PAMED's Regulatory Update

Last Updated: Aug 21, 2019

By Michael D. I. Siget, JD, MPA, PAMED’s Legislative & Regulatory Counsel

 

Regulatory Update - August 2019

Department of Health             Department of State


 

Department of Health

Medical Marijuana Regulations  August 2019

DOH is anticipating issuing proposed regulations relating to medical marijuana sometime in 2019. Currently, there are other regulations that DOH plans to issue first, so at this time, we anticipate that the regulations will not be issued as proposed until fall at the earliest.

Hospital Regulations  August 2019

DOH hopes to release proposed hospital regulations sometime in 2019, preferably in the first half of 2019. PAMED will review these regulations and provide comments, as well as provide information to members on how they may submit their own comments.

It is anticipated that the hospital regulations will look like a draft version that was circulated in 2017. DOH has not released updated versions of the regulations to stakeholders since, and DOH has indicated that it will not release a version until it submits the proposed regulations to the Independent Regulatory Review Commission (IRRC). If the proposed regulations are like the draft regulations from 2017, the following are some changes to expect with the new regulations:

  • Medical staff membership will no longer be limited to physicians, dentists, and podiatrists. While DOH will not mandate which practitioners must be on the medical staff, DOH will permit each hospital to determine which health care practitioners may be part of that hospital’s medical staff. With this change, you will likely have some hospitals that will keep their medical staffs the same as they are now while other medical staffs will open their membership to other types of practitioners.
  • With the above change, medical staff committees may be comprised of other practitioners for committees such as credentialing, tissue review, health information, medical care evaluation, pharmacy-therapeutics, radiation safety, bylaws, and infection control.
  • Health systems will be addressed in the new regulations. Hospitals can meet certain regulatory requirements by being part of a health system, such as an organized governing body; personnel recruitment, training, and education; business management capability; short and long-range planning capability; and fiscal services.
  • All bylaws of the health system shall apply to each hospital unless specifically stated otherwise; each hospital shall be specifically addressed in the health system bylaws of the governing body; the health system governing body minutes shall reflect the activities of each hospital individually; all minutes that related to a specific hospital shall be maintained at that hospital; and each hospital shall individually comply with all other requirements of the regulations unless specifically indicated.
  • Committees of an individual hospital may be comprised of representatives from other hospitals within the same health system. Each hospital must have at least one representative on the committee.
  • CRNAs may administer anesthesia without being under the direct supervision of the operating physician or anesthesiologist.
  • Photo ID badge requirements will be addressed for hospital workers.
  • Hospitals will be able to develop surge/overflow policies.

Prior to regulations being issued as proposed, they must be approved internally by Department officials, including the Secretary, the Deputy Secretary over the hospital program, the Bureau Director, the Division Director, the Legal Office, the Budget Office, the Legislative Office, and the Policy Office. The regulations must also be approved by the Department’s Health Policy Board. The Policy Board is set to meet at the end of July to review changes to the regulations, a copy of which will not be made publicly available. Once the regulations are approved by the necessary Department personnel, they must be approved by:

  • The Governor’s Budget Office.
  • The Governor’s Policy Office.
  • The Governor’s Office of General Counsel.
  • The Office of Attorney General.

If any of the above entities submit questions to DOH, or request changes, the approval process will start over with these entities. The three Governor’s Office entities must approve the regulations prior to the regulations being submitted to the Attorney General’s Office. The Attorney General’s Office has 30 days to review the regulations, but it may toll that time period if it submits questions to DOH.

Once the regulations are approved by the above entities, the regulations must be served on committees in the House and Senate. Hospital regulations will be served on both health committees. Those committees can submit questions; formally approve the regulations; formally disapprove the regulations; or take no action wherein the regulations are deemed approved by the legislative committees (this is usually the most common result from the committees).

In addition to service on the committees, DOH will also serve the regulations on the Independent Regulatory Review Commission (IRRC). IRRC will open the regulations for a 30-day comment period. After that period closes, IRRC has an additional 30 days to submit its own comments.

