2020 Legislative Session Summary
Medicaid MCO PBM Reform: In 2018, the General Assembly passed SB 5 with the goal of providing transparency in Medicaid Managed Care Organizations (MCOs) reimbursements to pharmacies. After an initial study revealed spread pricing and other practices that cost the state additional precious resources, the General Assembly looked to solve the problem of low pharmacy reimbursements in Medicaid managed care. So this session, Sen. Max Wise (R-Campbellsville) filed SB 50 that, as introduced, would have carved all pharmacy benefits out of Medicaid managed care and returned them to Medicaid Fee for Service where pharmacies would have received the Center for Medicare/Medicaid Services reimbursement rate of NADAC plus a dispensing fee of $10.64. Hospitals and Federally Qualified Health Centers raised concerns to a fever pitch about the legislation, arguing they would lose tens of millions of dollars in revenue due to the loss of reimbursement in the 340B program. The 340B program allows non-profit health centers and Federally Qualified Health Centers to purchase prescription drugs at reduced rates and in turn, they argued that they use those revenues to provide services to the uninsured. Both of these entities teamed up with Medicaid MCOs to oppose SB 50 as written, even though the bill would have left 340B claims in Medicaid managed care. The Department for Medicaid Services stated it wasn’t going to oppose or support a Medicaid carve out, but did want additional information from the federal government if 340B claims could be left in the Medicaid managed care program. Instead the Cabinet for Health and Family Services (CHFS) proposed moving to a singular pharmacy benefit manager (PBM) that each Medicaid MCO would be required to contract with and pay the state established pharmacy reimbursement rates. The state selected PBM would be prohibited from certain practices such as spread pricing and direct and indirect renumeration fees. The state would also establish a single preferred drug list that the state selected PBM would use.
The Senate passed the amended version of SB 50 without a single ‘no’ vote. The measure then moved to the House Appropriations & Revenue Committee. Rep. Steve Sheldon (R-Bowling Green) took the amended SB 50 and started negotiating changes with the CHFS and secured agreements on several suggested changes. Sheldon’s changes strengthened the measure including prohibiting mandatory mail order and prohibiting PBMs from forcing patients to use a specialty pharmacy in which they have ownership. The House version of the bill also added a ‘stop gap measure’ to ensure that as the existing PBM contracts expire Dec. 31, 2020, reimbursements aren’t reduced. To that end, no PBM would be allowed to reduce current reimbursements for any reason or create any new fee. If a PBM violates this section, they could be charged a $25,000 fine per occurrence. The House version also created a new Pharmacy Technical Advisory Council that would include reviewing reimbursement rates established by DMS.
The House version of the bill unanimously passed the House and the Senate agreed to the House changes. The governor signed the bill and because it contained an emergency clause it took effect immediately.
Voluntary non-opioid directive: As Kentucky continues to grapple with the effects of the opioid crisis, legislators continue to look for policy solutions to ensure patients use the medications appropriately. One measure filed this session, HB 11, would have required health care prescribers to provide patients with a non-opioid directive form that the patient would sign to elect not to be prescribed opioids. The information would then be placed in the patient’s electronic medical record and a prescriber would not be able to prescribe them an opioid except in certain situations. Physicians and other prescribers raised concerns, including that a patient can refuse to take a prescription any time they are prescribed an opioid. The bill was never heard in the House Health & Family Services Committee.
Insulin: One healthcare issue that received a lot of attention this session was patient access to insulin and other medications used to treat diabetes, especially access to affordable insulin products. Discussions over the 2019 interim resulted in multiples bills that were filed to try and address the need for increased access to treatments for diabetic patients. House Bill 12 sponsored by Rep. Danny Bentley (R-Russell) would have required the cost on a 30-day supply of insulin to be capped at no more than $100. The House adopted the measure, but in the Senate, provisions of another bill filed to address insulin access were added. It was the provisions of SB 23 sponsored by Sen. Phillip Wheeler (R-Pikeville) that would have required the creation of an insulin-assistance program for indigent or uninsured patients. The program would have been paid for with a fee placed on pharmaceutical manufacturers. Ultimately, the addition of this controversial provision led to the bill’s demise, including the provision of HB 12 to cap the cost of a monthly insulin prescription. Two additional companion bills were filed in the Senate that would have capped the cost of a monthly insulin prescription but neither were considered in the Senate (SB 69 and SB 118).
