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Connecticut Proposal to Cap Drug Price Increases Could Portend a Shift in the Drug Pricing Debate

March 17, 2022 | Blog | By Xavier Hardy

On March 15, 2022, a drug pricing bill proposed by Connecticut Governor Ned Lamont’s (S.B. 13) was referred to the state legislature’s nonpartisan legal counsel responsible for drafting and processing official legislation. The proposed legislation, which would cap increases on pharmaceutical drugs to the rate of inflation plus 2%, is notable because it represents a relatively aggressive approach to addressing high drug prices. The legislation would also establish a program to authorize the importation of Canadian pharmaceuticals into the state.
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OIG Issues Another Favorable Advisory Opinion on Treatment-Based Patient Incentives

March 15, 2022 | Blog | By Rachel Yount

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued another favorable Advisory Opinion on patient incentives (e.g. gift cards or cash equivalents) given as part of patients’ treatment plans. Though the OIG reiterated its concern that cash and cash equivalents given to patients can present substantial fraud and abuse risks, the OIG concluded that the arrangement presented a minimal level of risk.
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DOJ Keeps Focus on COVID-19 Related Fraud with Appointment of Director

March 14, 2022 | Blog

The U.S. Department of Justice (DOJ) has continued to investigate and prosecute alleged COVID-19 related fraud over the past two years since the pandemic began. On Thursday, DOJ announced the appointment of a Director for COVID-19 Fraud Enforcement, who will lead DOJ’s enforcement efforts in this area. Associate Deputy Attorney General Kevin Chambers will fill this position.
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New York To Require Licensure of Pharmacy Benefit Managers

February 25, 2022 | Blog | By Cody Keetch, Jean D. Mancheno

In an effort to counteract rising prescription drug costs and health insurance premiums, New York Governor Hochul signed S3762/A1396 (the Act) on December 31, 2021.  This legislation specifies the registration, licensure, and reporting requirements of pharmacy benefit managers (PBMs) operating in New York. The Superintendent of the Department of Financial Services (Superintendent) will oversee the implementation of this legislation and the ongoing registration and licensure of PBMs in New York. Notably, this legislation establishes a duty of accountability and transparency that PBMs owe in the performance of pharmacy benefit management services.
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Telehealth Update: New Bill Could Provide Much Needed Certainty to Providers and Patients

February 10, 2022 | Blog | By Ellen Janos, Cassandra Paolillo

On Monday, February 7, 2022, U.S. Senators Catherine Cortez Masto, D-Nevada, and Todd Young, R-Indiana, introduced the Telehealth Extension and Evaluation Act, which if passed, would extend several of the telehealth waivers for two years after the end of the federal public health emergency (PHE). See our previous coverage of telehealth during the COVID-19 pandemic. The PHE was most recently renewed for an additional 90 days on January 16, 2022. Since January 2020, providers who pivoted to telehealth in order to deliver care to their patients during the pandemic have had to closely monitor the status of the PHE, which the Secretary of HHS is only authorized to extend for 90 days at a time. Passage of the proposed legislation would provide some much-needed certainty and would give providers time to transition back to in-person care where necessary. It would also further the growth and expansion of telehealth services and continued integration into our health care delivery system.
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False Claims Act Settlements and Judgments Exceed $5.6 Billion in Fiscal Year 2021

February 2, 2022 | Blog | By Laurence Freedman, Jane Haviland

The Department of Justice announced in a February 1, 2022 press release (Press Release) that it obtained more than $5.6 billion in settlements and judgments from civil cases involving fraud and false claims in the fiscal year ending September 30, 2021 (FY2021) – the second largest annual total recovery in False Claims Act (FCA) history.
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First Circuit Adopts Deferential Standard for Review of Government Decisions to Dismiss FCA Whistleblower Cases

January 27, 2022 | Blog | By Kevin McGinty, Samantha Kingsbury

In a decision issued late last week, the First Circuit has adopted a deferential standard for review of government decisions to seek dismissal of whistleblower lawsuits brought under the False Claims Act (FCA). The court held that so long as the government explains its decision and provides the whistleblower with an opportunity to respond, the government’s motion must be granted absent evidence of collusion or unconstitutionality. This decision deepens a circuit split on the applicable standard under the FCA when the whistleblower objects to a government motion for dismissal.
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OIG Approves Online Retailer’s Discount Program

