News & Analysis as of

Patient Access New Regulations

Morgan Lewis - As Prescribed

Conditional Approval Proposals for FDA: Current Context and Potential Ramifications

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains a perennial focus of stakeholders...more

DLA Piper

Keeping Watch on the Inflation Reduction Act: Medicare Poses Part D Formulary Access Challenges

DLA Piper on

Key points include access to medicines in medicare is reduced as the IRA is implemented; fewer drugs are covered on Medicare Part D formularies in 2025 relative to 2024; medicines for serious conditions with high unmet needs...more

DLA Piper

DEA and HHS Propose Telemedicine Special Registration and Finalize Buprenorphine Telemedicine Prescribing Rules

DLA Piper on

On January 17, 2025, the US Drug Enforcement Administration (DEA) and the US Department of Health and Human Services (HHS) published two rules regarding telemedicine prescribing of controlled substances: a proposed rule...more

Epstein Becker & Green

Medical Diagnostic Equipment Accessibility Regulations Announced by DOJ Under Title II of ADA

Epstein Becker & Green on

To honor the 34th anniversary of the Americans with Disabilities Act (ADA), on July 26, 2024, the U.S. Department of Justice (DOJ) signed a long-awaited final rule to improve access to medical diagnostic equipment (MDE) for...more

Burr & Forman

Proposed Revisions to Title II of the ADA Impacting Healthcare Facilities

Burr & Forman on

The Department of Justice recently published a notice of proposed rulemaking applicable to healthcare entities covered under Title II of the Americans with Disabilities Act that relates to accessibility to medical diagnostic...more

McDermott Will & Emery

Trending in Telehealth: February 12 – February 26, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Troutman Pepper Locke

Virginia Advances Toward New Medical Cannabis License Application With New Regulations

Troutman Pepper Locke on

The Virginia Cannabis Control Authority (CCA), which assumed oversight of Virginia’s medical cannabis program from the Board of Pharmacy as of January 1, has promulgated regulations to govern medical cannabis operations in...more

McDermott Will & Emery

Trending in Telehealth: January 4 – 15, 2024

McDermott Will & Emery on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Foley Hoag LLP - Medicaid and the Law

The Supreme Court’s Talevski Decision: Medicaid Private Enforcement under Section 1983 Lives to See Another Day

Today’s post provides an important update on the Supreme Court case Health & Hospital Corporation of Marion County (HHC) v. Talevski. As readers will remember, our blog has been following this case since it made its way to...more

Burr & Forman

Hot Topics in Health Care - November 2022

Burr & Forman on

Physician Groups Voice Strong Opposition to Proposed Expanded Scope of Practice for Non-Physician Practitioners - The American Medical Association and over 80 other physician industry groups have come out in strong...more

Nossaman LLP

Anticipating AB 890’s Implementation: Now is a Good Time for Medical Staffs to Get Their Ducks in a Row

Nossaman LLP on

Given California’s shortage of primary care providers, nurse practitioners (“NPs”) are increasingly being asked to fill gaps in provider coverage.  With that background, Governor Newsom signed Assembly Bill 890 (“AB 890”)...more

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