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HHS Eases Buprenorphine Prescribing

— New rule raises cap on number of patients physicians can treat

MedpageToday

WASHINGTON -- The Obama administration announced a new rule that could lower the death toll from opioid overdoses, but the changes will be mostly meaningless without additional funding, officials said.

The Department of Health and Human Services (HHS) officially raised the limit on the number of individuals for whom prescribers can order medication assisted treatment (MAT), specifically buprenorphine, from 100 to 275.

"In the absence of congressional action, we're taking every step forward that we can," said HHS Secretary , referring to the stalemate in Congress over appropriating adequate funding for opioids.

Burwell announced the final rule alongside other key leaders in the administration during a press call Tuesday afternoon.

She also announced a Request for Information soliciting public comments about current HHS prescriber education and training programs and seeking new proposals; and spoke of plans to launch a dozen studies aimed at understanding opioid abuse and pain management. Burwell will be speaking with governors about the epidemic late next week, she said.

More than 28,000 Americans died from opioid overdoses in 2014.

The White House announced plans in February to spend $1.1 billion to alleviate the opioid crisis, but Congress has yet to make the needed appropriations.

"These funds would help make sure that everyone with an opioid disorder who wants treatment can get treatment," Burwell said.

HHS's Office of the Assistant Secretary for Planning and Evaluation (ASPE) anticipates that between 500 and 1,800 providers will request to increase the patient limit on buprenorphine in the rule's first year. If each of these prescriber increases his or her load by about 20-50 patients, the overall increase in patients receiving buprenorphine could range from 10,000 to 90,000 in the first year, said , ASPE's science policy director.

Jones estimates that the new rule could allow between 2,000 and 15,000 new patients access to buprenorphine in later years.

In 2014, approximately 600-700, 000 of the roughly 1 million Americans who received some type of medication assisted treatment, were prescribed buprenorphine, he said.

Botticelli noted that the increase in the patient cap is coupled with other changes included in the President's budget request including increasing the number of providers who can prescribe buprenorphine and deploying them to areas where they're needed most.

Congress has busied itself writing more than a dozen new bills, including the (CARA). However, none of these bills comes close to providing the $1.1 billion investment promised by the White House.

A House-Senate conference committee is to take up the CARA bill this week. The Republican draft conference report doesn't include the President's request, according to the administration. However, all of the Democratic conferees have requesting $920 million in funding, to be offset with reductions in "overpayment for certain Part B infusion drugs" and durable medical equipment.

The administration said many of the CARA provisions mirror its own priorities. But without substantial funding, "they are really insufficient to make a dent in providing treatment for people who desperately need it," said , director of National Drug Control Policy, on Tuesday's call.

Botticelli also said that Congressional Democrats will not back a bill unless it has a "significant infusion of resources." In response to questions about whether President Obama would veto such a bill, Botticelli called any speculations "premature."

Asked whether Congress could be expected to take action on opioids when it continues to delay funding the Zika virus, Botticelli said opioids is "top of the list" of urgent health priorities.

"I think it's very hard to walk away from the fact that there are 129 people dying every single day of an opioid overdose, many of those folks who could have been prevented [from dying] by receiving timely access to treatment."

In addition to raising the patient limit for qualified providers, the new HHS rule removes pain management questions from the scoring of the survey; and expands access to resources to help prescribers make safe decisions.

Burwell said that while there is little data to support a connection between survey questions and prescriber behavior, the changes to the survey scoring were made due to "an abundance of caution." The questions will remain so that pain management data can continue to be explored.

The rule is slated to take effect on Aug. 5, 2016.

The administration also announced a series of additional steps addressing opioids, such as requiring physicians in VA facilities and the Indian Health Services to check their Prescription Drug Monitoring Programs (PDMPs) before prescribing or dispensing the medication for more than 7 days.