On July 21, 2023, the Department of Health Care Access and Information of the California Health and Human Services Agency released a Notice of Proposed Rulemaking (the “Proposed Rule”) with regulations that would implement new financial and ownership transparency requirements for skilled nursing facilities (“SNFs”) in California.Continue Reading New Transparency Requirements for Skilled Nursing Facilities in California
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FTC Enforcement Against Sharing Consumer Health Information Continues
On March 2, 2023, the Federal Trade Commission (“FTC”) announced an enforcement action against California-based online counseling service BetterHelp, Inc. (“BetterHelp”) for allegedly sharing consumers’ health information, including sensitive information about mental health challenges, for advertising purposes in violation of Section 5 of the FTC Act.
This latest enforcement action comes just one month after…
CMS Issues Proposed Rule to Standardize Electronic Health Care Attachments Transactions and Electronic Signature under HIPAA
On December 21, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would adopt standards under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for “health care attachments” transactions, which would: (1) support health care claims adjudication and prior authorization transactions; (2) adopt standards for electronic signatures to…
The FDA Releases New Draft Guidance on Considering Health Care Disparities When Reviewing Proposed Devices
On October 21st, the U.S. Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). In the draft guidance, the FDA announced that when reviewing the eligibility of medical devices for the Program, the agency will also consider whether a…
FDA Issues Final Guidance on Clinical Decision Support Software
On September 28, 2022, the Food and Drug Administration (FDA) issued Clinical Decision Support Software final guidance. The guidance clarifies the agency’s scope of oversight and regulation of clinical decision support software based on the definition of a device in the Federal Food, Drug, and Cosmetic Act (FD&C Act). It also describes the criteria…
$900 Million Increase in Medicare Part A Payments One of Many Medicare Changes for SNFs in FY 2023
On July 29, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that updates Medicare payment policies and rates for skilled nursing facilities (SNFs) and enacts changes to the SNF Quality Reporting Program and the SNF Value-Based Purchasing Program beginning in FY 2023.
SNF Payment Rates and PDPM Adjustments
Nursing homes…
Crowell & Moring Survey Finds Companies Are Setting Environmental Goals, But Questions of Measurement Persist
A recent survey of top decision-makers by Crowell & Moring finds that nearly 80% of responding companies have identified and adopted environmental performance goals beyond what regulations require. Fewer than half of those surveyed measure their company’s performance against those goals—and in some cases are experiencing challenges implementing them.
Continue Reading Crowell & Moring Survey Finds Companies Are Setting Environmental Goals, But Questions of Measurement Persist
Crowell & Moring Releases Regulatory Forecast 2020 — Will Health Care Be Healthier in 2020?
Crowell & Moring has released its Regulatory Forecast 2020: What Corporate Counsel Need to Know for the Coming Year, a report that explores the impact of regulatory changes on the technology industry and other sectors, and provides insight into the house counsel can expect to face in the coming year.
For 2020, the Forecast…
Crowell & Moring Releases Litigation Forecast 2020 — Federal Agencies and Private Plaintiffs Turn Attention to Disability Issues
Crowell & Moring has released Litigation Forecast 2020: What Corporate Counsel Need to Know for the Coming Year. The eighth-annual Forecast provides forward-looking insights from leading Crowell & Moring lawyers to help legal departments anticipate and respond to challenges that might arise in the year ahead.
For 2020, the Forecast focuses on how the …
Podcast: Medicare Advantage Supplemental Benefits
Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s biweekly health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. In this “deep dive” episode, hosts Payal Nanavati and Joe Records talk to Barbara Ryland about benefits under Medicare Part C.
Subscribe to Payers, Providers, …