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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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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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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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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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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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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. Krebs

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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About Face: Laboratory-Developed Tests for COVID-19 Now Subject to EUA Requirements

November 19, 2021 | Blog | By Joanne Hawana, Benjamin Zegarelli

For over a year now, there has been speculation about how the Biden Administration would handle the chronically vexing regulatory issues associated with laboratory-developed tests (LDTs). On November 15, 2021 we finally got our answer when the August 2020 policy put in place by the Trump Administration was officially withdrawn. The Food and Drug Administration (FDA) also released corresponding updates to various guidelines related to the testing response to the ongoing public health emergency. Before summarizing all of these critically important developments, we’ll provide some quick history of what has been going on with LDTs since the pandemic began.
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Over the course of 2020, the Food and Drug Administration (FDA) released numerous guidance documents covering diverse areas and aimed at increasing the availability of various medical products to prevent, treat, and diagnose COVID-19. Some of our prior blog posts on those pandemic response activities implemented by FDA can be found here and here. In all of those actions, FDA made clear that the agency’s enforcement discretion policy was temporary, or that an emergency use authorization (EUA) was being granted pursuant to statutory criteria that include a requirement that there be “no adequate, approved, and available alternative to the product,” which by definition renders the EUA temporary, as well. Accordingly, several EUAs granted to diagnostic tests, therapeutic products, and medical devices have been revoked based on a determination that all of the criteria necessary to support emergency authorization under the statute can no longer be met. And although the public health emergency is not over even as 2021 comes to a close, FDA has kept its promise to continually reassess circumstances and needs on the ground in the United States and to modify policies and emergency authorizations as necessary.
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Last week, CMS announced its final Physician Fee Schedule Payment Policies (the “Final Rule”), which will become effective January 1, 2022. The Final Rule included several updates to Medicare coverage of telehealth services, including a number of COVID-19 related changes that will be extended or be made permanent. As previously covered, while temporary orders allowing expanded use of telehealth have increased access to care across the country during the public health emergency (“PHE”), the regulatory environment for telehealth has always been somewhat unsettled. The changes in the Final Rule described below signal a move towards increased access to telehealth for Medicare beneficiaries as regulators acknowledge the potential benefits of these alternate methods of delivering care.
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OIG Revises and Renames the Provider Self-Disclosure Protocol

November 10, 2021 | Blog | By Karen Lovitch, Rachel Yount

For the first time since April 2013, the Department of Health and Human Services’ Office of Inspector General (OIG) revised the Provider Self-Disclosure Protocol (SDP) on November 8, 2021. The SDP allows providers and other entities to voluntarily disclose and resolve instances of potential fraud involving federal health care programs, including potential overpayments and Anti-Kickback Statute (AKS) violations. The OIG originally published the SDP in 1998, and has since modified the SDP several times generally to make the SDP a more appealing option for providers and other health care entities.
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In the weeks leading up to FDA’s October 14, 2021 Transparency of AI/ML Enabled Medical Devices Workshop (Workshop) we took a brief look at the history of FDA’s regulation of medical device software and the agency’s more recent efforts in regulating digital health. In this post, we will provide an overview of the topics discussed at the Workshop and our impressions of the agency’s likely next steps.
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California’s Senate Bill 41: The Genetic Information Privacy Act

October 19, 2021 | Blog | By Stephnie John, Lara Compton

Our previous blog post on pending California privacy legislation included a prediction that has since materialized: Governor Newsom signed the Genetic Information Privacy Act (“GIPA”) on October 6, 2021, and the law will go into effect on January 1, 2022. GIPA establishes a number of mechanisms to close the existing gap in the protection of genetic information under the current framework of federal and state privacy laws. As discussed in our earlier post, GIPA contains a robust penalty structure, but it includes a number of carve-outs and does not apply to entities already subject to regulation under other health information privacy laws. Notably, GIPA does not reduce or eliminate obligations under other laws, including California’s more broadly applicable consumer privacy laws, such as the CCPA and breach notification statute, as recently amended by AB 825. Given Governor Newsom’s former concern about GIPA’s interference with mandatory COVID-19 testing reporting, the law also does not apply to tests that are conducted exclusively to diagnose whether an individual has a specific disease.
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By now, businesses operating in the over-the-counter (OTC) drug product space should all be familiar with the changes made by Congress to the regulatory system with the final OTC Monograph reform bill, which was included as part of the Coronavirus Aid, Relief, and Economic Security Act that was signed on March 27, 2020 (see our prior posts here and here).

As we’ve reported previously, at the end of 2020, the Office of Non-Prescription Drugs (ONP) of the Food and Drug Administration (FDA), launched a webpage for its brand new user Over-The-Counter Monograph User Fee Program (OMUFA) – available here – published programmatic fee rates for Fiscal 2021 (which ended on September 30, 2021), and subsequently posted a public arrears list of facilities that did not make their FY2021 facility payments as was required to be done by May 10, 2021. Drugs produced by those in-arrears facilities are considered misbranded under the law.
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In our last post, we took a brief look back through history at FDA’s approach to regulating medical device software and found that there is little distinction from the agency’s approach to hardware devices. Recently, however, FDA has announced several digital health initiatives aimed at improving the agency’s resources and policies governing software and data systems (including its own internal data systems) and changing the way the agency handles pre-market reviews of and compliance activities for software as a medical device (SaMD) and SaMD manufacturers. In this post, we will review FDA’s digital health improvement highlights from the past few years and take a quick look at the agenda for the transparency of AI/ML-enabled medical devices workshop scheduled for October 14, 2021.
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October 10th was the last day for Governor Newsom to sign or veto laws that were passed by the legislature this year. 2021 was a busy year for California legislators, who put forth hundreds of health-related bills in the wake of the COVID-19 pandemic. Unsurprisingly, not all of the bills became law (although some of them may be revisited next year). This blog post provides a summary of a few of the new health care laws that were signed into law by Governor Newsom, covering a wide range of health care providers.   
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