Analysis, commentary, and the latest developments in health care law and policy
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…
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…
On January 4, in its most recent effort to expand federal support for addressing health-related social needs (HRSNs), the Centers for Medicare & Medicaid Services (CMS) issued guidance to clarify an existing option for states to address HRSNs through the use of “in lieu of” services and settings policies in Medicaid managed care. This option…
On December 6, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a Proposed Rule that would (i) further enhance health data exchange by establishing data exchange standards for certain payers, (ii) improve patient and provider access to health information, and (iii) streamline processes related to prior authorization for medical items and services. The…
On October 21st, the U.S. Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). In the draft guidance, the FDA announced that when reviewing the eligibility of medical devices for the Program, the agency will also consider whether a…
Crowell & Moring and Crowell Health Solutions hosted a HealthTech roundtable with discussions focused on value-based care, health equity, data privacy, artificial intelligence, and other trends in health care technology in the Washington, D.C. office on October 27. The sessions featured numerous experts from health technology companies, advocacy organizations, and trade associations, all of whom…
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…
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…
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 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…