House Bill 249 also sponsored by Rep. Bentley would require the CHFS to publish a list of brand-named insulin products and the list price for the public. It would have prohibited a PBM from requiring a patient to pay a cost-sharing amount greater than what the pharmacy was being reimbursed, but it was never called for a committee vote.
Rep. Sheldon filed HB 423 that would have prohibited insurers from benefiting from rebates on prescription insulin and eliminate any insurers requirements for prior authorizations or step therapy. It too did not get called for a hearing in committee.
Co-prescribing of Naloxone: Rep. Bentley introduced HB 71 that would have required a prescriber to write a prescription for Naloxone whenever they prescribe an opioid. A prescriber would have also been required to provide education on overdose prevention to every patient receiving a prescription for an opioid. The bill was referred to the House Health & Family Services Committee where it languished.
Prescription Drug Coupon: House Bill 72 sponsored by Rep. Bentley would have required an insurer to count any patient co-pay or prescription assistance a patient received towards a copay or deductible. If these coupons are not counted towards a patient’s deductible, they lose the value of those cards and are forced to pay high out-of-pocket amounts sooner. The bill passed out of the House Banking & Insurance Committee despite some members arguing that the bill would increase insurance costs. The full House was set to consider the measure, but abruptly the measure was returned to the House Banking & Insurance Committee where it remained. While not all health insurers prohibit the prescription drug coupon from counting towards a patients’ deductible, some do and they opposed the measure actively with House leadership.
Pharmacists as Mental Health Providers: Legislation introduced by Rep. Bentley would have expanded the definition of a qualified mental health provider to include a psychiatric pharmacist. Qualified mental health professionals are allowed to assess mentally ill patients and determine if they need to be committed. Mental health care advocates concerned that pharmacists would be able to commit people raised concerns regarding HB 118. Instead, a compromise was reached to include a psychiatric pharmacist on the Mental Health Task Force created through HCR 49. The Mental Health Task Force would be responsible for studying mental health services including medication management of the mentally ill, but the Senate never considered the resolution.
Scope of Practice Expansions: Every year health care professions seek to increase their scope of practice and the services they can offer patients and this session was no different.
Physician Assistants: Prior to the passage of HB 135 this session, Kentucky was the only state to prohibit physician assistants from prescribing controlled substances. In its original form, it would have allowed physician assistants to prescribe and dispense controlled substances, but pharmacists’ advocates cried foul and the dispensing provision was removed. In its final form, physician assistants would be allowed to prescribe controlled substances schedule III, IV and V but not opioids.
Advanced Practice Registered Nurses: Once again, the APRNs were asking the General Assembly to remove the requirement of a collaborative practice agreement with a physician for APRNs with more than four years experience for prescribing controlled substances. House Bill 286 sponsored by Rep. Russell Webber (R-Shepherdsville) passed the House Licensing & Occupations Committee but was never considered for a vote by the full House. Physicians adamantly opposed this legislation.
Athletic Trainers: Senate Bill 125 changed the scope of practice of athletic trainers in Kentucky. Current state law allows athletic trainers to dispense medications to those they are providing services, and the athletic trainers wanted to expand that offering to patients who were children. The pharmacy community worked with the athletic trainers to remove the language stating that they can dispense medications, because what the trainers really wanted was the ability to administer medications. The bill passed and will take effect on July 15.
