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2015-2016StateLegislation. Legislative Issues of Concern  SCPhA’s lobbyists constantly track legislation that may be harmful to the profession.  Includes.

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Presentation on theme: "2015-2016StateLegislation. Legislative Issues of Concern  SCPhA’s lobbyists constantly track legislation that may be harmful to the profession.  Includes."— Presentation transcript:

1 StateLegislation

2 Legislative Issues of Concern  SCPhA’s lobbyists constantly track legislation that may be harmful to the profession.  Includes such legislation as:  Vending machines dispensing top 150 medications,  Nurses dispensing,  Remote pharmacists doing final check for multiple pharmacies.

3 Unresolved Legislative Issues  Compounding Legislation  Rep. Kit Spires (R-Lexington)  Sen. Ronnie Cromer (R-Newberry)  This legislation would update the Pharmacy Practice Act to include current standards regarding pharmacy compounding instead of just being guidance.  The SC Board of Pharmacy currently has no authority to enforce guidance through fines.  This legislation was set aside in the Senate due to pharmacy’s opposition to two amendments to this bill.

4 Immunization Authority Expansion  Expands a pharmacist’s ability to provide all CDC-approved adult immunizations without a prescription for individuals 12 years and older.  Includes all future CDC-recommended vaccinations for adults and adolescents including travel vaccines.  Authorizes student interns to immunize under the direct supervision of a certified immunizing pharmacist.

5 Immunization Authority Expansion cont.  Authorization to administer travel-related vaccines will only be given to pharmacists who have successfully completed a course of training that includes travel vaccine certification accredited by a health authority or professional body approved by the Board of Pharmacy and the Board of Medical Examiners.  Requires that all written protocols be completed no later than 180 days after the enactment of the law granting this expansion of authority.  Legislation is already opposed by SC Pediatricians.  Other potential opponents include: SC Medical Society, SC Family Practitioners and SC Nurses Association.

6 Scope of Practice Expansion  Redefines ‘Drug Therapy Management’ to say: “…..is that practice of pharmacy which provides the expertise of the pharmacist in a collaborative effort with the practitioner and other health care providers to optimize therapeutic outcomes for patients. Drug therapy management includes, but is not limited to,  Drug therapy outcomes for patients,  Drug therapy reviews,  Therapy consults and management,  Vaccinations,  Interpretation of laboratory results, and  Health and wellness programs.

7 Scope of Practice Expansion cont.  Redefines a ‘Health Care Provider’  Includes a pharmacist who is authorized to provide health care services within the pharmacist’s scope of practice pursuant to state law and regulation as regulated by the Board of Pharmacy and in accordance with Code of Regulations, Chapter

8 Scope of Practice Expansion cont.  Redefines ‘Pharmacist Care’ (formally Pharmacy Care)  ‘Pharmacist Care’ is the direct provision of post diagnostic drug therapy, disease management, medication outcomes and other pharmacy care services through which pharmacists, as part of a patient’s integrated health care team and in collaboration and cooperation with the patient, the patient’s practitioner(s) and other health care providers, design, implement, monitor, and manage therapeutic plans for the purpose of improving a patient’s quality of life.  Objectives include cure of disease, elimination or reduction of a patient’s symptomatology, arresting or slowing a disease process, or prevention of a disease or symptomatology.

9 Scope of Practice Expansion cont.  This process includes, but not limited to, the following primary functions:  Identifying potential and actual drug-related problems,  Resolving actual drug-related problems,  Preventing potential drug-related problems,  Ordering, interpreting and monitoring lab and other diagnostic tests for diseases to be managed,  Obtaining and reviewing patent medical and social history,  Initiating, adjusting and discontinuing drug therapy in collaboration with other health care providers,  Administering drugs and/or devices,  Formulating clinical assessments and developing therapy plans including medications, nutrition and life style changes, and  Participating in comprehensive integrated health care teams in patient centered care.

10 Why is Scope Expansion Important to Pharmacy?  It will have a direct impact on a pharmacy’s/pharmacist’s ability to participate in a patient’s medical home.  It will have a direct impact on a pharmacy’s ability to participate in future Medicaid/Medicare pharmacy networks.  If a pharmacy is not helping, or worse, hurting a health plan’s ‘star ratings’, that plan may not want you in the pharmacy network.  It may provide a future source of income for pharmacies beyond the filling process.

11 CMS Triple Rated ‘Star Ratings’  A1C’s  As measured against ADA standards (e.g. A1C’s = to or < 7.0)  Blood Pressure  Lipids  MTM These account for 45% of a health plan’s star rating.

12 MAC Transparency Legislation  Defines:  Claim  Insurer  Pharmacist  Pharmacy  Pharmacy Benefit Manager  List  Maximum Allowable Cost  Multiple Source Drug  Network Providers

13 MAC Transparency Legislation  A pharmacy benefit manager must not place a drug on a list unless:  The drug has at least three or more nationally available, therapeutically equivalent, multiple source generic drugs with a significant cost difference and is generally available for purchase by network providers domiciled in this state.  The products are listed as therapeutically and pharmaceutically equivalent or “A” or “AB” rated in the Food and Drug Administration’s (FDA) most recent version of the Orange Book.  The product must be available for purchase without limitations by all pharmacies in the state from national or regional wholesalers and not obsolete or temporarily unavailable.

