State and Federal Legislative Priorities for Pharmacy Jim Baumann, R.Ph. President KPhA KU School of Pharmacy Campus Convention February 21, 2015

 IMPACT!  The way you practice  The way you are paid and reimbursed  The way you can interact with patients  The way you run your business  The way you are taxed and regulated Why should you be in interested in Legislation that involves Pharmacy

 Provider Status H.R. 592  amends Title XVIII of the Social Security Act to enable patient access to, and coverage for, Medicare Part B services by state-licensed pharmacists in medically underserved communities. The bill would recognize pharmacists as healthcare providers. National Legislative Priorities

 Any Willing Pharmacy H.R. 793  Allowing Medicare Part D seniors to obtain medications from any pharmacy without penalty of higher co-pays  Eliminate “preferred pharmacy” networks especially in underserved rural areas. National Legislative Priorities

 Medicare Prescription Drug Price Negotiations Act SB 31  Authorizes secretary HHS to negotiate drug prices with manufacturers including rebates, discounts, and other price concessions. HHS will not be authorized to establish formulary or prevent plan sponsors to obtain additional discounts from manufacturers. Secretary would report to congress every 6 months on negotiation to achieve lower prices. National Legislative Priorities

 Medicare Part D PBM MAC Transparency Act H.R. 244  Requires PDP cannot enter into a contract with PBM without certain criteria  Prevents patient from being forced or incentivized to use a pharmacy that is owned by a PBM (retail, specialty, mail order) and that personal information cannot be transmitted from PBM to their entitites unless patient has authroized.  Requires MAC pricing to be updated every 7 days and disclosure on sources used to update price. National Legislative Priorities

 MedSync  MAC Transparency  Others  Medicaid Expansion  Medicaid Medication Reimbursement  Medicaid Mental Health PDL  Fiduciary Responsibilities of PBM’s with State Employee Health Plan State of Kansas Legislative Priorities

 MAC Transparency Talking Points  The bottom line: Pharmacies should know that they are going to be reimbursed for at least the cost of the medications they sell.  Most health insurance plans, including Medicare and Medicaid, use pharmacy benefits managers (PBMs), which act as middlemen to handle payments for prescription medications.  Pharmacies must contract with PBMs in order to stay in business, which gives the PBMs considerable market power.  Those contracts stipulate that pharmacies will be paid for generic medications using a strategy known as "MAC pricing" — for maximum allowable cost. The problem is that MAC pricing is usually confusing and opaque.  Each PBM's MAC pricing list is different. Most consider their lists trade secrets and refuse to disclose them to insurance companies or pharmacies — that includes the drugs on the lists, their prices, how they're determined, or how often they change.  When it comes to private insurance plans, no one but the PBMs know the drugs or prices on the lists, how they're determined, or how often they change.  The structure of the contract isn't negotiable; if a pharmacy wants access to the patients in a particular network, it must sign the contract.  PBMs frequently audit pharmacies and use technicalities to refuse to reimburse them for expenses. MAC Transparency SB 103

 Despite all this, pharmacies must enter into these one-sided contracts, not knowing how much they will be paid for any given drug on any given day. Pharmacies don't know if their reimbursement will even cover the cost of the medication.  By deciding which medications they will cover and how much they will pay, PBMs can effectively decide what medications are affordable for consumers to take and for pharmacies to carry.  This risks making medication unavailable to patients, especially in Kansas's smaller and rural communities, where there are a limited number of pharmacies. Issues with MAC Transparency

 What we’re asking for:  We aren't asking PBMs to open their books or reveal their secrets. What we want is some predictability in pricing.  Our legislation would...  Require PBMs to update their price lists every seven days, so they remain in line with actual wholesale costs.  Require PBM contracts to be clear about how MAC pricing is calculated.  Give authority to the Kansas Insurance Commissioner to oversee and enforce PBM contracts.  Require PBMs to document that the drugs on their MAC pricing lists are actually available at the low price for which they are willing to reimburse pharmacies.  MAC pricing transparency is not only fair and reasonable, it will benefit Kansas communities by keeping medication available to patients, and by keeping local pharmacies in business. MAC Transparency SB 103

 Medication Synchronization Talking Points  A major driver of rising health care expenditures is the cost associated with treating chronic illnesses. For many of these chronic illnesses, medications are the most cost-effective treatment, and yet patients routinely miss doses. Medication synchronization is increasingly being recognized as a tool that can improve adherence when patients are on a regular chronic medication regimen. It refers to the process of a pharmacy coordinating all of a patient’s chronic prescription medications to be filled on the same date each month.  Many patients fail to refill a prescription, or stop taking medications without consulting a health care professional.  Poor medication adherence leads to more frequent hospitalizations, poorer health, higher healthcare costs (up to $290 billion per year), and increased risk of death.  Pharmacists facilitate a critical role to ensuring proper and timely use of medications and medication adherence.  An emerging opportunity for pharmacists to help increase proper medication use and increase adherence, while improving pharmacy efficiency, is medication synchronization.  Medication Synchronization can streamline prescription refills for pharmacists, providers, and patients allowing patients to fill all of their medications on the same day each month.  Medication Synchronization also improves patient safety. Many people with chronic health problems and the elderly have mobility issues that limit their trips to the pharmacy.  By filling all of their prescriptions at the same time each month, it makes it more convenient for them to pick up their medicine and reduces the risk they will go off their medications because they have run out. Med Sync HB 2176

