Effective October 9th, 2014 the DEA will allow certain authorized registrants, including: manufacturers, distributors, reverse distributors and retail pharmacies to voluntarily administer controlled drug mail-back programs and maintain collection receptacles.

Effective October 6, 2014, Hydrocodone Combination Products (HCPs) will be schedule II substances under the Controlled Substances Act (CSA). For prescribers, the change primarily means that they may not authorize refills for any HCP prescriptions. However, they may issue multiple prescriptions authorizing a patient to receive a total of up to a 90-day supply of HCPs (if state law permits). DEA is allowing HCP prescriptions issued before October 6, 2014 that authorize refills to be refilled until April 8, 2015.

The U.S. Food and Drug Administration has issued several policy documents regarding compounded drug products for human use, as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013.

This week CMS released the final regulation addressing changes in the Medicare Part D Prescription Drug Program. The most beneficial change for pharmacy was found in Section 18: Prescription Drug Pricing Standards and Maximum Allowable Cost that will require the maximum allowable cost prices of drugs be updated at least every 7 days and disclosed in advance of their use. The MAC implementation requirements will be effective January 2016.

The Health Insurance Portability and Accountability Act (HIPAA) Security Rule requires that covered entities conduct a risk assessment of their healthcare organization. A risk assessment helps your organization ensure it is compliant with HIPAA’s administrative, physical, and technical safeguards. A risk assessment also helps reveal areas where your organization’s protected health information (PHI) could be at risk.

The proposed Medicare regulation was not part of the Affordable Care Act, but the controversy over the law meant that the Administration didn’t want another healthcare related fight. Most of the opposition to the proposed rule came from patients, physicians and drug companies concerned with the proposed changes to three protected drug classes. However, there was also significant opposition from pharmacy benefit managers (PBMs) and insurance companies specific to the proposed elimination of preferred networks.