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Summary: Major components of the HHS final rule. Effective August 8, 2016.

by ASAM Staff | July 6, 2016

On July 6, 2016, the Department of Health and Human Services (HHS) released a final rule to increase access to medication-assisted treatment with buprenorphine products in the office setting by allowing eligible practitioners to request approval to treat up to 275 patients. The final rule also includes requirements to ensure that patients treated by these practitioners receive high-quality care, and that aim to minimize the risk of diversion. Below is a summary of the major components of the final rule, which will be effective on August 8, 2016.

Please send additional questions about the final rule to ASAM’s advocacy team at advocacy@asam.org. We will compile member questions to share with HHS as they seek to educate prescribers on the rule’s implementation.

Eligible Practitioners

To be eligible for a patient limit increase to 275, a physician must possess a current waiver to treat up to 100 patients, must have maintained that waiver without interruption for at least one year, and meet one of the following requirements:

  1. Hold “additional credentialing,” meaning board certification in addiction medicine or addiction psychiatry by the American Board of Addiction Medicine (ABAM) or the American Board of Medical Specialties (ABMS) or certification by the American Osteopathic Academy of Addiction Medicine, ABAM or ASAM; or
  2. Practice in a “qualified practice setting,” meaning a practice that:
    1. Provides professional coverage for patient medical emergencies during hours when the practitioner’s practice is closed;
    2. Provides access to case-management services for patients including referral and follow-up services for programs that provide, or financially support, the provision of services such as medical, behavioral, social, housing, employment, educational, or other related services;
    3. Uses health information technology (health IT) systems such as electronic health records, if otherwise required to use these systems in the practice setting. Health IT means the electronic systems that health care professionals and patients use to store, share, and analyze health information;
    4. Is registered for their State prescription drug monitoring program (PDMP) where operational and in accordance with Federal and State law.
    5. Accepts third-party payment for costs in providing health services, including written billing, credit, and collection policies and procedures, or Federal health benefits.

Additionally, practitioners may not have had Medicare enrollment and billing privileges revoked under 42 CFR 424.535 nor have been found to have violated the Controlled Substances Act pursuant to 21 U.S.C. 824(a) to be eligible for the higher limit. 

Other Practitioners

The rule does not extend prescribing authority to clinicians other than physicians as the original DATA 2000 statute limits the practitioners eligible for the waiver to physicians. As such, HHS does not have the authority to extend prescribing privileges to other clinicians.

Process to Request a Patient Limit of 275

Eligible physicians wishing to treat up to 275 patients may request to do so by filling out a Request for Patient Limit Increase form. This form is under final review by the federal government and will be available soon.

The form will require physicians to attest that they meet the eligibility requirements and will be able to meet the additional responsibilities for behavioral health services, care coordination, diversion control, and continuity of care in emergencies and for transfer of care in the event that they do not request renewal of the higher patient limit or their renewal request is denied.

Physicians must reaffirm their eligibility every three years by submitting a renewal Request for Patient Limit Increase form at least 90 days before the end of the waiver period. HHS has pledged to work with DEA to synchronize the waiver renewal process with the renewal of a physician’s DEA registration.

SAMHSA will approve or deny a Request for Patient Limit Increase within 45 days.

New Formulations

In the proposed rule, HHS proposed that the Secretary would establish a process by which patients who are treated with medications subject to the patient limit that have features that enhance safety or reduce diversion, as determined by the Secretary, may be counted differently toward the limit. In the final rule, HHS determined that all patients treated with medications subject to the patient limit, including new formulations, will be counted against the patient limit in the same manner. HHS may choose to revisit this issue in the future.

Counting Patients

The final rule defines a “patient” as any individual who is dispensed or prescribed covered medications by a practitioner. For example, if a practitioner provides cross-coverage for another practitioner and in the course of that coverage the covering practitioner provides a prescription for buprenorphine, the patient counts towards the cross-covering practitioner’s patient limit until the prescription or medication has expired. However, if a cross-covering practitioner is merely available for consult but does not dispense or prescribe buprenorphine while the prescribing practitioner is away, the patients being covered do not count towards the cross-covering practitioner’s patient limit.

Reporting Requirements

The proposed rule had included proposed reporting requirements for physicians treating more than 100 patients to demonstrate they were providing appropriate psychosocial interventions, abiding by recommended diversion control protocols, and otherwise providing high-quality care. Due to public comments, including ASAM’s, that the proposed reporting requirements were not structured in a way that would meet their stated ends, SAMHSA decided to delay the finalization of the reporting requirements, and has issued a Supplemental Notice of Proposed Rulemaking to solicit additional comments on the proposed reporting requirements prior to finalizing them. ASAM will submit and share comments on the proposed reporting requirements.

