As of this writing, Pennsylvania’s state budget for the 2015-2016 fiscal year is nearly three months overdue, with little indication that Gov. Wolf and legislative leaders are getting any closer to reaching an agreement on taxes and spending. Of course, the situation could change quickly, and hopefully by the time you read this there will be some sort of breakthrough. In the meantime, school districts and social service agencies are beginning to feel the pain that comes with the lack of their annual state funding.
However, the state budget stalemate has not prevented legislative and regulatory action on other issues, many of which are health care-related. Following is an update on some of those actions that have occurred over the summer.
Expunging Minor Violations from a Practitioner’s Disciplinary Record
SB 538, legislation that would expand the obligation of professional licensees to notify their licensing board when they run afoul of the criminal law or another state’s licensing body, is just one step away from the governor’s desk, needing only Senate approval of amendments added by the House, which could occur in the near future.
One of the House amendments could benefit physicians and other licensees who have a minor transgression on their disciplinary record. Should the bill become law, certain violations could be expunged (erased) from a licensee’s record, provided that certain conditions have been met.
The types of violations that would be eligible for erasure fall into one of two categories:
1.failure to complete continuing education requirements or practicing for six months or less on a lapsed license, registration, certificate or permit. At least four years must have elapsed since the final disposition of the disciplinary record at the time of application for expungement; and
2.any violation, except those which resulted in license suspension or revocation, in which at least 10 years have elapsed since the final disposition of the disciplinary record at the time of application for expungement.
Thus, only minor violations would be eligible for expungement, and some time needs to have gone by since the problem was resolved. Anything serious enough to have warranted a license suspension or revocation would stay on a licensee’s disciplinary record permanently.
Other conditions would also have to be met in order for a licensee to apply to have a disciplinary black mark removed. Specifically:
1.the licensee must make written application for expungement not earlier than four years from the final disposition of the disciplinary record;
2.the disciplinary record must be the only disciplinary record that the licensee has with either the commissioner or a licensing board or commission under the commissioner’s jurisdiction;
3.the licensee must not be the subject of an active investigation related to professional or occupational conduct;
4.the licensee must not be in a current disciplinary status, and any fees or fines assessed must be paid in full; and
5.the licensee must not have had a disciplinary record previously expunged by the commissioner. You only get one bite at this apple.
As indicated, the bill may be enacted soon, and if so PAMED will provide all the information physicians need to initiate the process of requesting expungement of old, minor violations from their disciplinary record.
Gov. Wolf’s 2015 Regulatory Agenda
On July 25, the Governor’s Office released its Regulatory Agenda for calendar year 2015. The purpose of the Governor’s Regulatory Agenda is to provide advance notice of upcoming regulatory activity. The publication represents the Administration’s intentions regarding future regulations.
Following is a brief summary of the regulations proposed for action:
Achieving Better Care by Monitoring All Prescriptions Programs: The Department of Health plans to release proposed regulations to support the implementation of the forthcoming prescription drug monitoring program—Achieving Better Care by Monitoring All Prescriptions Programs (ABC-MAP)—in Spring 2016. The Department anticipates that these regulations will (1) improve the quality of patient care in Pennsylvania by providing prescribers and dispensers access to information about all controlled substances dispensed to a patient, and (2) aid regulatory and law enforcement in the detection and prevention of fraud, drug abuse, and criminal diversion of controlled drugs.
Anesthesia Regulations: The State Board of Dentistry plans to issue proposed regulations updating the standards for administration of general anesthesia, deep sedation, moderate sedation, minimal sedation, and nitrous oxide/oxygen analgesia in dental offices to conform to and adopt the current standards used by the dental profession.
Child Abuse Reporting Requirements: This winter, the State Board of Medicine and the Osteopathic Board of Medicine, plan to issue regulations to update the Board’s existing rules regarding the mandatory reporting of suspected child abuse pursuant to the recent amendments to the Child Protective Services Law (CPSL).
Compounding Regulations: This fall, the State Board of Pharmacy will issue, as proposed, updated regulations to improve the profession’s safe, sterile practices and procedures for the compounding of pharmaceutical products for patients.