Medical Marijuana: Kentucky continues to debate the issue of legalizing medical marijuana, but each year as a bill to do so takes a step forward it just can’t cross the finish line. Medical marijuana advocates continue to push the General Assembly for legislation and their champion in the House has been Rep. Jason Nemes (R-Louisville). Rep. Nemes filed HB 136 that would legalize non-combustible medical marijuana for those individuals with a medical marijuana card as recommended by their physician or prescribing healthcare provider. The patient would then present the card to a medical marijuana dispensary and the patient would receive the recommend amounts based on their medical diagnosis. Originally the legislation would have required the Alcohol and Beverage Control to regulate the medical marijuana industry, but healthcare advocates argued that was not the appropriate agency if it was for medical use, and the bill was changed to have the CHFS regulate medical marijuana. Pharmacists argued that if the product is truly medical like other prescription drugs then a pharmacist should have a role in furnishing the product. While permitted pharmacies cannot furnish medical marijuana because federally it is still designated as a Schedule I drug, some states have included a role for pharmacists. In working with Rep. Nemes, the pharmacy community was able to include a role for pharmacists. A medical dispensary would have to engage in a collaborative practice agreement with a pharmacist and the patient would have to have an initial consultation with a pharmacist prior to receiving the product. While the role for pharmacists as written in the bill isn’t exactly as pharmacists envisioned the process working, the House Judiciary Committee approved the amended version of the legislation as did the full House.
As HB 136 moved to the Senate, there were a lot of conversations about the bill, and Senate President Robert Stivers (R-Manchester) continued to say that there was a narrow window for the passage of medical marijuana legislation, but as the COVID-19 pandemic hit and legislative days were cancelled, the bill languished behind other more pressing issues. It is likely that these discussions will continue in the Senate next session, given that Sen. Stephen West (R-Paris) filed companion legislation legalizing medical marijuana in Kentucky.
Some representatives leery of the legalization of marijuana in any form filed legislation that would encourage research or create a research process in Kentucky. Rep. Bentley filed HCR 5 that would urge the federal government to expedite research on the efficacy and safety of medical marijuana. Bentley has filed this resolution in previous sessions and he was finally successful in its passage this session. House Health Family Services Chair Kim Moser (R-Taylor Mill) filed HB 463 that would have created Kentucky Center for Cannabis Research and appropriated $2.5 million to the University of Kentucky for creation of the center, but it wasn’t adopted by the General Assembly.
Mandatory Pill Counts: Rep. Derek Lewis (R-London) filed legislation that would have required pain clinics to conduct mandatory pill counts when patients are prescribed opioids for longer than three months. The pill count results would be recorded in KASPER. The bill was referred to the House Health and Family Services Committee, but was not called for a vote in committee (HB 202).
Patient Directed End of Life Care: House Bill 224 sponsored by Rep. Mary Lou Marzian (D-Louisville) would have established a procedure for terminally ill patients to self-administer medications for end-of-life care. The bill would have required the prescriber inform the pharmacist that the prescription was for end-of-life care and the prescriber would be allowed to pick up the prescription on behalf of the patient. The bill did not receive a hearing and therefore died in the House Health and Family Service Committee.
Prescription Drug Price Restrictions: Prescription drug costs have been a concern for patients across the country, and in Kentucky the conversation on reducing prescription drug costs led to multiple bills being filed. House Bill 248 filed by Rep. Bentley would have prohibited limited distribution of generic drugs or those with fewer than three competitors from engaging in unrestricted price increases and allow the attorney general to investigate price increases. The bill was referred to the House Health and Family Services Committee where it remained.
A measure referred to the House Banking and Insurance Committee would have limited the copay/coinsurance of epipens to no more than $50 per pen per month for children under the age of 18 (HB 519). Additionally, SJR 5 would have required the Cabinet for Health and Family Services to create a taskforce to study prescription drug affordability and price transparency. Neither of these measures advanced in the 2020 legislative session.
Drug Abuse Treatment: Given that Kentucky is still grappling with the effects of an opioid abuse epidemic, legislators are still looking for ways to make it easier to get patients into effective treatment programs. With that in mind, Rep. Kathy Hinkle (D-Louisa) filed HB 338 that would have created a drug treatment, prevention and recovery program funded through proceeds of lawsuits taken by state officials, such as the attorney general. Another bill filed by House Health & Family Services Chair Moser would have prohibited insurers, including Medicaid, from requiring or using utilization review for certain drugs used to treat alcohol or opioid addiction. The bill passed out of the committee chaired by Moser, but it was recommitted to the House Appropriations & Revenue Committee where it remained (HB 389).
