The upcoming 2015-2016 session of the General Assembly will begin on January 6, 2015, when House and Senate members are sworn in. However, Governor-elect Tom Wolf will not be sworn in until January 20. Wolf, a Democrat, will face an overwhelmingly Republican legislature, with the GOP controlling the House 119-84, and the Senate 30-20. It should make for an interesting two years.
State legislators ended the 2013-2014 legislative term with a flurry of activity, enacting several health care-related measures. Following is a summary of the significant initiatives enacted this year.
Regulation of Tanning Salons
Culminating years of hard work by PAMED and its allies, On May 6, 2014, Governor Corbett signed a new law banning use of tanning facilities by minors under the age of 17 and requiring parental consent for seventeen-year-olds. The new law (formerly HB 1259, now Act 41) also requires:
- Tanning facilities to post warning signs on the premises , and keep records for three years
- Customers to sign a written warning statement prior to tanning
- Tanning devices to meet federal and state standards
- Employees of tanning facilities to have training in both the use of the devices and recognition of customer skin types
There have been several versions of tanning bills over the years supported by the Pennsylvania Medical Society (PAMED), the Pennsylvania Academy of Dermatology and Dermatologic Surgery, and the Pennsylvania Chapter of the American Academy of Pediatrics. In past sessions tanning legislation would pass the Senate but stall in the House. However, persistence has paid off, and the new law went into effect on July 5, 2014.
Lyme Disease Bill Signed Into Law
Lyme disease is the most commonly reported vector-borne illness in the United States, and according to the Centers for Disease Control and Prevention (CDC), in 2012 it was also the country’s seventh most common nationally notifiable disease, despite the fact that 95 percent of the cases are reported from just 13 states. Pennsylvania sits at the top of that unfortunate baker’s dozen, joined only by Massachusetts as states with more than 5,000 confirmed or likely cases in 2012.
Senate Bill 177, signed into law by Governor Corbett on June 29, 2014, will establish a task force in the Department of Health to make recommendations to the Department regarding a wide range of surveillance, prevention, information collecting, and education measures. The Department will be charged with the task of developing a program of general public and health care professional information and education regarding Lyme disease, along with an active tick collection, testing, surveillance and communication program.
The Department will also be directed to cooperate with the Pennsylvania Game Commission, the Department of Conservation and Natural Resources, and the Department of Education to ensure that the information is widely disseminated to the general public, as well as to school administrators, school nurses, faculty and staff, parents, guardians and students.
The Pennsylvania Medical Society has long supported legislation calling for the state to take a more active role in information gathering and public education regarding Lyme disease. Unfortunately, earlier versions of the legislation also contained problematic language statutorily endorsing long-term antibiotic therapy, a controversial treatment protocol rejected by the CDC, which ultimately doomed those bills to failure.
However, the new law does not contain that highly contentious provision, and the Society is pleased with the bill’s enactment.
Controlled Substance Database Legislation Enacted
On October 27, 2014, Governor Corbett signed Senate Bill 1180 into law, authorizing the creation of a statewide controlled substance database.
The database will be housed at the Department of Health, where it will be run by a board consisting of the Secretaries of Health, Human Services, Drug and Alcohol Programs, State, Aging, the Insurance Commissioner, the State Police Commissioner, the Attorney General, and the Physician General (if the Secretary of Health is not a physician).
The board will aid prescribers in identifying at-risk individuals and referring them to drug addiction treatment programs, and will also refer information to the appropriate licensing board when the system produces an alert that there is a pattern of irregular prescribing or dispensing data.
It will also create a written notice prescribers and dispensers will use to let patients know that information regarding their prescriptions for controlled substances is being collected by the program.
Prescribers will not be required to submit prescribing information to the program, but dispensers must electronically submit information to the program regarding each controlled substance dispensed, no later than 72 hours after dispensing a controlled substance. However, prescribers at a licensed health care facility who dispense controlled substances limited to an amount adequate to treat a patient for a maximum of five days, with no refills, are exempted from the requirement to submit that information to the program.
While the language is a bit awkward, the intent is that prescribers are not absolutely required to query the database in all circumstances prior to prescribing a controlled substance, though the bill provides strong guidance for when that should take place. Specifically, a prescriber “must query the program for each patient the first time the patient is prescribed a controlled substance by the prescriber for purposes of establishing a base line and a thorough medical record, or if a prescriber believes or has reason to believe, using sound clinical judgment, that a patient may be abusing or diverting drugs.”
