CMS Wades Into the Opioid Debate

Reducing prescription drug abuse is a high priority item for several key legislators and for the Obama Administration. Proposed new rules for Medicare drug plan sponsors might help—but they also underscore the growing tension among the many different stakeholders in the pharmaceutical supply chain.

“Each entity in the regulated prescription drug supply must do their part to help prevent the diversion of medicines to help prevent inappropriate use or misuse.”

That principle, articulated by Pharmaceutical Research & Manufacturers of America Assistant General Counsel Kendra Martello during an Energy & Commerce/Commerce Subcommittee hearing on prescription drug abuse March 1, is entirely non-controversial. Witnesses from across the pharmaceutical supply chain (retail pharmacy, wholesalers, manufacturers) and political spectrum (federal legislators, state officials, agency heads) all agree that prescription drug abuse must be curbed and that everyone has a role to play.

If only there was clearer agreement on what exactly those roles should be.

As the Food & Drug Administration learned when it began what turned into a multi-year process to apply its new Risk Evaluation & Mitigation Strategy authority to the specific issue of abuse of long-acting opioids (a.k.a., Oxycontin abuse), the desire for action is very hard to translate into a meaningful changes in practice. (Also see "Regulatory Alchemy: The Transformative Power of the Opioid REMS" - Pink Sheet, 1 Jun, 2011.)

The Centers for Medicare & Medicaid Services may be about to learn that lesson as well. The agency is proposing to change the rules for Medicare Part D plan sponsors to require specific additional controls to address concerns about opioid abuse in Part D.

The changes, discussed deep inside the 131 page “call letter” CMS issues each year to solicit bids for Part D plan sponsors, do not seem unduly controversial on their face.

The agency cites a 2011 Government Accountability Office report that noted examples of “egregious overutilization” of controlled substances in Part D—individuals who received extraordinarily large quantities of opioids prescriptions, prescribed by as many as 50 different doctors. The agency is proposing several additional requirements for Part D plan sponsors to monitor for abused as a result. The specifics are fairly technical, having to do with the types of real-time and retrospective utilization management tools plans are expected to employ, with the key terms of art including “edits,” “quantity limits” and “DUM (drug use management”).

But the gist is very clear: Part D plans are supposed to do their part to monitor, prevent, and—when necessary—report apparent cases of inappropriate utilization of controlled substances.

Now, there might be room to quibble about how effective CMS’ proposals would be, and whether plans can adopt them as quickly as the agency wants (i.e., in 2013). But plans won’t fundamentally object to tougher utilization controls—they are, after all, on the hook for managing overall costs, so cutting utilization of controlled substances has an economic upside. And surely no one would object to the idea that CMS wants Part D plans to do more to stop opioid abuse.

Physicians Push Back

Not so fast.

The American Medical Association responded to the CMS proposal on March 2 with a letter questioning the basic assumption of CMS’ approach: i.e., that Part D plans (and insurance plans in general) are in a good position to restrain inappropriate use of controlled substances.

“As a threshold matter, we would urge CMS to acknowledge that physicians are best equipped to evaluate the medication needs of their patients and CMS should not promote the adoption of policies that substitute physician clinical judgment with that of sponsors,” AMA wrote.

In the February 17 draft call letter, CMS suggested otherwise. “Plan sponsors are in a unique position to evaluate medication overutilization,” the agency said. “They are a central data collection point for beneficiary medication dispensing events, which may be generated from multiple providers and pharmacies, which may be unaware that a beneficiary is receiving the same drug (or therapeutic equivalent) simultaneously from different providers and pharmacies.”

“To the contrary,” AMA responded. “Part D sponsors are not in a position to evaluate medication overutilization. The only information they have is the various claims that are submitted for prescription coverage. Sponsors do not know diagnoses and they do not know about any other services the patient is receiving that do not involve Part D coverage.”

“We acknowledge that there are instances where multiple prescribers and pharmacies are writing and dispensing medications to the same patient and unaware that the patient is receiving the same drug or similar drugs from other sources,” AMA continued. However, the medical association added, emphasizing the text in the letter: “The best way to address that information gap is for the plans to share the information with the other prescribers so that these prescribers can reconcile the patient’s multiple medications and ensure the beneficiary is getting appropriate care.”

AMA quibbles both with the scope of CMS’ proposal and the specific tools the agency wants to apply.

On the former point, AMA points to the same GAO report CMS cited. GAO “found that two drugs (hydrocodone and oxycodone) accounted for more than 80 percent of the instances of potential doctor shopping,” AMA said. Yet CMS wants plans to adopt “intensive” controls not merely for all opioids but “across the board.” (Indeed, CMS says it expects the new tools to be implemented for opioids “at a minimum” in 2013, and then will expect overutilization controls to be generally in place in following years.)

AMA also objects to the core of CMS’ proposal, namely that Part D sponsors set up systems that allow them to reject claims at the point of sale “in the event that a beneficiary’s prescription drug claims for opioid analgesics cannot be established as medically necessary to the plans’ satisfaction.”