Health Care Worker Identification Badge Regulations: Specific provisions of the 2011 Photo Identification Tag Regulations law went into effect on June 1, 2015. Even though the law related to the use of titles (e.g., Doctor, Nurse, etc.) and their precise placement on the badge did not go into effect until June 2015, many of those affected by the law (particularly physicians) have been in compliance with all components of the law since it was passed in 2011. This fall, the Department of Health plans to release proposed regulations for this law.
Injectable Medications, Biologicals, and Immunizations: The Board of Pharmacy plans to issue proposed regulations to implement the 2015 amendments to the Pharmacy Act this winter. These amendments allow a pharmacist to administer influenza vaccine to patients beginning at age nine and allow pharmacy interns to administer injectable medications, biologicals, and immunizations.
Laser Regulations: This fall, the State Board of Medicine will issue proposed regulations to clarify the requirements for the use and delegation of the use of medical lasers. The proposed rule will bring the Board’s regulations in line with the majority of other states with regulations related to these devices.
Osteopathic Prescribing Regulations: This fall, the State Board of Osteopathic Medicine anticipates its release of regulations to outline the minimum acceptable standards of practice that an osteopathic physician or physician assistant licensed by the Board must follow when prescribing, administering, or dispensing controlled substances or one specific additional drug which shares serious potential for addiction and abuse (butalbital). According to the Board, butalbital is a barbiturate that is known to have addictive and abuse potential and is prone to overuse by the consumer.
Legislation to legalize medical marijuana has cleared the state Senate by a vote of 40-7, and now awaits House action. Senate Bill 3, introduced by Sen. Mike Folmer (R-Lebanon County), was the subject of House and Senate public hearings earlier this year.
PAMED testified at the hearings, repeating our position that the FDA should relax marijuana’s status as a Schedule I drug to facilitate testing of a substance that seems to have some promise in treating children with epileptic seizure disorders, nausea in cancer patients, and other conditions. PAMED also believes the state should fund pilot studies that the Department of Health laid the groundwork for last year. However, until solid research results are in hand, the Society believes legalization would be premature.
The bill’s scope is broad, and goes beyond the legalization of cannabidiol, the non-psychoactive component of marijuana that seems to help some children with seizure disorders.
SB 3 would also legalize THC, the psychoactive component of marijuana, to treat cancer, epilepsy and seizures, ALS, cachexia/wasting syndrome, Parkinson’s disease, traumatic brain injury and post-concussion syndrome, multiple sclerosis, Spinocerebellara Ataxia (SCA), post-traumatic stress disorder, severe fibromyalgia, HIV/AIDS, glaucoma, and other conditions authorized by the Department of State pursuant to review initiated by a patient petition.
The bill originally would have permitted the medical use of marijuana edibles, raising concern over the risk of diversion and unintended harm. However, the Senate State Government Committee deleted edibles from the bill on April 21, while adding nebulizing (smoking and vaping would be prohibited).
The bill would authorize up to 65 growers and another 65 processors, raising questions about product consistency.
The bill as introduced would have permitted physicians, CRNPs, nurse midwives and physician assistants to all “recommend” medical marijuana to patients. However, the committee-approved amendment restricts that authority to physicians.
The bill provides that the Commonwealth cannot be held liable for any deleterious outcomes resulting from the medical use of cannabis by a registered patient. However, no similar protection is given to health care practitioners who would actually “recommend” non-FDA approved marijuana medications to their patients.
PAMED was recently joined by the following physician specialty societies in sending House members a joint letter expressing opposition to premature legalization of medical marijuana:
Pennsylvania Society of Anesthesiologists
American College of Physicians
Pennsylvania Allergy and Asthma Association
Pennsylvania Neurosurgical Society
Robert H. Ivy Society of Plastic Surgeons
Pennsylvania Society for Pulmonary Disease
Pennsylvania Rheumatology Society
Pennsylvania Chapter of the American College of Cardiology
Pennsylvania Occupational and Environmental Medical Society
Pennsylvania Academy of Otolaryngology
Pennsylvania Chapter of the American Academy of Pediatrics
Pennsylvania Psychiatric Society
Pennsylvania Chapter American College of Emergency Physicians
Nevertheless, there appears to be considerable rank and file support for medical marijuana among House members, though House leaders have taken a cautious, go-slow approach, and have spent much of the summer working to address concerns with the Senate legislation. Watch for a more modest House proposal to emerge early this fall.
