May 23-25

Question 1

What are the seven (7) NCPA legislative priorities, per the checklist?

Answer 1

1. H.R. 244: MAC Transparency Act [H.R. 244]
2. Encourage CMS to Finalize Guidance on DIR [DIR]
3. H.R. 793 and S.1190, Ensuring Seniors Access to Local Pharmacies Act [SENIORS]
4. S. 314 and H.R. 592, Provider Status Bills [PROVIDER]
5. Ensure Access Compounded Medication [COMPOUNDING]
6. TRICARE/NDAA [ARMED]
7. Ask them to Join the Congressional Pharmacy Caucus [CAUCUS]

Question 2

What are the three (3) goals of the MAC Transparency Act? [H.R. 244]

Answer 2

1. Increase TRANSPARENCY of generic drug payment rates in Part D, FEHB, and TRICARE retail pharmacy programs
2. Establish a DEFINITION of a drug pricing standard
3. PROTECT patient privacy and choice of pharmacy in Part D, FEHB, and TRICARE retail pharmacy programs

Question 3

How will H.R. 244 increase transparency of generic drug payments? (3 components) [H.R. 244]

Answer 3

1. Disclose the SOURCES used to set MAC prices
2. Provide pricing UPDATES at least once every seven days
3. NOTIFY pharmacies of any CHANGES in individual drug prices–in advance of the use–of such prices for the reimbursement of claims.

Question 4

How will H.R. 244 establish a definition of a drug pricing standard? [H.R. 244]

Answer 4

Definition of DRUG PRICING STANDARD specifically includes MAC as the pricing standard in all Part D, FEHB, and TRICARE retail pharmacy programs.

Question 5

How will H.R. 244 protect patient privacy and choice of pharmacy? (2 components) [H.R. 244]

Answer 5

1. Prohibiting a PBM from TRANSMITTING DATA to a PBM-owned pharmacy, unless the patient voluntarily chooses that pharmacy.
2. Prohibiting a PBM from requiring that a beneficiary use a retail or mail order pharmacy in which the PBM has an OWNERSHIP INTEREST.

Question 6

What does DIR stand for? [DIR}

Answer 6

Direct and Indirect Renumeration

Question 7

What are three categories of DIR fees? [DIR]

Answer 7

1. Pay to Play
2. Reconciliation
3. Performance Metric

Question 8

What is the current problem with DIR fees? [DIR]

Answer 8

1. Plan/PBM does not properly disclose how DIR fees are calculated,
2. Obscuring reimbursement; Allows high MAC reporting (defeating MAC transparency); inaccurate Medicare Plan Finder
3. Post Point-of-Sale concessions result in interest-free loan from Medicare Trust Fund to Plans.

Question 9

What does NCPA want from the CMS’s guidance on the “Final 2014 Part D” rule? [DIR]

Answer 9

That pharmacy concessions that can be “reasonably estimated” at the point-of-sale be reflected in the adjudication process.

Question 10

What are two (2) bills proposed to ensure seniors can access their pharmacy of choice? [SENIORS]

Answer 10

1. H.R. 793

2. S. 1190

Question 11

What is preventing seniors access to their pharmacy of choice? (3 components) [SENIORS]

Answer 11

1. PBMs are using preferred pharmacy networks,
2. That result in higher copays if patient goes outside of the network,
3. But many community pharmacies are never offered a contract anyway.

Question 12

What are the downsides of the current preferred pharmacy networks? (3 components)[SENIORS]

Answer 12

1. In a 2013 study by CMS, it was shown that savings were not proven, and that in at least 1 instance preferred networks were COSTLIER.
2. David Eistenstadt, healthcare economist 2014, says ‘any willing pharmacy’ superior to ‘preferred pharmacy;’ reduces cost by promoting COMPETITION.
3. CMS study, urban areas 2014, 54% of drug plans failed to meet ‘reasonable access to pharmacy’ – in rural areas, it is worse because Rx is often more than 20 miles away.