January 25, 2022 | Blog | By Rachel Yount

On January 19, 2022, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding an online retailer’s proposal to make its discount programs available to Medicaid beneficiaries. Currently, lower-income individuals are eligible for the retailer’s discount programs based on their enrollment in a number of assistance programs (e.g. Supplemental Security Income, Supplemental Nutrition Assistance Program), and the retailer proposes Medicaid enrollment as another category of eligibility.
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CMS Proposes Changes to Part D Regulations: Pharmacy Price Concessions

January 24, 2022 | Blog | By Hassan Shaikh

The next post in our series analyzing the recently proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs rule (Proposed Rule), focuses on a regulation impacting Part D sponsors and their reporting of pharmacy price concessions. According to CMS, the proposed change—which would require the “negotiated price” of a covered Plan D drug to be the lowest possible payment made to a pharmacy by a Plan D sponsor—is expected to (i) reduce out-of-pocket costs for plan beneficiaries at the pharmacy counter, (ii) create greater drug price transparency, (iii) stabilize the operating environment for pharmacies and (iv) improve market competition.
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CMS Proposes Changes to Medicare Advantage Regulations: Network Adequacy, Beneficiary Access, MLR Reporting, and MOOP

January 19, 2022 | Blog | By Bridgette Keller, Xavier Hardy

Continuing our series analyzing the recently proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs rules (Proposed Rule), this post focuses on a few items that are specific to Medicare Advantage (MA) Plans. Here, we discuss CMS’ proposals to (1) require initial and expanded services area applicants to submit their proposed contracted networks during the application process, (2) clarify that beneficiary access requirements during disasters and emergencies apply when there is a “disruption in access to health care,” (3) return to medical loss ratio (MLR) reporting requirements from 2014 – 2017, and (4) an adjustment to how the maximum out-of-pocket (MOOP) limit is calculated for dually-eligible beneficiaries.
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Co-Owner of Clinical Trial Company Pleads Guilty to Obstruction of Justice in Connection with Falsification of Clinical Trial Data

January 18, 2022 | Blog | By Jane Haviland, Joanne Hawana, Kate Stewart

On January 12, 2022, the co-owner of a clinical research site in Miami, Florida pleaded guilty to one count of obstruction of justice after she knowingly lied to a United States Food and Drug Administration (FDA) investigator during a 2017 regulatory inspection. Olga Torres co-owned the clinical research site, Unlimited Medical Research (UMR). During its years of operation, UMR was engaged as a clinical trial site by a number of pharmaceutical companies. The conduct that led to the obstruction of justice charge stemmed from a clinical trial conducted at UMR to evaluate the safety and efficacy of a pediatric asthma drug.
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Building on the Success of Medicare-Medicaid Plans, CMS Proposes Modifications for D-SNPs

January 14, 2022 | Blog | By Lauren Moldawer, Stephnie John

As we noted, Centers for Medicare & Medicaid Services (“CMS”) recently proposed its Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs rules (“Proposed Rule”) that would increase consumer protections and reduce health care disparities in Medicare Advantage (“MA”) and Part D. In the Proposed Rule, CMS proposes major modifications to its regulations governing Dual Eligible Special Needs Plans (“D-SNPs”), which are MA products specifically for individuals who are dually eligible for Medicare and Medicaid. These changes are informed by the success of CMS’ Financial Alignment Demonstration and Medicare-Medicaid Plans (“MMPs”). In fact, under the Proposed Rule, CMS is proposing that many key characteristics of MMPs be incorporated into D-SNPs. CMS is also proposing to update the definitions of Fully Integrated Dual Eligible Special Needs Plans (“FIDE SNPs”) and Highly Integrated Dual Eligible Special Needs Plans (“HIDE SNPs”) to incorporate successful characteristics of MMPs and to better clarify and differentiate these terms.
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CMS Proposes New Rules for Medicare Advantage and Part D

January 11, 2022 | Blog | By Bridgette Keller

Last week, CMS announced proposed rules seeking to increase consumer protections and reduce health care disparities in Medicare Advantage (MA) and Part D, with a strong emphasis on individuals who are dually eligible for Medicare and Medicaid. Over the next few weeks, the Mintz team will provide an in-depth review and analysis of the proposed rules here on our blog. In the meantime, here is summary of the proposed changes.
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An Overview of Pharmaceutical Sales Representative Licensure and Registration Laws in the United States

