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Revamping of Cosmetics Regulation and Safety

President Biden signed into law the “Consolidated Appropriations Act, 2023” on December 29, 2022 (the enactment date). The Act includes the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) which increases the authority of the United States Food and Drug Administration (“FDA”) to regulate cosmetics and provide enhanced protections for consumers. The new law includes … Continue Reading

Healthcare Non-Competes in 2022: Status Following Recent Developments

For healthcare entities that use non-compete agreements, the landscape has changed as much recently as it has at any point in recent memory.  Several developments at the federal level have created a potential pitfall that did not materially exist until recently, i.e., a non-compete agreement violating antitrust law.  Further, several recent state laws have heightened … Continue Reading

Healthcare Research: A Transatlantic and Trans-European Dialogue Seminar

On November 23rd, Squire Patton Boggs partner Elliot Golding will lead a panel of industry thought leaders in a discussion of transcontinental health research and data issues.  Topics to be explored include: What are the challenges that companies need to face in order to promote research with health data? What should evolve in the legal … Continue Reading

COVID-19 Vaccine Mandate Fundamentals for Healthcare Employers

Now that OSHA has issued its emergency temporary standard and CMS has issued its own emergency rule, the landscape has changed once again for healthcare employers in terms of addressing employees’ vaccination status.  Fortunately, they now have much more certainty, which allows for more specific and detailed planning to address the myriad vaccination-related requirements that … Continue Reading

OSHA and CMS to Require Employers to Mandate Vaccines or Weekly Negative Tests

The Occupational Safety and Health Administration, as well as the Centers for Medicare & Medicaid Services, are preparing to issue new requirements that will have a major impact on healthcare employers, as well as other employers across the U.S.  On Thursday, the executive branch announced its plans to have OSHA require employers to ensure that … Continue Reading

Will Patents Become More Political? The PTO Begins to Implement Arthrex

In United States v Arthrex, the Supreme Court held that 35 U.S.C. §6(c), which sets forth the authority of Patent Trial & Appeal Board (“PTAB”) Administrative Patent Judges (“APJs”), is unconstitutional because APJs effectively wield the power of principal officers (who require Senate confirmation) while being appointed as inferior officers (who do not require Senate confirmation). … Continue Reading

Healthcare Employers Take Note: OSHA Issues New Temporary Standard

Since the outbreak of COVID-19, the Occupational Safety and Health Administration had limited itself to issuing general guidance concerning COVID-19, as opposed to specific rules or standards. On Thursday, however, OSHA announced that it will issue its first standard specific to COVID-19 for healthcare workers. Although the standard is temporary, it creates significant obligations for … Continue Reading

Webinar: Got Data?: How the Health Data Rules are Changing

On June 1, SPB Partner Elliot Golding and other industry experts will co-present on the ABA Webinar: Got Data?: How the Health Data Rules are Changing. The program, organized by the American Bar Association (ABA) will address recent and upcoming developments impacting health data including, CMS and ONC final rules on information blocking and interoperability, HIPPA and guidance … Continue Reading

Federal Appellate Court Tosses Out HIPAA Penalty for Healthcare Data Breaches, Criticizes OCR

In a dramatic rebuttal of how the Department of Health and Human Services Office of Civil Rights’ (“OCR”) has historically enforced HIPAA with potential far-ranging consequences, the Fifth Circuit Court of Appeals recently handed down a landmark decision criticizing and restricting how OCR interprets HIPAA and OCR’s penalty authority.  OCR brought an enforcement action against … Continue Reading

AHLA Podcast: Labor and Employment Issues with COVID-19 Vaccine Distribution

Squire Patton Boggs Of Counsel Will Kishman recently participated with Kristin McGurn, Seyfarth Shaw LLP, in an American Health Law Association’s (AHLA) Speaking of Health Law podcast, “Labor and Employment Issues with COVID-19 Vaccine Distribution.”  It has been published on the AHLA’s Speaking of Health Law channel, and is available to the public.  You may … Continue Reading

HHS pirouettes back to original position that Provider Relief Fund payments may be used to replace gross revenue, not just profits, lost due to the coronavirus

On October 22, the Department of Health and Human Services (HHS) updated its guidance on how hospitals and other providers should report their use of the nearly $135 billion in Provider Relief Fund payments that have been distributed.  The Provider Relief Fund, initially established by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, is … Continue Reading