14 MAC Transparency Legislation cont.  A PBM must:  Ensure that all drugs on a list are generally available for purchase by pharmacies domiciled in this state from national and regional wholesalers.  Ensure that all drugs on the list are not obsolete, unavailable, or temporarily unavailable.  Make available to each network provider at the beginning of the term of the network provider’s contract, and upon renewal of the contract, the sources used to determine the maximum allowable cost pricing.  Make a list available within 5 business days to a network provider upon request in a format that is readily accessible to and usable by the network provider.  Update its MAC list every seven (7) calendar days and make the updated lists, including all changes in the price of drugs consistent with pricing changes in the marketplace, available to network providers in a readily accessible and usable format.  Maintain a procedure to eliminate products from the list of drugs subject to such pricing or modify MAC rates within three (3) business days when such drugs do not meet the standards and requirements of this ACT as set forth in order to remain consistent with pricing changes in the marketplace.

15 MAC Transparency Legislation cont.  Insurer (Plan Sponsor) Disclosures:  If a PBM utilizes a multi-source generic drug list for drugs dispensed at retail but does not utilize a similar list for drugs dispensed at mail, this must be disclosed to the plan sponsor in writing either in the contract or no later than twenty-one (21) business days from the implementation of the practice.

16 MAC Transparency Legislation cont.  Appeals Process:  All contracts between a PBM, a contracted pharmacy or, alternatively, a PBM and a pharmacy’s contracting representatives or agent such as a Pharmacy Services Administrative Organization (PSAO) shall include a process by which a network provider can appeal, investigate, and resolve disputes regarding multi-source generic drug pricing.  A network provider has 7 business days upon discovery, but no more than 60 days to appeal a MAC price if the reimbursement for the drug is less than the net amount that the network provider paid to the supplier of the drug.  At the beginning of the term of the network provider’s contract, and upon renewal, a PBM must provide the following to network providers:  A telephone number at which a network provider can contact the PBM and speak with an individual who is responsible for processing appeals; and  A final response to an appeal of a maximum allowable cost within seven (7) business days of submission.  If an appeal is denied, the PBM shall provide the reason for the denial and identify the national drug code (NDC) or the UDI of the product that is generally available and may be purchased by network providers domiciled in South Carolina at a price that is equal to or less than the maximum allowable cost.  If the appeal is sustained, the PBM must make a price adjustment to its list effective the date that the PBM makes the determination. Such price adjustment must be effective for all network providers.

17 Federal Legislation

18 H.R Pharmacists as Providers

19 H.R  H.R – Pharmacists as Providers  Introduced by:  Brett Guthrie (R-KY), G.K. Butterfield (D-NC) and Todd Young (R-IN)  Authorizes a licensed pharmacist to bill for Medicare Part B services as long as the provision of those services are within your scope of practice.  Does not supersede state practice act laws.

20 H.R  Millions of Americans lack adequate access to primary health care in the U.S.  Forty-three (43) of South Carolina’s forty-six (46) counties have been designated as “medically underserved.”  There are over 7,700 registered pharmacists in SC.  Most South Carolina residents on Medicare do not have access to important services provided by pharmacists.

21 H.R  There are 123 cosponsors of H.R in the U.S. House of Representatives  68 are Democrats; 55 are Republicans  South Carolina has 7 Congressmen  Only 1 is a cosponsor: Rep. Joe Wilson (R-2 nd Dist.)  Those who need to be contacted and asked:  Rep. Mark Sanford (R-1 st – Charleston area)  Rep. Jeff Duncan (R-3 rd – Anderson/Laurens area)  Rep. Trey Gowdy (R-4 th – Greenville/Spartanburg area)  Rep. Mick Mulvanie (R-5 th – Rock Hill/Gaffney/Sumter area)  Rep. James Clyburn (D-6 th – Columbia/Florence/Santee area)  Rep. Tom Rice (R-7 th – Myrtle Beach area)

22 H.R  Pharmacist billable services include:  Chronic disease management  Drug therapy management  Preventive screenings and related counseling and education, including  Glucose testing,  Blood pressure, and  Cholesterol

23 H.R According to the Association of American Medical Colleges:  By 2020, there will be 91,000 FEWER doctors than needed to meet demand.  The impact will be most severe in medically underserved communities.  In view of this anticipated shortage, pharmacists are in a position to play a greater role in the delivery of health care services.

24 H.R Underserved Community Defined According to the U.S. Department of Health & Human Services’ Health Resources Services Administration (HRSA), a medically underserved area is:  Those geographic areas that have too few primary care providers, high infant mortality rates, high poverty, and high elderly populations.

25 H.R Ensuring Seniors Access to Local Pharmacies Act

26 H.R  Introduced by:  H. Morgan Griffith (R-VA)  Currently, there are 80 co-sponsors representing 34 states  South Carolina has two co-sponsors:  Rep. Tom Rice (R-SC)  Rep. Joe Wilson (R-SC)

27 H.R  CMS had this concept in it’s 2015 call letter for the Medicare Part D program.  Additionally, the call letter would have defined what could be included as a MAC drug. It also defined AWP, WAC, etc. It provided for some PBM transparency.  PCMA immediately went to Congress to pressure CMS to withdrawal these new proposals.  NCPA has identified members of Congress in both houses to introduce legislation to make these changes law.

28 Questions? Contact: Craig Burridge, CEO SC Pharmacy Association


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