Emergency Situations

Physicians with a current waiver to prescribe up to 100 patients and who are not otherwise eligible to treat up to 275 patients may request a temporary (not longer than 6 months) increase to treat up to 275 patients in order to address emergency situations. An “emergency situation” is defined as a situation in which an existing State, tribal, or local system for substance use disorder services is overwhelmed or unable to meet the existing need for medication-assisted treatment as a direct consequence of a clear precipitating event. The precipitating event must have an abrupt onset, such as practitioner incapacity; natural or human-caused disaster; an outbreak associated with drug use; and result in significant death, injury, exposure to life-threatening circumstances, hardship, suffering, loss of property, or loss of community infrastructure.

23 comments

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  1. Very lucky it isn't me. Jan 11, 2017 - 05:18 PM
    The way a cigarette box has the warning " smoking causes disease and death". Opioid medication packets should say the same thing! Just because you get " pain meds" from a doctor, doesn't mean that they are not drugs! Even something as simple as an aspirin comes with a warning. Viagra commercials list possible side effects. One of which is DEATH. Why don't companies that make oxytocin, or Vicodin have commercials? Why don't they run down a list of " possible " side affects ? One of which could list WARNING!!! Can cause addiction, which can cause misery, broken marriages, and " possibly" DEATH even as taken as prescribed? Or even a commercial showing those shocking images like the cigarette companies do? No one. NO ONE ever wakes up and says " hmmm, today I'm going to become a drug addict"!!
  2. Tracy Nov 01, 2016 - 06:37 PM

    Please just stop with the craziness and help us!

    I've been on suboxone for 16 years. Not one relapse. ( active addict for 20) I continue mental health counseling and have recreated a life for myself and family.   It's all being threatened for what? For who? 

    The opiate epidemic is becoming worse not better, with the continued tightening of already useless regulations and "rules" are driving addicts back to the streets.  Like what happened with MMT we are being treated in a punitive manner. 

    Too many clients , not enough prescribers, not enough staff...They can't deal with us individually any more and my 45 min meeting with the psychiatrist is now 5 minutes every 2 months. They herd us in in groups of 30, she "lays" eye's on us. That's it.   Get this figured out please, if I had any other chronic illness NO doctor would treat me the way I've been treated.  

  3. Shawn Oct 19, 2016 - 09:39 PM

    My subutex doctor in miss. Just tol me that the dea or Feds sent out a letter to all the doctors in Florida and miss. That they are now only allowed to prescribe no more then 60 subutex or 60 suboxone strips a month for a patient? I was seeing him in Pensacola fl then he shut down n went back to his main office in miss and invited us new Pensacola patients to come see him there and I did because he was good and gave me subutex because I cannot take suboxone and in Florida it seems it's like pulling teeth to try and get the regular cheaper less side effect buprenorphine out of them and they only want to write ultra expensive cash cow suboxone which I can't even take and most insurances won't cover like my friends medicaire n yes it has all been driving him very suicidal ..is this a new law about 60 pill n no refill or what? I been with him awhile and he knows my other issues but is saying that and that I need to find a doctor inmpensacola even know he knows how bad it is here in Florida is this new law true?  And now I'm in panic attack mode because I'm going to Benin the same boat as my friend and having to fight with a doctor here trying to get plain cheap subutex not suboxone which I am allergic to how am I to go about continuing subutex not suboxone here..my doctor in miss said he would send the records n all n it says I'm allergic to naloxone in there but is a new doctor still going to try n force me on suboxone which is a waste a cash cow n naloxone is no good for a fetus or humans organs anyway n I have a horrid reaction to it why do they make such a big deal u can't abuse buprenorphine either it has a ceiling effect u can take 1 or 10 n not feel different n it fully blocks any other opiate no need for naloxone that was just a big pharm scam..I have xtra subutex at the end of the month every month when he was writing me 90 I took two a day mostly then I got to the max of 4 a day when I got in a car accident n I would take two a day mostly so no abuse...I need some answers cuz today was my last day seeing him and I don't want to go back to hell meaning of I can't find a subutex doctor here please answer that law question n help about me continuing to be prescribed subutex from a new doctor not suboxone and if u think they will give me a hard time even know I been taking subutex for a year and a half or more it's just I need a doctor in my own area now

