LEGISLATIVE UPDATE FOR ONCOLOGY PHARMACISTS

Transcription

1 LEGISLATIVE UPDATE FOR ONCOLOGY PHARMACISTS Ryan N. Bookout, PharmD, BCOP, BCPS Pharmacy Supervisor- Blood and Marrow Transplantation & Cellular Immunotherapy Moffitt Cancer Center August 2018

2 Objectives Explain the difference between lobbying and advocacy Identify the important US Congressional committees important to advocacy Oral parity Provider Status Drug Pricing Gag Clauses Medicare Part B to D 340 B Pricing Healthcare Reform Review national organizations advocacy information to keep yourself informed

3 CURRENT OVERARCHING THEME IN ADVOCACY Patient s Access to Care

4 Question 1 Slick Willy is an employed by NewExpensiveBios to explain their thoughts on current and upcoming legislation and influence congressional decision making. Janet McGoodheart is a member of the American Society for the Prevention of Cruelty to Animals and is meeting with her local Congress woman to discuss her groups ideas on the protection cats in shelters. Slick Willy s activities would be defined as: A) Advocating on behalf of NewExpensiveBios B) Lobbying on behalf of NewExpensiveBios

5 Lobbying Webster s definition: To conduct activities aimed at influencing public officials and especially members of a legislative body on legislation To attempt to influence or sway (someone, such as a public official) toward a desired action Examples- Amazon and Walmart lobbying against new proposed tariffs on imported goods Electric companies lobbying for price increases in the Florida State Legislature Accessed July 10, 2018

6 Advocacy Webster s definition: The act or process of supporting a cause or proposal To support or argue for (a cause, policy, etc.) : to plead in favor of (or against) Examples- Martin Luther King, Jr. advocated for equal rights for all people Matt Damon advocates for clean water Lobbying = Advocacy Advocacy DOES NOT = Lobbying Accessed July 10, 2018

7 Knowing Your Audience- US Congress What does Congress do Enact 12 separate funding bills to support all the functions of the government (each year) Enact policy measures to sustain, change, or modify existing laws and programs Pass measures to create a new law, program, or requirement Block action to stop changes or prevent modifications from being made to existing laws or programs

8 US Congressional Committees with Regards to Health Advocacy House of Representatives: Labor, Health and Human Services and Related Appropriations Subcommittee Funding for: Department of Health and Human Services FDA, HRSA, HIS,CDC, NIH, AHRQ, CMMS Energy & Commerce Committee (Health Subcommittee) Department of Health and Human Services Richard Hudson and G.K. Butterfield Ways & Means Committee (Health Subcommittee) Social Security and Medicare George Holding

9 US Congressional Committees with Regards to Health Advocacy Senate: Labor, Health and Human Services and Related Appropriations Subcommittee Funding for: Department of Health and Human Services FDA, HRSA, HIS,CDC, NIH, AHRQ, CMMS Health, Education, Labor and Pensions Committee (HELP) Finance Committee (Health Subcommittee) Richard Burr

10 Accessed July 10, 2018

11 Annual Budget Process Agencies submit a budget to OMB Full committee mark-up Floor debate and votes President releases official budget Subcommittee mark-ups Conference committee Congressional budget resolutions Appropriations committees subdivide budget allocations Bills signed by president

12 US Spending Versus Revenue By Congressional Budget Office - Public Domain, Accessed July 10, 2018

13 Role of the Hematology/Oncology Pharmacist Members need to hear from home and know the important role that oncology pharmacists play an important role in the delivery of care for individuals living with cancer. The knowledge and skills of an oncology pharmacist support a wide variety of functions in all aspects of patient care. The oncology pharmacist is often one of the few team members that fully understands the safety, efficacy, pharmacologic, and financial components of patient care in individuals with cancer. Oncology pharmacists often play a key role in the education of other health care providers, patients, and their caregivers.

14 Question 2 Currently, ERISA health plans (Employee Retirement Income Security Act) and all states have passed oral parity laws A) True B) False

15 Oral Chemotherapy Parity Oral chemotherapy agents are a large growing sector of cancer therapies Oral chemotherapy agents are not always covered through insurance equally IV anti-cancer agents are billed through the medical benefit Usually covered through copays with best coverage Medicare covers 80% then supplemental insurance covers Oral agents are billed through the pharmacy benefit Co-insurance Tiered positioning of oral agents with higher copays

16 Oral Chemotherapy Parity DM has Philadelphia chromosome positive Chronic Myeloid Leukemia (CML) and has a prescription for 100 mg po daily Thirty tablets of dasatinib 100 mg cash price $15,500 a month If DMs pharmacy prescription coverage is with a 20%, he pays $3100 a month If DMs pharmacy prescription coverage is with a copay, it may be placed in the highest tier of medications This is an insurance defect Insurance plans have not adjusted to keep up with the changing landscape of pharmacotherapy

17 Oral Chemotherapy Parity US House of Representatives (HR) Bill 1409 Lance Leonard (NJ) and Brian Higgins (NY) co-sponsors 168 Cosponsors NC cosponsors-david Price, Richard Hudson, Walter Jones Currently no Senate companion bill Previous Senatorial sponsor left office Right of First Refusal to replacement Championed by the Coalition to Improve Access to Cancer Care (HOPA is a steering committee member) Most likely this bill will not get through the 115th Congress but be sponsored again in the 116th Congress in Accessed July 10, 2018

18 Current US Oral Parity Landscape Accessed July 10, 2018

19 Current North Carolina Oral Parity Landscape House Bill 206 Cancer Treatment Fairness Act House has passed this bill twice Last in April 2017 Senate Bill 152 Sitting in Senate Rules committee as of June 14th, 2018 What can you do? Write letters to your Senators Give examples of how this is affecting your patients Visit your Senators in Raleigh and their home offices Accessed July 10, 2018

