Podcast — Drug Pricing: How Are Payers Responding to the IRA?
340B Drug Pricing Program Compliance
Inflation Reduction Act’s Drug Price Negotiation Provisions – What Now? – Diagnosing Health Care Podcast
Podcast: Inflation Reduction Act’s Drug Price Negotiation Provisions – What’s Next? - Diagnosing Health Care
Podcast: Chevron Deference: Is It Time for Change? - Diagnosing Health Care
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
Podcast: IP(DC): Drug Prices, Political Pressures & Patents
Drug Pricing Initiatives During the Trump Presidency
K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
Measures of success: How value-based pricing may change the pharmaceutical industry
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
In a recent speech, a senior official at the U.S. Department of Justice Antitrust Division noted that “in U.S. antitrust enforcement and competition policy, there is no more important question than what can we do to safeguard...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
The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2023 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1772-P),...more
On June 17, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Proposed Rule (link) that would materially modify current Medicaid Drug Rebate Program (MDRP) regulations. Comments are due no later than 5:00 p.m....more
Healthcare consumers continue to pay more and more toward their out-of-pocket healthcare costs, driving a shift away from volume-based compensation models toward outcomes-based payment arrangements. By all accounts,...more
With healthcare playing such a central role in the election, what could the Super Tuesday results mean for healthcare stakeholders? On March 2—the day before Super Tuesday—Manatt Health will explore these questions in a new...more
Big Pharma, with its relentless price gouging, may finally have poked in the eye the wrong people. But even as patients wait to see if hospitals, and now states and insurers, can beat down skyrocketing drug prices, isn’t it...more
In this week's episode, Lindsey Rogers-Seitz forecasts a number of critical issues spanning the health care industry that are likely to be points of focus in the coming year. Among these issues, Ms. Rogers-Seitz discusses the...more
Food/Dietary Supplements - FDA Releases Final Serving Size Guidance – The guidance is intended to “help manufacturers of packaged foods comply with the FDA’s updated Nutrition Facts labeling regulations. ...more
This week in Washington: Senate to hold a hearing on eligibility requirements under the Medicaid program, as well as a hearing to review a number of healthcare bills, including OTC drug safety, innovation and reform....more
Tens of billions of dollars. Those sound like hefty sums. But will it ever be enough? Will, say, $50 billion offer justice and appropriate recompense to a nation wracked by an opioid and overdose crisis?...more
For those who get a rise out of following the plight of plundering plutocrats, forget about pop culture shows like Succession, Dynasty, or Empire. Instead, it may be worth peeking in on the true-life Sackler family saga. It...more
Outlook for This Week in the Nation's Capital - Congress Returns. Both the House and Senate return this week from the August recess period....more
This week in Washington: Senate to markup the Labor, Health and Human Services, Education and Related Agencies Appropriations Act; House to hold hearings on improving maternal health and the Administration's apparent...more
This week in Washington: Senate to hold hearing on the enforcement of antitrust laws, while the House plans to cover a number of health care bills that reauthorize a variety of health programs for Americans. The House may...more
This week in Washington: The Senate continues to hold hearings on the cost of health care, the House will hold hearings on the federal approach to opioid treatment and strengthening health care in the U.S. territories. ...more
Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. HOUSE TO VOTE ON BILL COMBINING ACA, DRUG PRICING PROVISIONS - The House is scheduled to vote on legislation...more
Norman E. (Ned) Sharpless, M.D., recently took the helm as Acting Commissioner of the US Food and Drug Administration (FDA). Dr. Sharpless most recently served as the director of the National Cancer Institute, part of the...more
Sharpless Begins as FDA Acting Commissioner – On April 5, Norman E. “Ned” Sharpless, M.D., became the acting commissioner of the FDA. Previously he was the director of the National Cancer Institute....more
Upcoming Hearings - Tuesday, April 2, 2019 - House Committee on Energy and Commerce: “Priced Out of a Lifesaving Drug: The Human Impact of Rising Insulin Costs” - The Subcommittee on Oversight and Investigations of the...more
Upcoming Hearings - Tuesday, March 26, 2019 - House Committee on the Budget: “Department of Health and Human Services FY2020 Budget” - The House Committee on the Budget will hold a hearing examining the proposed...more
President Trump's fiscal year 2020 (FY20) budget proposal for the Department of Health and Human Services (HHS) reflects the Trump Administration's priorities to repeal and replace the Affordable Care Act (ACA), implement...more
As tens of thousands of Americans die from overdoses and many millions struggle with skyrocketing prescription medication costs, lawmakers and regulators in the nation’s capital plodded along with procedural steps they...more
On Tuesday, executives from seven of the largest pharmaceutical companies testified before the Senate Finance Committee on rising prescription drug prices. While the hearing was expected to be packed with fireworks as...more