Category: Healthcare

FDA Guidance Details Exemptions and Exclusions from Certain Drug Supply Chain Security Act Requirements Due to COVID-19 Public Health Emergency

On April 30, 2020, the U.S. Food and Drug Administration (“FDA”) published guidance clarifying the nature and scope of exemptions and exclusions to certain requirements under the Drug Supply Chain Security Act (“DSCSA”) triggered by the COVID-19 public health emergency. By waiving certain requirements under the DSCSA for the duration […]

OCR Issues Additional Guidance Regarding Enforcement Discretion in Connection with COVID-19 Community-Based Testing Sites

On April 9, 2020, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) announced that it will exercise its enforcement discretion and not impose penalties on covered entities or their business associates for noncompliance with Health Insurance Portability and Accountability Act (“HIPAA”) regulatory […]

Drug Pricing 2019 Year in Review

In 2019, Congress and the Administration set out to make strides to effectuate policies to curb the rising costs of prescription drugs. These efforts while significant in number, were few in completion. Congress, while spending months on an array of legislation, did not manage to send anything major to the […]

PhRMA Releases Updated Code on Interactions with Health Care Professionals

The Pharmaceutical Research and Manufacturers of America (“PhRMA”) recently issued an updated Code on Interactions with Health Care Professionals (the “Updated Code”). The Updated Code’s preamble states that it reinforces PhRMA’s intentions that interactions with health care professionals are professional exchanges designed to benefit patients and to enhance the practice of medicine. […]

OIG Report on Reasonable Assumptions in Manufacturer Reporting

Last week the Department of Health and Human Services Office of Inspector General (OIG) published a report titled “Reasonable Assumptions in Manufacturer Reporting of AMP and Best Prices” (Report) that reviewed the use of assumptions made by a sample of drug manufacturers participating in the Medicaid Drug Rebate Program (MDRP) […]

OIG Publishes Advisory Opinion on an Arrangement Involving an Excluded Individual

In OIG Advisory Opinion No.19-05, the Department of Health and Human Services Office of the Inspector General (OIG) concluded that it would not impose sanctions against a requestor under the civil monetary provision of the Social Security Act (SSA) that prohibits certain persons from contracting with individuals or entities known […]

Final Rule Issued by CMS re: New Enforcement Authorities to Reduce Criminal Behavior in Medicare, Medicaid and CHIP

The Centers for Medicare & Medicaid Services (CMS) issued late last week a final rule with comment period titled, Program Integrity Enhancements to the Provider Enrollment Process (CMS-6058-FC) (Final Rule). The Final Rule is intended to proactively prevent fraud and abuse against the Federal health care programs, including Medicare, Medicaid […]