Fighting opioid abuse, lowering drug prices, deregulation are goals of Medicare Part D rule

Several changes to Medicare Advantage and Medicare Part D prescription drug plans have been included in a proposed rule by CMS in an effort to fight opioid abuse among seniors while taking another step towards reducing regulations.

Much of the regulation dealt with implementation of 2016’s Comprehensive Addiction and Recovery Act (CARA). CMS is required under that law to come up with a framework for Part D sponsors to voluntarily implement a drug management program that limits “at risk” beneficiaries’ ability to receive substances the agency determines are “frequently abused.” Opioids would have that designation beginning in 2019.

In other opioid-related changes under the proposed rule, CMS would:

• Tie the definition of at-risk beneficiaries to the criteria used to identify potential opioid overutilizers under CMS’s existing Part D Opioid Drug Utilization Review (DUR) Policy and Overutilization Monitoring System (OMS).
• Allow a plan to limit an at-risk beneficiary’s access to opioids to a selected prescriber(s) and/or network pharmacy(ies).
• Limit the availability of the special enrollment period (SEP) for dually- or other low income subsidy (LIS)-eligible beneficiaries who are identified as at-risk or potentially at-risk for prescription drug abuse under such a drug management program.

“The President has been committed to lowering drug prices for seniors and fighting the opioid epidemic,” CMS said in a press release. “In response, CMS is working to lower drug prices by removing administrative hurdles to offer lower cost options to seniors on Medicare, as well as supporting private sector partners by providing them a much needed tool in the fight to end the opioid epidemic.”

Among the hurdles CMS proposed to remove were allowing mid-year changes to drug formularies. Under the proposed rule, plans would be able to replace brand name drugs with a new generic if it becomes available and is found to be clinically appropriate. Enrollees would have to advise that such changes to formularies can be made without a specific advance notice and there would be requirements for “protections” for people who need to continue taking the brand name drug.

The changes included in the rule would save Medicare an estimated $195 million annually between 2019 and 2013, according to CMS.

The proposed rule also contain several requests for information on future policy changes, such as “ applying some manufacturer rebates and all pharmacy price concessions to the price of a drug at the point of sale.” This drew quick reaction from the Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers.

“Requiring plans to estimate and apply manufacturer rebates at the point-of-sale would raise premiums by up to $28 billion and taxpayer costs by up to $82 billion over the next decade,” PCMA said in a press release. “Such a requirement would also create a windfall for drugmakers, who would pay up to $29 billion less in donut-hole discounts.”

Comments on the proposed rule will be accept through Jan. 28, 2018.