The Federal Office for Management and Budget has withdrawn the proposed omnibus guidance for the 340B Drug Pricing Program (previously referred to as the “Mega-Regs”), creating further uncertainty in the 340B Program. The guidance was proposed in the Fall of 2015, and would have updated all areas of 340B Program guidance. The guidance would have included significant changes to the definition of an eligible patient, and to 340B Program integrity provisions. By withdrawing the guidance, the Office of Management and Budget indicates that omnibus guidance will not be adopted as it was proposed. The new administration could issue new guidance that differs materially from the previous proposal. The withdrawal of the omnibus guidance coincides with a meeting between the President and the heads of major pharmaceutical companies.
“A robust, sustainable blood system is a crucial component of every health care system.” That is how Rand Corporation’s recently issued comprehensive report entitled “Toward a Sustainable Blood Supply in the United States” (the “Report”) begins. Issued as a result of research sponsored by the U.S. Department of Health and Human Services (“HHS”), the Report explores the challenges faced by the U.S. blood system and offers policy alternatives designed to ensure that such system remains sustainable.
On Jan. 12, 2017, the Office of Inspector General of the U.S. Department of Health and Human Services issued the third and final installment of its recent three-part rulemaking effort — a final rule updating its exclusion regulations, 82 Fed. Reg. 4100 (Jan. 12, 2017). This final rule follows two others that were published in December updating the OIG’s civil monetary penalty (CMP) regulations, 81 Fed. Reg. 88,334 (Dec. 7, 2016), and safe harbors under the anti-kickback statute and beneficiary inducement prohibitions, 81 Fed. Reg. 88,368 (Dec. 7, 2016).
New Hampshire is starting 2017 with stepped-up efforts to manage its oft-described opioid epidemic. Though the most recent regulations are directed at individual prescribers, and do not apply to the administration of opioids to patients in a health care setting, now is the time for New Hampshire hospitals, ambulatory surgical centers, urgent care facilities, and other health care facilities to revisit their protocols, record-keeping practices, and informed consent agreements relating to opioid prescribing.
A final rule published on January 18 implements the first major revisions to the federal regulations governing the confidentiality of substance-use disorder patient records (Part 2) since 1987. It finalizes a proposal from last February to modernize the regulations in light of the significant changes in the health care delivery system. On the same day, the Substance Abuse and Mental Health Services Administration (SAMHSA), also issued a supplemental notice of proposed rulemaking to request comments on the disclosure of Part 2 covered data by contractors, subcontractors, and legal representatives for purposes of carrying out payment, health care operations, and other health care related activities.