Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
Kim Brandt on the Latest Washington Healthcare News
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?
K&L Gates Triage: 340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
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
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more
The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) and the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule on May 6, 2024 (the “Final Rule”) under Section 1557 of the...more
On April 26, 2024, the United States Department of Health and Human Services (“HHS”) Office for Civil Rights and the Centers for Medicare & Medicaid Services issued a final rule under Section 1557 of the Affordable Care Act,...more
For the past month or longer, many providers have reported a significant impact on their revenue cycle due to the cyberattack on Change Healthcare, LLC. In light of that impact, the Centers for Medicare & Medicaid Services...more
Last week, the Centers for Medicare & Medicaid Services (CMS) announced that it would allow health plans under Medicare Part D (the Medicare prescription drug benefit) to cover Wegovy and other weight-loss medications if they...more
Earlier this week, President Biden released his Fiscal Year (FY) 2025 President’s Budget. As a reminder, every year, the White House releases a budget that serves as its official funding request to Congress for the following...more
This Week in Washington: House passes Lower Costs, More Transparency Act and SUPPORT Act Reauthorization; Senate HELP Committee reports SUPPORT Act Reauthorization and three other bills out of committee; ONC releases final...more
Sharpen your pencils and locate your reading glasses: the final Medicare payment regulations for calendar year (CY) 2024 will be released within the next week. In the last Regs & Eggs blog post, I discussed a major issue...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
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
Although most of the recent focus around the implementation of the Inflation Reduction Act (“IRA”) by the press and industry stakeholders has been on the Medicare Drug Price Negotiation Program, the IRA has several other...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
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
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
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
On February 14, 2023, and in response to Executive Order 14087 (“Lowering Prescription Drug Costs for Americans”), the Secretary of Health and Human Services (HHS) issued a report announcing the selection of three models that...more
On February 7, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published a report entitled, “Technical Assistance Brief: Implementation of Inflation-Indexed Rebates for Part B Drugs.” ...more
As the Biden administration moves ahead to implement provisions of the Inflation Reduction Act (IRA), including those related to drug negotiation and inflationary rebate, the administration announced three Medicare and...more
From an agency guidance and regulatory developments perspective, 2022 was fairly quiet until the latter part of the year. Consistent with past practice, the Office of Inspector General for the Department of Health and Human...more
The Centers for Medicare & Medicaid Services (CMS) and the US Department of Health and Human Services Office of Inspector General (OIG) continue to issue guidance regarding the implementation of the drug pricing provisions of...more
The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims...more
On January 3, 2023, the Department of Health and Human Services Office of Inspector General (OIG) publicly released two reports with respect to Medicare Part B average sales price (ASP)....more
On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (IRA). The drug pricing provisions in Subtitle B of Title I of the IRA, entitled “Prescription Drug Pricing Reform,” enact government...more