Health Care

CMS Proposes Additional Cuts to Part B Reimbursement of 340B Drugs

August 7, 2020 | Blog | By Daryl Berke

On August 4th, the Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) published the 2021 Hospital Outpatient Prospective Payment System (OPPS) proposed rule. The rule proposes to cut Medicare Part B reimbursement for 340B drugs by an additional 6% in 2021 and comes days after the D.C. Court of Appeals upheld a 340B rate reduction of nearly 30% in the 2018, 2019, and 2020 OPPS rules. The agency is relying on data collected through a recent 340B acquisition cost survey to justify the additional rate reduction.

FDA Greenlights Updates to the Purple Book Database

August 6, 2020 | Blog

As promised, the Food and Drug Administration (FDA) updated the Purple Book: Database of FDA-licensed Biological Products, providing greater transparency and a more user-friendly search functionality for the biological product and biosimilar industries. Earlier this year, FDA transitioned the Purple Book to a searchable online database. The August 3, 2020 release offers additional information on all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER) expanding the dataset used by the database. FDA also updated the available exclusivity information for further industry ease of reference. This update is the next phase of the agency’s plan to improve the accessibility of information related to biological products through expansion and digitization.

Telehealth Update: CMS Proposed CY 2021 Payment Policies, Extension of the Public Health Emergency, Increasing Access after COVID-19, and the Coronavirus Stimulus Package

August 5, 2020 | Blog | By Cassandra Paolillo, Ellen Janos

On August 4, CMS posted a proposed rule on CY 2021 Payment Policies, which included important updates about the expansion of Medicare covered telehealth services due to the COVID-19 pandemic. Here, we cover this and other important developments related to telehealth access during the pandemic and beyond.

340B Rate Cuts Are Legal, D.C. Circuit Court Holds

August 4, 2020 | Blog | By Daryl Berke

This week, the Friday surprise came courtesy of the D.C. Court of Appeals. In a long-awaited split decision, the court ruled that the U.S. Department of Health and Human Services (HHS) acted lawfully when it reduced Medicare Part B reimbursement to hospitals for 340B drugs by nearly 30%. The reduction in Part B reimbursement was originally proposed in the 2018 Outpatient Prospective Payment Services (OPPS) rule. HHS estimated it would reduce total Part B spending by $1.6 billion annually, and save Medicare beneficiaries millions in copayments. Covered entities sued to overturn the rate cut, and litigation has been ongoing since the rate cut was implemented in early 2018.

Massachusetts U.S. Attorney’s Office Enters into MOU with Office of the Special Inspector General for Pandemic Recovery

July 30, 2020 | Blog | By Karen Lovitch, Caitie Hill

United States Attorney Andrew E. Lelling recently announced that the U.S. Attorney’s Office for the District of Massachusetts entered into a Memorandum of Understanding with Special Inspector General Brian D. Miller of the Office of the Special Inspector General for Pandemic Recovery to investigate and prosecute fraud in the distribution of the funds authorized by the Coronavirus Aid, Relief, and Economic Security.

363 Sales as a Health Care M&A Tool, Part 1 – Overview

July 28, 2020 | Blog | By Deborah Daccord, William Kannel, Tim McKeon

Although health care may be well positioned to weather an economic downturn as an industry, certain sectors, including ambulatory surgery, vision, dermatology, dental, and other physician practices will bear the brunt of COVID-19 stay-at-home orders and patients delaying non-emergency care. While the onset of COVID-19 has delayed or derailed many transactions, strategic buyers should consider all of the different transaction tools available them to help maximize value and successfully get to closing. For knowledgeable investors and strategic buyers, now is the time to position yourself to acquire valuable health care assets at steep discounts.

For those unfamiliar with 363 Sales, a 363 Sale couples a flexible and fast process with ample liability protection for willing buyers. The primary benefit to a 363 Sale is that a buyer can acquire the debtor’s assets free and clear of virtually all liens, claims and encumbrances burdening the assets and the debtor. When a target is experiencing severe financial distress, the benefit of acquiring assets “free and clear of all liens” is extraordinarily valuable.

Trump Administration Releases Series of Executive Orders on Drug Pricing

July 27, 2020 | Blog | By Xavier Hardy, Daryl Berke

The Trump Administration issued a series of Executive Orders (“EOs” or “Orders”) Friday afternoon related to drug pricing. Several of the EOs seek to restart stalled or withdrawn policy initiatives previously announced by the Administration. Brief summaries of the EOs are below, and we will provide more detailed analysis this week.

Beyond COVID: House Committee Advances Several FDA-Related Bills

July 23, 2020 | Blog | By Margaret Jewett

Despite the COVID-19 pandemic, the House Energy & Commerce Committee continues work on several health policy issues, including Orphan Drug Act reform and continuous manufacturing.

