The Pharmacy Police? House Hearing Pushes CMS To Do More To Limit Opioid Abuse In Part D

The 21^st Century Cures legislation provides CMS with new authority to limit Part D beneficiary access to pharmacies and providers when there is concern about misuse or abuse of prescriptions. Now legislators want CMS to do even more.

Now that the House has passed a bill including a pharmacy “lock-in” provision to help limit opioid abuse in Medicare Part D, legislators are turning their attention to plan reporting standards in Part D and urging CMS to strengthen rules in that area.

A July 14 House Energy & Commerce/Oversight Subcommittee hearing on two recent HHS OIG reports “Questionable Billing and Geographic Hotspots Point to Potential Fraud and Abuse in Medicare Part D” and “Ensuring the Integrity of Medicare Part D,” focused on recommendations OIG has made to CMS over the years but that have not been implemented.

The hearing was framed as a general review of program integrity in Medicare Part D, tied to the June arrest of 243 individuals for their participation in fraud schemes resulting in $712 million in false billings. However, the focus of the discussion was on opioid abuse in Part D, making the hearing seem more like the next step in the Oversight Subcommittee’s broader review of all aspects of the opioid abuse epidemic.

Two themes surfaced most frequently in question and discussion from committee members: (1) the importance of enactment of a “lock-in” authority (already an element of the House 21^st Century Cures bill); and (2) an effort to get CMS to require plan sponsors to report all instances of potential fraud and abuse to the government, rather than rely on the current voluntary reporting system.

The IG has recommended requiring plans to disclose all cases of suspected fraud to CMS and/or the Medicare Drug Integrity Contractor (MEDIC) on five different occasions since Part D began in 2006.

Establishment of “Lock-in” Authority by CMS

The 21^st Century Cures bill that passed the House July 10 contains a section regarding lock-in authority, under which Part D plans would establish a program to limit the number of physicians and pharmacies allowed to prescribe and dispense frequently abused or diverted controlled substances to “high risk” enrollees.

The July 14 hearing allowed legislators to elicit testimony in support of enactment of those provisions, which remain somewhat contentious with provider groups and are certain to be debated further as the Senate takes over the process. Rep. Frank Pallone (D-N.J.) specifically asked OIG Assistant Inspector General Ann Maxwell to share her opinion of that section of the bill. OIG “believes that lock-in will be a significant move forward to protect the program beneficiaries from harm as well as the program from significant financial loss,” Maxwell replied.

The CMS witness at the hearing, Deputy Administrator and Director at the Center for Program Integrity Shantanu Agrawal, agreed: “We’ve seen beneficiaries that are really at safety risk from the levels of utilization of their opioid medications, we have been supportive of this sort of legislative change… I do believe it would have impact as it has in both the private sector as well as various Medicaid programs.” He noted that the President’s FY16 budget proposal asked for lock-in authority, repeating a long-standing request for the authority. (Also see "CMS and Opioids: The Role for Non-Drug Reimbursements" - Pink Sheet, 9 Apr, 2012.)

Mandatory Plan Sponsor Reporting

Beyond building the record of support for the pending legislation, committee members were eager to push CMS to move forward with OIG’s top recommendation for program integrity improvements. IG wants CMS to “require plan sponsors to report all potential fraud and abuse to CMS and/or the MEDIC.” The issue was raised by several committee members, including Reps. Diana DeGette (D-C.O.), Marsha Blackburn (R-T.N.) , Tim Murphy (R-P.A.) , and Yvette Clarke (D-N.Y.).

Blackburn rebuked CMS for not implementing the OIG recommendations, and called the voluntary nature of the reporting by plan sponsors “troublesome.” DeGette noted the falling number of plan sponsors voluntarily reporting potential instances of fraud to CMS: 40% did in 2010 (already a minority), and just 35% did in 2012.

CMS’ Agrawal emphasized that the agency is working to improve in that area, but suggested that the agency is not yet convinced that mandating reporting in every instance is the right solution.

“This is an area where we are working to make progress,” Agrawal said. “We give data to the plan sponsors on a quarterly basis, and just this year, implemented a system for them to be able to report back to us what actions they took as a result. I think that system, which allows the data to be recorded, searchable, and analyzable, has been an important step toward better reporting.”

The goal, Agrawal emphasized, is “getting health plans better data about leads they should be investigating and potentially taking action on.”

In response a question from DeGette about whether plan sponsors were doing enough to help prevent fraud, OIG’s Maxwell replied by emphasizing the lack of access to data to answer that question. ”If we had the data about the fraud abuse instances that they are detecting as well as the data about how they are responding, we would be able to answer that question with more authority,” she said. “We really don’t have the visibility that we think is necessary to hold them accountable.” Agrawal acknowledged that, while some of the plan sponsors do quite well in reporting and analysis, others have “opportunity for improvement” and that the lack of reporting makes it difficult to reach definitive conclusions.

Maxwell argued that the solution is simple: if full reporting would be helpful, CMS should simply demand it.  “Given the current state of affairs, that now it is voluntary program, we don’t have full compliance,” Maxwell said. “We believe we will not have full compliance unless it is mandated.  Without the comprehensive reporting of that data we can’t look across the entire program.”

CMS “conceptually” agrees with that, Agrawal said, but argued that it is not certain that mandatory reporting of all cases of suspected fraud would actually provide the most useful data.  Through the implementation of the PLATO system, a voluntary web-based system that allows CMS and plan sponsors to share info, CMS hopes to gather knowledge about what type of information returned by the plan sponsors is useful to both the agency, and other sponsors to assure compliance. With that knowledge, CMS will be able to make more efficient and mandatory reporting measures applicable to the system.

CMS is also urging a measure of patience from legislators while some other recent policy steps take effect. A key CMS effort to combat Part D fraud and abuse is the requirement that all Part D prescribers enroll in Medicare—and the related authority to exclude prescribers for inappropriate/fraudulent overprescribing.

Agrawal noted that CMS is working to enroll 400,000 prescribers in Medicare Part D by January 2016, and that this process, while crucial, takes time and considerable effort to avoid any unnecessary disruptions to patient care. (Also see "CMS Returns To Part D Rule, But Steers Clear of Controversial Policies" - Pink Sheet, 12 Feb, 2015.)

Of note, one OIG recommendation with which CMS did not concur is the exclusion of Schedule II refills when calculating final payments to plan sponsors. Agrawal said that CMS has concerns regarding the accuracy of the data sets on refills of the drugs, considering that early refills are illegal but partial refills are not, and those tend to particularly affect beneficiaries in long-term care facilities.