  4. Danella Roberts Oct 11, 2016 - 03:15 PM
    As a patient, I have seen many providers drive up the cost due to the fact they are currently not required to take insurance. Most providers who write for buprenorphine make it cost prohibitive and  impossible to participate because it can cost up to 200-300 dollars a month for a quick ten minute visit. I'm glad there are regulations because there are a lot of doctors who see addiction medicine as a way to make lots of cash!! I also feel Nurse Practitioners take the time to really listen to their patients and they should be allowed to write for this medication as well!!What a shame!! 
  5. David Garrell Aug 10, 2016 - 09:42 AM
    The regulations are too cumbersome and I believe that some physicians will just skip it and keep their 100 pts. The whole thing is rediculous
  6. Julie Thompson PMHNP-BC Aug 09, 2016 - 10:33 PM
    I am very disappointed to read that PMHNP's like myself will once again be excluded and limited from this area of medicine. I prescribe and administer Vivitrol injections in my current practice, and I can prescribe Buprenorphine as long as it is for "pain management". Not in the best interest of our patients at all.
  7. R. Burns M.D. Aug 02, 2016 - 01:08 PM
    This rule was always meant to help special interest parties, not patients.  It will allow board certified physicians, and now their physician extenders, or physicians who are working for health care centers, such as hospitals, to no longer be substantially hindered by the patient limits.  There are no other areas of medicine where a physician is limited to the number of patients being treated. The rule will not significantly increase access to care for patients as the original SAMHSA program was designed for PCPs, not specialists.  Most patients being treated with MAT are therefore being treated in programs for which the original law was intended. The practitioners for those programs are substantially excluded from increasing their limits unless they choose to attempt the board certification process. 
  8. Ashish V. Patel Aug 02, 2016 - 12:09 PM

    As a concierge medicine physician, I think that forcing physicians to accept 3rd party insurance as part of licensure or ability to treat is not only a mistake, but infuriating. ASAM should fight to keep doctors and patients free from the bounds of insurance regulations and paperwork.

    I wonder how much influence and lobbying from the health insurance industry was involved in the development of these rules. Can someone please explain how accepting 3rd party payments improves quality of care and safety?....all I've ever seen it do is take time away from actual patient care!

  9. Gary D, M.D. Aug 01, 2016 - 10:03 AM

    I practice Addiction Medicine only.  I am at  my limit of 100 patients.  A new patient is seen by me, after induction of medication, once a week for three weeks.  During that period, the patient's medication is adjusted, urine screens are done and the patient, if not already in counseling, locates and enrolls in a weekly (minimum) counseling program.  At the end of this period, the patient is allowed to be seen at two week intervals.  Then at some time in the future, (depending on the patient's progress and my evaluations, they are either "weaned" off the medication or advanced to visits once a month, if they are not candidate to be "weaned."

    I see my patients one full day a week.  But, it actually takes me 3 to 4 days a week to deal with patient management issues.  These issues would include prior-authorizations, chart-work, reviewing labs and making patient call-backs, answering letters from counseling services, parole officers, judges, etc. I think  you get the picture.

    If I were to increase my load by 175 new patients, my first month patient load would be 35 patients a day, five days a week (175/5 days=35)  besides seeing all of my existing patients.  Even after all these patients are advanced to two week visits, it would still be 18 patients a day plus my existing 100! Now, how and when do I deal with all the other management issues, as I stated above?

    This new HHS Rule is not going to help any of us that are actually treating patients.

    Though, it may help out in the counseling arena.  They will be able to ask and probably receive large government grants to build larger buildings, hire more staff, put on larger seminars, but they will not have the doctors, they need  to pass them the patients to fill their programs.

    Again, the doctor and the patient suffer.

  10. Michael W Shore, M.D. Aug 01, 2016 - 10:02 AM
    It is my understanding that Board certified addiction physicians do not have to be in an insurance panel nor accept insurance.  I as well wonder how the burdensome and increasingly common PA requirements will impact on solo practitioners such as myself if we increase our Bup numbers and see a corresponding increase in PA requirements.  Michael W Shore, M.D.
  11. Andrew Nicholson, MD, JD Jul 21, 2016 - 09:43 PM

    "Accepts third-party payment for costs in providing health services, including written billing, credit, and collection policies and procedures, or Federal health benefits."

