Health Care
Viewpoints
Filter by:
FDA’s Holiday Present from Congress: Bipartisan Reforms to the Accelerated Approval Framework, Long-Awaited Cosmetic Modernization, and Expansion of Certain Existing Programs
January 10, 2023 | Blog | By Joanne Hawana
On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act for 2023, colloquially referred to as the omnibus funding bill, that includes a similarly expansive and diverse piece of legislation called the Food and Drug Omnibus Reform Act (FDORA). This latest addition to the rich history of amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes a variety of new and important changes to the laws governing therapeutic products and medical devices, clinical trials, and (in a much rarer occurrence) cosmetics and other personal care products. Many of the statutory changes had been requested by the Food and Drug Administration (FDA), whether formally via budget requests or more informally via its leadership. The agency also received an increase of $226 million (or 6.5%) in its congressional appropriation for fiscal year 2023 as compared to its funding level for fiscal year 2022, suggesting continued bipartisan support for its public health mission.
Read more
Cosmetic Regulatory Reform Finally Becomes Law
January 3, 2023 | Blog | By Joanne Hawana, Jean D. Mancheno
As the 2022 calendar year ended, the Consolidated Appropriations Act, 2023 was signed into law by President Biden. The massive piece of legislation included the Modernization of Cosmetics Regulation Act of 2022 (MOCRA), comprising a long-awaited update to the nation’s cosmetic laws. MOCRA amends Chapter VI of the Federal Food, Drug, and Cosmetic Act (FD&C Act). As noted by one of the bill’s co-sponsors, Senator Dianne Feinstein, after its passage, it finally brings the federal government’s “oversight tools” for cosmetics and personal care products “into the 21st century.”
Read more
OCR Warns Providers Against Disclosing PHI on Social Media Platforms in Response to Negative Reviews in Settlement with Dental Practice
December 22, 2022 | Blog | By Lara Compton, Kathryn Edgerton, Pat Ouellette
As illustrated by a recent Office for Civil Rights (OCR) settlement with a dental practice, health care entities continue to struggle with how to respond to negative online reviews while maintaining compliance with the HIPAA Privacy Rule. Given the significant reputational harm that negative reviews on Yelp and other social media and public platforms (Platforms) can create, providers may be tempted to respond to such negative comments with patient specifics in an attempt to mitigate harm to their businesses.
Read more
OIGs Report on Expanded Telehealth Service Access and Use, Program Integrity Risks During Year One of COVID-19 Pandemic
December 21, 2022 | Blog | By Karen Lovitch, Pat Ouellette, Sophia Temis
The Pandemic Response Accountability Committee (PRAC) Health Care Subgroup recently published an expansive report that highlighted the sheer volume of expanded access to and use of telehealth services in certain federal health care programs during the first year of the COVID-19 pandemic. The report also focused on program integrity risks related to this expanded use and included recommended safeguards for future oversight of telehealth services.
Read more
California Legislative Update Part II: Upcoming Changes for Health Facilities
December 20, 2022 | Blog | By Lara Compton, Xavier Hardy
Governor Gavin Newsom signed 997 bills into law in 2022, including a substantial number relating to health care. In Part II of our legislative update, this blog post summarizes many of the laws relevant to health facilities, a number of which will go into effect January 1, 2023.
Read more
CMS Issues Additional Flexibilities to the ACO REACH Model’s Benefit Enhancements
December 16, 2022 | Blog | By Rachel Yount
As Accountable Care Organizations (ACOs) and providers gear up for the start of the new ACO REACH Model in 2023, CMS recently issued helpful policy updates to the model’s benefit enhancements (BEs). Under BEs, CMS waives certain Medicare payment requirements for services provided to REACH beneficiaries through the REACH ACO’s participant providers and preferred providers. REACH ACOs can opt to use one or more of the BEs, which are designed to create flexibility in managing REACH beneficiaries’ care. REACH ACOs have full control over which providers participate in any BE. As discussed below, CMS recently announced updates to two of the model’s BEs – the 3-Day Skilled Nursing Facility (SNF) Rule Waiver and the Nurse Practitioner (NP) Services.
Read more
Is Your Website Collecting PHI Under OCR's New Tracking Technologies Bulletin?
