Health Care

Telehealth Update: States Move to Permanently Expand Access to Telehealth

March 30, 2021 | Blog | By Cassandra Paolillo, Ellen Janos

Over the past year the telehealth landscape has been a patchwork of temporary waivers and regulations, expanding access during the COVID-19 pandemic but leaving providers and patients uncertain about whether the positive coverage and reimbursement changes and relaxation of pre-pandemic restrictions would continue in the future. In recent weeks, we have seen a number of state actions making permanent changes to expand access to telehealth. These changes suggest a positive trend towards making telehealth an integral part of the care delivery system, although the complicated regulatory frameworks still present challenges to providers seeking to treat patients via telehealth.

Health Care Enforcement Kept the DOJ Fraud Section Busy in 2020

March 8, 2021 | Blog | By Eoin Beirne, Grady Campion

On February 24, 2021, DOJ’s Criminal Division Fraud Section published its annual year-end summary. The Fraud Section focuses on prosecuting white-collar crime. The report summarizes enforcement activity in the past year and discusses notable cases from the Fraud Section’s three litigation units: (1) the Health Care Fraud (HCF) Unit; (2) the Foreign Corrupt Practices Act (FCPA) Unit; and (3) the Market Integrity and Major Frauds (MIMF) Unit. In summarizing the Fraud Section’s main achievements from 2020, the report also provides valuable insights on what lies ahead for the Fraud Section in 2021. This post focuses on the health care enforcement portion of the Fraud Section’s report.

DOJ Reaches Acquisition Settlement with Geisinger, Evangelical; Demonstrates Department’s Willingness to Challenge a Minority Investment

March 8, 2021 | Blog | By Bruce Sokler, Evelyn French

Last week, Geisinger Health (“Geisinger”) and Evangelical Community Hospital (“Evangelical”) reached a settlement agreement with the Department of Justice (“DOJ”), resolving the DOJ’s ongoing litigation challenging Geisinger’s partial acquisition of Evangelical. Notably, the settlement agreement, among other terms, limits Geisinger’s ownership interest in Evangelical to a 7.5% passive investment and prevents Geisinger from exercising any control or influence over Evangelical.

FDA Releases Definitive Statement on Fake Registration Certificates

March 4, 2021 | Blog | By Benjamin Zegarelli

On March 3, 2021, FDA issued a statement acknowledging that certain entities produce certificates of registration for medical device manufacturers and clarifying that the agency does not issue such certificates. The agency also announced that it sent letters to 25 entities demanding that they stop producing these false and misleading certificates because some device manufacturers and distributors are using them to claim that the devices they produce or sell are cleared, approved, or otherwise authorized by FDA.

FTC Abandons Appeal of Philadelphia Hospital Merger, Allowing Jefferson and Einstein to Proceed with Creation of 18-Hospital System

March 2, 2021 | Blog | By Bruce Sokler, Joseph Miller, Robert Kidwell

Back in December, we wrote about a district court ruling rejecting the Federal Trade Comission’s (“FTC”) motion to enjoin the proposed combination of Thomas Jefferson University (“TJU”) and Albert Einstein Healthcare Network (“Einstein”) that would create an 18-hospital system in the Philadelphia area. The FTC and the Pennsylvania Attorney General had alleged the merger would lead to TJU/Einstein controlling at least 60% of the inpatient GAC hospital services market in a portion of Philadelphia. Following the district court decision, the FTC quickly appealed to the Third Circuit Court of Appeals and filed an emergency motion for a stay pending appeal. Days later, a three-judge panel denied the government’s motion without comment.

HHS’ OCR Announces Enforcement Discretion for HIPAA Noncompliance Relating to Online COVID-19 Vaccination Appointment Scheduling Applications

February 25, 2021 | Blog

The Department of Health and Human Services’ Office for Civil Rights (OCR) has announced that it will exercise its enforcement discretion for health care providers’ and their business associates’ noncompliance with the HIPAA rules with respect to their good faith use of online or web-based scheduling applications for scheduling COVID-19 vaccination appointments. OCR will not impose penalties for such noncompliance during the COVID-19 nationwide public health emergency.

Working Together, FDA, NTIA, and Domain Registries Take Down 30 Websites Illegally Selling Opioids

February 10, 2021 | Blog

The Food and Drug Administration (FDA) and the National Telecommunications Information Administration (NTIA) in partnership with three domain name registries disabled nearly 30 websites illegally offering opioids for sale. Working together as part of a pilot program jointly created by the Department of Health and Human Services (HHS) and the Department of Commerce (Commerce), FDA and NTIA aim to reduce the availability of unapproved and misbranded opioids illicitly offered for virtual sale. Based on several joint warning letters and the subsequent shuttering of numerous websites illegally selling opioids, it would appear the partnership is a success. Both agencies and the domain registries have committed to continuing this working relationship beyond the pilot program. Time will tell if the continued joint effort reduces the unlawful sale of opioids online and in turn, minimizes the risks associated with the opioid crisis.

