521: Fraud, Waste, and Abuse Prevention (Part 521). This blogpost highlights certain provisions from the first of Part 521’s three subparts, Subpart 521-1, that are relevant to New York Medicaid providers as they structure and update their compliance programs.
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Protecting Health Information Post Roe – Part 2: Steps for Health Care Providers
July 21, 2022 | Blog | By Cynthia Larose, Dianne Bourque
In this second of our two-part blog series on protecting health information post Roe, we discuss legal and practical strategies that health care providers can take to protect the information of their patients. State laws that restrict or criminalize abortions will require significant amounts of health information to enforce, putting new pressure on health care providers caught in the middle of competing obligations to their patients and to regulatory and law enforcement authorities making lawful requests for this information.
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Will a Nonprescription Birth Control Pill Be FDA’s First Approval under its Long-Awaited “ANCU” Proposed Rule?
July 20, 2022 | Blog | By Joanne Hawana
Unintended downstream consequences are likely to abound in the wake of the June 24, 2022 Dobbs decision that overruled Roe v. Wade, as Mintz attorneys have addressed in other contexts. Those looking ahead have raised concerns about women’s continued access to the wide array of birth control options that have been approved for use in the United States by the Food and Drug Administration (FDA). This post provides a brief historical background on how OTC birth control pills have been regulated under the Federal Food, Drug, and Cosmetic Act and reviews the FDA's Additional Conditions for Nonprescription Use (ACNU) Proposed Rule.
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Two Recent False Claims Act Settlements Highlight the Benefits of Self-Disclosure, Remediation, and Cooperation
July 19, 2022 | Blog | By Karen Lovitch, Lauren Moldawer, Jane Haviland
Disclosing known or suspected fraud to regulators can have its benefits. As reported in a previous post, the Department of Justice (DOJ) issued policy guidance in 2019 on providing credit in False Claims Act (FCA) settlements to corporations for “disclosure, cooperation, and remediation” (the Policy Guidance). Since then, the industry has been watching to see how DOJ implements this Policy Guidance.
Two settlements announced earlier this month seem to demonstrate that DOJ is applying the Policy Guidance in resolving FCA cases. Although the facts of these two settlements differ significantly, they highlight the benefits of self-disclosure, cooperation with the government in its investigation, and proactive efforts to remediate non-compliance.
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Two settlements announced earlier this month seem to demonstrate that DOJ is applying the Policy Guidance in resolving FCA cases. Although the facts of these two settlements differ significantly, they highlight the benefits of self-disclosure, cooperation with the government in its investigation, and proactive efforts to remediate non-compliance.
Post-Dobbs Abortion-Related Travel Benefits: Surveying Employers’ Options
July 13, 2022 | Blog | By Michelle Capezza, Patricia Moran
Dobbs impacts employer-sponsored group health plan coverage for abortion services in states where abortion is, or becomes, illegal, and abortion-related travel benefits. While our earlier post focused on coverage of abortion and abortion-related travel services under a group health plan, and related ERISA preemption considerations, in this post Mintz attorneys Alden Bianchi, Michelle Capezza and Patricia Moran examine other approaches available to employers that seek to make these benefits available, such as HRAs, health FSAs, excepted benefit EAPs and HSAs.
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FDA’s Review of Pulse Oximeter Performance Continues a Trend in Addressing Biases in Digital Health Technologies
July 12, 2022 | Blog | By Benjamin Zegarelli
The U.S. Food and Drug Administration (FDA) will schedule a public meeting of the Medical Devices Advisory Committee later this year to discuss study results, real-world data, and other evidence concerning the accuracy and performance of pulse oximeters. The planned meeting is consistent with the agency’s recent efforts to evaluate the need for and options to address transparency and diversity in the design and development of artificial intelligence/machine learning (AI/ML) based software devices (see our post covering FDA’s Transparency of AI/ML Enabled Medical Devices Workshop) and in clinical trial design. It is unclear whether or how the outcome of the planned meeting on pulse oximeters will affect prescription and over-the-counter (OTC) pulse oximeters currently on the market, but it is possible that the meeting could lead FDA to impose new testing or labeling requirements for pulse oximeters, and perhaps even other devices that use light-based sensors to evaluate certain biometrics.
