Joseph Metro

Joseph Metro

Reed Smith

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HRSA Publishes 340B Drug Pricing Program Omnibus Guidance Notice: Significant Policy Ramifications Should Trigger Public Comment

On August 28, 2015, the Health Services Resources Administration (“HRSA”) published its 340B Drug Pricing Program Omnibus Guidance Notice in the Federal Register. Although many aspects of the Notice reiterate previous HRSA...more

9/2/2015 - 340B Comment Period Covered Entities Drug Pricing GPOs Healthcare Healthcare Providers HHS Hospitals HRSA MCOs Medicaid Medicare Omnibus Guidance Pharmaceutical Manufacturers Pharmacies Physicians Prescription Drugs

OIG Will Not Impose Sanctions on Entities for Program That Provides Free Drugs to Patients Experiencing Delayed Insurance...

On August 5, 2015, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG) issued Advisory Opinion No. 15-11 (the “Opinion”) in response to a request by pharmaceutical manufacturers that...more

8/20/2015 - Anti-Kickback Statute Breakthrough Therapy Designation Cancer Civil Monetary Penalty FDA Federal Health Care Programs (FHCP) HHS Medicare Part D OIG Patient Assistance Programs Pharmaceutical Manufacturers Pharmacies Prescription Drugs

HRSA Issues 340B Drug Discount Program Civil Money Penalty Proposed Rule

On June 17, 2015, the Health Resources and Services Administration (HRSA) issued a proposed rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act as part of the...more

6/23/2015 - Affordable Care Act Civil Monetary Penalty Drug Pricing HRSA Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Public Health Service Act Section 340B

OIG Issues Advisory Bulletin Impacting Independent Charity Patient Assistance Programs

On May 21, 2014, the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) issued its “Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs” (SSAB) to...more

6/3/2014 - Anti-Kickback Statute Charitable PAPs Civil Monetary Penalty Drug Manufacturers Generic Drugs Healthcare HHS OIG Prescription Drugs

OIG Proposes Rule to Implement Expanded Civil Monetary Penalty Authority under the ACA

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a proposed rule that would amend the health care program civil monetary penalty (CMP) regulations (Proposed Rule)....more

5/21/2014 - Affordable Care Act Civil Monetary Penalty Drug Manufacturers HHS OIG Pharmaceutical Prescription Drug Coverage Prescription Drugs Proposed Regulation

Are Internal Compliance Investigations Privileged? D.C. District Court Rules No

U.S. District Court for the District of Columbia holds documents related to internal investigations of possible violations of corporate code of conduct not protected from disclosure under either attorney-client privilege or...more

3/17/2014 - Attorney-Client Privilege Chief Compliance Officers Compliance Corporate Counsel Disclosure Internal Investigations Work-Product Doctrine

ACA Affordable Insurance Exchanges and Qualified Health Plans

In This Issue: Exchanges and Types of Plans To Be Offered Through Exchanges; Essential Health Benefits; Premiums; Cost Sharing Reductions; and Other Issues. Excerpt from Exchanges and Types of Plans To Be...more

3/15/2013 - Affordable Care Act Essential Health Benefits Health Insurance Exchanges Healthcare Premiums Qualified Health Plans Reinsurance SHOP Program

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