 There are several barriers to medication synchronization. When attempting to synchronize a patient’s medications, some prescriptions are deemed “refill too soon” by the insurer or third party. Some insurers allow only 1 claim per 30 day period, making it difficult to synchronize medications. Another issue is that patients are often charged a full month’s co pay for just a partial fill to synchronize their medications. Several states are addressing these issues with legislation. Connecticut passed legislation in 2013, and over 10 other states have active legislation, including Missouri. Barrier to Med Sync

 What we’re asking for:  Our legislation would...  Allow for a prorated daily cost-sharing right to prescriptions that are dispensed for less than a 30 day supply when it is in the best interest of the patient.  Prohibit denial of such coverage or prorated dispensing fees  Give authority to the Kansas Insurance Commissioner to oversee and enforce this statute.  Medication synchronization increases medication adherence and will benefit Kansas patients by keeping required medications more easily accessible to patients Med Sync HB 2176

 Medicaid Expansion  Follow Federal Guidelines according ACA  Medicaid Medication Reimbursement  Change reimbursement formula and dispensing fee  Medicaid Mental Health PDL  Allow Mental Health Medications to be managed by PDL and DUR process  Medicaid Delay New Drugs for Formulary Access  Change access for new drugs from immediately until reviewed by PDL to 6 months non approved and then reviewed Medicaid Bills

State of Kansas Board of Pharmacy Priorities & Changes Dave Schoech, R.Ph. Chair, Kansas Board of Pharmacy

Regulation vs. Statute Regulation  A regulation is a direction adopted by the executive branch (governor) which has the binding effect of law and then empowers a particular department (board of Pharmacy) to make regulations to implement the intent of the general law. Statute  A statute is a law passed by the legislative body such as a congress (house and senate & signed by governor)  Changes and amendments in statutes require the legislature to vote and pass new or revised law.

 Collaborative Practice  Technician Certification Kansas Board of Pharmacy

Practice of Pharmacy  KSA a (b) (1) ‘‘Practice of pharmacy’’ means the interpretation and evaluation of prescription orders; the compounding, dispensing and labeling of drugs and devices pursuant to prescription orders; the administering of vaccine pursuant to a vaccination protocol; the participation in drug selection according to state law and participation in drug utilization reviews; the proper and safe storage of prescription drugs and prescription devices and the maintenance of proper records thereof in accordance with law; consultation with patients and other health care practitioners about the safe and effective use of prescription drugs and prescription devices; performance of collaborative drug therapy management pursuant to a written collaborative practice agreement with one or more physicians who have an established physician-patient relationship; and participation in the offering or performing of those acts, services, operations or transactions necessary in the conduct, operation, management and control of a pharmacy. 18

New Language  performance of collaborative drug therapy management pursuant to a written collaborative practice agreement with one or more physicians who have an established physician-patient relationship 19

KSA a (b)(2)  (2) ‘‘Collaborative drug therapy management’’ means a practice of pharmacy where a pharmacist performs certain pharmaceutical-related patient care functions for a specific patient which have been delegated to the pharmacist by a physician through a collaborative practice agreement. A physician who enters into a collaborative practice agreement is responsible for the care of the patient following initial diagnosis and assessment and for the direction and supervision of the pharmacist throughout the collaborative drug therapy management process. Nothing in this subsection shall be construed to permit a pharmacist to alter a physician’s orders or directions, diagnose or treat any disease, independently prescribe drugs or independently practice medicine and surgery. 20

KSA a (b)(3)  (3) ‘‘Collaborative practice agreement’’ means a written agreement or protocol between one or more pharmacists and one or more physicians that provides for collaborative drug therapy management. Such collabo- rative practice agreement shall contain certain specified conditions or limitations pursuant to the collaborating physician’s order, standing order, delegation or protocol.  A collaborative practice agreement shall be: (A) Consistent with the normal and customary specialty, competence and lawful practice of the physician; and (B) appropriate to the pharmacist’s training and experience. 21

KSA a (b)(4) (4) ‘‘Physician’’ means a person licensed to practice medicine and surgery in this state. 22

New Statute KSA (a) Not later than 90 days after the effective date of this act, the state board of pharmacy and the state board of healing arts shall appoint a seven-member committee to be known as the collaborative drug therapy management advisory committee for the purpose of promoting consistent regulation and to enhance coordination among such boards with jurisdiction over licensees involved in collaborative drug therapy management. Such committee shall advise and make recommendations to the state board of pharmacy and state board of healing arts on matters relating to collaborative drug therapy management. 23

Collaborative Drug Therapy Management Advisory Committee One member of the board of pharmacy appointed by the board of pharmacy, who shall serve as the nonvoting chairperson; (2) three licensed pharmacists appointed by the state board of pharmacy, at least two of whom shall have experience in collaborative drug therapy management; and (3) three persons licensed to practice medicine and surgery appointed by the state board of healing arts, at least two of whom shall have experience in collaborative drug therapy management. 24

Pharmacy Technicians  (a)… Every person registered as a pharmacy technician shall pass an examination one or more examinations identified and approved by the board within 30 days of the period or periods of time specified by the board after becoming registered. The board shall adopt rules and regulations identifying the required examinations, when they must be passed and establishing the criteria f or the required examination examinations and a passing score scores. The board may include as a required examination any national pharmacy technician certification examination.  Expands Board of Pharmacy authority pertaining to pharmacy technician registration. 25

Questions?