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Health Insurance Maintenance During Massachusetts Paid Family and Medical Leave - Draft Regulations Issued
July 11, 2022 | Blog | By Patricia Moran
White House Issues Telehealth Guidance on Substance Use Disorder Services
July 11, 2022 | Blog | By Lara Compton, Cody Keetch, Jean D. Mancheno
On June 22, 2022, the White House Office of National Drug Control Policy (ONDCP) issued guidance advocating for Congress and federal agencies to make permanent certain telehealth access measures for people struggling with substance use disorders (SUD). The guidance, titled Telehealth and Substance Use Disorder Services in the Era of Covid-19: Review and Recommendations (Guidance), made four recommendations geared at increasing telehealth access, utilization, and equity among individuals who have experienced an SUD. This blogpost with provide an analysis of the four recommendations and their implications.
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Post-Dobbs – Government Agencies Seek to Provide Guidance
July 7, 2022 | Blog | By Marc Aspis
Protecting Health Information Post Roe Part 1: Steps for Women
July 5, 2022 | Blog | By Dianne Bourque, Cynthia Larose
Much has been written about how existing privacy laws such as HIPAA are unhelpful to women in the wake of Dobbs vs. Jackon Women's Health Organization ruling. In the first of this two-part blog post series, the Mintz team breaks down the legal rights and practical strategies that women can use to protect their own information.
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PBMs Continue to Draw Federal Scrutiny: PBM Transparency Act of 2022
June 30, 2022 | Blog | By Bridgette Keller, Hassan Shaikh, Sergey Smirnov, Jewel Duberry-Douglas
As we noted in our last PBM Regulatory Roundup, there has been a wave of state regulation focused on PBM practices in the wake of Rutledge and Webhi. However, PBMs are also facing federal reform efforts. The Pharmacy Benefit Manager (PBM) Transparency Act of 2022 (the Act) was recently proposed in the U.S. Senate and intends to incentivize “fair and transparent” PBM practices, prohibit spread pricing and claw backs of payments to pharmacies, and empower the Federal Trade Commission (FTC) and state attorneys general in enforcement actions to stop “unfair and deceptive” PBM business practices.
At the same time, government watchdogs are also taking action: on June 7, 2022, the FTC announced that it would launch an inquiry into vertically integrated PBMs, and the Office of the Inspector General (OIG) for the Department of Health and Human Services expects to release a report in 2022 following completion of its analysis of Medicaid Managed Care Organization (MCO) PBM pricing.
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At the same time, government watchdogs are also taking action: on June 7, 2022, the FTC announced that it would launch an inquiry into vertically integrated PBMs, and the Office of the Inspector General (OIG) for the Department of Health and Human Services expects to release a report in 2022 following completion of its analysis of Medicaid Managed Care Organization (MCO) PBM pricing.
DOJ and FTC Virtual Workshop: Agencies Discuss Novel Approaches to Address Competition Issues in Pharmaceutical Mergers
June 23, 2022 | Blog | By Evelyn French, Tinny Song
Summer 2022 Is Here – Do You Know How the FDA User Fee Legislation Is Going?
June 2, 2022 | Blog | By Joanne Hawana
Anyone who has spent any time around health care policymaking circles in Washington, D.C. has heard about the intense five-year cycle Congress goes through in order to reauthorize the biggest user fee programs at the Food and Drug Administration (FDA). Mintz previously published this wonderful explanation of the process complete with an estimated timeline for how this year’s reauthorization was likely to go. As a reminder, the current authorization for FDA’s various human product user fee programs – with the exception of the over-the-counter drug program that was freshly created in 2020 – will expire on September 30, 2022 with the end of the federal government’s fiscal year, unless they are renewed by Congress before that time.
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Potential Pitfalls of Telehealth Prescribing
May 31, 2022 | Blog | By Lara Compton, Ellen Janos, Cassandra Paolillo
As we’ve previously covered, while Congress has acted to extend certain COVID-era telehealth flexibilities (mostly related to Medicare coverage) beyond the Public Health Emergency (PHE), the future of prescribing controlled substances via telehealth is uncertain. Although the American Telemedicine Association and other industry groups continue to advocate for changes to allow telehealth providers to prescribe controlled substances in certain circumstances, without further action by Congress or the Drug Enforcement Administration (DEA), telehealth providers who prescribe controlled substances will need to conduct an in-person examination of the patient once the PHE ends.
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Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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