A federal plan calling for Medicare Advantage Part D sponsors to deny potentially unsafe pain drugs such as hydrocodone and oxycodone—perhaps to patients who may be "doctor shopping"—has incurred strong objection from the American Medical Association.
The 131-page "advance notice" from the Centers for Medicare and Medicaid Services, which would take effect Jan. 1, 2013, calls for Part D sponsors to employ more effective ongoing and retrospective drug utilization reviews, or layers of formulary management, for each of their enrollees. The goal is to protect them from receiving harmful quantities of any drug, as well as minimize overutilization.
CMS says that overdoses of such drugs can occur when patients get prescriptions for the same or similar opioids from multiple physicians. Drugs that contain the same potentially harmful ingredient, such as acetamenophen, may become harmful, as doses would accumulate in the patient, the letter says.
"We believe that if point-of-sale (POS) safety edits, such as "therapeutic duplication," "maximum dose exceeded," "refill too soon," or quantity limits (QLs) were appropriately implemented, such egregious overutilization can be averted," the agency said. The new policy is outlined in CMS's "Advance Notice of Methodological Changes for Calendar Year (CY) 2013 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2013 Call Letter," published February 17.
But the AMA vehemently objects, saying the policy would empower health plans to overrule doctors' medical decisions, thus preventing patients from getting drugs for pain and other conditions they legitimately need.
The policy "will engender significant confusion when beneficiaries pick up prescriptions and (are) informed that their insurance plans have denied coverage," AMA executive vice president James L. Madara, MD wrote in a March 2 letter to Medicare Director Jonathan Blum.
"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," Madara wrote.
But the CMS document says that Part D drug plan sponsors "are in a unique position to evaluate medication overutilization" because 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," Madara wrote, "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. 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."
Madara wrote that CMS should "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 (Part D drug plan) sponsors."
CMS, however, said its policy change was in part in response to a report last September from the Government Accountability Office.
That report detailed "egregious overutilization of medications from Part D beneficiaries who were obtaining medications from a minimum of five different prescribers and a maximum of fifty prescribers, with the vast majority of beneficiaries receiving medications from between five and ten providers.
The medications most often identified as being potentially overprescribed were hydrocodone containing products (e.g., Vicodin and Lortab ) followed distantly by oxycodone containing products (e.g., Percocet and Oxycontin)."
Madara says the AMA strongly agrees with the need for combating prescription drug abuse and diversion. But he says the new policy's pitfalls would be compounded when a Part D drug plan is allowed to restrict access to other drugs as well. "This is especially troubling when the population of patients impacted will be elderly, more likely to be medically fragile, and less likely to be equipped to navigate the already bewildering array of Part D sponsor and pharmacy practices, policies, and requirements."
Besides, he wrote, 80% of the drug safety problem under discussion deals with just two types of drugs, oxycodone and hydrocodone.
But the lengthy CMS policy letter explains with an actual case how unsafe drug prescription policies in place today can elude checks in the current system.
"A beneficiary is receiving care from 13 different physicians over the course of one year. Nine of these providers are writing for controlled substances. The patient is receiving methadone 30mg/day from one provider routinely each month, while receiving oxycodone SR 80mg three tablets/day routinely each month from another provider.
"Neither provider prescribes the other prescriber’s medication, so it is conceivable that they are each unaware the patient is on both of these Schedule II controlled substances, which must be rewritten each month.
"In addition, the patient is receiving #90 Hydrocodone, 10mg/acetaminophen 650mg each month from a different provider with five refills while receiving #90 Hydrocodone 7.5mg/acetaminophen 750mg also with five refills within one week from a different provider. The patient appears to be taking 4.2 gm of acetaminophen per day which is over the FDA maximum recommended dose due to risk of hepatic toxicity."
Not only was the patient using multiple prescribers for multiple substances, the letter said, but because each product was within the FDA maximal dosing limit so normal formulary management tools would not be triggered.
The CMS letter discusses other issues with current Part D drug plan distribution practices:
- Patterns of scheduled maintenance opioid therapy (both long and short duration medications) that repeat from month to month, from different providers, need to be investigated to ensure patient safety and prevent overutilization.
- Schedule III narcotics, unlike Schedule II narcotics, are not required to be rewritten each month allowing up to five refills and can more easily pose a threat of recurrent overprescribing—daily acetaminophen exposure can be dangerous, and the intent of each prescriber above was to provide a lower quantity of a hydrocodone/acetaminophen containing product, and to that end, a limited quantity of opioid exposure.
- The FDA daily maximum dose of 4gm of acetaminophen across all scheduled substances should be implemented by plans, and
- Sponsors should develop effective DUR programs, which include case management, outreach to providers, and if necessary, beneficiary-level controls to prevent overutilization of opioid therapy and ensure beneficiary safety.