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Recent Federal and State Legislative Action Targeting Health Care Staffing Agencies
October 5, 2022 | Blog | By Stephnie John
Nurse and health care professional staffing shortages during the COVID-19 pandemic resulted in a significant increase in the use of temporary health care professional staffing. Shortages have also lead to the increase in the use of travel nurses, causing state lawmakers to prioritize regulation of health care staffing agencies. This post provides an overview of recently enacted and proposed state legislation requiring licensure or registration of health care staffing companies and/or nursing pools.
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MintzRx — The 340B Drama Continues
October 3, 2022 | Blog
MintzRx — Drug Pricing Update: The Inflation Reduction Act
October 3, 2022 | Blog
MintzRx — Summer 2022 Enforcement Round-Up: Key Trends in Pharmacy Enforcement Actions
October 3, 2022 | Blog
MintzRx — Medicaid Best Price Value Based Purchasing Rules Took Effect July 1, 2022
October 3, 2022 | Blog
HHS, Treasury and Labor Issue More Guidance on the No Surprises Act
October 3, 2022 | Blog | By Marc Aspis
On August 19, 2022, the Departments of Health and Human Services, Treasury and Labor (the "Departments") issued final rules (the “Final Rules”) incorporating comments received on the interim rules issued in July and October 2021, clarifying some of the requirements set forth in Title I of Division BB of the Consolidated Appropriations Act, 2021 (the "Act") and the interim rules and accounting for relevant federal court rulings. In particular, the Final Rules primarily address three distinct but related topics: (1) eliminating the “rebuttable presumption standard,” (2) adding new rules regarding “downcoding,” and (3) reminding the arbitrators of their written requirements. In this post Mintz attorneys Mark Aspis and Alden Bianchi discuss the implication of the Final rules which will be effective on October 25, 2022.
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MintzRx — Tension Over Copay Assistance and Maximizer Programs Continues
October 3, 2022 | Blog
MintzRx — OCR Provides Post-Dobbs Guidance on Non-Discrimination to Pharmacies
October 3, 2022 | Blog
MintzRx — Pressure to Combat High Drug Prices Lands PBMs in the Hot Seat
October 3, 2022 | Blog
FDA Is Accepting EUA Requests for Monkeypox Tests, But Time is of the Essence
September 28, 2022 | Blog | By Benjamin Zegarelli, Joanne Hawana
The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the Department of Health and Human Service’s declaration of a public health emergency under Section 564 of the Food, Drug and Cosmetic Act on August 9, 2022. Subsequently, the Secretary declared on September 7 that in vitro diagnostics for monkeypox were needed to respond to the public health emergency, and the FDA released its guidance on the same day. The monkeypox test guidance describes the agency’s general expectations and approach for test development and validation, as well as the EUA request process.
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New York Office of Medicaid Inspector General Proposes Regulations on Self-Disclosure Program
September 26, 2022 | Blog | By Karen Lovitch, Jean D. Mancheno, Cody Keetch
This post is the third and final installment of our blog series on the proposed regulations published by the New York State Office of Medicaid Inspector General (OMIG). The proposed regulations would repeal the current Part 521 - Provider Compliance Programs of Title 18 of the New York Codes, Rules and Regulations 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). If enacted, the proposed rules would implement changes related to Medicaid provider compliance programs, Medicaid managed care organization (MMCO) fraud, waste, and abuse prevention, and Medicaid providers’ “obligation to report, return, and explain Medicaid overpayments through OMIG’s Self-Disclosure Program.”
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OCR HIPAA Privacy Rule Enforcement Roundup: Right of Access Initiative and Improper PHI Disposal
September 22, 2022 | Blog | By Pat Ouellette
The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) has been busy over the past month announcing new enforcement actions and settlement agreements related to violations of the Privacy Rule implemented under the Health Insurance Portability and Accountability Act (HIPAA). OCR’s latest actions offer a reminder for HIPAA Covered Entities that Privacy Rule enforcement activity can come in a variety of types and sizes.
