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Advertisement OIG Issues Advisory Opinion Allowing Pharmaceutical Company’s Payment of Travel, Food and Lodging Expenses for Indigent and Rural Patients Thursday, January 14, 2021 In its final Advisory Opinion of 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) approved a pharmaceutical company’s request to provide financial assistance to patients who were prescribed a cancer drug that the company manufactured. In Advisory Opinion 20-09, the OIG determined it would not impose sanctions under the Anti-Kickback Statute (AKS) or beneficiary inducement provision of the Civil Monetary Penalties Law (CMP) for an arrangement where a pharmaceutical manufacturer covers the expenses for qualifying patients for travel, lodging and limited out-of-pocket expenses (i.e., meals) related to the treatment of the patient with the manufacturer’s drug. The drug is subject to a Risk Evaluation and Mitigation Strategy, which includes ....
The Settlement In a Tuesday statement, HHS OCR says its settlement with Banner Health came after two complaints. In the first complaint, a patient said she requested access to her medical records in December 2017 but did not receive the records until May 2018. The second complaint alleged that another individual requested access to an electronic copy of his records in September 2019, but the records were not sent until February 2020. “This first resolution of the year signals that our right of access initiative is still going strong and that providers of all sizes need to respect the right of patients to have timely access to their medical records,” said Roger Severino, OCR director. ....
Monday, January 11, 2021 On December 30, 2020, the US Department of Health and Human Services (HHS) Office of General Counsel (OGC) released an Advisory Opinion concluding that providers participating in the 340B Program (“covered entities”) are entitled to purchase covered outpatient drugs at 340B discounted prices even when those drugs are distributed by third-party contracted pharmacies (“contract pharmacies”) on the covered entity’s behalf. The Advisory Opinion responds to drug manufacturers who have recently declined to distribute 340B drugs through contract pharmacies. The Advisory Opinion is available here. IN DEPTH Background Guidance issued by the Health Resources and Services Administration (HRSA) in 1996 provided that 340B covered entities may elect to sign a contract with a pharmacy to dispense drugs purchased at 340B prices to the covered entity’s patients. The 1996 guidance generally limited the contract pharmacy option to those ....
AARP CEO Jo Ann Jenkins has called for an improved vaccine rollout in a letter to HHS. Delays and disorganization have slowed access for millions. ....