The Centers for Medicare & Medicaid Services' latest proposals to curb the overuse of painkillers could have a lot of unintended consequences, hospice and palliative care advocates are warning.
With opioid and heroin addiction problems plaguing many states, CMS wants to increase its oversight in Medicare Part D "remove consistently poor performers" from the program, such as one Florida physician who Medicare's Inspector General flagged in 2009 for prescribing a two-year supply of morphine and oxycodone for just one patient.
Under the new proposal, physicians or health professionals eligible to prescribe under state law would have to be certified by Medicare to write Part D prescriptions. Starting in 2015, Part D sponsors or their pharmacy benefit managers would be instructed to deny a pharmacy claim if it does not contain a professional's national Medicare provider identifier or if the professional does not have an opt-out affidavit.
That type of certification could help prevent fraudulent prescribing by empowering Part D plans. But palliative care advocates are worried that additional proposals could end up cutting off painkiller access for patients with serious illnesses, such as those with cancer relying on opioids for pain management.
CMS is proposing new criteria for revoking or suspending health professionals' Part D prescribing rights, including prescriptions of controlled substances in "excessive dosages" or "for indications that were not medically accepted."
Those criteria, though, could cast an overly broad net and end up disenfranchising practitioners writing legitimate prescriptions, as Hillary Lum, MD, a University of Colorado geriatrics professor, wrote to geriatric, palliative and primary care providers.
For instance, Lum wrote, a rural primary care doctor who serves as the medical director for a region's only hospice provider could interpret the rule and decide that s/he can't prescribe for patients who s/he hasn't seen and who can't come into an office. That could lead to "an entire region without access to appropriate palliative care."
Physicians could be subject to Part D revocation if a coroner examining a recently deceased cancer patient who was taking high-dose opioids ends up mislabeling the case as an overdose, Lum wrote.
Another gray area, Lum said, stems from evolving evidence and disagreements among practitioners for when painkillers or other palliative treatments are "medically accepted" -- such as in the case of dyspnea, shortness of breath. Some clinicians or Medicare reviewers might flag opioid prescriptions for dyspnea as inappropriate, but according to Lum and others, there's increasing evidence of benefits for offering opioids to patients with shortness of breath who have COPD, congestive heart failure, cancer or terminal illness.
Lum and other palliative practitioners are hoping to convince CMS regulators to adjust the proposed rules to avoid situations that could be punitive to some providers or end up limiting patient access to drugs for pain management. CMS's latest bid to curtail prescription drug abuse and prescribing fraud comes as the palliative and hospice movements are gaining more traction, especially in trying to bring end-of-life care out of the hospital setting.
One change to CMS's proposal that palliative advocates want to see is a way to appeal suspension and revocation decisions. The "proposed regulations lack a description of any form of due process by which providers would be able to describe the validity of their prescribing practice," Lum noted.