Question 13

What is NCPA seeking to fix the problem with preferred pharmacy networks and senior pharmacy care access? (3 components) [SENIORS]

Answer 13

1. H.R 793 and S. 1190 would allow community pharmacies that are located in
2. medically underserved areas (MUAs), medically underserved populations (MUPs), or health professional shortage areas (HPSAs)
3. to participate in Medicare Part D preferred pharmacy networks

Question 14

What are two (2) bills proposed to give pharmacists’ provider status in health professional shortage areas (HPSA)? [PROVIDER]

Answer 14

1. H.R. 592

2. S. 314

Question 15

What do H.R. 592 and S. 314 change? (4 components)[PROVIDER]

Answer 15

1. amending Social Security Act,
2. to allow Pharmacists to be recognized as providers under Medicare Part B.
3. at reimbursement for 85% of physician fee schedule
4. Without expanding services beyond scope given by State pharmacy laws.

Question 16

What four (4) roles can pharmacists play beyond dispensing, as providers? [PROVIDER]

Answer 16

1. Health and Wellness Screenings
2. Chronic Disease Management
3. Immunization administration
4. Medication management

Question 17

Why is it urgent that pharmacists are recognized as providers? (3 components) [PROVIDER]

Answer 17

1. About 36 million patients may get health coverage by Patient Protection and Affordable Care Act
2. Association of American Medical Colleges projects 91,000 fewers physicians than needed by 2020.
3. Community pharmacies are often located in rural areas where there is no reasonable physician access.

Question 18

What has changed in compounding that has caused NCPA concerned? (3 components) [COMPOUNDING]

Answer 18

1. Congress passed Drug Quality and Security Act,
2. Which amended the Food, Drugs and Cosmetic Act,
3. and the FDA has released questionable guidelines on implementation.

Question 19

What are seven (7) concerns NCPA has with the FDA guidelines for the DQSA amendment? [COMPOUNDING]

Answer 19

1. Compounded medications for office-use
2. FDA inspections
3. Bulk-drug Substances
4. FDA Pharmacy Compounding Advisory Committee
5. Long Term Care Concerns on Repackaging
6. Veterinary Compounding

Question 20

What is NCPA’s problem with FDA guidelines for Office-Use Compounded Medications? (3 components) [COMPOUNDING]

Answer 20

1. Guidelines require individual prescription for 503A pharmacies,
2. Therefore office-use is restricted to 503B pharmacies.
3. But congress intended 503A pharmacies to compound for office-use.

Question 21

What is NCPA’s problem with FDA inspections? (2 components) [COMPOUNDING]

Answer 21

1. FDA is inspecting compounding pharmacies using manufacturer guidelines, e.g. the CGMP (Current Good Manufacturing Practice)
2. But they are best held to USP or other state-adopted pharmacy inspection standards.

Question 22

What is NCPA’s problem with FDA guidelines for acceptable bulk-drug substances? (2 components)[COMPOUNDING]

Answer 22

1. Guidelines say that USP monographs for dietary supplements are not applicable and therefore does not allow dietary supplements in compounded medications,
2. But the FDA has no basis as this guideline is inconsistent with the language of the law.

Question 23

What is NCPA’s problem with the FDA Pharmacy Compounding Advisory Committee? (4 components)[COMPOUNDING]

Answer 23

1. Improper member selection and renewal process,
2. member’s conflict of interest,
3. unequal time for nominator’s to defend substance,
4. confusing nominating process.

Question 24

What is NCPA’s problem with the FDA repackaging guidelines? (2 components) [COMPOUNDING]

Answer 24

1. The guidelines limit how much medication can be repackaged at one time,
2. This has significant consequences on the Long Term Care community.

Question 25

What is NCPA’s problem with the FDA guidelines on veterinary compounding? (2 components)[COMPOUNDING]

Answer 25

1. The FDA guidelines for veterinary compounding, the Draft Guidance for Industry (#230) are harmful,
2. and their authority to propose guidelines for veterinary pharmacy is not granted by the Drug Quality and Security Act.

Question 26

What are TRICARE and NDAA? [ARMED]

Answer 26

1. Tricare is a health care program of the United States Military.
2. NDAA is National Defense Authorization Act and contains sections for implementation of Tricare.

Question 27

What is NCPA seeking for TRICARE/NDAA? (4 components) [ARMED]

Answer 27

1. Congress to support inclusion of Drug Acquisition Cost Parity
2. Which allows military to use pharmacy of choice,
3. Rather than being forced to use mail order,
4. Which will achieve greater savings in Tricare.