Navigating the Labyrinth of Private Equity Investments in Health Care – Diagnosing Health Care
HHS Office for Civil Rights Director Melanie Fontes Rainer on Progress and News at OCR
ERISA Blog | Changes to the HIPAA Privacy Rules A Primer for Self-Insured Group Health Plans
Hospice Insights Podcast - A Refresh: What’s New in the New OIG General Compliance Program Guidance
The Presumption of Innocence Podcast: Special Edition | Episode 36 - Rolling Change: The DEA Turns Over a New Leaf on Marijuana Scheduling
Understanding the HHS OIG’s General Compliance Program Guidance
OMG. . .The OIG is at it Again
The FTC's Health Privacy Enforcement Actions
Medical Device Legal News with Sam Bernstein: Episode 19
Episode 303 --- Deep Dive into the HHS-OIG Compliance Program Guidance
Counsel That Cares - The Private Payer's Perspective on Value-Based Care
Medical Device Legal News with Sam Bernstein: Episode 17
Podcast - Data Privacy and Tracking Technology Compliance
Podcast - A Conversation on Cannabis: Are Challenges or Changes Coming?
Heed Caution: Takeaways From the OIG's Advance Care Planning Report
2023 Human Resources Outlook Podcast Series: EMEA
Telehealth Risk Report: What the Government Found
UPIC Report Card: The OIG’s Evaluation of the UPICs Provides Insight Into the Future of Hospice Audits
HIPAA Tips With Williams Mullen - Telehealth After the Pandemic
Beyond Hospice: The OIG Renews Its Scrutiny of Home Health Agencies
As we have previously reported, the Inflation Reduction Act (IRA) changed the government’s treatment of certain prescription drugs under the Medicare program by directing the Secretary of Health and Human Services (HHS) to...more
On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more
Since its enactment in 2022, the validity of the Inflation Reduction Act (IRA) and its drug price negotiation program (Program) has been repeatedly challenged in District Court, with little success. Boehringer Ingelheim’s...more
The Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022, and includes key sections addressing climate and clean energy, corporate taxes and health care. The health care provisions...more
We Americans pay more for prescription medications than just about anywhere else on the globe. And Big Pharma keeps jacking prices higher....more
A domino has fallen, but the question remains whether there are more to come. On February 12, 2024, the U.S. District Court for the Western District of Texas dismissed a challenge to the Department of Health and Human...more
Today, the district court for the Western District of Texas granted the government’s motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price Negotiation Program of the Inflation...more
Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more
The Biden Administration recently announced a plan to leverage an old tool in a new way to try to reduce drug costs: exercising “march-in rights” under the Bayh-Dole Act for drugs that were supported by government funding. ...more
On October 31, 2023, FDA approved Amgen’s Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Janssen’s Stelara (ustekinumab). Stelara has been selected by the Center for Medicare & Medicaid Services...more
Denial of Motion to Dismiss and Motion for Preliminary Injunction in Chambers of Commerce case - On Friday, September 29, the court in Dayton Area Chamber of Commerce et al. v. Becerra et al. (S.D. Ohio, Judge Newman)...more
The ability to directly negotiate drug prices has been a policy goal for Democrats for many years and was recently accomplished through the Inflation Reduction Act’s (“IRA”) Medicare Drug Price Negotiation Program (the...more
The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more
Two weeks ago, HHS announced the first 10 drugs that will be subject to the new Drug Price Negotiation Program under the Inflation Reduction Act (“IRA”). Six of the manufacturers whose drugs are on the list and several other...more
The Inflation Reduction Act (IRA), signed into law on August 16, 2022, allows the federal government to negotiate prices for some high-cost drugs covered under Medicare. ...more
Health care has been one of the most active issue areas in the 118th Congress. The activity by the health committees of jurisdiction in both the House and the Senate has been fueled in part by efforts to reauthorize various...more
On Tuesday, August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) released the first ten prescription drugs selected for price negotiation with manufacturers (Selected Drugs) under the Inflation Reduction Act of...more
While only slightly past the midway point of 2023, it has already been a busy year for developments in drug pricing. Notably, CMS released its final guidance in preparation for price negotiations and the first 10 drugs...more
The Inflation Reduction Act’s Medicare Drug Price Negotiation Program has now officially kicked off. Earlier today (August 29, 2023), the White House announced the list of the first 10 selected drugs under the program, prior...more
\On August 29, 2023, Health and Human Services (“HHS”) announced the first ten drugs covered by Medicare Part D selected for negotiation under President Biden’s Inflation Reduction Act of 2022 (“IRA”), which was signed into...more
HHS has announced the ten drugs that will be included in the first year of the Inflation Reduction Act’s new Drug Price Negotiation Program....more
The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. The statute sets a deadline of September 1, 2023 for the Secretary of Health and Human Services (HHS) to publish a list of the 10...more
This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more
In recent months, six different lawsuits have been filed challenging the Inflation Reduction Act (IRA)’s Drug Price Negotiation Program (the “Program”), with a flurry of activity likely in the coming months before the...more
Today, Thursday, March 9, President Biden unveiled his Fiscal Year (FY) 2024 budget request, the third of his presidency. The $6.1 trillion proposal calls for $1.9 trillion in discretionary spending and $4.2 trillion in...more