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Compliance HRSA

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Mintz - Health Care Viewpoints

Will Sustained Pressure on the 340B Program Finally Lead to Much Needed Reform?

As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

ACA-Required Coverage of Contraceptive Care Remains Agency Focus

Once again, the U.S. Departments of Labor, Health and Human Services, and the Treasury have issued guidance on the Affordable Care Act’s (ACA) required coverage of contraception without cost sharing, clarifying the permitted...more

Health Care Compliance Association (HCCA)

CARES Act appeals: Key steps in addressing denials and repayments

With the onset of the COVID-19 pandemic, Congress initiated several programs to help businesses weather the difficult economic conditions. The Coronavirus Aid, Relief, and Economic Security (CARES) Act provided two of these...more

Health Care Compliance Association (HCCA)

FCA Lawsuit Alleges Three Hospitals Were Overpaid PRF ‘High-Impact’ Money and Kept It

Report on Medicare Compliance Volume 32, no 25 (July 2023) The former chief hospital executive of Bayonne Medical Center (BMC) in New Jersey has filed a False Claims Act (FCA) lawsuit alleging the hospital and two others...more

Proskauer - Employee Benefits & Executive...

Preventive Care in a Post-Braidwood World: Agencies Release Guidance on Preventive Services Coverage Requirements

The Departments of Labor, Treasury, and Health and Human Services (the “Departments”) recently released guidance for group health plans on required preventive services coverage. The guidance was issued in response to a...more

Foley & Lardner LLP

Federal Agencies Issue Firm Reminder that No-Cost Coverage Requirements for Employee Contraceptives Remain Post-Roe

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On July 28, 2022, in light of the United States Supreme Court’s recent decision overturning Roe v. Wade, the United States Department of Labor (DOL), in conjunction with the Departments of Health and Human Services (“HHS”)...more

Tucker Arensberg, P.C.

HHS Requesting Physician COVID Relief Payback of $100 Million

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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

Foley & Lardner LLP

Let’s Talk Compliance Recap: Provider Relief Fund Reporting Requirements & Compliance Concerns

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In the latest installment of our “Let’s Talk Compliance” series, Foley & Lardner’s Alexis Bortniker and PYA’s Martie Ross answered numerous questions regarding Provider Relief Fund (PRF) reporting requirements. A recording of...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 30, Number 15. News Briefs: April 2021 #3

Report on Medicare Compliance 30, no. 15 (April 19, 2021) - CMS’s supplemental medical review contractor (SMRC) has added outpatient therapy claims to its list of postpayment reviews, according to its website. The SMRC,...more

Hinshaw & Culbertson - Health Care

COVID-19 Compliance Issues For Federally Qualified Health Centers

On March 24, 2020, Health Resources & Services Administration (HRSA) released newly updated Novel Coronavirus (COVID-19) Frequently Asked Questions (FAQs), which outline multiple COVID-19 related issues for federally...more

Holland & Knight LLP

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

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The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

BakerHostetler

340B Guidance: Eight Key Points Covered Entities Should Consider

BakerHostetler on

On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more

K&L Gates LLP

HRSA Issues 340B Program Omnibus Guidance

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On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

Baker Donelson

HRSA Issues Long-Awaited 340B Program Omnibus Guidance Proposal

Baker Donelson on

After much anticipation, the Health Resources and Services Administration (HRSA) late last week released its 340B Drug Pricing Program Omnibus Guidance Proposal (the Proposal). HRSA indicates that its goal in issuing the...more

King & Spalding

Also In The News - Health Headlines - August 2015 #3

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Review of 340B Program Omnibus Guidelines Extended – Last week, the White House Office of Management and Budget (OMB) posted that the review of the 340B Program Omnibus Guidelines had been extended. The Health Resources and...more

Baker Donelson

Final Rule on 340B Orphan Drug Exclusion Imposes New Compliance Requirements on Covered Entities and Contract Pharmacies

Baker Donelson on

The 340B program permits eligible hospitals and other “safety-net” providers (Covered Entities) to purchase covered outpatient drugs from pharmaceutical manufacturers at significant discounts. The Affordable Care Act and the...more

Foley & Lardner LLP

340B Drug Pricing Program Update: Hospital Recertification and Recent Audit Activity

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As part of its expanded authority resulting from the Patient Protection and Affordable Care Act (PPACA), the Health Resources and Services Administration (HRSA) is continuing its efforts to ensure compliance with 340B Drug...more

King & Spalding

HRSA Issues Final 340B Orphan Drug Exclusion Rule: Agency’s Narrow Interpretation of Statutory Prohibition Puts Compliance...

King & Spalding on

On July 23, 2013, the Health Resources and Services Administration (HRSA) issued a final rule clarifying the orphan drug exclusion for certain covered entities created by the Affordable Care Act (ACA) (“Final Rule”). The...more

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