CMS Issues Another Round of Sunshine Reporting FAQs

The Centers for Medicare & Medicaid Services (CMS) issued today another round of FAQs related to the implementation of the Sunshine Act.  Pharmaceutical, biotechnology and medical device manufacturers and group purchasing organizations (GPOs) started tracking data on August 1, 2013.  Below is a list of the new 25 CMS FAQs organized […]

CMS Call for Comments Re: Sunshine Act

The Centers for Medicare & Medicaid Services (CMS) recently issued a Federal Register notice requesting comments related to the Sunshine Act, section 6002 of the Affordable Care Act.  Specifically, CMS is requesting comments on the implementation of the registration process, attestation process, dispute and resolution processes, assumptions document, and data retention requirements […]

No Doubt About It: Sunshine Reporting Will Draw Interest

Since the introduction of the Sunshine Act legislation several years ago, one question has been whether transparency will impact relationships between pharmaceutical and medical device manufacturers and health care providers and entities.  Others have wondered whether patients, enforcement authorities and the public at large will be interested in the reported data.  While these […]

CBO Estimates Employer Mandate and Related ACA Delays To Cost $12 Billion

On July 30, 2013, the Congressional Budget Office (“CBO”) and the Joint Committee on Taxation (“JCT”) raised their estimate of the 10-year net cost of the health insurance coverage provisions under the Affordable Care Act (“ACA”) by $12 billion to $1,375 billion.  At the request of Congressman Paul Ryan, Chairman of […]

Grassley Letter to Walgreens Expresses Interest in 340B Contract Pharmacy Arrangments

On July 31, 2013, Senator Chuck Grassley (R-IA), Ranking Member of the Senate Judiciary Committee, sent a letter to Walgreens, Inc., requesting additional information about the pharmacy chain’s participation as a contract pharmacy in the 340B Drug Discount Program.  While the letter does not allege any wrongdoing by Walgreens, it […]

TIME IS UP! Sunshine Data Tracking Starts Today

The day long awaited by the health care industry has finally arrived.  Today is the day that pharmaceutical, biotechnology and medical device manufacturers and group purchasing organizations (GPOs) must begin tracking payments and other transfers of value provided to “covered recipients” in accordance with Section 6002 of the Affordable Care Act (commonly […]

HHS Requests Information Regarding the Affordable Care Act’s Nondiscrimination Requirements

On August 1, 2013, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) published a Request for Information (“RFI”) regarding the nondiscrimination provisions set forth in Section 1557 of the Affordable Care Act (“ACA”). This Section prohibits discrimination on the basis of race, […]