May/June 2019 | Page 9

G ove r n men t Re lat ions New State Law Requires Use of Electronic Prescriptions The Pennsylvania General Assembly passed HB353 (now Act 96 of 2018), which requires health care providers to electronically prescribe all Schedule II-V controlled substances, except when they are directly dispensed or administered by the provider (other than the pharmacists). EXEMPTIONS Act 96 includes a number of exemptions. Providers do not have to comply with this mandate if any of the following apply: 1. If a veterinarian issues the prescription. 2. If the prescription is not available to be issued or received due to a temporary technological or electrical failure (in this situation, a provider must, within 72 hours, see to correct any cause for the failure that is reasonably within his or control). 3. The prescription is dispensed by a practitioner or pharmacy located outside of Pennsylvania. 4. The prescription is prescribed by a provider who or a health care facility that does not have either of the following: • Internet access. • An electronic health record system. 5. Instances when a provider treating a patient in an emergency department or health care facility determines that it is impractical for the patient to obtain the controlled substance if it were prescribed electronically, or it would cause an untimely delay that adversely impacts the patient’s medical condition. 6. Prescriptions issues for patients enrolled in a hospice program, and residents in a nursing home or residential health care facility. 7. Situations in which controlled substance compounded prescriptions and prescriptions containing certain elements required by the FDA or any other governmental agency cannot not be prescribed electronically. 8. Prescriptions issues pursuant to an established and valid collaborative practice agreement between the provider and pharmacist, a standing order or a drug research protocol. 9. Prescriptions issues in an emergency situation pursuant to federal or state law, and Department of Health (DOH) regulations. 10. Where the pharmacy that receives the prescription is not set up to process electronic prescriptions. 11. Controlled substances that are not required to be reported to the Prescription Drug Monitoring System (PDMP). COMPLIANCE Providers who do not qualify for any of the above mentioned exemptions must start complying with the law by October 24, 2019. Providers who are unable to timely comply with the requirements may petition DOH for an exemption based on economic hardship, technical limitations or exceptional circumstances. DOH will adopt regulations establishing the form and specific information providers should include when petitioning for an exemption. PDA will inform members once this form is available. DOH may approve an exemption for a specified amount of time, not to exceed one year from the date of approval. The exception may be renewed annually, subject to approval. PDA recommends that providers still take steps necessary to comply with Act 96 even when petitioning DOH for a hardship exception. Be prepared to comply by October 24 in case DOH does not grant the hardship exemption. PENALTIES Providers who violate the Act are subject to the following penalties: • An administrative penalty of $100 for the first ten violations. • An administrative penalty of $250 for each subsequent violation, up to a maximum of $5,000 per calendar year. • Violations will reset and not carry over to subsequent calendar years. DOH will NOT report violations to the provider’s licensing board, nor does the provider need to self-report any violations. Licensing boards will NOT take disciplinary actions for any violations of Act 96 of 2018. Providers will have the ability to appeal any fine assessed by DOH. MAY/JU N E 2019 | P EN N SYLVAN IA DEN TAL JOURNAL 7