By Michael D.I. Siget, JD, MPA, PAMED's Legislative & Regulatory Counsel
With the state legislature looking to finalize a budget, I thought it would be a good time to review some Pennsylvania bills of importance to physicians that have been enacted into law. I will also give an update on some bills that have passed either the Pa. House or the Senate.
In this Bills on the Hill, I will be reviewing bills on:
- The creation of a new rare disease advisory council
- Physician assistants
- Investigational drugs
- Epinephrine auto-injectors
- Lyme disease
- Electronic prescribing
- Changes to the Prescription Drug Monitoring Program (PDMP) law
- Registration of pain management clinics
- Reporting responsibilities and expungement opportunities for licensees
HB 239, introduced by Rep. Marcy Toepel, creates a Rare Disease Advisory Council within the Pennsylvania Department of Health. Among other duties, the Council will coordinate statewide efforts for the study of the incidence and prevalence of rare diseases within the Commonwealth and the status of the rare disease community. In addition, the Council is tasked with researching and determining the most appropriate method to collect rare disease data, and information concerning individuals with rare diseases, as the Council deems necessary and appropriate to conduct comprehensive surveys of rare diseases diagnosed in the Commonwealth, subject to all applicable privacy laws and protections. Under this law, a "rare disease" is defined as "a disease or condition that affects fewer than 200,000 individuals living in the United States."
HB 239 was signed into law by Gov. Wolf on July 7, 2017, as Act 14 and took effect immediately. It has a sunset date of June 30, 2025.
HB 424, introduced by Rep. Kerry Benninghoff, will allow physician assistants (PA) to sign a death certificate for a patient under the care of that PA. Under the law previous to this bill, PAs were permitted to determine the cause of death and pronounce death, but they were not permitted to sign a death certificate.
HB 424 was signed into law by Gov. Wolf on July 7, 2017 as Act 17. It will take effect on Sept. 5, 2017.
BILLS THAT HAVE PASSED THE HOUSE OR SENATE
HB 45, introduced by Rep. Robert Godshall and cited as the "Right-to-Try Act," would allow eligible patients with a terminal illness to use investigational drugs, biological products, and devices not yet approved by the U.S. Food and Drug Administration. Under this bill, a manufacturer of an investigational drug, biological product, or device may make available, and an eligible patient may request them, as long as the patient has a terminal illness and meets other requirements in the bill. A health care provider who in good faith recommends or participates in the use of an investigational drug, biological product, or medical device under this bill will be immune from criminal or civil liability or professional misconduct.
HB 45 passed the House of Representatives (193-0) on April 18, 2017. It is currently in the Senate.
HB 125, introduced by Rep. Matt Baker, would standardize the credentialing process for health care practitioners in the Commonwealth. All health insurers licensed to do business in the Commonwealth would be required to accept the CAQH credentialing application or other nationally recognized form designated by the Pennsylvania Insurance Department. The bill would require health insurers to issue a credentialing determination within 45 days after receiving a complete credentialing application.
HB 125 passed the House of Representatives (190-0) on May 24, 2017. It has been referred to the Senate Banking and Insurance Committee.
HB 126, introduced by Rep. Matt Baker, would allow a health care practitioner to prescribe epinephrine auto-injectors in the name of an authorized entity. Under this bill, an employee or agent of an authorized entity or other individual associated with the entity who has completed required training may administer or provide epinephrine auto-injectors for immediate administration to any individual or provide epinephrine auto-injectors to the parent, guardian, or caregiver of that individual if the employee or agent believes in good faith that the individual is experiencing anaphylaxis, regardless of whether the individual has a prescription for an epinephrine auto-injector or has previously been diagnosed with an allergy. Under this bill, an "authorized entity" is "any entity or organization, other than a school entity or a nonpublic school, which has an employee or agent who has completed the required training and at which allergens capable of causing anaphylaxis may be present." These entities include recreation camps, colleges and universities, daycare facilities, youth sports leagues, amusement parks, restaurants, places of employment, and sports arenas.
HB 126 passed the House of Representatives (191-0) on March 22, 2017. It is currently in the Senate.
HB 174, introduced by Rep. Matt Baker, would require insurance coverage for Lyme disease and related tick-borne diseases as prescribed by a patient's health care practitioner, regardless if the treatment plan includes short-term or long-term antibiotic treatment. Coverage of longer-term antibiotic treatment may not be denied solely because the treatment may be characterized as unproven, experimental, or investigational in nature for the treatment of Lyme disease and related tick-borne illnesses. The bill also provides immunity protection to health care practitioners for prescribing, administering, or dispensing longer-term antibiotic therapies provided the health care practitioner maintains the requisite standard of care for the patient.