January 6, 2022 | Blog | By Jean D. Mancheno, Joanne Hawana

On January 1, 2022, S.B. 763 took effect in Oregon, requiring pharmaceutical sales representatives (“PSR”) to obtain a license prior to marketing or promoting pharmaceutical products to health care providers. Oregon is not the first jurisdiction to enact such a law, but it is one of few jurisdictions in the United States to require licensure or registration of PSRs. This post discusses S.B. 763 and similar laws, regulations, and ordinances that are in effect in Nevada, Illinois, and Washington, D.C. below.
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Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started

January 5, 2022 | Blog | By Joanne Hawana, Benjamin Zegarelli

It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12 months and consider what the agency is likely to focus on going forward. This year, however, we’re taking a different approach and will be providing more of a birds-eye view of our favorite federal agency as it stands as of the end of 2021. Because there is just too much going on at the administrative, enforcement, and legislative levels to get into the details of everything in one fell swoop. So make sure you’re signed up for Mintz Health Law Viewpoints to receive updates throughout the year on issues as they develop.
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Information Blocking Rule: Key Considerations for 2022

December 29, 2021 | Blog | By Pat Ouellette

While the Office of the National Coordinator for Health Information Technology (ONC) issued the 21st Century Cures Act; Interoperability, Information Blocking, and the ONC Health IT Certification Program (Information Blocking Final Rule) back in May 2020, many entities are still parsing out compliance strategies and seeking additional regulatory guidance to understand how the rule will be enforced. Broadly-speaking, information blocking is a practice that is likely to interfere with, prevent, or discourage access, exchange, or use of electronic health information (EHI). For example, a health system might require patient written consent before sharing the patient’s EHI with unaffiliated providers. Another example of information blocking is that a health IT developer might charge a fee to a health care provider to perform an export of EHI so that the provider can switch to a different health IT platform.
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FDA Issues Draft Device Guidance in Preparation for the End of the Public Health Emergency

December 27, 2021 | Blog | By Benjamin Zegarelli

On December 22, 2021, FDA took another step in rolling back enforcement policies implemented in response to the COVID-19 pandemic by publishing guidance documents describing the regulatory requirements for devices that were authorized under the emergency use authorization process and those under temporary FDA policies implementing specific enforcement discretion during the pandemic once the Public Health Emergency for COVID-19 ends. The Transition Plan Guidances will help device manufacturers prepare for the end of the PHE and continue to commercialize devices necessary for the long-term response to COVID-19.
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New Year, New Laws: An Overview of New Laws Impacting New York Nursing Homes in January 2022

December 21, 2021 | Blog | By Cody Keetch, Jean D. Mancheno

Throughout 2021, former Governor Andrew Cuomo introduced sweeping legislation to initiate reform in nursing homes licensed under Article 28 of the New York Public Health Law. While many of these laws took effect this past year, some are set to take effect in the New Year and beyond. Below we provide a brief overview of three that are taking effect in January 2022.
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OIG Reiterates its Longstanding Concern about Joint Ventures between Health Care Providers/Suppliers and Referral Sources

December 1, 2021 | Blog | By Rachel Yount

On November 22, 2021, the Office of Inspector General for the Department of Health and Human Services (OIG) posted a negative Advisory Opinion regarding a proposed joint venture (JV) for the provision of therapy services (Proposed Arrangement) between an existing therapy services provider (Therapy Services Provider) and the owner of long-term care facilities (LTC Owner). This Advisory Opinion is yet another example of OIG guidance reiterating its view that joint ventures formed between entities in the position to provide health care items or services and entities in the position to refer business can present risk under the federal Anti-Kickback Statute (AKS).
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Entirely Virtual Shareholder & Member Meetings Now Permitted in New York

November 23, 2021 | Blog | By Cody Keetch, Jean D. Mancheno

On November 8, 2021, Governor Hochul signed legislation to permanently amend the New York Business Corporation Law and New York Not-for-Profit Corporation Law. Under the new law, for profit and not-for-profit corporations are permitted to hold their shareholder or member meetings solely through virtual means, unless such virtual meetings are prohibited by a corporation’s articles of organization or bylaws.
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