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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.

9 comments

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  1. Michelle Sep 06, 2017 - 05:02 PM
    I'm a little confused. Is it legal that my doctor calls in a prescription for a month but then a staff person calls and releases them weekly? I would just like to know if it is legal or not that the pharmacy and doc basically have this understanding to hold suboxone?
  2. E Foley Sep 04, 2017 - 07:08 PM

    I know an individual who has been in a Suboxone program for awhile. The money is running out. It is a very expensive program . I'm sad that this program although good is out of reach for most people who could benefit from it. 

     

     

  3. 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>
  4. 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!
  5. 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
  6. 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.)

  7. 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/
  8. 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,
  9. 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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