What Happened

Baldpate Hospital, a private psychiatric hospital in Georgetown, Massachusetts, settled civil allegations with the DEA and the U.S. Attorney's Office over an unregistered methadone clinic.

The government alleged that Baldpate Hospital operated a clinic dispensing methadone to heroin-addicted patients without registering as a DEA Narcotic Treatment Program, as required under the Controlled Substances Act. The government also alleged the hospital failed to maintain required records and inventories of the methadone in its possession.

Without admitting wrongdoing beyond the settlement terms, the hospital agreed to pay $29,500 to resolve the claims. The settlement was announced September 27, 2011.

What Went Wrong

A hospital operated a narcotic treatment program without the registration and recordkeeping the Controlled Substances Act requires for it. Key failures included:

  • The hospital dispensed methadone to opioid-dependent patients through a clinic that was never registered with DEA as a Narcotic Treatment Program.
  • Required records and inventories of the methadone in the hospital's possession were not maintained as the CSA requires.
  • The registration gap was not caught internally before it drew a federal civil enforcement action.

How It Could Have Been Prevented

  • Confirm DEA Narcotic Treatment Program registration status before operating any clinic that dispenses methadone or buprenorphine for opioid use disorder.
  • Maintain complete, current controlled-substance receiving, dispensing, and inventory records as required for every DEA registration held by the facility.
  • Run periodic internal compliance reviews of any specialty clinic operating under its own controlled-substance authority, separate from the hospital's general pharmacy.

Related Guidance

Sources