Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
[Podcast] Food for Thought and Thoughts on Food: What to Expect in 2023
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
Congress Returns. The House and Senate will be back in session on September 9, 2024, with a joint focus on completing consideration of a continuing resolution (CR) to maintain government funding beyond the end of fiscal year...more
News Briefs - Physicians Responsible for Meeting CMS Information Blocking Rules - The Centers for Medicare & Medicaid Services and Office of the National Coordinator for Health Information Technology issued a final rule that...more
Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It...more
On July 10, 2024, CMS issued a proposed rule that identifies and seeks public comments on a broad array of proposed changes to the Medicare Physician Fee Schedule (PFS) and Medicare Part B payments (the Proposed Rule) for...more
On June 13, 2024, the Justice Department announced arrests in what it called the nation’s first criminal case against digital health company executives over allegations that those executives caused illegal prescriptions for...more
Every year, the New Jersey legislature passes statutes that impact healthcare beyond rate increases under the Medicaid program. Last year was no different, and the discussion below highlights some of those statutes, such as...more
News Briefs - Lawmakers Mull Lifting Restrictions on Physician-Owned Hospitals - Nearly 15 years ago, the construction of doctor-owned hospitals largely ground to a halt. But federal lawmakers now are considering bills that...more
On May 8, 2024, the U.S. House of Representatives Ways & Means Committee passed a bipartisan bill entitled the “Preserving Telehealth, Hospital and Ambulance Access Act” by a vote of 41-0, which will potentially have...more
May 11, 2024, marked one year since the end of the COVID-19 public health emergency (PHE), and not much has changed in Medicare telehealth policy. We are still operating under temporary waivers and flexibilities and, as a...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Abstract Issue: As states continue to enact new restrictions on abortion since the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, access to critical reproductive health and abortion care...more
News Briefs - House Subcommittee Considering 15 Bills to Expand Telehealth - A major House subcommittee is considering 15 bills to expand access to telehealth services as the clock ticks on a Dec. 31 deadline on pandemic-era...more
News Briefs - Telehealth Access Challenged as Internet Subsidy Program Ends - More than 23 million low-income households -- urban, suburban, rural, and tribal -- are enrolled in the federal discount program Congress created...more
Six months into the fiscal year, Congress has finally passed FY2024 appropriations. It was a painstaking process, which many expected to include policy victories that both sides could celebrate. Instead, the spring work...more
On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising 42 CFR Part 8, which regulates opioid treatment programs (OTPs). The final rule is the first update to...more
Attorneys general across the country have joined in litigation related to mifepristone, a drug used for medication abortions. A case currently before the Supreme Court, FDA v. Alliance for Hippocratic Medicine, could affect...more
On February 2, 2024, the Department of Health and Human Services (HHS) issued a Final Rule that expands access to medications for the treatment of opioid use disorder (OUD) via telehealth modalities and “take-home” doses....more
News Briefs - Experts Warn Hospitals Face Increased Risk for Cyberattacks - Cybersecurity experts are warning that hospitals around the country are at risk for attacks like the one that is crippling operations at a premier...more
The U.S. Department of Health and Human Services (“HHS”) and the Substance Abuse and Mental Health Service Administration (“SAMHSA”) published a final rule on Feb. 2, 2024, that cemented significant Pandemic-era flexibilities...more
In a significant stride toward expanding access to addiction treatment services, the Substance Abuse and Mental Health Services Administration (SAMHSA) published, on January 31, its Final Rule allowing telehealth access to...more
House Energy and Commerce Committee Holds Hearing on Healthcare Costs. The hearing included discussion on what factors are causing cost increases for individuals, for the healthcare sector, and for federal health programs...more