HHS Finalizes Highly Anticipated Final Rule Amending Anti-Kickback Statute and Stark Law Regulations, Part VI: Changes to Fundamental Stark Law Terminology

February 8, 2021 | Blog | By Karen Lovitch, Rachel Yount

In this final post of our blog series on the substantial changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law), we cover change to (i) key Stark Law terminology, and (ii) the scope and application of the Stark Law exceptions. The Centers for Medicare & Medicaid Services (CMS) finalized new definitions for various key terms used in the Stark Law regulations as well as revisions to existing terms that are generally intended to provide more certainty and flexibility. This post discusses a few of the highlights, but the final regulations contain many others.

HHS Finalizes Highly Anticipated Final Rule Amending Anti-Kickback Statute and Stark Law Regulations, Part V: Cybersecurity Technology and Electronic Health Records

February 4, 2021 | Blog | By Karen Lovitch, Rachel Yount

On January 19, 2021, significant changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) went into effect. The sweeping changes come through two final rules – one issued by the Office of Inspector General (OIG) addressing changes to the AKS and the Beneficiary Inducements CMP, and one issued by the Centers for Medicare & Medicaid Services (CMS) addressing changes to the Stark Law.

In this fifth installment of our blog series covering the changes, we dive into (i) the new AKS safe harbor and Stark Law exception for cybersecurity technology and related services, and (ii) the significant changes to the existing safe harbor and exception for electronic health records (EHR) technology.

Telehealth Update: Extension of the Public Health Emergency, OIG Workplan Updates, and the Protecting Access to Post-COVID 19 Telehealth Act

February 3, 2021 | Blog | By Cassandra Paolillo, Ellen Janos

Since the beginning of the pandemic, telehealth providers have seen a dramatic increase in demand for their services along with a number of temporary regulatory measures aimed at expanding telehealth access to more patient populations. In this post, we outline some important developments that will bring greater certainty to telehealth providers and suggest that expanded access to telehealth is here to stay.

Recent Amendments to the FDA Laws Attempt to Clarify and Improve Existing Systems

January 28, 2021 | Blog | By Joanne Hawana

Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings (as reported by our colleagues in this post), several important changes to the laws enforced by the Food and Drug Administration (FDA) were recently enacted by Congress. As legislative actions, those changes are of course unaffected by President Biden’s regulatory freeze and so we thought worth a summary to ensure our readers are up to speed on the large amount of activity that occurred in the final weeks of the 116th Congress and the Trump Administration.

Fifth Circuit Vacates $4.3M HIPAA Penalty and Potentially Opens the Door for Future HIPAA Enforcement Challenges

January 25, 2021 | Blog | By Dianne Bourque

With a notably sharply worded opinion, the Fifth Circuit recently vacated over $4.3 million in penalties levied against the University of Texas M.D. Anderson Cancer Center (M.D. Anderson) by the Department of Health and Human Services (HHS) for a series of alleged HIPAA violations. The case stems from three separate incidents that occurred between 2012 and 2013. In two instances, M.D. Anderson workforce members lost unencrypted protected health information (PHI), while the third incident involved the theft of a faculty member’s laptop also containing unencrypted PHI. On appeal, the Fifth Circuit concluded that HHS’s civil monetary penalties order against M.D. Anderson was arbitrary, capricious, and contrary to law, vacating the penalties and pointedly criticizing the agency’s actions and arguments in this matter.

Beyond its harsh words for HHS, this opinion is notable for calling into question some longstanding HHS enforcement practices and interpretations of the HIPAA regulations. The opinion also makes clear that regulated entities should check the math when HHS levies a fine. Although limited in its precedential authority, the Fifth Circuit’s opinion, at the very least, gives HIPAA-regulated entities some new food for thought if faced with an HHS enforcement action.

HIPAA Amendments and Other Trump Regulatory Actions on Hold

January 21, 2021 | Blog | By Dianne Bourque, Cassandra Paolillo

In the waning days of the Trump administration, the Office for Civil Rights (“OCR”) announced a number of new initiatives, including proposed HIPAA amendments, discussed here, and a very recent COVID-19 related Notice of Enforcement Discretion. Under the Notice of Enforcement Discretion, published on January 19, 2021, OCR announced that it would not impose penalties for non-compliance with HIPAA on covered entities making good faith use of online or web-based applications for COVID-19 vaccination scheduling. With the swearing in of President Biden, these and other regulatory initiatives, including all regulations that have been sent to the Office of the Federal Register, but not yet published, are to be withdrawn until a department or agency head appointed by President Biden reviews and approves the rule.