PBM Reform: Community pharmacies across the state have argued for years that the behaviors of Pharmacy Benefit Managers (PBMs) need to be reformed. These entities are the prescription drug middlemen who reimburse pharmacies for the prescription drugs they dispense and arguably unfairly reimburse pharmacies. Rep. Sheldon, a community pharmacist championed PBM reform in the commercial space by filing three bills. House Bill 398 would have made multiple changes to how prescription drugs are reimbursed. First, it would have prohibited claim adjudication fees, which are fees charged by PBMs and oftentimes aren’t assessed until long after the patient has left the pharmacy. It would have prohibited insurers and the PBMs they contract with from requiring patients to use mail order pharmacies. It would have also given the Commissioner of the Department of Insurance the ability to review and approve rates if they chose to do so. House Bill 399, would have made changes to the practice of pharmacy audits – a new profit area for PBMs and a way to recoup additional dollars from pharmacies. Essentially the measure would have prohibited a PBM from recovering any claims found in an audit except in the case of an actual overpayment or fraud. In other words, if the patient received the medication and there was no fraud or overpayment, the PBM couldn’t recoup any money from the pharmacy. Finally, HB 400 would have prohibited PBMs from requiring patients to use pharmacies in which they have a financial interest. All of these bills were referred to the House Banking & Insurance Committee and didn’t receive a hearing.
Treatment of Lyme disease: Sponsored by Rep. Sheldon, HB 435 would have allowed a physician to prescribe, dispense or administer long-term antibiotic use to treat Lyme disease and prohibited any licensing board from taking action against the physician. All health insurers would be required to pay for long-term antibiotic use for the treatment of Lyme disease. The bill passed out of the House Health & Family Services Committee, but it was reassigned to the House Appropriations & Revenue Committee where it remained.
Reimbursement for pharmacist services: House Bill 462 sponsored by Rep. Bentley would have required health insurers and workers’ compensation companies to reimburse pharmacists for services currently within their scope of practice. Kentucky pharmacists are authorized to perform certain medical services statutorily or through administrative regulation, but they are not reimbursed for these services by insurers. This legislation did not include a scope of practice expansion, but it merely would have provided reimbursement for services pharmacists are legally allowed to perform within their scope of practice today. Pharmacists would have been reimbursed for services at no less than the allied health professionals’ rate for the same service. Insurance companies and physicians claimed that the legislation was too broad and would create additional costs. The bill was referred to the House Banking & Insurance Committee where it stayed until the end of the legislative session.
Medicaid Managed Care Contracts: Kentucky has utilized Medicaid Managed Care Organizations (MCOs) companies to provide health care coverage for most of its Medicaid population for a number of years and many healthcare professionals continue to push for reforms. Legislators have joined the cause and filed multiple bills regarding Medicaid MCO contracts and how they operate. Sen. Stephen Meredith (R-Grayson) filed three bills on the topic. The first, SB 29 would have required Medicaid MCOs to provide copies of provider contracts to the Medicaid Oversight Committee and require that rural healthcare providers be paid at least the median reimbursement rate of the closest urban community providers. Senate Bill 30 would have limited the number of Medicaid MCOs to three, from the current five. This bill passed the Senate and the House Health and Family Services Committee but was never voted on by the full House. Finally, Meredith also filed SB 34 that would have prohibited Medicaid from charging patients a copay for any services. Senate Bill 29 and SB 34 never received committee hearings.
Also filed in the House was HB 477 that would have prohibited the CHFS from contracting with a health insurer for Medicaid managed care services if they don’t offer basic health insurance on the commercial market. House Bill 609 would have allowed the Department for Medicaid Services to deny contract changes between pharmacies and PBMs contracted with a Medicaid managed care organization. House Bill 608 would have required the Department for Medicaid Services to set or create PBM reimbursement rates to pharmacy. None of these measures advanced in the House Banking & Insurance Committee.