20 PHARMACY & MEDICALLY UNDERSERVED AREAS ENHANCEMENT ACT Otherwise known as Provider Status

21 Provider Status H.R. 592/S. 109 Pharmacy and Medically Underserved Areas Enhancement Act Bipartisan legislation that will amend section 1861 (s) (2) of the Social Security Act to include pharmacists on the list of recognized healthcare providers Pharmacists would be able to offer Medicare beneficiaries the same services that they are authorized to provide by their state pharmacy practice acts Nurse Practitioners used this route to become providers

22 Accessed July 10, 2018

23 AKA Provider Status H.R. 592 introduced in January 2017 by Representatives Guthrie (R-KY), Reed (R-NY), Butterfield (D-NC), and Kind (D-WI) 275 Cosponsors: 161 Republicans-114 Democrats S. 109 introduced in January 2017 by Senators Grassley (R-IA), Collins (R-ME), Brown (D-OH), and Casey (D-PA) 52 Cosponsors: 28 Republicans-23 Democrats-1 Independent Championed by Patient Access to Pharmacists Care Coalition (PAPCC) Sponsors including APhA, ASHP, HOPA, NCAP

24 DRUG PRICING

25 Gag Clauses A pharmacy gag clause is prevents pharmacists from informing customers about paying out of pocket for a prescription when the out-of-pocket costs are lower than the co-pay Part of pharmacy contracts that has developed with health insurance and pharmacy benefit managers Currently 15 states have enacted bans on gag clauses since 2017 Senate HELP Committee has been working on bill to ban gag clauses NC HB 466

26 Gag Clauses Senate HELP Committee has been working on bill to ban gag clauses NC HB 466 enacted 2017 Prohibits implementation of gag clauses in PBMpharmacy contracts Prohibits PBMs from requiring payment in excess of retail price

27 Medicare Part B to D Remember when filgrastim and peg-filgrastim switched from all being given in infusion centers and to sending prescriptions for fills at outpatient pharmacies? Health Insurers have moved some medications from Part B to Part D already American Patient s First Designed as increased competition Sending a report to the President on whether lower prices on some Medicare Part B drugs could be negotiated for by Part D plans Accessed July 10, 2018

28 Medicare Part B to D Questions needing clarification How will cancer therapies be covered? FDA indications only versus off-label use Will the shift be transparent and equal among all Part D insurances? How will patients be notified of the changes? How will cost sharing be evaluated? Will there be a demonstration project and how will this be explained to patients? Adapted from the HOPA response to the Drug Pricing Blueprint. Accessed July 10, 2018

29 Question 3 The 340B Discount Drug program covered entities have been affected to which of the following occurrences? 1. Decrease in the number of Medicaid patients 2. Affordable Care Act creation allows for expansion of covered entities 3. Decrease in the number of Medicare recipients Pharmacy & Therapeutics Nov; 35(11):

30 340 B Drug Pricing The 340B Drug Discount Program is a US federal government program established in 1992 Hospitals and clinics qualify for the program based simple rules developed by HRSA Drug manufacturers provide outpatient drugs at a lower cost to eligible health care organizations and covered entities HRSA sets a ceiling price for all medications in the program Accessed July 10, 2018

31 340 B Drug Pricing Issues with the program and challenges ahead 340 B price ceiling adjustments How will this change reimbursement? Will this be financially toxic to hospitals and clinics? Will this change the ability to help the underserved? Changes to oversight authority to allow better control of the program Redefining what patients can be in the program Managing how covered entities use the savings

32 HEALTHCARE REFORM

33 Healthcare Landscape Affordable Care Act (ACA) Repeal and Replace Even with Republican control in both the US House and Senate, nothing has changed Removal of the Individual Mandate Allowance of Less than Plans available for purchase Limited coverage offerings for healthy people Will this lead to the creation of sick pools?

34 Healthcare Landscape Affordable Care Act (ACA) Lawsuits against ACA could change healthcare for all Removing ban denying coverage for patients with preexisting conditions How could this change healthcare across the country? Could this pose problems for cancer patients?

35 Healthcare Landscape Universal Healthcare/ Medicare for All Current estimates up to $37.6 trillion over 10 years Modeled after Medicare? 80/20 coverage with supplemental purchase options? Medicare Part D coverage for medications? Differing rules? Donut hole? Accessed July 31, 2018

36 HOW CAN YOU KEEP UPDATED

37 Keeping Informed American Society of Health Systems Pharmacists (ASHP) ASHP Advocacy and Issues Homepage for ASHPs advocacy portal Key Issues Current advocacy issues facing pharmacists 340B, compounding, drug shortages, healthcare reform, reimbursement ASHP Daily Briefing Has multiple sections that will include governmental and healthcare information and issues pertinent to oncology pharmacists Leading the News, Quality and Safety, Regulatory, Health Coverage and Access Useful for health policy advocates as daily distilled information on current issues

38 Keeping Informed American Society of Clinical Oncology (ASCO) Advocacy and Policy ASCOs policies, position statements, guidance, and advocacy news all on their website Useful to see where our physician counterparts are positioning themselves for oncology advocacy Hematology/Oncology Pharmacy Association (HOPA) Advocacy Public Policy agenda Advocacy Activities includes Issue Briefs and Position Statements Get Involved - ideas and tools to start grassroots advocacy

39 LEGISLATIVE UPDATE FOR ONCOLOGY PHARMACISTS Ryan N. Bookout, PharmD, BCOP, BCPS Pharmacy Supervisor- Blood and Marrow Transplantation & Cellular Immunotherapy Moffitt Cancer Center August 2018