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
The health care regulatory space realized significant regulatory and enforcement developments in 2024 that are influencing how providers and industry stakeholders approach various compliance measures and enforcement...more
On January 15, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 25-01, a favorable opinion analyzing a pharmaceutical manufacturer’s free product offering to...more
On December 4, 2024, OIG issued its fall 2024 Semiannual Report to Congress (the Report), which provides a comprehensive overview of the agency’s work completed during the reporting period of April 1, 2024, through September...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 Centers for Medicare and Medicaid Services (CMS) continues to take steps implementing the Inflation Reduction Act of 2022 (IRA). Newly revised guidance issued on December 14, 2023, makes notable changes and clarifications...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
In its August 15, 2023, Enforcement listserv notice, the U. S. Department of Health and Human Services Office of Inspector General (“OIG”) published its Work Plan Updates for August. This article will highlight three of the...more
On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) released initial program guidance addressing the inflation rebate provisions of the Inflation Reduction Act of 2022 (IRA). These provisions apply to how...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
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 December 19, 2022, OIG released its annual report analyzing Medicare Part B spending on laboratory tests over the past year. According to OIG, Medicare Part B spending on laboratory tests increased 17% from $8.0 billion in...more
In a follow-up to its recent reports on billing outside the hospice benefit for drugs and durable medical equipment (DME), the Office of Inspector General’s (OIG) new data report identifies billions being billed to Medicare...more
Last week, OIG released a report analyzing trends in the last decade relating to Medicare payments for hospice beneficiaries outside of the hospice per diem. In the report, OIG notes that CMS has taken the position that...more
Kim Brandt, partner at Tarplin, Downs & Young has long provided the healthcare community with her expertise in all things Washington, having spent substantial time at CMS, the OIG at HHS and on Capitol Hill. She’ll be...more
On September 30, 2021, OIG posted Advisory Opinion No. 21-14 regarding a chiropractor’s proposal to extend an existing discount program covering a package of services to include federal health care program beneficiaries. OIG...more
The Department of Justice (“DOJ”) has reported that in 2020, the government prosecuted dozens of laboratory owners and operators for anti-kickback related offenses responsible for hundreds of millions in alleged federal...more
On May 28, 2021, OIG released its Semiannual Report to Congress (the Report). The Report describes OIG’s work during the 6-month semiannual reporting period of October 1, 2020, through March 31, 2021 (the Semiannual Reporting...more
Compliance Today (March 2021) - The Centers for Medicare & Medicaid Services (CMS) has provided the following compliance notice: “In a recent report, the Office of Inspector General (OIG) determined that Medicare made...more
Companies who feel the Public Health Emergency (PHE) waivers and exceptions have rendered telemedicine “immune” from compliance oversight might be surprised to learn what federal regulators have in the works. The Office of...more
Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more
The OIG updates its Work Plan monthly to identify audits and evaluations that are underway or proposed by the OIG's Office of Audit Services and Office of Evaluation and Inspections. The October 2019 update identifies new...more
This week in Washington: House returns from recess and has scheduled hearing on caring for aging Americans; Senate to hold hearing on rising electronic cigarette use among youth and will hold a confirmation hearing for Dr....more
California physician Donald Woo Lee was found guilty Oct. 17 for his role in providing medically unnecessary procedures to Medicare beneficiaries, upcoding, and repackaging single-use catheters for re-use, the Department of...more
Long time readers of our blog may recall that five years ago, I predicted that 2014 might be a game-changing year for the 340B Drug Discount Program. 2014 saw attempts at regulatory changes, but a successful court challenge...more
Providers, plans, and vendors that provide services under the Medicare Advantage program, should be aware that the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) is once again...more