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CMS Proposes Significant Changes to Medicare Advantage & Part D for 2021 and Beyond, Part 2: CMS Proposes to Codify Supplemental Benefit Rules and Update MLR
February 25, 2020 | Blog | By Tara E. Dwyer, Lauren Moldawer
As a continuation of our series on the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program (the “Proposed Rule”) released by the Centers for Medicare & Medicaid Services (“CMS”) earlier this month, this blog focuses on CMS’s codification of its recent guidance on supplemental benefits, including guidance on Special Supplemental Benefits for the Chronically Ill (“SSBCI”). It also discusses CMS’s proposed changes to the medical loss ratio (“MLR”) to account for changes in supplemental benefits.
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340B Ceiling Price Transparency – HRSA Now Requiring Pharmaceutical Manufacturers to Issue Refunds to Covered Entities for Overcharges
February 24, 2020 | Blog | By Daryl Berke
As regular readers of our blog know, the Centers for Medicare & Medicaid Services (CMS) intensified its push for drug pricing transparency in 2019. In 2020, we see a continuation of those efforts, and their impacts on the 340B program are now starting to reveal themselves. On January 1, 2019, the Health Resources & Services Administration (HRSA) finally implemented the ceiling price and manufacturer civil monetary penalties (CMPs) regulations that the agency proposed in 2017. The regulations implement certain provisions of the Affordable Care Act and were initially scheduled to go into effect on February 28, 2017, but were repeatedly delayed.
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Health Care Data Breaches Are Increasing Both in Number and Cost
February 20, 2020 | Blog
It feels like we’ve been seeing a lot more health care breaches caused by hackers and other IT security incidents recently, and there’s a good reason why: a recent report by cloud security company Bitglass confirms that both the number of breaches and individuals affected by breaches caused by hackers and IT incidents grew significantly last year. Bitglass analyzed data from the breach portal, affectionately known as the “Wall of Shame,” published by the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). Pursuant to the HITECH Act, HHS is required to post a list of all reported breaches that affect 500 or more individuals. OCR classifies the types of breaches reported on the Wall of Shame, and the "Hacking/IT Incident" category includes a variety of breaches, including malicious intrusion, malware, ransomware, phishing, and general IT security failures.
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Closing the Orphan Drug Act Loophole
February 18, 2020 | Blog
On Tuesday, February 11, 2020, Senators Bill Cassidy (R-LA), Jeanne Shaheen (D-NH), and Tammy Baldwin (D-WI) introduced legislation to eliminate the “orphan drug loophole.” Current law allows the Food and Drug Administration (FDA) to grant seven years of market exclusivity to a drug manufacturer if the drug is intended to treat a disease or condition affecting fewer than 200,000 patients in the U.S., or less commonly, if the manufacturer cannot expect to recover the costs of developing and marketing a drug. In some cases, even if the drug developer meets the orphan drug criterion of having no hope of recovering the costs, the drug does actually become profitable—some significantly so—but competitors are still barred from entering the market with a lower-cost alternative during the 7-year exclusivity period that exists by operation of law. To combat this issue, the recently introduced Senate bill (as well as a nearly-identical House bill introduced in October 2019) targets a loophole that allows market exclusivity under the Orphan Drug Act to be extended for future versions of the same drug without the drug's manufacturer having to show that the drug remains unprofitable.
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CMS Proposes Significant Changes to Medicare Advantage & Part D for 2021 and Beyond, Part 1: Updates to the Star Rating System and Suspension of the Past Performance Methodology
February 13, 2020 | Blog | By Tara E. Dwyer, Lauren Moldawer
In CMS’s recently released proposed rule (the Medicare and Medicaid Programs: Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program and Programs of All-Inclusive Care for the Elderly) (the “Proposed Rule”) and supplemental HPMS memos, CMS is proposing several significant changes to its star rating system and to its methodology for reviewing plan past performance. This blog post highlights the key details of the proposed changes to the star rating system and past performance methodology and their potential impact on Medicare Advantage and Part D plans.