340B Administrative Dispute Resolution Goes Live Amid a Flurry of 340B Litigation

January 18, 2021 | Blog | By Daryl Berke

The U.S. Department of Health and Human’s Services (HHS) Health Resources and Services Administration’s (HRSA) long-awaited administrative dispute resolution (ADR) final rule went into effect last week, on January 13, 2021. The ADR regulations, which have lingered in HHS since 2010, arrive amid increasing tensions and a flood of 340B-related litigation between covered entities, manufacturers, and HHS.

Looking Ahead: FDA in 2021

January 8, 2021 | Blog

Politics will have an effect on FDA policies in 2021, including with respect to the ongoing COVID-19 response, manufacturing, compliance, digital health, laboratories, user fees, device servicing, and more.

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Supreme Court Holds that ERISA Does Not Preempt Arkansas PBM Law: The Impact on Employer Sponsored Group Health Plans

December 31, 2020 | Blog | By Tara E. Dwyer

In a recently decided case, Rutledge v. Pharmaceutical Care Management Association, the U.S. Supreme Court held that the Employee Retirement Income Security Act of 1974 (ERISA) does not preempt an Arkansas statute that regulates reimbursement levels paid by Pharmacy Benefit Managers (PBMs) to local pharmacies.

HIPAA 2021 – What Can We Expect?

December 28, 2020 | Blog | By Dianne Bourque, Ellen Janos

As we’re all painfully aware, public health issues dominated 2020 and with the country’s attention focused on COVID-19 testing, status, transmission and care, HIPAA went mainstream. Health information became critical not only for health care providers, but for all manner of businesses, employers, property owners, and the national media. HIPAA – or more often than not “HIPPA” – was frequently touted in the news and on social media as the reason why COVID-related information could or could not be shared. As we head into 2021 with the pandemic raging on, the vaccination program underway, and a new administration taking over, here is a look at what we expect for “HIPPA” in 2021.

FDA in 2020: What a Year! (Part 3 of 3)

December 23, 2020 | Blog | By Joanne Hawana

In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug Administration (FDA) has continued to make substantial progress on its non-COVID priorities as well, which we cover in this part 3 of our year-end post.

FDA in 2020: What a Year! (Part 2 of 3)

December 22, 2020 | Blog | By Joanne Hawana

Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over the past year. We’ll also begin looking forward into 2021 and the agency’s transition to an incoming Biden Administration.

FDA in 2020: What a Year!

December 15, 2020 | Blog | By Benjamin Zegarelli

What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was thrust into the public eye amidst the COVID-19 pandemic. This was the year many Americans became familiar with lesser-known and niche policies like those governing emergency use authorizations (EUAs) and with the role of FDA in regulating laboratory developed tests (LDTs). The agency also took some flak for seeming to bow to political pressure in authorizing hydroxychloroquine for emergency use as a potential COVID-19 treatment, then rescinding the authorization, as well as for its less-than-accurate pronouncements of positive data concerning convalescent plasma treatment. These were reminders that the agency Americans trust to protect the public does get things wrong sometimes and is susceptible in some ways to political pressure, and that effectively ensuring the public health requires a balance between safety and effectiveness and patient access to medical products. As we look ahead, we eagerly anticipate how FDA will protect and promote public health in a Biden administration. In this post we’ll explore the FDA’s device law and policy activities from 2020.

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March 30, 2021 | Blog | By Cassandra Paolillo, Ellen Janos

March 8, 2021 | Blog | By Eoin Beirne, Grady Campion

March 8, 2021 | Blog | By Bruce Sokler, Evelyn French

March 4, 2021 | Blog | By Benjamin Zegarelli

March 2, 2021 | Blog | By Bruce Sokler, Joseph Miller, Robert Kidwell

February 25, 2021 | Blog

February 10, 2021 | Blog

February 8, 2021 | Blog | By Karen Lovitch, Rachel Yount

February 4, 2021 | Blog | By Karen Lovitch, Rachel Yount

February 3, 2021 | Blog | By Cassandra Paolillo, Ellen Janos

January 28, 2021 | Blog | By Joanne Hawana

January 25, 2021 | Blog | By Dianne Bourque

January 21, 2021 | Blog | By Dianne Bourque, Cassandra Paolillo

January 18, 2021 | Blog | By Daryl Berke

January 8, 2021 | Blog

December 31, 2020 | Blog | By Tara E. Dwyer

December 28, 2020 | Blog | By Dianne Bourque, Ellen Janos

December 23, 2020 | Blog | By Joanne Hawana

December 22, 2020 | Blog | By Joanne Hawana

December 15, 2020 | Blog | By Benjamin Zegarelli

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