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Kentucky Regulatory, Legislative and Reimbursement Report – July-August-September 2015

Kentucky Regulatory Update

  • Pharmacy Services in Long Term Care Facilities
    • On August 1 2015, the Board of Pharmacy published a new proposed regulation (201 KAR 2:370) regarding pharmacy stock in LTCF.  August 31 ended the public comment period.  Regulation took  effect November 5, 2015.
    • BOP regulations committee deferred action on regulatory changes regarding the use of automation in LTCF until 2016.  Click here for regulation.
  • Emergency Drugs
    • New language includes a maximum of 36 emergency drugs, 6 deep in the emergency kit, in which 6 drugs are controlled medications. A waiver can be requested to increase the number of non-controlled medications.
  • Pharmacy Stock
    • Pharmacy stock drugs are limited to 150 non-controlled items, 15 deep. Pharmacy stock drugs in a personal care facility are limited to 30 non-controlled items, 5 deep.  A waiver can be requested to increase the number of non-controlled medications.
  • Collaborative Care Agreements
    • On August 1 2015, the Board published proposed regulatory changes to 201 KAR 2:220 that will conform the existing regulation on collaborative care agreements to the statutory changes made HB 377. The Board filed the changes and the regulation is expected to be before the Administrative Regulation Review Subcommittee at its November 2015 meeting.
  • HIV/AIDS Continuing Education Repeal
    • Mandatory HIV/AIDS CE has been repealed. Becomes effective September 4, 2015.
  • Mandatory Patient Counseling
    • Proposal would mandate patient counseling by the pharmacist in instances where there is a change in the prescription order or change in the manufacturer when dispensing a generic product. The board of pharmacy regulations committee is expected to take action at the end of 2015.
  • APRN Prescribing
    • May prescribe non-controlled medications with CAPA-NS in emergency situations when physician is unavailable.
  • Physician Assistants
    • Physician supervising must review and countersign no less than 10% of all medical notes written by PA every 30 days.
  • Pharmacy Technicians
    • PTCB elevating standards for national and re-certification
    • Over the next 7 years will mandate background checks, accredited education requirements and changes in CE programs for acceptance in re-certification
  • Marijuana Proposed Regulation
    • Representative Stumbo from Prestonsburg proposed HB 3 Gatewood Galbraith Medical Cannabis Act. It would have required the Department for Public Health to operate a medical cannabis program.
    • Requirements for the prescribing and dispensing of marijuana include:
      • A “Debilitating Medical Condition”
      • Diagnosis from physician KBML to issue certificates to physicians
      • Registry ID card from DPH
      • No more than 60-day supply
      • Available through dispensaries 1 in each development district
      • Pursuant to a medical order
      • Subject to KASPER reporting
    • The bill would have created “Task Force on Risk Evaluation and Mitigation Strategies for Medical Cannibis”.  There was an informational meeting in House Health & Welfare Committee but it died  in  committee.

Kentucky Legislative Update

The following legislative priorities will be discussed during the 2016 Kentucky Legislative Session

  • PBM Licensure and MAC Transparency Enforcement
    • SB 12 was originally passed in 2013 which included criteria that PBMs must follow in providing transparency for pricing, formulary, and coverage of generic products. PBMs are not complying with certain portions of the bill.  Additional language is being requested during the 2016 legislative session to strengthen the bill:
    • Notification to the pharmacy on where drugs can be purchased at or below the MAC price if the appeal for improper reimbursement is denied. Provision of MAC prices.
    • Require PBMs to adjust the reimbursement for the billed claim, retroactively.
  • Biosimilar Products
    • Biotechnology industry continues to push for legislation that will place a restriction on the substitution. Biosimilar to Neupogen is Zarxio manufactured by Sandoz.
  • Repeal of the Term Limits for Board of Pharmacy Members
    • At least one member of the BOP is continuing to push for legislation that will allow members to serve more than two four-year terms. A bill was introduced in 2015 but failed to pass after the pharmacy community raised strong objections.
  • Medication Synchronization
    • SB 44 requires health plans to provide medication synchronization program for patients on multiple medications for a treatment of a chronic illness.
  • Specialty Products
    • PBMs are including more products into a ‘specialty’ category and requiring ‘specialty pharmacies’ to dispense them. Many independent pharmacies cannot meet the requirements of a ‘specialty pharmacy’.

Foundation for a Healthy Kentucky

  • Foundation for a Health Kentucky releases data on ACA implementation in Kentucky
    • The Study of the Impact of the Affordable Care Act (ACA) on Health Coverage, Access, Quality, Cost, and Outcomes in Kentucky (Study), funded by the Foundation for a Healthy Kentucky, is a three-year mixed methods study analyzing the key effects of the ACA in Kentucky. The Study is conducted by the State Health Access Data Assistance Center (SHADAC), a health policy research institute at the University of Minnesota. As part of the Study, the research team produces Quarterly Snapshots to track ACA implementation indicators in a timely way.

Kentucky’s First Greenhouse

  • Senior Living Residence
    • Christian Care Communities today opened the doors to Kentucky’s first Green House® Residence – The Home Place at Midway – that revolutionizes assisted living, memory care and skilled nursing care for older adults. The $13.5 million Green House® community is located at 101 Sexton Way, across from Midway College.
    • Please click here for more information.

Kentucky Department for Medicaid Services

  • Medicaid Patients Face Disenrollment
    • The Kentucky Department for Medicaid Services has implemented a new process regarding address updates for Medicaid patients. As of Aug. 18, 2015, any Kentucky Medicaid Patient who does not have a correct address on file in the kynect Self-Service Portal, and who has any mail returned as undeliverable, will be dis-enrolled from Medicaid if the address is not updated within a short time period.
    • In all likelihood, patients will discover that they no longer have coverage when their prescriptions are being refilled. Pharmacies may want to let your Medicaid patients know that this process is being implemented, and that they need to make sure that their correct address is on file, especially if they have moved in the last year.
  • Kynect has posted additional information on this dis-enrollment process which can be reviewed here.  A copy of the Provider Letter can be accessed here. And, in addition, refer to the following information for FAQs.

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