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H.R.4697

Prevent Drug Addiction Act of 2016

This bill, sponsored by Elizabeth Esty [D-CT-5], was introduced 3/3/16 and referred to the Committee on Energy and Commerce, Ways and Means, Judiciary and Subcommittee on Crime, Terrorism, Homeland Security, and Investigations. Cosponsors are Ryan Costello [R-PA-6], Stephen Knight [R-CA-25] and Joe Courtney [D-CT-2].  Related bills are S.1431 (Prescription Drug Abuse Prevention and Treatment Act of 2015 and S.1913 (Stopping Medication Abuse and Protecting Seniors Act of 2015.

For personal opinion on this bill, please see the post “H.R.4697 The Worst Bill So Far”.

Purpose:  To provide for increased Federal oversight of prescription opioid treatment and assistance to States in reducing opioid addiction, diversion, and deaths.

SEC. 2. Consumer education campaign.

Amends Part A of title V of the Public Health Service Act (42 U.S.C. 290aa et seq.) by adding at the end the following:

(a) Grants to States and nonprofit entities for consumer education about opioid addiction, including methadone addiction. Such education shall include information on the dangers of opioid addiction, how to prevent opioid addiction including through safe disposal of prescription medications and other safety precautions, and detection of early warning signs of addiction. $15,000,000 for each of fiscal years 2017 through 2021is authorized to be appropriated to carry out this section.

SEC. 3. Practitioner education.

Education requirements—amends Section 303(f) of the Controlled Substances Act (21 U.S.C. 823(f)) by adding to the list of actions “against public interest and safety” if the practitioner has not had the training requirements. Additional training is added to Section 303(g) for those practitioners involved in the dispensing of opioids in maintenance or detoxification treatments or opioid treatment programs. Funding for the enforcement of these requirements is specified as coming from the licensing fees paid by prescribers.

SEC. 4. Operation of opioid treatment programs.

Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended by adding that a registered opioid treatment program must provide to restricted patients a “take-home dose of a controlled substance related to the treatment involved, to receive a dose of that substance under appropriate supervision” when the office is closed.

SEC. 5. Mortality reporting.

Part A of title V of the Public Health Service Act (42 U.S.C. 290aa et seq.), as amended by section 3, is further amended by adding at the end the following:

SEC. 506D. Mortality reporting.

A Model Opioid Treatment Program Mortality Report shall be completed and submitted to the Administrator for each individual who dies while receiving treatment in an opioid treatment program.

This bill also requires states to submit a form for every individual who signs a death certificate where an opioid is detected in the body.

From this information the Administrator will develop a Model Opioid Treatment Program Mortality Report. This will then feed into the National Opioid Death Registry to track opioid-related deaths and information related to such deaths. The registry shall be designed as a uniform reporting system for opioid-related deaths and shall require the reporting of information with respect to such deaths, including—

“(A) the particular drug formulation used at the time of death;

“(B) the dosage level;

“(C) a description of the circumstances surrounding the death in relation to the recommended dosage involved;

“(D) a disclosure of whether the medication involved can be traced back to a physician’s prescription;

“(E) a disclosure of whether the individual was in an opioid treatment program at the time of death;

“(F) the age and sex of the individual.

SEC. 6. Development of prescription drug addiction prevention and treatment quality measures across each relevant provider setting.

Amends Subpart I of part D of title IX of the Public Health Service Act (42 U.S.C. 299b–31 et seq.). Quality measures may be structure-oriented (such as the required presence of a hospital-based treatment program), process-oriented (such as requiring patients to be informed of the addictive qualities of the medication being prescribed), or outcome-oriented (such as assessing family satisfaction with care).”

SEC. 7. Programs to prevent prescription drug addiction under Medicare part D.

Amends Section 1860D–4(c) of the Social Security Act (42 U.S.C. 1395w–10(c)). This gives authority for limiting a beneficiary’s access to coverage for addictive drugs to the Prescription Drug Program Sponsor.  The PDP Sponsor has authority to 1) identify beneficiaries that are “at-risk” for prescription drug addiction. 2) select the provider for the beneficiary 3) select the pharmacy for the beneficiary. The PDP Sponsor is supposed to ensure reasonable access.

(5) UTILIZATION MANAGEMENT TOOL TO PREVENT DRUG ADDICTION—designed to prevent addiction and diversion of drugs at pharmacies.

This provides for a retrospective utilization review in Medicare to identify individuals that receive addictive drugs at a frequency or in amounts that are not clinically appropriate; and providers of services or suppliers that may facilitate the addiction to or diversion of addictive drugs by beneficiaries.

And finally, the standard reports of what they’ve achieved follow a year later.

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