Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Podcast: IP(DC): Drug Prices, Political Pressures & Patents
The 60-day Refund Rule, created by the 2010 Affordable Care Act, requires providers to report and return Medicare and Medicaid overpayments within 60 days of identifying them. See Section 1128J(d) of the Social Security Act,...more
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
Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the...more
Congress ended a busy work period after passing the Inflation Reduction Act (IRA) last week. This Holland & Knight alert summarizes the healthcare provisions in the IRA and provides an outlook on health policy issues that may...more
On March 17, the same day we wrote about proposed legislation in Connecticut to cap drug price increases, Governor Charlie Baker of Massachusetts included a similar proposal in his proposed budget. Similar to the Connecticut...more
Medicare and Medicaid programs themselves are not old enough to qualify for Medicare coverage (quick history lesson: President Lyndon Johnson signed the Social Security Amendments into law on July 30, 1965, and the Medicaid...more
On November 19, 2021, the U.S. House of Representatives voted to approve the Build Back Better Act (H.R. 5376, the “BBB Act”), the budget reconciliation bill that includes much of President Biden’s economic and social policy...more
The Big Picture - Before leaving for its August recess, the Senate made progress on two major Biden Administration priorities by passing bipartisan infrastructure legislation and a fiscal year (FY) 2022 budget resolution....more
This Week: The government shutdown continues; Congress finishes organizing and finalizing committee members and begins to focus on the issues. Concern has been raised that the Centers for Medicare and Medicaid Innovation...more
Days before politicians will face voters who tell pollsters they’re angry and upset about health care issues, President Trump made his first visit to the nation’s giant Health and Human Services Department to roll out a...more
Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more
Note: All fiscal estimates cited over a ten-year budget window refer to the Fiscal Year 2019-2028 budget window. The President's fiscal year 2019 (FY19) budget proposal for the Department of Health and Human Services (HHS)...more
The Trump Administration on Feb. 12 released its Fiscal Year (FY) 2019 budget request, titled "An American Budget." Unlike last year's budget, which was released in late May, the release of this budget conforms to the typical...more
On Tuesday, May 23, the White House released the President's fiscal year 2018 (FY18) budget, launching a contentious and consequential debate that is expected to last through the end of the fiscal year and possibly beyond....more
Meeting privately with Senate Republicans to discuss next steps on the ACA was among the first actions taken last week by the new Secretary of the U.S. Department of Health and Human Services Tom Price. But GOP senators left...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
This Week: Congress remains in recess, but members write letters on Mylan’s EpiPen…CBO says repealing Part B Demo would cost $395 million…CMS releases data on hospice utilization and finds spending and utilization vary in...more
This Week: MedPAC votes on changes in Part D... Senate HELP Committee reports five “Cures” bills... One report shows uninsured number decreasing... Another says, but we still need the safety net. ...more
I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...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
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