After both comment periods close, DOH will have two years to answer the questions submitted to it, revise the regulations as necessary, and get the applicable approvals from the Governor’s Office and the Attorney General’s Office (see above), before it submits final regulations to IRRC for approval.

Given these timeframes, if DOH were to issue proposed hospital regulations in 2019, the timeframe before they are approved as final, and go into effect, would be between 2020-2021.

PAMED opposes medical staff membership changes and opposes authorizing CRNAs to administer anesthesia without being under the supervision of an anesthesiologist or other physician. If DOH proposes these changes, PAMED will actively oppose them and will be submitting comments to IRRC in opposition of these changes. In addition, PAMED will alert its members of these proposed changes and recommend that members submit comments to IRRC as well.

PAMED may also, if it chooses to do so, lobby legislators to disapprove the regulations or to ask legislators to lobby DOH and the Governor’s Office to keep the medical staff membership regulations in place as they currently read. PAMED may also, if it chooses to do so, seek legislation concerning medical staff membership to override any regulatory changes that DOH proposes.

PAMED staff presented this information to the Board of Trustees at its May 2019 board meeting.

PAMED staff will continue to monitor this situation and provide updates as they occur.

HIV Reporting Regulations – August 2019

DOH issued proposed regulations regarding reporting complete reporting of CD4-Lymphocyte, Viral Load and Genotyping Test Results Relating to HIV on May 25, 2019.  PAMED members were notified of these proposed regulations and how to comment through The Dose e-mail newsletter. According to DOH, Pennsylvania is only one of four states that does not requiring the reporting of all CD4 T-lymphocyte counts, viral loads and genotyping test results. DOH is seeking to amend its regulations to require the reporting of all CD4 T-lymphocyte cell counts relating to HIV infection, as well as all viral load test results and genotyping results. Final regulations are due from DOH to IRRC by June 24, 2021. PAMED will continue to monitor these regulations and provide updates as they occur.


 

Department of State

Naturopathic Doctor Registration Regulations – August 2019

The State Board of Medicine (SBOM) has indicated that it intends to scale back the first draft of these regulations and now intends to have these regulations pertain to registration of naturopathic doctors only. Previously, the draft regulations contained scope of practice provisions and other provisions that PAMED argued were beyond the scope of the legislation enacted.

The SBOM is still in the early stages of drafting internal regulations.  The SBOM has not made any drafts available to the public. However, the SBOM has held several informational meetings that PAMED has attended, including a meeting in July. SBOM is hoping to produce a set of regulations that will be accepted by the differing naturopathic groups.

At this time, the SBOM is asking the differing naturopathic groups to meet to see if they can come to a compromise on the regulations, including issues pertaining to use of the term “naturopathic doctor.”  

Public Health Dental Hygiene Practitioners – May 2019

On March 23, 2019, the State Board of Dentistry (Board) issued proposed regulations relating to public health dental hygiene practitioner (practitioners) practice sites to implement Act 60-2016. Act 60 gave the Board the ability to add other locations it deemed appropriate for practitioners in addition to those enumerated by the General Assembly. The Board is recommending adding “an office or clinic of a physician who is licensed by the State Board of Medicine or the State Board of Osteopathic Medicine” as an acceptable location for the practice of these practitioners. The Board cites that it believes this additional location will expand access to oral health care and education by these practitioners and will assist patients, particularly pediatric patients, find a dental home by way of the annual referral to a dentist as required under the regulations.

PAMED notified membership of these proposed regulations in the April 4, 2019 edition of The Dose and provided information to its members on how to submit comments or questions. Comments or questions were due by April 22, 2019.

