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 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
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 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
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 December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule which, in part, seeks to amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for when an...more
Introduction - On 6 December 2022, the Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a report (Report) that summarized findings of HHS-OIG’s review of laboratories with questionably high...more
On January 25, 2022, the U.S. Court of Appeals for the Second Circuit affirmed a lower court ruling that the Secretary of HHS violated the due process rights of Medicare beneficiaries by failing to provide an administrative...more
This week in Washington: CBO Scores Reconciliation Package While House Waits....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 October 13, 2021, the in-person portion of the annual informaconnect Medicaid Drug Rebate Program (MDRP) Conference concluded in New Brunswick, New Jersey. A day earlier, on October 12, 2021, a joint hearing was held in...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
When the COVID-19 pandemic began, no one imagined that it was here to stay for more than a year and counting! Many thought it would take at most a couple of months for the outbreak to resolve and the stay-at-home orders,...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
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) recently updated its 2021 Work Plan in January to include audits of Medicare Part B and home health telehealth services by OIG’s Office...more
This week in Washington: Congress gets organized for next Congress; House passes health care bills; COVID-19 vaccine is the talk of the town....more
Happy Thanksgiving everyone. In a pre-holiday flurry, the Trump Administration has released four long-awaited health care policies impacting a wide range of health industry participants. On the drug pricing front, the...more
The White House released three Executive Orders on July 24, 2020 setting forth policies that the Administration believes will “deliver lower prescription drug prices to American patients.” A fourth Executive Order tying...more
On July 24, 2020, President Trump signed three Executive Orders aimed at lowering prescription drug costs and increasing patients’ access to life-saving medications. A fourth Executive Order was discussed, which could reduce...more