Prescription drug compliance is now a priority for government enforcement. The current epidemic of prescription drug abuse, combined with increasing annual government expenditures for prescription drugs, has thrust this issue into the government spotlight. Key recent government activities include the following:
- Last month, the Office of Inspector General (OIG) published an investigation revealing that in 2009, Medicare paid millions of dollars for drugs ordered by individuals or entities who clearly had no authority to do so. Among the ten most problematic states studied (which included Michigan), the figure exceeded $26 million.
- Another OIG report found that 2,367 retail pharmacies had “questionable” Medicare Part D billings during 2009.
- Medicare accrediting entities have recently been citing hospitals for permitting unauthorized individuals to prescribe drugs, especially controlled substances in the operating suite.
- The DEA has focused on controlled substance abuse and diversion, taking serious action against Walgreens, CVS and several pain clinics for improper storage, handling, prescribing and recordkeeping of controlled substances.
- The federal Health Resources Services Administration is actively auditing 340B Covered Entities for compliance with 340B Program Guidelines.
- Effective August 1, 2013, the Sunshine Law requires drug and device manufacturers to start collecting data regarding physician ownership interests and payments made to physicians and research hospitals.
Given this flurry of government enforcement activity, providers are well-advised to make prescription drug compliance efforts a priority. Here are some general suggestions:
- Review your prescription drug (especially controlled substance) acquisition, handling, resale and prescription activities for compliance with federal and state law.
- Confirm that individuals in your organization who write prescriptions, especially for controlled substances, have authority to do so under state law, and that their prescriptive practices satisfy federal and state drug control and controlled substance laws and Medicare/Medicaid requirements.
- If you are a 340B Covered Entity or Contract Pharmacy, prepare for audit by HRSA or a drug manufacturer.
- If you or your organization receive funds from a drug manufacturer, prepare for compliance with the Sunshine Law.