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
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CMS Issues “In Lieu of” Services Guidance to Address Health-Related Social Needs in Medicaid Managed Care
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…
CMS Issues a New “Advancing Interoperability and Improving Prior Authorization Processes” Proposed Rule
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…
The FDA Releases New Draft Guidance on Considering Health Care Disparities When Reviewing Proposed Devices
On October 21st, the U.S. Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). In the draft guidance, the FDA announced that when reviewing the eligibility of medical devices for the Program, the agency will also consider whether a…
Crowell & Moring and Crowell Health Solutions Host a Forum to Discuss Trends in Value-Based Care and Health Technology Innovation
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…
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 …