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  1. R. 4697 “Prevent Drug Addiction Act of 2016” danger-fi325x

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.

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

The purpose says it all without even reading the particulars. Prescription opioid treatment should be in the hands of physicians, not the Federal government. The end product of a bill like this will be for the Justice Department to use it to attack more doctors and bring opioid management of pain to an end. Also, with the short title “Prevent Drug Addiction Act of 2016”  and with a purpose such as this—to oversee prescription treatment—you can see where the thoughts of the government are—that prescription opioids cause drug abuse.  Bottom line:  THEY DON’T. We have to get government officials to see that.  Please refer anyone to my explanation of the cause of drug abuse that you can find on my page Need Healing From Drug Abuse located on my website

But I will proceed with summarizing the text of the bill to speak to any particular problems I see there.

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 providing 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.

I have no problem with education or training of practitioners involved in the prescribing of controlled substances. In general, medical schools in the past did not teach anything about pain management. So for doctors trying to take care of their patients, we have to depend on CME (continued medical education).  But that is required already by State Medical Boards. It is at the state level that these requirements should be made, and enforced. It should not be criminal to not take a course.

The problem here is that the DEA has already taken more jurisdiction in determining what is “against public interest and safety”. They don’t even pay attention to the list of requirements. My re-certification in 2011 was deemed by Judge Wing at my Administrative Hearing to be “against public health and safety” when he decided to not re-issue it. But none of the listed requirements on the CSA were met for him to make that decision. This requirement of training simply gives the DEA another method to withhold certification from a legitimate doctor. It is basically a way to strong-arm the entire profession to not prescribe opiates because without a DEA certification a doctor will not be accepted by most commercial insurance companies to take care of their patients.

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.

Now supposedly the Administrator of the Substance Abuse and Mental Health Services Administration will provide references on what “acceptable arrangements” would be. But in my opinion, this again is a window opened by the legislature for the Justice Department to attack doctors involved in opioid treatment programs.

Throughout the last 20 years, doctors have been held responsible for what patients do outside of their control. This bill will hold the doctor criminally responsible for what patients do with their “take-home” doses. This is just another way to attack doctors.

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 requiring that 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.

Will they use this against doctors to charge more with criminal activity for patient deaths? As long as the prescription is written appropriately, the doctor should not be held responsible if the patient uses the medication in other ways.  What we need are laws that completely exempt the doctor from being charged criminally using the CSA. We have come far afield from the original intentions of Congress when that bill was written.

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.

In my opinion, this report will be used primarily for propaganda purposes, to skew the data of cause of death. There will be a lot of legitimate people dying of standard cause that should have opioids in their system. To say that they will see if the medication can be traced back to a physician’s prescription means that they would use this to prosecute.  Does that mean the end of opioids for hospice care? What doctor would not be scared of this type of setup for criminal charges?

One medication, methadone, is specifically targeted in the report on mortality. At least they are aware that methadone is becoming more and more involved in accidental and intentional drug-related suicide. But that is the fault of the government. When legitimate pain patients are forced to the street to self-treat, they often reach for methadone. But methadone is a long-acting medication and has to be dosed several days to see an effect. So an uninformed person would take a pill, see no effect, take another, and do that several times. Then they overdose and die without even knowing what they’ve done. That is not the doctor’s fault. Face it—the increase in drug addiction and death is the fault of the government through the attacks on legitimate pain management physicians.  If they want to see change for the better, EXEMPT physicians from the CSA completely, as originally intended. Then pain management can go back to the doctor’s office and get off of the street.

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).”

Again, making general procedure in a doctor’s office possibly criminal will simply prevent doctors from acting in the best interest of the patient. They simply won’t get involved in the treatment. That is possibly the reasoning behind the making of these laws—cut out the doctor because of all the red tape.

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.

I’m not sure who the PDP Sponsor is, but from reading the Bill, it would appear to be a person in Medicare who approves or disapproves the prescription request. This 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.

A “Utilization Management Tool to Prevent Drug Addiction, designed to prevent addiction and diversion of drugs at pharmacies, 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.

This whole section on Medicare tightens the screws to Medicare patients receiving appropriate care for pain. People can be identified by someone in an agency and declared “at-risk”. The criteria they will probably use to determine this is simply life as we know it today—frequent physician change looking for treatment, pharmacy hopping because you can’t get your prescription filled, etc. It looks like they simply want to label pain patients as addicts. Nowhere in this section is there any input from the actual physician.

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

My original estimation of the purpose and mechanics of this bill is, I’m afraid to say, correct.