Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Podcast: IP(DC): Drug Prices, Political Pressures & Patents
As discussed in last week’s Regs & Eggs blog post, the US Department of Health and Human Services (HHS) recently released additional budget documents to support the department’s fiscal year (FY) 2026 discretionary request....more
"Rather than reacting, you must be proactive and preventive. By doing this, you will not only be prepared for the potential obstacles that face your company, but you will most likely eliminate obstacles before they appear." ...more
After almost a year of negotiations among congressional Democrats and the White House, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022. It passed in the US Senate by a vote...more
This week, House Democrats will unveil a sweeping health care bill aimed at lowering premiums and out-of-pocket costs, and to target actions taken by the Administration to undermine the individual market. This comes on the...more
This week, Congress returns to Washington for its lame duck session with uncertain expectations for what gets done between now and the next funding deadline of December 7, 2018. There are a number of legislative items that...more
The Affordable Care Act (ACA), as a whole, did not have a significant impact on pharmacy services per se. However, a complete repeal would likely impact certain areas of pharmacy services including the drug benefit for the...more
As LGBTQ rights have taken center stage in political and social issues, FordHarrison has been following ground-breaking litigation related to LGBTQ rights and providing updates. In the latest decision, a federal judge in...more
As we start a new year, let’s take a look back at a few hot topics that emerged in the managed care industry in 2015 and will likely be drivers of developments in 2016. Industry Consolidation – The Changing Landscape - ...more
Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more
Cuts in Mandatory Entitlement Programs Center of Budget Negotiations: As budget negotiators from both sides of the Hill come together to work out a two-year budget deal, determining how sequestration relief will be paid for...more
This Week: Congress Avoids a Government Shutdown... House and Senate Approves Measure to Expand the Affordable Care (ACA) Act Small Group Market to 100 Employees...Affordable Care Act (ACA) Health Insurers to Receive Only...more
In Kane ex rel. U.S. v. Healthfirst, Inc., the federal district court for the Southern District of New York (District Court or Court) provided on August 3 the first and long-awaited interpretation as to when a health care...more
The Southern District of New York has spoken on one of the first issues to confront those seeking compliance with the new “60-day rule” under the Affordable Care Act (ACA), and it does not bode well for defendant hospitals...more
This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more
The Patient Protection and Affordable Care Act (“PPACA”), signed into law on March 23, 2010, included a provision (the “Report and Refund Mandate”), broadly requiring health care providers, suppliers, Part D plans and managed...more
This Week: Senate Reauthorizes Older Americans Act; Bill Heads to the House... White House Holds 2015 Conference on Aging and Launches Several New Administration Healthy Aging Initiatives Enveloping Alzheimer’s, Dementia,...more
The Affordable Care Act authorized the Department of Health and Human Services (HHS) to require a physician, dentist or other healthcare provider to be enrolled in the Medicare program before they can issue a prescription...more
This Week: House E&C Releases Discussion Draft of 21st Century Cures Legislation Ahead of Legislative Hearing... FDA Finalizes Biosimilar Guidance Documents... CMS Updates Wage Index and Payment Rates for the Medicare Hospice...more
Biosimilars Are Generally Treated as Single Source Drugs - On March 30, 2015, in the wake of the first biosimilar product licensed by the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Fiscal Year 2015 Work Plan on October 31. The Work Plan provides the OIG’s planned reviews and activities with respect to...more
On October 3, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published an unexpected, yet long-awaited, set of proposed rules that would add new anti-kickback law safe harbors,...more
On October 2, 2014, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) published a proposed rule containing revisions to both the Anti-Kickback Statute (AKS) safe harbors and the civil...more
CMS recently issued a Final Rule with respect to the Medicare Part D and Medicare Advantage programs (the “Final Rule”) implementing certain Affordable Care Act provisions. The Final Rule follows a January 10, 2014 Notice of...more
The Advance Notice ("Advance Notice") of Methodological Changes for Calendar Year ("CY") 2015 for Medicare Advantage ("MA") Capitation Rates, Part C and Part D Payment Policies and 2015 Call Letter was released by the Centers...more
Last week, CMS published a final rule implementing the ACA’s medical loss ratio (“MLR”) requirements that will apply to the Medicare Advantage (Part C) and prescription drug (Part D) programs beginning in contract year 2014. ...more