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Final Rules Compliance Health Care Providers

Saul Ewing LLP

Trump on Transparency: Making America Healthy Again Through Executive Order 14221; How Plan Sponsors Can Respond

Saul Ewing LLP on

One mandate under the PPACA required health care providers, non-grandfathered health insurance issuers and self-insured group health plans to provide consumers with access to information about the cost of services before they...more

McDermott Will & Emery

CMS Implements First Major Updates to Lab Personnel Requirements in 30+ Years

On December 28, 2024, a long-awaited Centers for Medicare & Medicaid Services (CMS) final rule became effective, significantly updating laboratory personnel requirements under Subpart M of the Clinical Laboratory Improvement...more

Hendershot Cowart P.C.

Major Changes to Texas Medical Board Rules: What Healthcare Providers Need to Know

Hendershot Cowart P.C. on

On January 9, 2025, the Texas Medical Board (TMB) implemented comprehensive changes to its rules, marking a significant shift in how medical spas, IV hydration clinics, and other healthcare facilities operate in Texas....more

Verrill

Prescription for Change: Massachusetts Pharmacies Undergo Regulatory Revamp

Verrill on

Pharmacies doing business in Massachusetts must act now – The Massachusetts Board of Registration in Pharmacy (the “Board”) has announced a series of new and long-awaited pharmacy licensure regulations that took effect in...more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more

Baker Donelson

Upcoming Deadline to Apply for Medicare-Funded Residency Positions

Baker Donelson on

Teaching hospitals training over their graduate medical education (GME) caps have limited opportunities to receive additional funding from Medicare. ...more

Goodwin

DEA Announces a Third Extension of COVID-19 Telehealth Flexibilities for Prescription of Controlled Medications

Goodwin on

On November 15, 2024, the Department of Health and Human Services (HHS) and the US Drug Enforcement Agency (DEA) issued a joint regulations further extending the flexibilities that have been in place relating to prescribing...more

Ropes & Gray LLP

FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis

Ropes & Gray LLP on

On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more

King & Spalding

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU)

King & Spalding on

Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications - On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more

Burr & Forman

Failure to Return Credit Balances (Especially to Medicare and Medicaid) Can Create Significant Liability

Burr & Forman on

Every health care provider has “credit balances,” which occur when a provider receives more money than it is owed for services rendered. Credit balances can be caused by a number of factors, including incorrect coding,...more

McCarter & English, LLP

Nursing Home Update

The federal government has made a variety of changes to federal requirements aimed at improving the quality of care at long-term care facilities across the country. In May 2024, the United States Department of Health and...more

McDermott Will & Emery

CMS Updates Scope of Providers Subject to Provisional Period of Enhanced Oversight

The Centers for Medicare & Medicaid Services’ (CMS) 2025 Home Health Prospective Payment System final rule (Final Rule) expanded the scope of providers subject to a provisional period of enhanced oversight (PPEO) to include...more

Ropes & Gray LLP

Biden Administration Finalizes Its Last Changes To Health Data Interoperability and Information Blocking Regulations

Ropes & Gray LLP on

In December 2024, the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (“ASTP/ONC”) within the U.S. Department of Health and Human Services (“HHS”) published two...more

Harris Beach Murtha PLLC

"No Surprises Act" Ruling Favors Regulators, Insurers

Federal regulators recently won a large legal victory when the Fifth Circuit Court of Appeals upheld several provisions of the rule regulating Qualified Payment Amount (“QPA”) calculations under the No Surprises Act (the...more

Holland & Knight LLP

HHS Finalizes Key Information Blocking Exceptions

Holland & Knight LLP on

The finalization of information blocking exceptions were announced just in the "St. Nick" of time by the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy (ASTP), formerly known as...more

Stevens & Lee

Compliance Deadline Imminent: HIPAA Final Rule to Support Reproductive Health Care Privacy

Stevens & Lee on

Around the corner is the Dec. 23 deadline to have your organization bring its HIPAA Notice of Privacy Practices into compliance with the U.S. Department of Health & Human Services’ Office for Civil Rights Final Rule modifying...more

Ankura

Is there room for AI in the ICU? Guiding Principles and Compliance Considerations

Ankura on

Artificial Intelligence (AI) offers unprecedented opportunities to enhance patient care, streamline clinical documentation, and support medical decision-making processes. More and more healthcare professionals find themselves...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Justice Department Rule on Accessible Medical Diagnostic Equipment Carries Broad Implications for Healthcare Industry

The U.S. Department of Justice (DOJ) recently published a final rule on the accessibility of medical diagnostic equipment (MDE) and other accessibility-related practices that promises to have broad impact on the health care...more

Burr & Forman

FTC Non-Compete Ban: Implications for the Health Care Industry

Burr & Forman on

Earlier this year, the Federal Trade Commission (FTC) approved a final rule that invalidates most post-engagement non-compete covenants in all agreements. This rule prohibits use and enforcement of non-compete covenants and...more

Benesch

Pulse on AI + Healthcare: An Introduction to Healthcare AI Innovation in an Evolving Regulatory Landscape

Benesch on

The expansion of artificial intelligence (“AI”) applications in healthcare (“Healthcare AI”) has made recent headlines, from the transformation of clinical diagnostics with increased accuracy, to use of personalized medicine...more

Saul Ewing LLP

HHS OCR Issues Post-Dobbs Final Rule to Address Reproductive Health Care Privacy Protections

Saul Ewing LLP on

On April 22, 2024, the U.S. Department of Health & Human Services (“HHS”) Office for Civil Rights (“OCR”) announced a final rule to support reproductive health care privacy (the “Reproductive Rule”). According to the HHS OCR...more

Husch Blackwell LLP

Confidentiality of Substance Use Disorder Records: HHS Finalizes Changes to Part 2 Rule

Husch Blackwell LLP on

On February 8, 2024, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) finalized long-awaited modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at...more

Health Care Compliance Association (HCCA)

Compliance with Medicare’s updated 2024 split (or shared) visit policy

Split (or shared) visits—the current term used by the Center for Medicare & Medicaid Services (CMS)—allow non-physician practitioners (NPPs) and physicians who work for the same employer/entity to share patient visits on the...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

DOJ Final Rule on Website Accessibility for State and Local Governments Portends Significant Changes for Private-Sector Websites

The U.S. Department of Justice’s (DOJ) recent release of an advance copy of its final rule on website accessibility for state and local governments under Title II of the Americans with Disabilities Act (ADA) provides a...more

Holland & Knight LLP

HHS Publishes Final Rule Governing Healthcare Conscience Protections

Holland & Knight LLP on

On Jan. 11, 2024, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) published its 2024 Final Rule governing healthcare conscience protections, "Safeguarding the Rights of Conscience as...more

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