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Friendly Reminder: HIPAA Still Applies During the Coronavirus Outbreak
February 12, 2020 | Blog
As the coronavirus remains to be an active outbreak with cases increasing within the United States, this is a good time to review how HIPAA applies in a public health emergency, including its restrictions and flexibility in these types of situations. Accordingly, last week, the Office for Civil Rights (OCR) released a helpful bulletin on how the HIPAA Privacy Rule comes into play with the coronavirus outbreak and other public health emergencies.
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Massachusetts Considers Drug Pricing Transparency Laws
February 10, 2020 | Blog
Like many states, Massachusetts is considering drug pricing transparency legislation. The legislation would require pharmaceutical manufacturers to disclose certain pricing information. Governor Charlie Baker has proposed legislation which would expand upon current reporting requirements for drug manufacturers in Massachusetts, and the Massachusetts Senate passed legislation which includes drug price transparency requirements and increased regulatory oversight of the pharmaceutical industry in Massachusetts.
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CMS Proposes Significant Changes to Medicare Advantage and Part D for 2021 and Beyond
February 7, 2020 | Blog | By Tara E. Dwyer
This week, the U.S. Department for Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) released a proposed rule (the Medicare and Medicaid Programs: Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program and Programs of All-Inclusive Care for the Elderly), the 2021 Medicare Advantage and Part D Advance Notice of Methodological Changes for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies (Part II), and multiple Health Plan Management System (HPMS) memos and notices covering topics including Medicare Advantage (MA) benefits, Medicare Part D bidding, and suspension of its Past Performance Review Methodology.
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Artificial Intelligence in Health Care
February 5, 2020 | Blog
Artificial Intelligence is a growing part of our day-to-day life. And AI promises to improve our health care system. ML Strategies Vice President Christian Tomatsu Fjeld recently sat down with other experts for a panel discussion hosted by the San Francisco Business Times to discuss AI and some business and policy considerations across multiple industries. This viewpoint considers some of the impacts on health care specifically, and links out to the panel's discussion.
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New Government Action Aims to Increase Competition among Biological Products: FDA and FTC Step Up Industry Pressure
February 4, 2020 | Blog | By Joanne Hawana
Continuing progress on the initiatives announced in its Biosimilars Action Plan in July 2018 (see our prior post here), the Food and Drug Administration (FDA) released information about several important biosimilar-related actions on February 3, 2020. These recent moves make clear that FDA Commissioner Stephen Hahn, who was confirmed and sworn in to his new role at the tail end of 2019, is continuing to focus agency resources on the Biosimilars and Drug Competition Action Plans developed under the leadership of his predecessor, Dr. Scott Gottlieb.
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FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round
February 3, 2020 | Blog
As discussed in an earlier blog post, the process for reauthorizing human medical product user fee programs at the Food and Drug Administration (FDA) for another 5-year period is getting started this year. Below we highlight some changes made to the programs when they were last reauthorized through the 2017 Food and Drug Administration Reauthorization Act (FDARA) (P.L. 115-52) and consider what could be included in the upcoming user fee reauthorization package.
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OIG Advisory Opinion Permits a Pharmaceutical Manufacturer to Provide Financial Assistance to Needy Patients Receiving Risky Cell Therapy
January 30, 2020 | Blog | By Karen Lovitch, Jane Haviland
The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Requestor) to provide financial assistance for travel, lodging, and other expenses to certain patients receiving a cell therapy that it offers (the Arrangement). The OIG concluded that the Arrangement could potentially violate the Anti-Kickback Statute as well as the prohibition on beneficiary inducement in the Civil Monetary Penalties Law (the Beneficiary Inducement CMP) but ultimately declined to impose administrative sanctions.
