January Legislative Update: Drug Abuse Reforms, Pharmacy Tech Registration, MAC Tranparency Passes!
Antonio Ciaccia, Director of Government & Public Affairs and Michelle Fitzgibbon, Lobbyist
With our biggest goals already achieved earlier in this General Assembly (MAC transparency, consult agreements, med sync), we worked over the past several months to pass additional legislation that would make this General Assembly one of our most successful legislative stretches in OPA history.
SB 319: Pharmacy Tech Registration, Drug Abuse Prevention, MAC Transparency Improvements
SB 319, sponsored by Senator John Eklund (R-Munson Township), makes several pharmacy law changes if signed, including:
- Requires that all pharmacy technicians register with the Ohio State Board of Pharmacy by spring 2018. This is not a licensing requirement, but provides a sufficient tracking mechanism for the Board and for employers to ensure adequate quality standards for technicians and to get a better handle on prescription drug theft by technicians.
- Specifies certain activities, excluding any that require the exercise of professional judgment, that a pharmacy technician or trainee may, under the direct supervision of a pharmacist, engage in. OPA worked to ensure that technician responsibilities are clearly defined, allow them to greater assist pharmacists, and keep abilities within a proper administrative scope. We successfully combatted several proposals that we felt opened patients to risk of harm, and opened pharmacists up to extra liability.
- Specifies that not more than a 90-day supply of an opioid analgesic may be dispensed or sold, and that a prescription cannot be filled if more than 14 days have elapsed since it was issued or, if the prescription specifies the earliest date on which it may be filled, 14 days since that date. This ensures that pain medication is being filled legitimately – when pain is actually being felt by a patient.
In December, OPA was successful in advancing an amendment offered by Rep. Robert Sprague (R-Findlay) into SB 319 that will further improve Ohio’s maximum allowable cost (MAC) transparency laws. The changes will:
- Require PBMs to provide MAC pricing lists to pharmacies in an electronic format that can also be easily searched. No more packets of paper to sort through; no more waiting for MAC lists to arrive.
- Require PBMs to provide pharmacies their procedure for eliminating products from a MAC pricing list, upon the pharmacy’s request. This will better ensure that drugs which should not be subject to MAC, do not appear on MAC lists.
- Require PBMs to have an electronic means for pharmacies to submit MAC appeals. No more paper forms!
- Require on a MAC price appeal denial that the PBM provide the pharmacy the National Drug Code AND the name of the wholesalers from whom the drug was available for purchase at the benchmark rate set by the PBM. This is important, because it not only provides the pharmacy the chance to purchase the drug, but more importantly, it ensures that MAC prices are based upon prices that actually reflect the market. Ohio will be one of only a handful of states across the country with this type of language.
- Clarifies that, on a successful MAC appeal, the PBM is required to update the reimbursement to the pharmacy’s upheld appeal price.
This language makes it clear that if your pharmacy successfully appeals a MAC claim, the PBM shall update the reimbursement to your pharmacy’s appeal price.
- Requires PBMs to report MAC pricing spreads in aggregate amounts to plan sponsors on a quarterly basis. Maintains ‘spread pricing’ disclosures to plan sponsors, while alleviating administrative burdens.
- Gives the Ohio Department of Insurance rule-making authority to enforce the provisions of the law. This means that more details and procedures can be worked through in rule.
Ultimately, the PBM language is not everything we need, but these improvements should alleviate many issues being experienced in the current marketplace, and provide greater accountability. There is still much work to be done in the next General Assembly. Continue to send us issues you are experiencing with MAC pricing and other reimbursement structures.
We are pleased to report that SB 319 passed both chambers and, as of this writing, awaits a signature from Governor John Kasich!
SB 332: Pharmacist Drug Administration, Infant Mortality Reforms
Rep. Sarah LaTourette’s (R-Bainbridge Township) HB 421, which allowed pharmacists to administer certain long-acting medications to patients, was successfully voted out of the House. Because the end of the 131st General Assembly was approaching, OPA got HB 421’s language added to SB 332 thanks to an amendment from Senator Gayle Manning (R-North Ridgeville). SB 332 is a comprehensive infant mortality reform bill championed by Senator Shannon Jones (R-Springboro) and Senator Charleta Tavares (D-Columbus).