Controlled Substances Database Progress Update
It now appears certain that the long-awaited statewide controlled substances database will not be operational until sometime in 2016. That word comes from the Department of Health, which is charged with housing the program.
The law creating the database, Act 191 of 2014, set June 30, 2015, as the date it was supposed to be operational, but that didn’t happen, for a number of reasons.
First, creating a robust, interactive system that will be used daily by thousands of health care practitioners is no small task. And while it’s disappointing that Pennsylvania is the only state besides Missouri that doesn’t have an operational database, we do benefit from the opportunity to look at what other states have done and identify best practices. The Department is doing that now, and it takes some time.
The second problem is money. The $2.1 million earmarked to build and operate the system for the next year is tied up in the ongoing state budget stalemate. How long it will take to resolve that impasse is anyone’s guess. Fortunately, the state recently received a $900,000 grant that can be used to get the ball rolling financially.
The board that is to run the database, made up primarily of Gov. Wolf cabinet members, held a public meeting on Sept. 15, and revealed that the process of selecting a vendor to build the system is now under way. That process should be complete before the end of the year, but then comes the task of actually creating the database. Hence, the likelihood that the program won’t be operational until 2016.
Allowing Traveling Team Physicians to Treat Players without a Pennsylvania License
Most sports fans are aware that college and professional teams often bring their team physicians with them when they travel to another state to compete. This makes sense, because the team physician would be most familiar with the players, along with any injuries or other medical conditions they may be dealing with.
This seemingly straightforward situation becomes complicated if the out-of-state team physician actually treats a player while they are competing in Pennsylvania, because our state law requires physicians to be licensed in Pennsylvania in order to practice here. Thus, under the letter of the law a duly licensed out-of-state team physician who has an established physician/patient relationship with the team’s players, and who may be treating them for anything from asthma to post-concussion follow-up to a sore knee, technically must stand aside and allow a Pennsylvania-licensed physician, who likely doesn’t know the players at all, to treat them when the team is playing in Pennsylvania.
In order to address this situation, 21 states currently allow for visiting team physicians to practice in their state without meeting home state licensing requirements. As indicated above, Pennsylvania is not among them. However, Sen. Jake Corman (R-Centre County), whose district includes Penn State’s main campus in State College, has introduced legislation that would ease our physician licensing requirements in those circumstances.
SB 685 and 686 (one for MDs and one for DOs) provide that any visiting team physician who is licensed in their home state and has an agreement with a sports team to provide care for the team while traveling, may treat the team’s players while they compete in the Commonwealth without a Pennsylvania license.
Specifically, under the bills a physician who is licensed in good standing to practice in another state is exempt from the licensure requirements of Pennsylvania’s Medical Practice Act and Osteopathic Medical Practice Act while practicing in the Commonwealth if either of the following apply:
(1) The physician has a written or oral agreement with a sports team to provide care to the team members and coaching staff traveling with the team for a specific sporting event to take place in the Commonwealth, or
(2) The physician has been invited by a national sport governing body to provide services to team members and coaching staff at a national sport training center in this Commonwealth or to provide services at an event or competition in this Commonwealth which is sanctioned by the national sport governing body (think Little League World Series) so long as: (i) The physician’s practice is limited to that required by the national sport governing body, and (ii) The services provided by the physician must be within the area of the physician’s competence.
A physician who is exempt from Pennsylvania licensure under the bills would not be permitted to provide care or consultation to any Commonwealth resident other than those specifically allowed by the legislation, or practice at a health care clinic or health care facility, including an acute care facility.
The Senate Consumer Protection and Professional Licensure Committee approved the bills without objection on Sept. 17, and the measures could receive consideration by the full Senate in the near future.