SCR169

A Concurrent Resolution urging the President and Congress of the United States and the Department of Health and Human Services to ease patient limits applicable to private physicians who prescribe buprenorphine.

Whereas, In the current legal environment, it can be harder for opioid addicts to get the medication they need to treat their addiction than it is for them to get the drugs that feed it; and

Whereas, Buprenorphine is an oral opioid agonist medication, which is categorized as a Schedule III controlled dangerous substance (CDS), and is used in medication-assisted substance use disorder treatment as an effective means to wean opioid dependent people off of more dangerous and addictive opioid drugs, including prescription painkillers such as OxyContin, Percocet, and Vicodin, and more illicit opioid drugs such as heroin and fentanyl, without the detrimental side effects of withdrawal; and

Whereas, The federal Department of Health and Human Services (DHHS) has recognized that buprenorphine is less toxic than methadone and is significantly less likely than other CDS to lead to abuse, overdose, or physical or mental damage; and

Whereas, Clinical studies show that the use of buprenorphine effectively lowers the risk of a fatal opioid overdose, more than doubles the chance that an opioid dependent person will stay in recovery and avoid a relapse, and offers a far greater chance of recovery from addiction than treatments that do not involve medication, such as 12-step programs or residential stays; and

Whereas, While more than 900,000 U.S. physicians (nearly all physicians in the country) are authorized to prescribe addictive opioid painkillers, fewer than 32,000 physicians are authorized to prescribe buprenorphine to people who have become addicted to opioid drugs; and

Whereas, Pursuant to section 303(g) of the federal “Controlled Substances Act” (21 U.S.C. 823(g)), as amended by the “Drug Addiction Treatment Act of 2000” (DATA 2000), Pub.L.106-310, in order for a private physician to prescribe buprenorphine outside of a formal Opioid Treatment Program (OTP), the physician must obtain a federal waiver from the registration requirements that are applicable to OTPs under the “Narcotic Addict Treatment Act of 1974,” Pub.L.93-281; and

Whereas, Any physician who obtains a DATA 2000 waiver is prohibited by statute from prescribing buprenorphine to more than 30 patients at any one time; however, the law authorizes the DHHS to change this patient limit at any time, through regulation; and

Whereas, Pursuant to DHHS regulation, any private physician who wishes to prescribe buprenorphine to more than 30 patients at a time will be authorized to do so only if the physician waits a full year after the initial DATA 2000 waiver is approved, and then applies for and obtains a second federal waiver authorizing the prescription of buprenorphine to up to 100 patients at a time; and

Whereas, On August 8, 2016, DHHS adopted a new rule, which raised to 275 the maximum number of patients that an authorized physician may treat with buprenorphine at any one time, but this higher patient limit will only be applicable if: the physician has already utilized, for a full year, a federal waiver authorizing the treatment of 100 patients with buprenorphine; the physician has obtained advanced credentialing in addiction medicine or psychiatry, or practices in a qualified practice setting; and the physician applies for and obtains a separate federal waiver authorizing the expansion of the patient limit up to 275 patients; and

Whereas, Even when a physician has successfully obtained a waiver of the 100 patient limit, the waiver is not permanent, and the physician will be required to undergo the same waiver request and approval process every three years thereafter, if the physician wishes to maintain the authorization necessary to continue to provide buprenorphine treatment to up to 275 patients at a time; and

Whereas, Because federal law restricts the number of patients who may be treated with buprenorphine, only 49 percent of opioid dependent people in the United States, and slightly more than 50 percent of opioid dependent people in New Jersey, are currently able to access the buprenorphine treatment they need; and

Whereas, As noted by the American Society of Addiction Medicine, there is no other disease in America, other than opioid addiction, for which medical treatment is subject to a federally-established patient limit; and