SB 332 (and HB 421) allows pharmacists (under a physician protocol) to administer by injection any of the following drugs, if the patient has a valid prescription for the drug:
- Any opioid antagonist used to treat drug addiction and administered in a long-acting or extended-release form;
- Any antipsychotic drug administered in a long-acting or extended-release form;
- Hydroxyprogesterone caproate (a prescription hormone used to lower the risk of preterm birth);
- Medroxyprogesterone acetate (a prescription contraceptive);
- Cobalamin (vitamin B12).
The bill also permits a pharmacist to administer epinephrine or diphenhydramine, or both, to an individual in an emergency resulting from any possible adverse reaction to a drug administration.
Aside from the pharmacist provisions, the bill also addresses several other initiatives aimed at improving Ohio’s infant mortality rates.
We are pleased to report that SB 332 passed both chambers and as of this writing, awaits a signature from Governor John Kasich!
HB 505: Biosimilar Substitution
HB 505 will allow pharmacists to substitute biosimilar interchangeable drugs for patients similarly to generic drug substitutions. OPA was successful in amending the original language to allow for most electronic system entries to constitute notification to the prescriber, thus reducing significant pharmacy administrative burden.
OPA worked to add a provision to expand different language allowances a prescriber can use to convey “Dispense As Written” or “DAW.” We have had pharmacies get penalized on PBM audits in the past when treating similar words (i.e., do not substitute, brand medically necessary, etc.) as equivalent to DAW. The bill provides that in the case of a written or electronic prescription, substitution of a generically equivalent or interchangeable biological product is prohibited if the prescriber handwrites or actively causes to display on the prescription “dispense as written,” “D.A.W.,” “do not substitute,” “brand medically necessary,” or any other statement or numerical code that indicates the prescriber’s intent to prevent substitution. In the case of an oral prescription, the bill provides that substitution is prohibited if the prescriber specifies that the drug is medically necessary or otherwise indicates the prescriber’s intent to prevent substitution. This language will ensure that those types of prescriptions are still lawfully valid and, thus, should be insulated from PBM audit takebacks based upon insignificant, technical errors.
HB 505 passed both the House and the Senate, and heads to the desk of Governor Kasich!
HB 285: Pharmacist Combining of Refills
HB 285 will allow pharmacists to combine prescription refills up to a 90-day supply of a non-controlled, maintenance drug. In the case of a prescription that authorizes a drug to be dispensed by refilling the prescription one or more times, a pharmacist who is filling or refilling the prescription may dispense a quantity or amount of the drug that varies from the quantity or amount of the drug that otherwise would be dispensed pursuant to the prescription if the following conditions are met:
- The total quantity or amount of the drug that may be dispensed by filling and refilling the prescription does not exceed a 90-day supply of the drug.
- The action taken by the pharmacist does not result in a quantity or amount of the drug being dispensed that exceeds the total quantity or amount that may be dispensed by filling and refilling the prescription.
- The prescription is not for a controlled substance.
- The prescription is for one of the following:
1) A maintenance drug to be taken on a regular, recurring basis to treat a chronic condition;
2) A drug to be taken on a regular, recurring basis to prevent disease;
3) A contraceptive.
- If the prescription is for a maintenance medication, the patient has used an initial 30-day supply of the drug, or a 90-day supply of the drug has previously been prescribed to the patient, and the pharmacist determines, after consulting with the patient, that the drug has stabilized the patient’s condition.
- The prescriber did not include limiting language on the prescription, such as “dispense as written,” or otherwise specify that the quantity or amount of the drug to be dispensed may not vary from the quantity or amount specified in the prescription.
- Dispensing multiple refills is appropriate for the patient, as determined by the pharmacist’s exercise of professional judgment after consulting with the patient.
HB 285 passed both the House and the Senate, and heads to the desk of Governor Kasich!
OPA thanks all of our members and volunteers who helped refine, improve, and advance these pieces of pharmacy legislation. You are all part of the advocacy machine, and we couldn’t do it without you!
Pharmacy Political Action Committee
Please consider financial support of our legislative efforts by contributing to the OPA Pharmacy PAC. One hundred percent of Pharmacy PAC money goes to help candidates who support pharmacy in Ohio. Visit http://bit.ly/OPA_PAC to make a donation!
For more information, contact Antonio Ciaccia at 614.389.3236 or firstname.lastname@example.org.
April 21-23, 2017
Greater Columbus Convention Center, Columbus, OH
May 11, 2017
Makoy Center, 5462 Center Street, Hilliard, OH 43026
May 23, 2017
OPA Office - 2674 Federated Blvd, Columbus, OH 43235
May 23, 2017
OPA Office - 2674 Federated Blvd, Columbus, OH 43235