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State Opportunities under the 340B Drug Discount Program by Bill von Oehsen Counsel Public Hospital Pharmacy Coalition Phone: 202-872-6765 Email: [email protected]

State Opportunities under the 340B Drug Discount Program by Bill von Oehsen Counsel Public Hospital Pharmacy Coalition Phone: 202-872-6765 Email: [email protected]

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Page 1: State Opportunities under the 340B Drug Discount Program by Bill von Oehsen Counsel Public Hospital Pharmacy Coalition Phone: 202-872-6765 Email: william.vonoehsen@ppsv.com

State Opportunities under the 340B Drug Discount Program

byBill von Oehsen

CounselPublic Hospital Pharmacy Coalition

Phone: 202-872-6765Email: [email protected]

Page 2: State Opportunities under the 340B Drug Discount Program by Bill von Oehsen Counsel Public Hospital Pharmacy Coalition Phone: 202-872-6765 Email: william.vonoehsen@ppsv.com

OVERVIEW OF 340B PROGRAM

• Eligible entities include high Medicaid acute care hospitals owned by or under contract with state or local government; community health centers; ADAPs; family planning clinics; AIDS, TB and STD clinics; and other HRSA grantees

• Use of drugs limited to “patients” of 340B covered entity

• Discounts are calculated using the Medicaid rebate formula; but 340B pricing is better because (1) sales do not involve retail pharmacies thereby avoiding retail mark-ups and (2) 340B providers regularly negotiate sub-ceiling prices

• Medicaid must be billed at acquisition cost to avoid duplicate discounts

Powers Pyles Sutter & Verville, PC Bill von Oehsen(202) 466-6550 [email protected]

Page 3: State Opportunities under the 340B Drug Discount Program by Bill von Oehsen Counsel Public Hospital Pharmacy Coalition Phone: 202-872-6765 Email: william.vonoehsen@ppsv.com

0.0%

34.6%

47.9%49.0%51.7%

60.5%

80.0%

100.0%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

BACKGROUND ON U.S. PHARMACEUTICAL MARKET:COMPARISON OF PRICES

Source: Data derived from Prescription Drugs: Expanding Access to Federal Prices Could Cause Other Price Changes, U.S. General Accounting Office, GAO/HEHS-00-118, August 2000 and How the Medicaid Rebate on Prescription Drugs Affects Pricing in the Pharmaceutical Market, Congressional Budget Office Papers, January 1996.

Powers Pyles Sutter & Verville, PC Bill von Oehsen

(202) 466-6550 [email protected]

Private Sector Pricing

“Best Price”

Page 4: State Opportunities under the 340B Drug Discount Program by Bill von Oehsen Counsel Public Hospital Pharmacy Coalition Phone: 202-872-6765 Email: william.vonoehsen@ppsv.com

0%

20%

40%

60%

80%

100%

BACKGROUND ON U.S. DRUG MARKET: COMPARISON OF PRICES*

Av

era

ge

Wh

ole

sa

le P

ric

e

Market Share

60%25% 11%1% 1%

100.0%

80.0%

60.5%51.7%

49.0%

44.8%

1%

Medicaid

FSS

340B

VA

PBM and Other Private Insurance

Market Share

CashCustomers

Powers Pyles Sutter & Verville, PC Bill von Oehsen(202) 466-6550 [email protected]

* Chart is based on rough estimates

Page 5: State Opportunities under the 340B Drug Discount Program by Bill von Oehsen Counsel Public Hospital Pharmacy Coalition Phone: 202-872-6765 Email: william.vonoehsen@ppsv.com

340B OPPORTUNITIES FOR STATES

• Encouraging eligible facilities within the state to enroll in 340B

• Using 340B-discounted drugs for state and county prisoners

• Maximizing use of 340B within state-funded managed care plans

• Including 340B providers in state bulk purchasing initiatives

• Sole source contracts with 340B providers to furnish high-cost chronic care drugs

Powers Pyles Sutter & Verville, PC Bill von Oehsen(202) 466-6550 [email protected]

Page 6: State Opportunities under the 340B Drug Discount Program by Bill von Oehsen Counsel Public Hospital Pharmacy Coalition Phone: 202-872-6765 Email: william.vonoehsen@ppsv.com

340B OPPORTUNITIES FOR STATES:EXTENSION TO PRISONS

• States and counties may contract with 340B hospitals or other 340B facilities to provide health care services, including pharmacy services, to correctional populations

• Prisoners must be “patients” of the 340B provider to be eligible to receive discounted drugs

• Texas recently implemented this approach as a result of legislation passed last year (S.B. 347)

• Other state agencies, e.g., mental health hospitals?

