NCPA Legislative Update
Federal & State
Matthew DiLoreto
Senior Director, State Government Affairs
Setting the Scene for Legislative Priorities
 Soaring generic price spikes with significant lags in PBM
reimbursements
 Inability to participate in both government and private provider
networks
 Unregulated and non-transparent fees applied to pharmacy (DIRs)
 Inability to be recognized and/or reimbursed for services provided
 Increased Congressional interest in generic price spikes
 Increased interest by CMS with Managed Care oversight
 Increasing a pharmacist’s abilities to practice to the extent of their
expertise
2016 CMS Final Call Letter –
MAC Pricing Updates
 Effective January 1, 2016, MAC pricing is subject to the
mandatory 7-day updating
 CMS “reminds” Part D sponsors that MAC updates must be
provided to pharmacies “in a manner that is usable by
pharmacies” so they can validate prices
 Part D sponsors must also disclose updated MAC drug prices
to pharmacies in advance of their use for reimbursement
 NCPA working with congressional offices to weigh in with CMS
to effectively enforce these MAC provisions
 Letter sent to CMS by eleven Congressmen requesting proper
enforcement
The MAC Transparency Act H.R. 244
 Introduced by:
 Reps. Doug Collins (R-GA)
 Dave Loebsack (D-IA)
 Current Co-sponsorship: 22
 Would increase transparency of generic drug payment rates in
Medicare Part D, the Federal Employees Health Benefits
Program (FEHB) and TRICARE, by requiring PBM’s to:
 Protect patient privacy and choice in Part D and FEHB by
prohibiting a PBM from requiring that a beneficiary use a retail
or mail order pharmacy in which the PBM has an ownership
interest
Ensuring Seniors Access to Local Pharmacies
Act H.R. 793/S. 1190
 H.R. 793 introduced by:
 Reps. Morgan Griffith (R-VA) and Peter Welch (D-VT)
 Current Co-Sponsorship: 56
 S.1190 introduced by:
 Senate by Sens. Shelly Moore Capito (R-WV), Tom Cotton (R-AR),
Joe Manchin (D-WV) and Sherrod Brown (D-OH)
 Current Co-Sponsorship: 10
 “Any Willing Pharmacy” which would allow community
pharmacies located in medically underserved areas (MUA’s),
medically underserved populations (MUP’s) or health
professional shortage areas (HPSA’s) to participate in Medicare
Part D preferred pharmacy networks
Pharmacy and Medically Underserved Areas
Enhancement Act (Provider Status)
H.R. 592/ S.314
 H.R. 592 introduced by:
 Reps. Brett Guthrie (R-KY), Todd Young (R-IN), G.K. Butterfield (D-NC)
and Ron Kind (D-WI)
 Current Co-Sponsorship: 185
 S. 314 introduced by:
 Sens. Chuck Grassley (R-IA), Sherrod Brown (D-OH), Mark Kirk (R-IL)
and Bob Casey (D-PA)
 Current Co-Sponsorship: 28
 Would permit pharmacists in medically underserved communities to
both provide and be reimbursed under Medicare Part B for services
outlined in their state’s existing scope of practice
 Consistent with precedent established by the Nurse Practitioners
(NP’s) and Physicians’ Assistants (PA’s) provider status efforts;
pharmacist services would be reimbursed at 85% of the physician
fee schedule
Other Notable Issues
 TRICARE Pilot Program – Preferred Networks
 Coordination with CMS, including Part D Team, on
DIR assessment and MAC implementation
 21st Century Cures – Pharmacy Lock-in provision
 United States Department of Labor ERISA Hearings
 Compounding Regs/MOUs (i.e.: Interstate, Veterinary, LTC)
Most Active State Legislative Issues in 2015
 MAC Transparency Legislation
 PBM Regulation and Enforcement
 Medication Synchronization
 Biosimilar Substitution
 Any Willing Pharmacy / Provider
Nationwide State Legislative Successes
 MAC Transparency Legislation
 24 States (New York pending Governors signature)
 PBM Fair Audit
 33 States
 Anti-Mandatory Mail Order
 8 States
 Medication Synchronization
 11 States
Most Notable Wins of 2015
 Georgia (HB470)
 MAC Transparency & Strengthening of Fair Audit Law
 Signed into law: May 2015
 Arkansas (3 wins)
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Strengthening of MAC Transparency Law (SB688)
PBM Enforcement as TPA (SB487)
Patient Consent (SB542)
Signed into law: April 2015
 Washington (SB5557)
 Pharmacist Recognition
 Signed into law: May 2015
 Ohio
 MAC transparency signed as part of state budget
 Includes plan sponsor disclosure and notable enforcement.
 Signed into law: June 30, 2015
 Wisconsin
 MAC transparency signed as part of state budget
 Signed into law: July 12, 2015
Multiple 2015 Florida Victories
 MAC Transparency
 Expansion of Provider Capabilities (HB655)
 Revises the term of “Licensed Practitioner” to include consultant pharmacist or doctor(s) of
pharmacy licensed under state statute.
 Requires clinical laboratories to make services available to specified licensed practitioners.
 Prohibits such clinical laboratory from charging different prices
 Expansion of Immunization Capabilities (HB279)
 Provide all immunizations/vaccines listed within the US CDC Adult Immunization Schedule in
effect on February 1, 2015
 Provide all immunizations/vaccines recommended by the US CDC for international travel in
effect on July 1, 2015
 Provide any immunizations/vaccines approved by the SBOP during emergencies declared by
the governor
 Supervisory and coursework required for intern administration
Evolving MAC Transparency Legislation
 Original priorities:
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What information - “Sources utilized” - to determine MACs
Standardized disclosure of MACs to pharmacy (i.e. 7 days)
Standardization for what constitutes a “MAC’d” drug
Clearly defined appeals process for both pharmacy and PBMs
 New priorities in addition to the above standards:
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PSAO or contracting agent relationship
Updated MACs must be “utilized for reimbursement”
NDCs must be available to retail pharmacies in the state
Enforcement mechanism(s)
PBM Retaliation
• Iowa MAC Transparency Lawsuit
• ERISA challenge victory
• Arkansas Express Scripts Contract Amendment
• Distributed in response to strengthened MAC law
• Arkansas PCMA Lawsuit
• Awaiting formal filing
“If they are shooting at you, you must be doing something right…”
Questions