Prescribers will be able to designate employees for purposes of accessing the program on their behalf, and prescribers will be permitted to query the program both for an existing patient and for prescriptions written using their own DEA number. Dispensers may query the program for a current patient to whom the dispenser is dispensing or considering dispensing any controlled substance.
All law enforcement and grand jury queries of the program must be funneled through the Attorney General’s office. Those queries may take place without restriction for Schedule II controlled substances, but for all other schedules, a court order based on an active investigation will be required. Access to the database is also granted to various other state officials for specifically enumerated purposes.
A prescriber or dispenser who has submitted or received information from the program and has held the information in confidence cannot be held civilly liable or disciplined in a licensing board action for submitting the information or not seeking or obtaining information from the program prior to prescribing or dispensing a controlled substance.
There are significant civil and criminal penalties for improperly accessing the database or misusing information obtained from it.
The system is supposed to be up and running by June 30, 2015, so the Department of Health has a lot of work to do during the next eight months. Naloxone/Good Samaritan Bill Also Enacted On September 30, 2014, Governor Corbett signed another piece of opioid legislation into law. Senate Bill 1164, which cleared both the Senate and House unanimously, does two important things.
As originally introduced and passed by the Senate, it provided Good Samaritan immunity to individuals who seek to obtain aid for someone experiencing a drug overdose. The reason this matters is that individuals with someone experiencing an overdose may have been engaged in illegal activity at the time (i.e. selling drugs), and may be reluctant to seek help for fear of getting themselves in trouble with the law. The bill removes that obstacle, prohibiting law enforcement personnel from prosecuting an individual if he/she only became aware of the criminal activity because the individual was aiding a person experiencing a drug overdose.
The House of Representatives added an equally significant amendment to the bill, allowing naloxone, a lifesaving opioid antagonist, to be prescribed to first responders like firemen and police officers, as well as to friends and family members of persons identified as being at risk of experiencing a drug overdose. The House amendment also provides liability protection to prescribers and the aforementioned individuals if they administer naloxone in good faith to someone who they believe is experiencing a drug overdose.
The new law became effective on November 29, 2014.
Down Syndrome Bill Signed into Law
Signed into law by Governor Corbett on July 18, 2014, House Bill 2111 (now Act 130) will require a health care practitioner that administers, or causes to be administered, a test for Down syndrome to an expectant or new parent to, upon receiving a positive test result, provide the expectant or new parent with educational information made available by the Department of Health.
Though well-intentioned, the new law will force a physician to use one-size-fits-all, state-issued material that may not be appropriate for every patient. The requirement became effective in September 2014.
Physician Dispensing in Workers Compensation
A legislative initiative to place limits on physician reimbursements for dispensing drugs in workers’ compensation cases has borne fruit, as the state House and Senate approved a bill and Governor Corbett signed it into law on Oct. 27, and takes effect on Dec. 26, 2014.
House Bill 1846, introduced by Rep. Marguerite Quinn (R-Bucks), will cap the reimbursement rate for drugs and pharmaceutical services in the workers’ compensation system at 110 percent of the original manufacturer’s average wholesale price (AWP), calculated as of the date of dispensing.
A physician seeking reimbursement for drugs dispensed by a physician will be required to include the original manufacturer’s national drug code (NDC) number, as assigned by the Food and Drug Administration, on bills and reports. A repackaged NDC number would be prohibited and would not be considered the original manufacturer’s NDC number.
Additionally, under the bill no outpatient provider, other than a licensed pharmacy, will be permitted to seek reimbursement for drugs dispensed in excess of the following, commencing on the employee’s initial treatment following injury:
For Schedule II drugs, one initial seven-day supply, and one additional 15-day supply if the employee needs a medical procedure, including surgery;
For Schedule III drugs which contain hydrocodone, one initial seven-day supply, and one additional 15-day supply if the employee needs a medical procedure, including surgery; For all other prescription drugs, one initial 30-day supply.
No outpatient provider, other than a licensed pharmacy, will be allowed to seek reimbursement for an over-the-counter drug.
Proponents of the legislation asserted that there has been a rapid increase in physician dispensing of repackaged drugs in Pennsylvania, specifically within the workers’ compensation system. This practice is alleged to dramatically inflate costs borne by insurance companies, employers, and ultimately, by taxpayers.
A July 11, 2012, New York Times article asserts that these increased costs nationally amount to “hundreds of millions of dollars annually.”
According to published reports, physician dispensing typically begins when drug distributing firms purchase large quantities of drugs (e.g. 1,000 to 10,000 tablets) and repackage the drugs into single prescription sizes (e.g.14, 21, 28 tablets) appropriate for dispensing directly to patients. It is asserted that as part of the repackaging process, drugs are assigned a new national drug code (NDC) number and inherit a new average wholesale price (AWP), one that is typically far greater than the AWP established by the original manufacturer.