Further Update on FDA’s Comprehensive Regenerative Medicine Framework: November 2020 Deadline Extended by Six Months

July 21, 2020 | Blog | By Joanne Hawana

About a month ago, I predicted on this blog that Food and Drug Administration’s November 2020 enforcement discretion deadline announced as part of its Comprehensive Regenerative Medicine Policy Framework would most likely not be extended. My view was based on a June 17 editorial by agency leadership discussing the risks of unapproved cellular therapy products, which didn’t suggest an extension was forthcoming, as well as an increase in Warning/Untitled Letters related to such products as compared to this time last year. In that earlier blog post I wrote: “Nothing in this newly published editorial suggests that [the Food and Drug Administration (FDA)] will be taking its proverbial foot off the pedal to slow down its efforts towards further oversight of the private stem cell clinic industry after November 2020.”

Bipartisan Group of Senators Introduces Legislation to Waive 340B Eligibility Requirements Due to COVID-19

July 21, 2020 | Blog | By Daryl Berke

On July 2, a bipartisan group of six senators introduced legislation to waive 340B eligibility requirements for hospitals participating in the program during the COVID-19 pandemic. S. 4160 permits hospitals that are 340B-eligible based on their disproportionate share (“DSH”) adjustment percentage to maintain eligibility even if their DSH adjustment percentage falls below the requisite threshold.

HHS Further Amends 42 CFR Part 2, Easing Some, But Not All, Burdens on Substance Use Disorder Treatment Providers

July 17, 2020 | Blog | By Dianne Bourque

The U.S. Department of Health and Human Services (HHS) recently released a final rule further amending 42 CFR Part 2 regulations (Part 2) to allow greater sharing of patient records related to substance use disorder (SUD) treatment. For the past few years, we have seen a push to better align the incredibly strict requirements of Part 2 with HIPAA in order to increase care coordination and promote patient outcomes, particularly in light of the opioid epidemic, which has unfortunately escalated during the COVID-19 pandemic. HHS has been inching toward the harmonization of Part 2 with HIPAA and has now adopted a final rule to address some of the confusion caused by differences between the two regulatory schemes. In conjunction with the release of the final rule, HHS also issued a helpful fact sheet explaining the major changes.

COVID-19 Relief Programs: Recent Criminal Enforcement and Anticipated Trends

July 9, 2020 | Blog | By Eoin Beirne, Nicole Henry

Leading up to a webinar on July 15, 2020, we are publishing a blog series covering the risks of enforcement against companies that received COVID-19 relief funds under the CARES Act and strategies for mitigating those risks. This third, and final, installment of our series discusses emerging and anticipated criminal enforcement involving COVID-19 relief programs.

OIG Approves Discount Medical Plan Referral Arrangement

July 6, 2020 | Blog | By Theresa Carnegie, Jane Haviland

On June 26, the Department of Health and Human Services Office of the Inspector General (OIG) issued Advisory Opinion No. 20-03 approving the payment by a discount medical plan organization (DMPO) of a five dollar ($5.00) fee to chiropractors for the referral of new members to the DMPO. OIG determined that even though the arrangement could result in prohibited remuneration, it would not impose administrative sanctions or civil monetary penalties for violation of the federal Anti-Kickback Statute (AKS).

COVID-19 Relief Programs: The Anticipated Wave of False Claims Act Cases and Oversight Agency Enforcement Activities

July 2, 2020 | Blog | By Brian Dunphy, Geoffrey Friedman, Caitie Hill, Jane Haviland, Karen Lovitch

Leading up to a webinar on July 15, 2020, we are publishing a blog series covering the risks of enforcement against companies that received COVID-19 relief funds under the CARES Act and strategies for mitigating these risks. This second installment of our series discusses our predictions related to litigation and enforcement activities. We expect a substantial number of False Claims Act (“FCA”) investigations and lawsuits initiated mainly by whistleblowers (also known as “relators”). The FCA remains the government’s primary enforcement tool for pursuing alleged fraud by recipients of government funds, and FCA claims present substantial risk because the statute permits treble damages and significant per-claim penalties. For example, an erroneous $100,000 loan under the Paycheck Protection Program (“PPP”) can result in $300,000 in FCA damages, or more.

Massachusetts Adopts Permanent Telehealth Policy for the First Time

July 1, 2020 | Blog | By Ellen Janos

Last Thursday, the Massachusetts Board of Registration in Medicine (BORIM) approved its first permanent telehealth policy. The Board had previously approved this policy on an “interim” basis in response to the COVID-19 pandemic on March 16, 2020. This policy is an important step for the Massachusetts BORIM as it had previously hesitated to provide any formal guidance on the practice of telehealth.