Whereas, Although patient limits were established in this area to prevent the creation of pill mills and the diversion of buprenorphine for unlawful purposes, researchers have now concluded that any threat of buprenorphine diversion is minor compared to the lifesaving potential of the drug, and this finding has been used by the DHHS as a basis upon which to support the relaxation of other federal restrictions applicable to buprenorphine; and

Whereas, The current federal laws and regulations restricting the number of patients to whom buprenorphine may be prescribed by a private physician are anachronistic holdovers that evidence the nation’s long-standing prejudice against the disease of addiction, and that fail to reflect the current body of knowledge about buprenorphine and its positive effects, while unfairly singling out addicts and the doctors who treat them and preventing many opioid dependent persons from obtaining the medicine they need to overcome their addictions; now, therefore,

Be It Resolved by the Senate of the State of New Jersey (the General Assembly concurring):

1. The President and the Congress of the United States are respectfully memorialized to enact legislation to eliminate the statutorily established patient limit that is applicable, under the provisions of the “Drug Addiction Treatment Act of 2000,” Pub.L.106-310, to private physicians who prescribe buprenorphine to patients outside of a formal Opioid Treatment Program.

2. The Secretary of the Department of Health and Human Services is respectfully requested to take appropriate regulatory action to eliminate the regulatory waiver requirements that must currently be satisfied in order for a physician to prescribe buprenorphine to more than 30 patients at a time; and to liberally expand the patient limit beyond the current statutory and regulatory maximums, as may be necessary to ensure that all opioid dependent persons are able to receive the medication they need.

3. A copy of this resolution, as filed with the Secretary of State, shall be transmitted by the Clerk of the General Assembly or the Secretary of the Senate to the President and Vice-President of the United States, the Majority and Minority Leaders of the United States Senate, the Speaker and Minority Leader of the United States House of Representatives, the Secretary of the Department of Health and Human Services, and every member of Congress elected from this State.

STATEMENT

This concurrent resolution respectfully urges the President and Congress of the United States and the Department of Health and Human Services (DHHS) to ease patient limits that are applicable to physicians who prescribe buprenorphine outside of a formal Opioid Treatment Program (“private physicians”).

The federal “Controlled Substances Act,” as amended by the “Drug Addiction Treatment Act of 2000” (DATA 2000), Pub.L.106-310, currently limits to 30 the number of patients who may be treated by a private physician with buprenorphine at any one time. However, the law authorizes the DHHS to change this patient limit, through regulation, as it deems appropriate. In implementing DATA 2000, the DHHS has established regulatory processes pursuant to which the statutorily-established 30 patient limit may be waived, and the patient limit increased. However, these waiver processes are burdensome and repetitive, and even after all relevant waivers have been secured, the maximum number of patients that a private physician will be able to treat at one time with buprenorphine is 275 patients. A private physician must also take action, every three years, to renew the waiver that authorizes the physician to prescribe buprenorphine to this maximum number of patients.

Because federal law restricts the number of patients who may be treated with buprenorphine, only 49 percent of opioid dependent people in the United States, and slightly more than 50 percent of opioid dependent people in New Jersey, are currently able to access the buprenorphine treatment they need. As noted by the American Society of Addiction Medicine, moreover, there is no other disease in America, other than opioid addiction, for which medical treatment is subject to a federally-established patient limit.

Although patient limits were established in this area to prevent the creation of pill mills and the diversion of buprenorphine for unlawful purposes, researchers have now concluded that any threat of buprenorphine diversion is minor compared to the lifesaving potential of the drug. This finding, moreover, has been used by the DHHS to support the agency’s relaxation of other federal restrictions applicable to buprenorphine.

Because the current patient limits associated with buprenorphine are anachronistic holdovers that fail to reflect the current body of knowledge about buprenorphine and its positive effects, and that prevent many opioid dependent persons from obtaining the medicine they need, this resolution urges the federal government to take both legislative and regulatory action, as appropriate, to either fully eliminate or liberally expand these patient limits, so as to ensure that all opioid dependent persons are able to receive the medication-assisted treatment they need.