December 7, 2022 | Blog | By Dianne Bourque, Lara Compton, Kathryn Edgerton, Cassandra Paolillo, Kate Stewart
Covered Entities and Business Associates should promptly and carefully review their use of online tracking technologies on their websites and mobile apps following a bulletin (Bulletin) published by the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) last week. The Bulletin addresses multiple facets of compliance with HIPAA when using online third-party tracking technologies (Tracking Technologies). In doing so, OCR significantly expands its interpretation of the definition of Protected Health Information (PHI) to include, in some instances, identifiable information gathered by Tracking Technologies where a user visits a website and does not interact with the entity in any other way. In its Bulletin, OCR interprets the act of an individual visiting a website as evidence of a relationship or anticipated future relationship between the visitor and the entity.
Read more
New Year, New Laws: Changes to New York Health Care Provider Staffing Laws Taking Effect in January 2023
November 30, 2022 | Blog | By Cody Keetch, Jean D. Mancheno
In this post, we summarize the reforms under Article 28 of the New York Public Health Law and changes to general hospital and nursing home staffing laws and discuss what these changes mean for both.
Read more
DOJ Charges 10 Defendants for Allegedly Defrauding Public and Private Health Insurers Out of $11.1 Million Through Business Email Compromise Schemes
November 28, 2022 | Blog | By Kathryn Edgerton
This post provides insights and recommendations surrounding the DOJ's charges against 10 defendants involved in business email compromise schemes.
Read more
Health Care Workforce Shortages Persist in Massachusetts and the United States
November 22, 2022 | Blog | By Ryan Rasdall
The Massachusetts Health and Hospital Association (MHA) also recently released a survey raising similar alarm bells about health care workforce shortages in Massachusetts. The survey, An Acute Crisis: How Workforce Shortages are Affecting Access and Costs, provided a stark overview of the challenges facing Massachusetts, including health care workforce shortages, labor costs, and capacity constraints.
Read more
CMS Announces Changes to the MSSP Designed to Increase MSSP Participation and Promote Equity within the MSSP
November 17, 2022 | Blog | By Rachel Yount
The Centers for Medicare & Medicaid Services (CMS) recently announced changes to the Medicare Shared Savings Program (MSSP) designed to improve equity within the MSSP and increase the percentage of Medicare beneficiaries in accountable care arrangements. The changes are included in the Calendar Year 2023 Physician Fee Schedule final rule (Final Rule), which is scheduled for publication on November 18, 2022.
Read more
PBM Regulatory Roundup (Fall 2022): State Medicaid Enforcement Efforts Continue As Legislative Activity Slows Down
November 14, 2022 | Blog | By Bridgette Keller, Hassan Shaikh
Though the flurry of state PBM-focused legislation slowed down with the summer recess, there has still been plenty of noteworthy PBM news. This roundup focuses on state Medicaid enforcement activities involving Centene and provides a brief overview of recent legislative activity.
Read more
California Legislative Update Part I: New Requirements for Licensed Health Care Professionals
November 11, 2022 | Blog | By Kathryn Edgerton, Lara Compton
As of the close of the 2021-22 legislative session, Governor Gavin Newsom signed into law health care related legislation tackling issues from management of health care costs to reproductive rights. In Part I of our legislative update, we summarize many of the laws relevant to licensed health care professionals.
Read more
Advance Regulatory Review of California Health Care Transactions by the New Office of Health Care Affordability to Begin in 2024
November 9, 2022 | Blog | By Lara Compton, Kathryn Edgerton, Daria Niewenhous
The health omnibus trailer SB-184, which created the Office of Health Care Affordability (OHCA), is set to usher in a significant change in California’s health care regulatory landscape. In this post, we provide a preliminary review of the material changes that are set to begin in 2024.
Read more
Connecticut Joins the Interstate Medical Licensure Compact and the Psychology Interjurisdictional Compact
November 3, 2022 | Blog | By Jean D. Mancheno, Cody Keetch
Effective October 1, 2022, Connecticut adopted the Interstate Medical Licensure Compact (IMLC) and the Psychology Interjurisdictional Compact (PSYPACT). As of the date of this post, Connecticut joins 38 other states who have adopted the IMLC and 34 other states that have adopted the PSYPACT. This blog post provides an overview of the IMLC and PSYPACT and analyzes its impact in Connecticut.
Read more
Serial Relator Brings Multiple Lawsuits Alleging False Claims Act Violations Premised on Paycheck Protection Program Fraud
November 2, 2022 | Blog | By Laurence Freedman, Jane Haviland
This blog highlights a recently unsealed qui tam case brought by relator GNGH2, Inc against 15 entities that allegedly operated nursing homes in the Bronx, New York and in Florida and various health care staffing agencies.
