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Centers for Medicare & Medicaid Services (CMS) 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

Hogan Lovells on

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

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

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

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

Hogan Lovells on

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

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

ArentFox Schiff

Physician Fee Schedule Proposed Rule for 2022 Released: What Pharmaceutical Manufacturers Need to Know

ArentFox Schiff on

The Centers for Medicare & Medicaid Services (CMS) calendar year 2022 rule proposing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Proposed Rule) will officially be published in...more

King & Spalding

OIG Releases Semiannual Report to Congress

King & Spalding on

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

Health Care Compliance Association (HCCA)

CMS offers correct billing tips for nonphysician outpatient services provided before or during inpatient stays

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

McGuireWoods Consulting

Washington Healthcare Update - November 2020 #3

McGuireWoods Consulting on

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

Akin Gump Strauss Hauer & Feld LLP

Friday Evening Health Care Regulatory Blitz!

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

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