Part D “sponsors should not be making clinical determinations and overruling physician prescribing judgments,” AMA wrote. “It has the potential to be highly disruptive to patient-physician relationships and undermine their mutual trust. Serious medical consequences would exist if Part D plans suddenly disallow legitimate prescriptions and create conditions leading to the under treatment of pain.”

Rather than set up a new regulatory standard for plan sponsors, AMA urges CMS to “work with MA and Part D sponsors to partner with all of the state-based prescription drug monitoring programs (PDMP) in order to share prescribing information. We have strongly supported congressional and Administration efforts to increase funding for the adoption of PDMPs as well as for upgrades that provide real time access to physicians at the point of care.”

“Another effective strategy for addressing the information gap would be to require prescription drug plans to provide a copy of a patient’s explanation of benefits (EOB) to all of the physicians who have prescribed for the beneficiary. Prescription drug plans currently do not share any data or drug claims information with a patient’s prescribing physicians. This would have the added benefit of increasing adherence/compliance and flag medication reconciliation needs or potential doctor shopping.”

“The AMA strongly agrees that combating potential prescription drug abuse and/or diversion is a pressing national priority.” They just don’t think CMS’ approach is the right way to do it.

Typical of Unsettled Alignments

That sentiment is probably shared by every stakeholder in the distribution system: no one disagrees with the idea that prescription drug abuse is a problem that requires urgent action by everyone in the health care system. But everyone also has a problem with at least one specific solution that has been proposed or implemented so far.

That theme was amply demonstrated during the March 1 subcommittee hearing.

Take the testimony of Health Care Distribution Management Association CEO John Gray. As with the other witnesses, “HDMA strongly believes that the healthcare industry as a whole, the government and all supply chain stakeholders—doctors, pharmacists, distributors and manufacturers—must work collaboratively to effectively detect and fight prescription drug abuse and diversion.” He went on to highlight efforts by the industry to combat the problem and declared that preventing Rx abuse is in keeping with the wholesalers’ mission “to operate the safest and most secure and efficient supply chain in the world.”

However, “despite the efforts of our industry, we find ourselves in a conundrum,” Gray said. “Distributors are often held accountable, with incomplete information, for diversion from parts of the supply chain they do not control.”

“Pharmaceutical distributors do not manufacture controlled substances. We do not license pharmacies or health care providers. We do not write prescriptions for patients. We do not ‘dispense’ products to patients. We do not see the prescription a patient presents at a pharmacy for filling. A single pharmaceutical distributor does not know—and has no way of knowing—if a pharmacy customer is purchasing prescription drugs for another distributor.”

And yet, DEA can and will act against wholesalers for shipments that appear to be excessive—as Cardinal Health Inc. learned in February when the enforcement agency sought to shut down its Lakeland, Florida distribution center based on DEA’s concerns that the facility was supplying “pill mills” in the state. (DEA’s injunction request is on hold as the company fights the shutdown order in court.)

That issue, no doubt, explains why HDMA sent its current head to testify, while the trade associations were content to let more junior staff participate in the March 1 hearing.

Gray urged that DEA recognize that prescription drug abuse is not the same as illegal drug use, and “requires a different mindset” to resolve. Specifically, the agency should balance the need to assure access against the need to cut off diversion and abuse, and therefore apply “proportionate enforcement…for distributors who have implemented anti-diversion controls.”

Last but not least, HDMA wants DEA to share more information with wholesalers about areas of concern to help distributors prevent diversion.

So, while pharmacists and other stakeholders raised concerns about the REMS with FDA, and AMA is concerned about CMS’ efforts to take on prescription abuse, HDMA has a bone to pick with DEA. The one common point is that all agree that they should not be singled out for regulation to combat abuse—not when it is a problem that requires action by all stakeholders.

Legislation Likely on Certification

For now, the objections and implicit finger-pointing among stakeholders doesn’t seem to be deflecting a path towards relatively modest legislation. In fact, it may be helping: the reactions by various trade groups underscore the message from the Obama Administration that it is serious about tackling prescription drug abuse, and the various regulatory actions are evidence of that.

Subcommittee Chair Mary Bono-Mack (R-Calif.) seems to be on board with legislation that focuses on enhancing the DEA certification process for physicians, a step that aligns well with the FDA REMS plan in particular.

That is a far cry from some of the ideas she suggested during a 2011 hearing, where she said the simplest solution would be for DEA to cut production quotas for oxycodone and other highly abused drugs. (Also see "Controlling Opioids: REMS Meets Congressional Resistance" - Pink Sheet, 1 Jun, 2011.)

But it is also clear that Bono-Mack isn’t convinced that the certification change will go far enough.

She described the proposed legislation as a “good starting point,” but also made clear that enhanced education won’t matter unless it leads to change in practice.

“Like anyone in recovery knows, we have to admit we have a serious problem.” Bono-Mack said. “Americans today simply are prescribed too many medicines.” Or, as she put it immediately after listening to the industry panelists: "I'm frustrated anytime I hear denial. There's plenty of blame to go around. Donald Trump would say, ‘You're fired."

That statement underscores why all the parties in the pharmaceutical distribution chain really do have a shared stake in finding a solution to prescription abuse—and should be a warning of the consequences of the finger-pointing gets out of hand.