Read more
Supreme Court Declines to Weigh in on False Claims Act Pleading Requirements
October 25, 2022 | Blog | By Brian Dunphy, Laurence Freedman, Ashley Markson
The Supreme Court recently denied petitions for writs of certiorari in three closely watched cases where parties asked the Court to clarify the heightened pleading standard governing fraud allegations under the False Claims Act (FCA). The heightened pleading requirements of Federal Rule of Civil Procedure 9(b) require that, for allegations of fraud (which include FCA claims), “a party must state with particularity the circumstances constituting fraud or mistake.” Among other things, a cause of action for “false claims” must allege the defendants submitted false claims, or caused false claims to be submitted, to the government. The crux of the issue petitioners asked the Court to address is whether, to meet Rule 9(b)’s requirements for FCA causes of action, relators must allege in the complaint specific details of false claims allegedly submitted to the government for payment. This issue typically arises in qui tam cases under the FCA after the government declines to intervene.
Read more
California Passes New Law Requiring Physicians and their Employers to Notify Patients about the Open Payments Database
October 11, 2022 | Blog | By Lara Compton, Rachel Yount
A new California law (AB 1278) will require physicians and their employers to provide patients with several forms of notices about the Open Payments database, starting January 1, 2023. The law is intended to increase patients’ awareness of the Open Payments database so they can make informed decisions about drugs and devices prescribed by their physician. This blog post provides an overview of the Open Payments Program, what exactly California's AB 1278 entails, and the implications of the law come January 2023 and January 2024.
Read more
Regulatory Roundup: Important FDA Developments at the End of September 2022
October 10, 2022 | Blog | By Joanne Hawana, Benjamin Zegarelli
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary roundup for our readers!
Read more
Recent Federal and State Legislative Action Targeting Health Care Staffing Agencies
October 5, 2022 | Blog | By Stephnie John
Nurse and health care professional staffing shortages during the COVID-19 pandemic resulted in a significant increase in the use of temporary health care professional staffing. Shortages have also lead to the increase in the use of travel nurses, causing state lawmakers to prioritize regulation of health care staffing agencies. This post provides an overview of recently enacted and proposed state legislation requiring licensure or registration of health care staffing companies and/or nursing pools.
Read more
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
Explore Other Viewpoints:
- Antitrust
- Appellate
- Arbitration, Mediation & Alternate Dispute Resolution
- Artificial Intelligence
- Awards
- Bankruptcy & Restructuring
- California Land Use
- Class Action
- Complex Commercial Litigation
- Construction
- Consumer Product Safety
- Cross-Border Asset Recovery
- Debt Financing
- Direct Investing (M&A)
- Diversity
- EB-5 Financing
- Education & Nonprofits
- Employment
- Energy & Sustainability
- Environmental Enforcement Defense
- Environmental Law
- FDA Regulatory
- Federal Circuit Appeals
- Financial Institution Litigation
- Government Law
- Growth Equity
- Health Care
- Health Care Compliance, Fraud and Abuse, & Regulatory Counseling
- Health Care Enforcement & Investigations
- Health Care Transactions
- Health Information Privacy & Security
- IP Due Diligence
- IPRs & Other Post Grant Proceedings
- Immigration
- Insolvency & Creditor Rights Litigation
- Institutional Investor Class Action Recovery
- Insurance & Financial Services
- Insurance Consulting & Risk Management
- Insurance and Reinsurance Problem-Solving & Dispute Resolution
- Intellectual Property
- Investment Funds
- Israel
- Licensing & Technology Transactions
- Life Sciences
- Litigation & Investigations
- M&A Litigation
- ML Strategies
- Medicare, Medicaid and Commercial Coverage & Reimbursement
- Mergers & Acquisitions
- Patent Litigation
- Patent Prosecution & Strategic Counseling
- Pharmacy Benefits and PBM Contracting
- Portfolio Companies
- Privacy & Cybersecurity
- Private Client
- Private Equity
- Pro Bono
- Products Liability & Complex Tort
- Projects & Infrastructure
- Public Finance
- Real Estate Litigation
- Real Estate Transactions
- Real Estate, Construction & Infrastructure
- Retail & Consumer Products
- Securities & Capital Markets
- Securities Litigation
- Special Purpose Acquisition Company (SPACs)
- Sports & Entertainment
- Strategic IP Monetization & Licensing
- Tax
- Technology
- Technology, Communications & Media
- Technology, Communications & Media Litigation
- Trade Secrets
- Trademark & Copyright
- Trademark Litigation
- Venture Capital & Emerging Companies
- White Collar Defense & Government Investigations
- Women's Health and Technology