News & Analysis as of

Department of Health and Human Services (HHS) Reporting Requirements Compliance

Health Care Compliance Association (HCCA)

Overlapping surgeries: Time for a compliance checkup?

Overlapping surgeries is a practice that has been used for many years by healthcare providers (such as hospitals and surgical centers). This practice generally refers to situations where one lead attending surgeon is...more

Health Care Compliance Association (HCCA)

NY Medical College Clashes With OIG After Audit Questions $7.5M, PI Salaries, ‘Illegible Signatures’

New York Medical College (NYMC) officials thought the HHS Office of Inspector General’s (OIG) audit was wrapping up in December 2021, based on what “the original senior auditor” told them. But the auditor retired and work...more

BakerHostetler

Are You Complying with ClinicalTrials.gov Reporting Obligations?

BakerHostetler on

Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health (NIH) failed to disclose the results of over one-third of the clinical trials...more

Sheppard Mullin Richter & Hampton LLP

CMS Releases Updates to Hospital Pricing Transparency Rule

On April 26, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released a fact sheet on Hospital Price Transparency Enforcement Updates (the “Fact Sheet”) under the Hospital Price Transparency Rule (the “Rule”)....more

Goodwin

Pharma Manufacturer Federal Government Price Reporting: Recent Litigation and Settlements

Goodwin on

​​​​​​​Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP)  has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more

Williams Mullen

Physician Group Monitoring of “Open Payments”

Williams Mullen on

Is your physician group monitoring the Open Payments database? Each June, the Centers for Medicare and Medicaid Services (CMS) releases data showcasing the payments made by reporting entities to physician groups and other...more

Tucker Arensberg, P.C.

HHS Requesting Physician COVID Relief Payback of $100 Million

Tucker Arensberg, P.C. on

HHS sent notices to noncompliant physicians and facilities on March 10, 2022 giving them 30 days to return funds paid to healthcare providers who have not complied with the agency’s reporting requirements....more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 6. In This Month’s E-News: June 2021

Report on Research Compliance 18, no. 6 (June 2021) - Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440,...more

Baker Donelson

Overview of HHS Provider Relief Fund Payments and Updated Guidance

Baker Donelson on

On May 1, 2020, the Department of Health and Human Services (HHS) announced additional payments under the COVID-19 Provider Relief Fund to reimburse providers for health care related expenses and revenue losses attributable...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 4. In This Month's E-News: April 2020

Report on Research Compliance 17, no. 4 (April 2020) The Food and Drug Administration has accused a University of Michigan physician and professor of conducting research for more than three years after his approval from the...more

Health Care Compliance Association (HCCA)

'Misinterpretation' of Breach Rule, Lack of Internal BAA Cost Hospital Group $2.1M

Report on Patient Privacy 19, no. 12 (December 2019) - Sentara Hospitals, a nonprofit group of 12 medical centers in Virginia and North Carolina, will implement a fairly minimal two-year corrective action plan (CAP) and...more

Morgan Lewis

OIG Recommends Increased Oversight and Reporting Requirements for Hospice

Morgan Lewis on

In keeping with its recent recommendations to CMS, the Office of Inspector General for the US Department of Health and Human Services (OIG) is recommending increased oversight and compliance reporting requirements for...more

Cadwalader, Wickersham & Taft LLP

In Closely Watched Case, Federal Court Upholds the Government’s Position on Provider Mandate to Report and Return Medicare and...

The Patient Protection and Affordable Care Act (“PPACA”), signed into law on March 23, 2010, included a provision (the “Report and Refund Mandate”), broadly requiring health care providers, suppliers, Part D plans and managed...more

Carlton Fields

Data Collection Under The Sunshine Act

Carlton Fields on

Data collection requirements under the Physician Payment Sunshine Act commenced August 1, 2013. This provision of the Patient Protection and Affordable Care Act and the corresponding regulations require an entity that is...more

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