CMS Adds 11 New Approved Telehealth Services During the COVID-19 Pandemic and Updates Guidance to States on Medicaid Telehealth Expansion

On October 14, the Centers for Medicare and Medicaid Services (CMS) announced that it has expanded its list of telehealth services approved for Medicare beneficiaries during the COVID-19 Public Health Emergency (PHE).  The eleven telehealth services CMS just added are for cardiac and pulmonary rehabilitation.  CMS approved them using an expedited process it unveiled in … Continue Reading

Kamala Harris – Where the Vice Presidential Nominee Stands on Key Healthcare Issues

On Tuesday, August 11, 2020, presumptive Democratic presidential nominee Joe Biden announced Sen. Kamala Harris (D-CA) as his vice presidential running mate. Since joining Congress in 2017, Sen. Harris has largely served as a bridge between progressive and moderate Democratic positions and policies. She has made immigration, equal pay and reproductive health rights core planks of her … Continue Reading

Public Records Show Agencies Are Vigorously Enforcing New COVID-19 Requirements Against Healthcare Providers

Since the COVID-19 outbreak began, healthcare providers have faced a slew of new regulatory requirements. As many healthcare providers know, enforcement agencies have taken starkly different approaches in terms of how often, and how vigorously, they enforce these requirements. Recent reports show, however, that agencies are closely enforcing workplace safety requirements relating to COVID-19, especially … Continue Reading

Recent Supreme Court Decision Creates Basis For Challenge To HHS’s Rescission Of Anti-Discrimination Protections

Most readers are likely familiar with the landmark decision issued by the U.S. Supreme Court last week, in which the Court held that Title VII prohibits discrimination on the basis of sexual orientation and transgender status. (Read more about this decision here.) That decision not only provided important clarification to the scope of protections for … Continue Reading

Growing Bullseye on Skilled Nursing Facilities

Although nursing homes appreciate the recent release of $4.9 billion in financial assistance, the bullseye on them continues growing.  Troubles that preceded the COVID-19 crisis have gotten worse for facilities caring for high risk seniors.  They face scrutiny over death rates from COVID-19, as well as how they will use relief money.… Continue Reading

CARES Act Medicare Money – View From Former Prosecutors

The CARES Act requires Medicare providers to attest to multiple certifications.  Former prosecutors examine how law enforcement may scrutinize these certifications. Marisa Darden, David Maria, and Thomas Zeno also offer tips on how providers who receive CARES Act funds can insulate themselves from scrutiny.  Their article can be found here.  … Continue Reading

Updated HHS Guidance on Provider Relief Fund Payments Could Help Providers Navigate Coming Oversight

On May 29, and June 2, the Department of Health and Human Services (HHS) updated its “Provider Relief Fund FAQs” on disbursements made to providers from the $175 billion Provider Relief Fund initially established by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, for expenses and lost revenues attributable to the coronavirus pandemic.  HHS’s … Continue Reading

The Time is Now for Providers to Apply for Some of the Remaining $130 Million Available Under the FCC’s COVID-19 Telehealth Program

As previously reported, Congress and Department of Health and Human Services (HHS) have removed longstanding regulatory barriers to the broad deployment of telehealth for general care during the COVID-19 pandemic. In parallel, the Coronavirus Aid, Relief, and Economic Security (CARES) Act has established the Federal Communication Commission (“FCC”) COVID-19 Telehealth Program, (the “FCC Program”) to … Continue Reading

Federal Government Issues Alert on Top Ten Cybersecurity Vulnerabilities

Robust cybersecurity continues to be of paramount importance as the COVID-19 outbreak develops and cybercriminals seek to exploit a remote workforce, which necessitates that companies check their policies, procedures, and controls to ensure they are addressing the highest areas of risk.  On May 12, 2020, the Cybersecurity and Infrastructure Security Agency (“CISA”) at the U.S. … Continue Reading

CMS Pumps the Brakes on Additional Medicare Accelerated and Advanced Payments as it Simultaneously Deploys COVID-19 Emergency Fund Grants

The Centers for Medicare and Medicaid Services (CMS) announced that it is “reevaluating amounts that will be paid under its Accelerated Payment Program and suspending its Advance Payment Program to Part B suppliers effective immediately.”  CMS explained that it is pumping the brakes because it has already made almost $100 billion in accelerated or advanced … Continue Reading
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