LEGISLATIVE UPDATE FOR ONCOLOGY PHARMACISTS Ryan N. Bookout, - - PowerPoint PPT Presentation

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 budget to OMB President releases

• fficial budget

Congressional budget resolutions Appropriations committees subdivide budget allocations Subcommittee mark-ups Full committee mark-up Floor debate and votes Conference committee Bills signed by president

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

• f 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
• ther 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)
• f 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

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

https://www.hhs.gov/sites/default/files/AmericanPatientsFirst.pdf . Accessed July 10, 2018

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

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. 2010 Nov; 35(11): 632–634.

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

http://medpac.gov/docs/default-source/reports/may-2015-report-to-the-congress-overview-of-the-340b-drug-pricing- program.pdf?sfvrsn=0. Accessed July 10, 2018

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”
• f the program
• Redefining what patients can be in the program
• “Managing” how covered entities use the “savings”

HEALTHCARE REFORM

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?

Healthcare Landscape

• Affordable Care Act (ACA)
• Lawsuits against ACA could change healthcare for all
• Removing ban denying coverage for patients with pre-

existing conditions

• How could this change healthcare across the

country?

• Could this pose problems for cancer patients?

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?

https://newrepublic.com/minutes/150286/new-study-universal-health-care-shows-partisans-bad-reading-studies. Accessed July 31, 2018

HOW CAN YOU KEEP UPDATED

Keeping Informed

• American Society of Health Systems Pharmacists (ASHP)
• ASHP Advocacy and Issues
• Homepage for ASHPs advocacy portal
• https://www.ashp.org/Advocacy-and-Issues
• Key Issues
• Current advocacy issues facing pharmacists
• 340B, compounding, drug shortages, healthcare reform, reimbursement
• https://www.ashp.org/Advocacy-and-Issues/Key-Issues
• 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

• ashp_daily_briefing@ashp.custombriefings.com

Keeping Informed

• American Society of Clinical Oncology (ASCO)
• Advocacy and Policy
• ASCOs policies, position statements, guidance, and advocacy news all
• n their website
• Useful to see where our physician counterparts are positioning

themselves for oncology advocacy

• https://www.asco.org/advocacy-policy
• Hematology/Oncology Pharmacy Association (HOPA)
• Advocacy
• http://www.hoparx.org/advocacy/
• Public Policy agenda
• Advocacy Activities includes Issue Briefs and Position Statements
• “Get Involved”- ideas and tools to start grassroots advocacy
• http://www.hoparx.org/advocacy/get-involved

LEGISLATIVE UPDATE FOR ONCOLOGY PHARMACISTS

Ryan N. Bookout, PharmD, BCOP, BCPS Pharmacy Supervisor- Blood and Marrow Transplantation & Cellular Immunotherapy Moffitt Cancer Center August 2018