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Pharmaceutical Manufacturer Pays $7.9 Million to Resolve Allegations that it Caused the Submission of Over-the-Counter Drugs to Medicare Part D
September 20, 2022 | Blog | By Joanne Hawana, Rachel Yount
On September 15, 2022, the Department of Justice (DOJ) announced a $7.9 million settlement with generic manufacturer Akorn Operating Company LLC (Akorn) to resolve allegations that Akorn caused the submission of over-the-counter (OTC) drugs to Medicare Part D in violation of the False Claims Act (FCA). Because Medicare Part D only covers prescription drugs, the pertinent drugs were not eligible for Medicare reimbursement. The conduct at issue under this settlement is a relatively novel basis for FCA liability, but we may see similar government enforcement actions in the future as the federal government actively encourages drug manufacturers to “switch” prescription drugs to OTC status in order to enhance their accessibility and reduce costs. This blog post provides an overview and analysis of the settlement.
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The Government's Long Game for Investigating COVID-era Relief Fraud
September 16, 2022 | Blog | By Eoin Beirne
Various COVID relief programs pumped $5 trillion into the economy, incredibly quickly, and with relatively minimal vetting. Within that enormous and necessary set of economic stimulus packages was likely the greatest amount of fraud committed on the government in the shortest amount of time in history. This article takes a look at the various issues facing government agencies as they attempt to investigate allegations of PPP fraud related to pandemic-era applications and the role of the Pandemic Response Accountability Committee in coordinating and overseeing these investigations.
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California Attorney General Probes Bias in Health Care Algorithms
September 12, 2022 | Blog | By Lara Compton, Jane Haviland
A spurt of letters from California Attorney General, Rob Bonta, to leaders of hospitals and other health care facilities sent on August 31, 2022 signaled the kickoff of a government probe into bias in health care algorithms that contribute to material health care decisions. This blog post highlights the California Office of the Attorney General’s initiative to address disparities in health care and what this probe may mean for the use algorithms and AI in health care.
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FDA Announces Review of Opioid Prescribing Regulations and Framework for Preventing Overdose-Related Deaths
September 7, 2022 | Blog | By Joanne Hawana, Samantha Kingsbury
The head of the Food and Drug Administration (FDA), Dr. Robert Califf, announced on August 30, 2022 that, in addition to an extensive review of opioid regulations, the agency is launching a framework aimed at preventing overdose-related deaths. Commissioner Califf previously committed to leading a review of opioid regulations during his December 2021 confirmation hearing, in response to repeated questions from Senators regarding FDA’s response to the ongoing opioid epidemic and broader public criticism of the agency’s historical actions in the space. The commitment to regulatory review also follows criticism FDA has received over the years for approving OxyContin in 1995 and many other addictive opioid drugs since then without requiring more thorough warning labels and other protections that could help combat misuse and over-prescribing.
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Telehealth Update: Assessing PHE Flexibilities, Pending Legislation Entering Fall 2022
September 1, 2022 | Blog | By Ellen Janos, Cassandra Paolillo
Many of the flexibilities upon which telehealth providers have come to rely in recent years are tied to the federal Public Health Emergency related to the COVID-19 pandemic (PHE). As we move into Fall 2022, we review the current state of the PHE flexibilities around Medicare reimbursement and prescription of controlled substances, examine pending legislation that, if passed, would bring greater certainty to patients and providers, and discuss what we know about the status of a possible PHE extension.
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New York Office of Medicaid Inspector General Proposes Regulations on Medicaid Managed Care Fraud, Waste, and Abuse Prevention
August 31, 2022 | Blog | By Cody Keetch, Jean D. Mancheno
On July 26, 2022, we published a blog post detailing part one of three of proposed regulations published by the New York State Office of Medicaid Inspector General (OMIG). 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). In this post, we summarize the second subpart of Part 521 covering proposed regulations that would require MMCOs to develop and implement programs to detect and prevent fraud, waste, and abuse in the Medicaid program.
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Summer 2022: Key Trends in Pharmacy Enforcement Actions
August 29, 2022 | Blog | By Lauren Moldawer, Grady Campion, Pat Ouellette
Pharmacies have long been a focus of enforcement actions brought by the Department of Justice (DOJ) and Department of Health and Human Services Office of Inspector General (OIG). This summer has been no exception, with the DOJ and OIG bringing a number of fraud cases against pharmacies and pharmacists. We also saw enforcement against pharmacies for allegedly falsifying prior authorization information and providing more insulin than the pharmacy billed to payors. This blog summarizes some of these and other key pharmacy enforcement trends this summer.
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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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