News & Analysis as of

Office of the Inspector General Medicare Part B

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | June 2024 Recap

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

Hogan Lovells

CMS Issues Updates Regarding ASP: Negative ASP, Radiopharmaceuticals, Restatements, and Skin Substitutes

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The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers. ...more

ArentFox Schiff

CMS Issues Revised Guidance Implementing Medicare Inflation Rebates Under the Inflation Reduction Act

ArentFox Schiff on

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

Mintz - Health Care Viewpoints

Mintz IRA Update — Other Key IRA Programs and Developments: The Medicare Prescription Drug Inflation Rebate Program and Maximum...

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

Harris Beach PLLC

HHS Office of Inspector General Publishes August Work Plan Updates

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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

Goodwin

CMS Issues Proposed Guidance on Inflation Rebates Under Medicare Part B

Goodwin on

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

Foley Hoag LLP

OIG Technical Assistance on Part B Inflation Rebates Implementation Barriers and CMS’ Proposed Solutions in Recent Part B...

Foley Hoag LLP on

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

Mintz - Health Care Viewpoints

EnforceMintz — Significant 2022 Regulatory and Policy Developments

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

ArentFox Schiff

CMS and OIG Issue Guidance on Implementation of the Inflation Reduction Act

ArentFox Schiff on

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

Mintz - Health Care Viewpoints

CMS Proposed Rule for Refunding Overpayments Would Align With False Claims Act “Knowledge” Standard

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

Hogan Lovells

HHS OIG issues ASP reports exploring need for guidance and increased oversight in ASP reporting

Hogan Lovells on

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

King & Spalding

OIG Publishes Annual Medicare Laboratory Test Spending Report: COVID Tests, Chemistry Tests Drive Largest Annual Increase in...

King & Spalding on

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

Foley & Lardner LLP

Will CMS’s Proposed Rule on “Identified Overpayments” Increase Reverse FCA Cases?

Foley & Lardner LLP on

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

King & Spalding

OIG Review Identifies 378 Labs That Allegedly Billed Medicare Part B at Questionably High Levels for COVID-19 Tests

King & Spalding on

OIG issued a report last week examining alleged billing irregularities relating to COVID-19 tests (the Report). The Report explains that in response to increased Medicare Part B spending on COVID-19 tests in 2020, OIG...more

Robinson+Cole Health Law Diagnosis

OIG Issues Reports Reviewing Laboratory Billing Practices and Noting Increased Spending by Medicare Part B on Laboratory Tests

As the year comes to a close, the government has signaled a specific focus on clinical laboratories for 2023.  On December 6, 2022, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued...more

K&L Gates LLP

COVID-19: A Roadmap to Fraud Investigations: Office of Inspector General Targets Labs for Billing COVID-19 Add-On Tests

K&L Gates LLP on

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

Husch Blackwell LLP

Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion

Husch Blackwell LLP on

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

King & Spalding

OIG Report Analyzes Payments in Excess of Hospice Per Diem Rate

King & Spalding on

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

Arnall Golden Gregory LLP

OIG’s First Advisory Opinion of 2022 Allows for Expansion of Discount Programs

On January 19, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) released a favorable advisory opinion, OIG Advisory Opinion No. 22-01 (the “Opinion”), analyzing a proposed expansion of...more

King & Spalding

Court of Appeals Affirms Ruling that Hospital Utilization Review Committee’s Medicare Part A Inpatient Reclassifications Trigger...

King & Spalding on

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

McGuireWoods Consulting

Washington Healthcare Update - November 2021 #3

McGuireWoods Consulting on

This week in Washington: CBO Scores Reconciliation Package While House Waits....more

Health Care Compliance Association (HCCA)

Kim Brandt on the Latest Washington Healthcare News

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

Hogan Lovells

MDRP and 340B: Updates from last week

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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

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Chiropractor Arrangement to Offer Discounts

King & Spalding on

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

Goodwin

DOJ Recoups a total of $1.8 Billion from Health Care Fraud in 2020, Laboratory Recoupments Alone Account for Hundreds of Millions

Goodwin on

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

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