    This rule does not seem to have a rational basis related to public welfare. Maybe someone could explain. Agencies have broad discretionary power but this seems like an over reach. I am not certain compelling physician prescribers  of  buprenorphine  to accept payment in a certain manner is appropriate, or within the scope of authority. It seems open to legal challenge.

    Also these rules have different practice standards for board certified addiction medicine physicians and those not board certified. Those few who are board certified in addiction medicine can practice without the need for a "qualified practice setting". This effectively allows for board certified physicians to practice outside of a "qualified practice setting". This would be a "lower" standard of practice, following the assumptions made in the rules.  If practicing in a "qualified practice setting" is important for patient health and safety, then why would this standard enforced on only some prescribers? There is no rational basis for this. 

  12. Molly Rutherford Jul 21, 2016 - 05:27 PM
    Requiring providers to participate with third parties will limit the effect of this rule, especially in Kentucky. Physicians need to stand strong and united, refuse to work for third parties, and instead work for our patients (direct pay). I read an article recently that said doctors got where we are by following rules. We should remember our oath first, rules second. People are dying.
  13. Darryl Jul 18, 2016 - 11:21 AM
    Only one requirement has to be met. I'm not understanding why that is so hard. Help me understand.
  14. Dr. Thomas Donofrio D.O. Jul 15, 2016 - 04:08 PM

    Once again, the W

    ashington beurocrats took a great idea and filled it full of beurocracy.  Greatly disappointed. 

  15. Michael Miller. M.D. Jul 15, 2016 - 03:17 PM
    I don't get why there is a requirement of participation in an insurance plan, as one of the criteria for increasing the maximum number allowed to 275 patients.  This just adds another barrier to more patients being eligible for Suboxone treatment, and perpetuates the shortage of physicians.  Many of the patients needing Suboxone do not have any kind of insurance for office visits.  This has nothing whatsoever to do with ensuring patients receive high quality of care.
  16. Diane R. E. Keahey Jul 14, 2016 - 05:44 PM
    Saddened by the fact as a Certified Subtance Abuse Practitioner, I can not prescribe because I am a Family Nurse Practitioner. Oh My Goodness, why? 
  17. Lucile Gauger, PA-C Jul 12, 2016 - 12:06 PM
    <p>I am saddened to see the neglect from our administration and colleagues regarding Physician Assistant's and Nurse Practitioner's prescribing privileges of buprenorphine. &nbsp;I do not feel supported by ASAM. &nbsp;The American Academy of Physician Assistant's has been at the table begging for a scrap and we came up with nothing.</p><p>I was one of the medical staff of our Bup CTN in 2001. &nbsp; For 15 years I have been helping persons with opioid dependence induct onto buprenorphine and maintain their recovery. &nbsp;I had some hope that I would finally be able to prescribe this schedule III medication. &nbsp;</p><p>Everyone, &nbsp;please work to change the law to include Physician Assistant's and Nurse Practitioner's.</p><p></p><p></p><p></p><p></p>
  18. Crystal B Jul 11, 2016 - 11:21 AM
    The increase will allow more patients to obtain treatment. Yes there will be additional PA's needed, but if the provider and the patient are both doing what they need to be doing then the PA's are simple. Provider needs to document accordingly, patient needs to comply with the requirements- whether complaint UDS, keeping therapy appointments etc.. Both the patient actively taking the steps for a healthy recovery and the provider being professional and completing adequate documentation and recommendations- holding the patient accountable are important in the success and positive outcomes. Is this treatment right for everyone...no, but for those that it is, and follow the recommended guidelines the higher the chance of it helping. No system, process, medication therapy will be perfect or flawless or even work for everyone that tries it, but the more people that can get help from it the better. It is easy to point out the negatives or to say something won't work than to adapt to the change and try to make it work. Recovery takes time, effort, and patience, and so do it's treatment options : ) Where there's a will, there's a way!
  19. ken cairns Jul 10, 2016 - 06:48 PM
    I told them under comments that i have served for 10years in difficult circumstances, with n0 problems and huge gratitude, that my solo simple practice as was the original conception of obot just blend w ones practice   that has thus served so well for so long and it is what i can do and all I can do and my pts want it to stay as is and not at age 81 have to get more boards and bungle around trying t0 fit their invented authorized practice situation or whqatever and I shared w them the truth that this is what people want and need out here where I exist but that people all around were dying because of gov cap on services and how needed it was that I be able to help more and no one else was showing up out here to prevent the needless loss of life and smugly they responded thagt they know more about it than I do from their nondoc offices wherever they may be at the top and selfrighteously far from ever personalaly feeling what it is like let the dying continue...I submit this w boundless sadness
  20. John Jacobs, MD Jul 08, 2016 - 03:07 PM

         It's fitting that the first post here is from a corporation.  The business model is easy for governments and corporations to understand, but it is not a good model for recovery.  Patients need to know their physician understands them and values them as more than a number.  It seems to me that the winners here are the insurance companies and the physicians who work for them, instead of the patients.  The bare economics of the situation are that every time a patient dies from an opioid overdose, the insurance company, public or private, profits, since payment for treatment is no longer an issue.  