CMS Proposes Rule to Pave the Way for Value-Based Drug Purchasing

June 26, 2020 | Blog | By Theresa Carnegie

The Centers for Medicare & Medicaid Services (CMS) has taken another step to further the adoption of value-based purchasing within the health care industry. (Readers may recall the Department of Health & Human Services’ two proposed rules – one from CMS and another from the Office of Inspector General – issued late last year, aimed at reducing barriers to value-based arrangements, which we discussed here.) CMS released its new proposed rule to “support state flexibility to enter into innovative value-based purchasing arrangements (VBPs) with manufacturers, and to provide manufacturers with regulatory support to enter into VBPs with payers, including Medicaid.”

DOJ Announces Another Increase to Already-High False Claims Act Penalties

June 26, 2020 | Blog | By Samantha Kingsbury

Last Friday, the Department of Justice (DOJ) announced another increase to civil monetary penalties assessed under the False Claims Act (FCA), among other statutes. DOJ made these adjustments to account for inflation, in accordance with the Bipartisan Budget Act of 2015, and they apply to penalties assessed after June 19, 2020, for violations occurring after November 2, 2015.

Senate HELP Committee Signals Support for Permanently Expanding Telehealth Access

June 24, 2020 | Blog | By Cassandra Paolillo, Ellen Janos

Last week, the Senate Committee on Health, Education, Labor & Pensions (“Senate HELP”) held a hearing entitled “Telehealth: Lessons from the COVID-19 Pandemic," during which the Committee members expressed support for permanently expanding access to telehealth services. In this blog post, we discuss the Committee's proposals and the additional steps needed to permanently expand access to telehealth.

Update on FDA’s Comprehensive Regenerative Medicine Framework: Looming November 2020 Deadline Preceded by a Flurry of Letters from CBER and a New JAMA Editorial

June 23, 2020 | Blog | By Joanne Hawana

As we discussed in our last update on the Food and Drug Administration’s Comprehensive Regenerative Medicine Policy Framework back in December 2019 (during the much simpler, pre-COVID-19 world), this coming November will conclude the three-year period of enforcement discretion announced by the agency when it first articulated the policies and goals of this “comprehensive framework.” In particular, under the dual-track program announced in 2017, the Food and Drug Administration (FDA) has been focused on: (1) clarifying the regulatory criteria for product marketing through guidance and providing support to legitimate product developers through formal and informal interactions; and (2) removing unapproved, unproven, and potentially unsafe products from the U.S. market.

COVID-19 Relief Programs: Mitigating and Responding To Enforcement Risk

June 22, 2020 | Blog | By Brian Dunphy, Jane Haviland, Nicole Henry, Karen Lovitch

Since the early days of the pandemic, Mintz’s COVID-19 Compliance & Enforcement Defense Task Force has closely monitored and advised clients on the evolving COVID-19 relief programs, including those created by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The CARES Act provided for over $2 trillion in relief funds, which is the largest emergency assistance package in American history. The numerous CARES Act programs have continued to develop through, among other things, the passage of the Paycheck Protection Program and Health Care Enhancement Act, the Paycheck Protection Program Flexibility Act of 2020, and rapidly changing regulatory guidance and FAQs. As one example, the government recently wrestled with whether to make public the list of about 4.6 million entities that received more than $500 billion from the Paycheck Protection Program (PPP) under the CARES Act. After initially refusing to disclose PPP loan recipients, the Small Business Administration and Treasury Department decided to make public the names of entities that received loans larger than $150,000, as well as the dollar range of each loan.

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August 7, 2020 | Blog | By Daryl Berke

August 6, 2020 | Blog

August 5, 2020 | Blog | By Cassandra Paolillo, Ellen Janos

August 4, 2020 | Blog | By Daryl Berke

July 30, 2020 | Blog | By Karen Lovitch, Caitie Hill

July 28, 2020 | Blog | By Deborah Daccord, William Kannel, Tim McKeon

July 27, 2020 | Blog | By Xavier Hardy, Daryl Berke

July 23, 2020 | Blog | By Margaret Jewett

July 21, 2020 | Blog | By Joanne Hawana

July 21, 2020 | Blog | By Daryl Berke

July 17, 2020 | Blog | By Dianne Bourque

July 9, 2020 | Blog | By Eoin Beirne, Nicole Henry

July 6, 2020 | Blog | By Theresa Carnegie, Jane Haviland

July 2, 2020 | Blog | By Brian Dunphy, Geoffrey Friedman, Caitie Hill, Jane Haviland, Karen Lovitch

July 1, 2020 | Blog | By Ellen Janos

June 26, 2020 | Blog | By Theresa Carnegie

June 26, 2020 | Blog | By Samantha Kingsbury

June 24, 2020 | Blog | By Cassandra Paolillo, Ellen Janos

June 23, 2020 | Blog | By Joanne Hawana

June 22, 2020 | Blog | By Brian Dunphy, Jane Haviland, Nicole Henry, Karen Lovitch

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