HB 174 passed the House of Representatives (188-6) on May 23, 2017. It has been referred to the Senate Banking and Insurance Committee. Similar legislation has been introduced in the Senate (SB 100) by Sen. Stewart Greenleaf.
HB 353, introduced by Rep. Tedd Nesbit, would require, except when dispensed or administered directly to the patient by a practitioner or his agent (other than a pharmacist) to an ultimate user, practitioners to electronically prescribe Schedule II-IV controlled substances (does not include Schedule V) as opposed to using traditional prescription pads, unless an exception applies:
- Emergency situations as prescribed by regulation.
- Prescriptions issued by a veterinarian.
- Prescriptions issued when an electronic prescription is not available due to a temporary technological or electrical failure.
- Prescriptions dispensed by a pharmacy located outside of the Commonwealth.
- Prescriptions issued by a practitioner or health care facility that does not have Internet access or an electronic health record (EHR) system.
- Prescriptions issued by a practitioner treating a patient in an emergency department or a health care facility under circumstances when the practitioner reasonably determines that electronically prescribing controlled substances would be impractical for the patient to obtain the controlled substance prescribed by the electronic prescription or would cause an untimely delay resulting in an adverse impact on the patient's medical condition.
HB 353 passed the House of Representatives (194-0) on June 20, 2017. If enacted, it would take effect one year after being signed into law. It has been referred to the Senate Health and Human Services Committee.
HB 395, introduced by Rep. Gene DiGorolamo, would exempt non-narcotic Schedule V controlled substances used to treat an epilepsy or seizure disorder from the initial querying requirements under the Achieving Better Care by Monitoring All Prescriptions Program (ABC-MAP) Act, known as the PDMP law. It would also exempt a prescriber from having to query the PDMP system, after the initial query, for a patient under hospice care.
HB 395 passed the House of Representatives (190-0) on April 26, 2017. It has been referred to the Senate Health and Human Services Committee.
HB 1043, introduced by Rep. Matt Baker, would require pain management clinics to be registered with the Pennsylvania Department of Health. Subject to certain exemptions such as hospitals, long-term nursing facilities, and ambulatory surgical centers, a "pain management clinic" is defined as "a facility that advertises in any medium for a type of pain service and where, in any calendar month, a majority of patients of the prescribers at the facility are provided treatment for pain that includes the use of controlled substances." The bill would require registration, regular inspections, and pre-requisites for an entity that meets the definition of a pain management clinic.
HB 1043 passed the House of Representatives (191-0) on May 8, 2017. It has been referred to the Senate Health and Human Services Committee.
HB 1532, introduced by Rep. Kristin Phillips-Hill, would provide Medicaid Managed Care Organizations (MCOs) with access to the information contained in the PDMP system. MCOs would be allowed to query the system to review the requested dispensing or prescribing of a controlled substance to an individual to whom the MCO provides services under the Commonwealth's plan for medical assistance under the federal Social Security Act. In addition, if the MCO has reason to believe that a controlled substance prescribed or dispensed to an enrollee is fraudulent, the MCO is required to notify the Department of Human Services and the Office of Attorney General.
HB 1532 passed the House of Representatives (112-78) on July 7, 2017. It has been referred to the Senate Health and Human Services Committee.
SB 354, introduced by Sen. Robert Tomlinson, would standardize reporting requirements across all licensing boards by requiring all licensees, registrants, and certificate holders to report any disciplinary conduct by any licensing board or an arrest, indictment, or conviction within 30 days. Failure to report would result in disciplinary action.
A second part of this bill would allow a licensee, registrant, certificate holder, or permit holder to make written application to the applicable board to have a licensure violation for discipline expunged from the individual's record. The following provisions would apply:
- The discipline must be for a violation involving failure to complete continuing education requirements or for practicing for six months or less on a lapsed license, registration, certificate, or permit.
- The application must make written application for expungement no earlier than four years from the final disposition of the disciplinary record.
- The discipline must be the only discipline on the individual's record.
- The individual must not be the subject of an active investigation related to professional or occupational conduct.
- The individual must not be in current disciplinary status.
- The individual must not have had a disciplinary record previously expunged.
- The individual must pay all costs associated with the expungement as established by regulation.
While the individual's public record will be expunged, the violation will still be on file with the licensing board and may be used for any regulatory purpose and may be released by the licensing board upon request from law enforcement or other governmental body as permitted by law.
SB 354 passed the Senate (47-0) on May 8, 2017 and the House of Representatives (198-0) on June 28, 2017. However, the House amended SB 354 and it has been referred back to the Senate to see if the Senate will concur in the House's amendments.