         Would anyone ever do a study to find out how many lethal overdoses happen when someone's medicaid has been turned off, or their insurance is stalling about a "prior authorization."  Are there any studies documenting how often insurance companies mislead patients and physicians?  Or how much time is wasted dealing with insurance companies?  Or how many patients feel alienated by the business model of medicine, which too often makes health care facilities seem to run on the same model as the drug dealer?  It's as though ASAM has forgotten about the importance of the therapeutic relationship.  Health care businesses, paid by third party payers, see physicians and other helpers merely as labor.  How many studies  are done to look at the rates of suicide or opioid overdose as a function of staff turnover?  Or as a function of changes in what the insurance covers? 

       The requirement that we accept third party payment is the child of a conflict of interest - physicians who really work for insurance companies pretending they are working for patients.  

        Say a patient who had opioid dependence, in a rural area, has a doctor he or she trusts.  Who then, other than another medical board, would benefit  by the requirement that in order to prescribe buprenorphine,  that the doctor get yet another board certification?

         How many patients will decline treatment, knowing that electronic records are required?  No electronic records are really in confidence, and people  want to be treated as human beings, not  as data points.  

         One can't help but wonder about the role of managed care in facilitatiing the growth of the opioid epidemic.  Physicians have been pressured  by clinics, and the managed care companies they work for, to see patients quickly, and not to talk with them at length about the risks of addiction from opioid pain medicines, and plans for help in this regard.  

         The state prescription drug monitoring programs have definite beneftis.  But there sees to be too little attention to how much the decrease in doctor shopping for pills may have contributed  to an increase in heroin deaths.   

         I tell my patients that they are not responsible for their addiction, but they do have some  responsibility for their recovery. What then are we saying when patients with medicaid know they can't get billed if they don't show for appointments?  Some clinics then terminate these patients  in response.  At methaodne clinics, patients want to continue  their group therapy and individual counseling after they are finished detoxing, but medicaid will only pay for the psychological help if the patients are still taking medication.  Do the benefits of accepting medicaid really outweigh the benefits of a sliding scale?  Is participation in medical care run on the business model so necessary?

         (A speaker at ASAM once cautioned not to use terms such as "junky."   Why is there not a similar objection to terms like "prior authorization" that really mean "the insurance company is delaying payment for treatment."  The term "junky" conjures images of people wandering in junk yards for scraps that might be left by other people of a "higher class," just as the term "prior authorization" conjures images of the priority of businessmen over patients, and conjures images of physicians having to look to an authority, in this case, an insurance company, prior to treating a patient. Use of the term "prior authorization" serves to perpetuate the popular misunderstanding that insurance companies not only take priority over patients, but actually authorize medicine, when all they really do is to authorize themselves to pay for it.)

  21. Jonathan Ciampi Jul 08, 2016 - 12:18 PM
    We are excited about the new increase.  At Bright Heart Health, we are making prescribing easy for physicians.  Physicians can focus on patient care, while Bright Heart staff manage all the administrative efforts including - prior auth, symptomatology tracking of outcomes, scheduling, and drug-screens, and Bright Heart therapists provide a comprehensive evidence-based psychotherapy curriculum. If you want the headache taken out of prescribing, see our services - http://www.brighthearthealth.com/data2000-waiver-physician-services/
  22. Allan Zubkin Jul 07, 2016 - 09:16 PM
    I think it is incumbent upon wavered physicians to work to increase their patient limit to 275. The need for treatment is great, and now we have been given the opportunity,
  23. allen jackson Jul 07, 2016 - 08:48 PM
    It is becoming more and more difficult for my patients! The Insurance companies are requiring a Prior authorization.the forms are 2 pages, want pregnancy tests, setting limits of medications. If we take more patients , what can we do with the barrage of Prior Authorizations requirements. This worries my patients, increases relapse and is expensive for the patient to cover their Medes until the Prior Authorization comes through.

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