Pennsylvania’s existing pharmacy fee schedule sets the maximum reimbursement rate at 110 percent of the AWP for workers’ compensation pharmaceuticals, but the claim is that the higher AWP of repackaged drugs allows physicians, middlemen, and drug distributing firms to earn millions of dollars in profits.
Indeed, some dispensing firms advertise on their websites that physicians can earn hundreds of thousands of dollars in profits by dispensing drugs in their offices. The new law is intended to address that practice.
Epinephrine Auto-injector (EpiPen) Bill Signed Into Law
The Pennsylvania Medical Society (PAMED) scored another end-of-session legislative victory this year, as the state House and Senate approved a bill that will provide help for school children with severe allergies. Governor Corbett signed the measure into law on November 3, 2014.
The bill was driven by the knowledge that in an anaphylactic emergency, prompt action is essential, and in theory the school nurse would be able to administer the auto-injector almost immediately. However, in practice complicating factors may delay the quick administration of epinephrine to a child who is having an anaphylactic episode. The school nurse could be indisposed for any number of reasons, with catastrophic consequences.
For that reason, in 2012 the PAMED House of Delegates endorsed legislation that would allow epinephrine auto-injectors to be stored in a secure location in a classroom, and to permit a school to designate one or more non-nurse staff members to receive training so they could administer the medication in an emergency.
Working with Rep. Dick Stevenson (R-Mercer County) and Sen. Matt Smith (D-Allegheny County), PAMED steered the bill through the House and Senate without a single negative vote (a real rarity).
The bill permits a public or private school to authorize a trained school employee to:
provide an epinephrine auto-injector that meets the prescription on file for either the individual student or the school to a student who is authorized to self-administer an epinephrine auto-injector; and
administer an epinephrine auto-injector that meets the prescription on file for the school to a student that the employee in good faith believes to be having an anaphylactic reaction.
Physicians and CRNPs will be able to prescribe epinephrine auto-injectors directly to the school for that purpose.
Appropriately, the bill contains a number of safeguards to ensure patient safety:
A school that opts into the program may maintain at a supply of epinephrine auto-injectors, but they must be kept in a safe, secure location.
A school that authorizes the provision of epinephrine auto-injectors shall designate one or more individuals at each school who will be responsible for the storage and use of the epinephrine auto-injectors.
Individuals who are responsible for the storage and use of epinephrine auto-injectors must successfully complete a training program that will be developed and implemented by the Department of Health.
When a student does not have an epinephrine auto-injector or a prescription for an epinephrine auto-injector on file, a trained school employee may utilize the school’s supply to respond to anaphylactic reaction under a standing protocol from a physician or CRNP.
In the event a student is believed to be having an anaphylactic reaction, the school nurse or an individual in the school who is responsible for the storage and use of epinephrine auto-injectors shall contact 911 as soon as possible.
Parents who wish their child to be exempt from the provisions of the new law can simply sign a form and opt out. And school employees who administer an auto-injector pursuant to the law will have emergency response provider and bystander Good Samaritan civil immunity.
The new law will take effect on December 30, 2014, though the Department of Health has another 90 days after that to get the mandated training program up and running.
New Child Abuse Reporting Laws go into Effect
In the wake of the Sandusky child abuse situation at Penn State, significant changes have been made to Pennsylvania’s Child Protective Services Law, and many of the most important amendments will go into effect on Dec. 31, 2104.
Physicians who don’t see children in their practice still need to pay close attention to these changes, because they will now need to report suspected child abuse identified in certain circumstances outside their professional capacity.
Additional changes include, but are not limited to:
- The new definition of child abuse is more specific and has been expanded.
- Physicians will no longer be able to fulfill their reporting obligation simply by making a report to their supervisor or other designated person in their workplace.
- The penalties for failing to make a mandatory report are increased.
- Physicians have new mandatory child abuse recognition and reporting training requirements as a condition of licensure.
PAMED has developed a package of materials to help physicians understand and comply with the new requirements. The materials, which can be accessed on the PAMED website, include:
- An overview of the physician reporting requirements
- An explanation of the expanded definition child abuse
- Child abuse Frequently Asked Questions
- Risk factors, signs, and symptoms of child abuse
- An archived Dec. 4, 2014, webinar to help physicians understand the changes to the law
As mandated reporters, Pennsylvania physicians have always taken their responsibility to protect our children seriously. These materials will help them do so while remaining compliant with the significant changes to state law.