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Health Plan Transparency Rule: Comment Period Ends This Week
January 29, 2020 | Blog | By Lauren Moldawer
In November 2019, the Department of Health, along with the Department of Treasury and Department of Labor (“Departments”) released a proposed rule requiring group health plans and health insurance issuers in the individual and group markets to disclose cost-sharing information to enrollees (“Proposed Rule”). Earlier this month, the Departments extended the deadline for comments on Proposed Rule to January 29, 2020. To date and with one day remaining in the comment period, the Departments have already received over 20,000 comments on the Proposed Rule.
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FDA User Fees: How Do They Work?
January 28, 2020 | Blog
A history of FDA human medical product user fee programs, including those for prescription drugs (PDUFA), generic drugs (GDUFA), biosimilars (BsUFA), and medical devices (MDUFA), their negotiation and reauthorization, and how manufacturers and patients can participate and get involved in the negotiations.
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Recap of Our Health Law and Policy Year-in-Review Posts for 2019
January 27, 2020 | Blog | By Joanne Hawana
Over the past month or so, our Health Care Team has published a number of posts examining important developments and trends in health law and policy during 2019, as well as providing some thoughts on what we expect to see in 2020. Our posts cover a range of topics, including health care enforcement trends, HIPAA updates, priorities from the Food and Drug Administration (FDA), and drug pricing initiatives. In case you missed one, below are links to all of our annual review posts (plus a few extras).
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Growing Number of States Enact Drug Pricing Transparency Laws
January 23, 2020 | Blog | By Rachel Yount
Drug prices continue to be a hot button issue in American politics. While many of the Trump Administration’s efforts to curb increasing drug prices stalled in 2019, a number of state legislatures have adopted drug price transparency laws in recent years. Since 2015, Vermont, Nevada, California, Maryland, Louisiana, New York, Oregon, Colorado, Connecticut, Maine, Texas, and Washington have all adopted drug pricing transparency laws. These laws are designed to incentivize manufactures to lower drug prices by requiring them to report information about drug price increases and their justification for how drug prices are set. We have been tracking and summarizing these laws, and you can find our summary here.
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Health Care Enforcement Year-in-Review and 2020 Outlook: Criminal Case Developments
January 22, 2020 | Blog | By Eoin Beirne, Nicole Henry, Jason Burrell, Jane Haviland
As discussed in our article recently published by Law360, criminal health care enforcement in 2019 was in many ways a continuation of 2018, with opioid-related enforcement continuing to be the clear top priority for the Department of Justice (DOJ), in addition to DOJ's sustained focus on prosecuting individuals and data-driven identification of health care fraud. This post provides an overview of our article, which covers these issues and our expectations for 2020 in detail.
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Health Care Enforcement Year-in-Review and 2020 Outlook: Civil Fraud Enforcement Developments and Trends
January 21, 2020 | Blog | By Brian Dunphy, Laurence Freedman, Karen Lovitch, Nicole Henry, Clare Prober
As discussed in our article recently published by Law360, 2019 brought yet another year of robust health care enforcement activity, and the False Claims Act (FCA) remains the government’s most powerful civil health care enforcement tool. This post will give an overview of our article, which covers these issues and more in great detail.
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Regulatory Agencies Launch Unified Website for Biotechnology Regulation
January 16, 2020 | Blog
In a coordinated effort, the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9, 2020. The website serves to streamline information regarding agriculture biotechnology products, which are regulated by FDA, USDA, and EPA. The implementation of the website is in response to the June 2019 Executive Order issued by President Donald Trump on Modernizing the Regulatory Framework for Agricultural Biotechnology Products. The Unified Website for Biotechnology Regulation complements prior joint actions such as the Coordinated Framework for the Regulation of Biotechnology, an Obama administration effort to reform the biotechnology regulatory process by enhancing transparency, predictability, and efficacy.
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Health Care: A Clearer Vision in 2020? Don’t Bet On It
January 15, 2020 | Blog | By Tara E. Dwyer
As we noted in our previous blog post, there are several legislative priorities in the health care space that could see action this year. There are also a variety of activities beginning this year that could set the stage for later action. Here’s what we’re tracking for a 2020 health care legislative package.
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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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