PAMED also submitted comments to the Board on April 3, 2019. PAMED is seeking clarification on how these regulations will affect physicians and physician offices that choose to place these practitioners within the office setting. Specifically, PAMED asked the Board to clarify the following: 

  1. Is physician employment of such practitioners voluntary?
  2. What role will the Board play in approving these arrangements or otherwise reviewing the terms or conditions between a physician or physician’s office and a public health dental hygiene practitioner?
  3. What are the responsibilities of the physician or the physician’s office to public health dental hygiene practitioners practicing in their office, i.e. must physicians provide specified oversight and to what extent? If there will be oversight responsibilities, will those responsibilities be specified in the final-form regulations?
  4. Will the Board oversee issues that could arise in physician offices, including with physicians specifically, or will the Board refer those issues to the State Boards of Medicine and Osteopathic Medicine or another appropriate agency?

The Board will review all comments and questions submitted to it and respond accordingly.  The Board has until April 22, 2021 in which to submit final-form regulations to the Independent Regulatory Review Commission for review and approval.

PAMED will continue to monitor these regulations and provide updates to its members.

Compounding Regulations – August 2019

IRRC approved the Pharmacy Board’s regulations on compounding at its May 16, 2019 meeting. The regulations were published in the June 22, 2019 edition of the Pennsylvania Bulletin. In April 2017, PAMED submitted comments to the Board and IRRC regarding the Board’s proposed regulations. As part of its comments, PAMED asked the Board for clarification on the following:

  1. Whether pharmacists may compound a drug in anticipation of receiving a prescription but may not dispense or send a drug to the prescribing practitioner until they receive the patient-specific prescription, i.e. that these regulations prohibit dispensing compounded drugs “for office use”? In addition, do the proposed regulations limit a physician’s ability to order and purchase compounded drugs from the compounding pharmacy for the purposes of storing them in the office for future use?
  2. Does § 27.605 require a patient-specific prescription in order for a pharmacy to be able to send a batch of a compound drug directly to a physician for administration to that patient?
  3. To what extent, if any, do the Board’s regulations prohibit or otherwise limit a physician from compounding drugs on their own in-office for administration to the physician’s own patients?

The Board responded to PAMED’s comments as follows:

Initially, IRRC commented that the Preamble states that “all compounding shall be done in accordance with the current version of the United States Pharmacopeia (USP)”, but pointed out that section 390-8(2) of the Pharmacy Act (63 P.S. §390-8(2)) provides that “nothing herein shall be construed to prevent a duly licensed medical practitioner from dispensing, compounding or otherwise giving any drug to his own patients after diagnosis or treatment of said patient, if such compounding, preparing and dispensing is done by said licensee himself The comment included a request to clarify the effect, if any, of this regulation on licensed medical practitioners other than pharmacists. Commenters Pennsylvania Academy of Ophthalmology, Pennsylvania Allergy and Asthma Association, American Academy of Dermatology and Pennsylvania Academy of Dermatology and Dermatologic Surgery, Pennsylvania Medical Society and the Pennsylvania Academy of Otolaryngology — Head and Neck Surgery expressed similar concerns.

The Board considered this comment and notes that nothing in the proposed regulation indicates it applies to practitioners other than pharmacists. The Pharmacy Act does not provide the Board the authority to regulate practitioners other than pharmacists, and the Board feels the focus of the proposed regulation makes clear the Board’s intent to regulate compounding by pharmacists only.

IRRC also asked whether the provisions in § 27.604 and 27.605 prohibit dispensing compounded drugs “for office use”. Both IRRC and the Pennsylvania Medical Society asked whether these provisions (1) prohibit dispensing compounded drugs “for office use,” (2) limit a physician’s ability to order and purchase compounded drugs from the compounding pharmacy for the purposes of storing them in the office for future use; or (3) require a patient-specific prescription in order for a pharmacy to be able to send a batch of a compounded drug directly to a physician for administration to a patient.

To eliminate this confusion, the Board has removed these sections from the final-form regulation. Instead, the Board will rely on the reference to the Federal requirements and the USP in §27.601. However, the Board would point out that section 503a of the Federal Food, Drug and Cosmetic Act uses the terms “identified individual patient” and “identified patient.”

The final-form regulatory package can be accessed here: http://www.irrc.state.pa.us/regulations/RegSrchRslts.cfm?ID=3174


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