The U.S. government is planning a new crackdown on doctors, pharmacies and patients who over-prescribe or abuse painkillers as part of a major overhaul of the federal Medicare Advantage and Part D prescription drug programs.
The Centers for Medicare and Medicaid Services (CMS) unveiled the crackdown in a series of proposed rule changes that would give the agency sweeping new powers to prevent prescription fraud.
The changes are outlined in a 678-page report released this week. If enacted, the new regulations would take effect in 2015 and save an estimated $1.3 billion, according to the Obama administration. The public has a 60-day period to comment on the changes.
“Prescription drug abuse is a serious and growing problem nationwide. Unfortunately, the Medicare Part D prescription drug program (Part D) is not immune from the abuses associated with this nationwide epidemic,” the agency said in a statement.
As part of its fraud and abuse strategy, CMS said it would “leverage” information about Part D prescription drug claims by nearly 37 million elderly and disabled Americans by sharing the data with law enforcement agencies, and pharmacy and physician licensing boards.
“A centerpiece of this strategy that focuses on protecting beneficiaries is the identification of Part D enrollees who have potential opioid or acetaminophen overutilization issues that indicate the need to implement appropriate controls on these drugs for the identified beneficiaries. In addition, data analysis is employed to identify prescribers and pharmacies that may warrant further action to curb fraudulent or abusive activities,” CMS said.
The proposed regulations would also bring physicians under greater federal oversight by requiring that all doctors or non-physician practitioners who write prescriptions under Part D be enrolled in Medicare.
Medicare enrollment would be revoked “if CMS determines that he or she has a pattern or practice of prescribing Part D drugs that is abusive” or if a practitioner’s license or Drug Enforcement Administration (DEA) Certificate of Registration is suspended or revoked.
The proposed rule changes would also give “CMS, its antifraud contractors, and other oversight agencies” direct access to information from pharmacies that fill prescriptions under Medicare and Part D prescription drug programs. The agency said the change is needed “to provide more timely access to records” during investigations of prescription fraud and abuse.
CMS is already tracking the use of opioids and acetaminophen by Part D beneficiaries. Although the agency says its efforts have led to a “substantial reduction” in beneficiaries with “potential opioid issues”, the actual numbers suggest the problem is small and already declining.
In 2011, over 22,000 Part D beneficiaries were identified as having potential problems with opioids or acetaminophen, according to CMS.
By 2013, that number had dropped to only 4,351 beneficiaries. Over 9 million Americans are currently prescribed opioids or acetaminophen through the Part D program – which means only 0.05% may have a problem with the drugs.
In 2013, CMS made only 60 referrals to law enforcement based on its analysis of prescription drug claims. Another 182 investigations are underway for potential referral to law enforcement agencies.
Under the proposed rule changes, CMS would be allowed to take administrative action against beneficiaries, physicians and pharmacies when a pattern or practice of abusive prescribing is identified.
National Pain Report is seeking additional information from CMS about the regulatory powers the agency is seeking.