Deceptive Legal Advertising: Rep. Kim Moser (R-Taylor Mill) filed HB 481 that would have required entities soliciting participation in lawsuits to provide a disclaimer on the advertisement that a patient should seek medical advice prior to stopping medication based on the claims in the advertisements. The trial attorneys opposed this measure arguing that it puts unnecessary restrictions on advertisements. The bill was referred to House Judiciary Committee and was never discussed.
Medical Ethics Protection: Legislation filed in the House and Senate would have prohibited employers of pharmacists and other healthcare providers from inquiring whether or not a potential employee had a moral or ethical objection to any medical care they may be required to provide. A pharmacist would have been allowed to refuse to participate in a medical service to which they had a moral or ethical objection and the employer could not retaliate against them. An employer when hiring a pharmacist could ask if they had moral or ethical objections. Senate Bill 90, sponsored by Sen. Meredith, was the measure that was poised to move, and HB 501 was its companion legislation in the House. Meredith successfully pushed the measure through the Senate Judiciary Committee, but it was not without controversy. Hospitals and other medical professional organizations raised concerns that legislation such as this could create healthcare shortages across the commonwealth where it was already difficult to find healthcare services for treatments such as drug abuse. The bill was amended to remove any reference to health insurers, because as the bill was written initially, it would have included health insurers and given them the ability to refuse to provide certain health care services. It was also amended to remove psychologists. The bill did advance out of committee and was poised to pass the Senate, but unexpectedly Senate Leadership moved the bill back to committee and it was never voted on by the full Senate.
Controlled Substance Advisory Council: As many healthcare professions look to expand their scope of practice to include prescribing controlled substances, Rep. Moser filed legislation that would reinstate the Controlled Substance Advisory Council to provide advice to state licensing boards on appropriate prescribing; the council would include three pharmacists (HB 502). Moser also filed HB 620 that would have created a council and required each state licensing board to create regulations relating to reviewing, investigating, and enforcing violations of prescribing practices. Pharmacists would have been included in this, but since they cannot prescribe it was unclear why they were included. The bill was referred to the House Licensing, Occupations & Administrative Regulations Committee, but it never received a hearing.
Cannabidiol: A resolution filed by Rep. Richard Heath (R-Mayfield) would have urged Congress to reassess the legal definition of hemp to allow products to contain up to 1% THC. House Concurrent Resolution 57 passed the House but was not considered by the Senate Agriculture Committee.
Infants Born Alive: Senate Judiciary Committee Chair Whitney Westerfield (R-Hopkinsville) filed SB 9 that would have required any healthcare provider, including a pharmacist, present during a birth to care for an infant born alive, including during late-term abortions. The bill passed the Senate easily, but it was amended in the House to say that the attorney general could seek injunctive relief for abortion clinics continuing to provide services during a state of emergency. The measure became more controversial, but it passed the House and Senate and was subsequently vetoed by the governor. The General Assembly didn’t have the opportunity to override the veto since they had already adjourned.
Health Insurer-Provider Fair Contracting: Senate Bill 70 as filed would have required fair contracting practices between Medicaid MCOs and healthcare providers would have required health insurers to negotiate contracts in good faith, prohibit all or nothing contracts and allowed healthcare providers to reject individual specific portions of the contract. Sponsored by Sen. Westerfield, the bill was referred to the Senate Banking & Insurance Committee, but it failed to get a hearing.
Medication Disposal: A bill advocated for by coroners would have required coroners to collect and dispose of unused medications in the home a person who had died. The bill, SB 144, was referred to the Senate State & Local Government Committee, but it failed to pass.
COVID Immunity: Senate Bill 150, the COVID relief bill, included language that ensures that any healthcare provider providing treatment for COVID-19 that may not be approved yet by the FDA would be immune from liability. The bill passed and was signed by the governor. It is in effect until the emergency ends or when the General Assembly returns for the next annual session.
Task Force on COVID Preparedness: During the final days of the session, legislation was filed in the House and Senate to create task forces to study the emergency preparedness of the commonwealth, but neither measure was enacted. SJR 246; HR 135