LEGISLATIVE UPDATE FOR ONCOLOGY PHARMACISTS Ryan N. Bookout, PharmD, BCOP, BCPS Pharmacy Supervisor- Blood and Marrow Transplantation & Cellular Immunotherapy Moffitt Cancer Center August 2018
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
CURRENT OVERARCHING THEME IN ADVOCACY Patient’s Access to Care
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
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 https://www.merriam-webster.com/dictionary/lobby#h2. Accessed July 10, 2018
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 https://www.merriam-webster.com/dictionary/advocacy. Accessed July 10, 2018
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
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
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
https://www.nationallatinonetwork.org/policy-action/policy-101/legislative-process. Accessed July 10, 2018
Annual Budget Process Agencies submit a Full committee Floor debate and budget to OMB mark-up votes President releases Subcommittee Conference official budget mark-ups committee Appropriations Congressional committees Bills signed by budget resolutions subdivide budget president allocations
US Spending Versus Revenue By Congressional Budget Office - https://www.cbo.gov/publication/52408, Public Domain, https://commons.wikimedia.org/w/index.php?curid=57008629. Accessed July 10, 2018
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.
Question 2 • Currently, ERISA health plans (Employee Retirement Income Security Act) and all states have passed oral parity laws • A) True • B) False
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
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 is @ $15,500 a month • If DMs pharmacy prescription coverage is with a coinsurance @ 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
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 2019 https://www.congress.gov/bill/115th-congress/house-bill/1409/cosponsors?q=%7B%22cosponsor- state%22%3A%22North+Carolina%22%7D Accessed July 10, 2018
Current US Oral Parity Landscape https://i0.wp.com/peac.myeloma.org/wp-content/uploads/2018/02/AdvoMapUpdate%C2%AE-2018v3.png?resize=700%2C481. Accessed July 10, 2018
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 http://www.wect.com/story/38430050/cancer-treatment-fairness-act-still-sitting-in-senate-rules-committee. Accessed July 10, 2018
PHARMACY & MEDICALLY UNDERSERVED AREAS ENHANCEMENT ACT Otherwise known as Provider Status
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”
https://datawarehouse.hrsa.gov/ExportedMaps/MUA/HGDWMapGallery_MUA.pdf. Accessed July 10, 2018
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
DRUG PRICING
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
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 PBM- pharmacy contracts • Prohibits PBMs from requiring payment in excess of retail price
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