Powers Pyles Sutter & Verville, PC Bill von Oehsen(202) 466-6550 [email protected]

Page 7: State Opportunities under the 340B Drug Discount Program by Bill von Oehsen Counsel Public Hospital Pharmacy Coalition Phone: 202-872-6765 Email: william.vonoehsen@ppsv.com

340B OPPORTUNITIES FOR STATES:STATE-FUNDED MANAGED CARE

• Drugs are about 35 percent more costly when purchased through PBMs instead of 340B program

• Shifting drug purchases from PBMs to 340B providers can lower costs for the plan which can be passed on to the state

• For Medicaid programs, this is an alternative to states carving out pharmacy from the plan’s benefits package and returning it to a fee-for-service program in order to collect Medicaid rebates.

• Application to managed care plans for state employees?

Powers Pyles Sutter & Verville, PC Bill von Oehsen(202) 466-6550 [email protected]

Page 8: State Opportunities under the 340B Drug Discount Program by Bill von Oehsen Counsel Public Hospital Pharmacy Coalition Phone: 202-872-6765 Email: william.vonoehsen@ppsv.com

340B OPPORTUNITIES FOR STATES: ENCOURAGING 340B PARTICIPATION

• 340B program reduces Medicaid reimbursement for outpatient drugs because 340B providers are required to bill Medicaid at acquisition cost in most instances

• For example, according to a recent analysis, 340B hospitals are saving state Medicaid programs an average of almost $300,000 per hospital per year

• Many hospitals, community health centers, and other eligible facilities are not participating in 340B

• By assisting eligible entities with 340B enrollment, states can lower their Medicaid expenses

Powers Pyles Sutter & Verville, PC Bill von Oehsen(202) 466-6550 [email protected]

Page 9: State Opportunities under the 340B Drug Discount Program by Bill von Oehsen Counsel Public Hospital Pharmacy Coalition Phone: 202-872-6765 Email: william.vonoehsen@ppsv.com

MANAGED CARE DISEASE MANAGEMENT

• 340B providers participating in managed care plans can develop disease management programs for enrollees having high drug costs

• Plans can steer enrollees suffering from chronic diseases to these 340B-based disease management programs (e.g., AIDS, diabetes, asthma, heart disease, etc.)

• 340B providers can use mail order or contracted retail pharmacies to increase access by getting federal approval as an alternative methods demonstration project

Powers Pyles Sutter & Verville, PC Bill von Oehsen(202) 466-6550 [email protected]

Page 10: State Opportunities under the 340B Drug Discount Program by Bill von Oehsen Counsel Public Hospital Pharmacy Coalition Phone: 202-872-6765 Email: william.vonoehsen@ppsv.com

340B OPPORTUNITIES FOR STATES: BULK PURCHASING

• Volume plus preferred drug list moves market share and creates savings

• By pooling their volumes, 340B providers and states can theoretically negotiate better discounts

• Savings equals subceiling discounts for 340B covered entities and supplemental rebates for state

• Two-tiered pricing to accommodate state purchases that do not qualify for best price exemption

Powers Pyles Sutter & Verville, PC Bill von Oehsen(202) 466-6550 [email protected]

Page 11: State Opportunities under the 340B Drug Discount Program by Bill von Oehsen Counsel Public Hospital Pharmacy Coalition Phone: 202-872-6765 Email: william.vonoehsen@ppsv.com

340B Opportunities for States Bulk Purchasing

P R

I C

E S Rebates or Upfront

Discounts

State MentalEmployees Prisons Schools Health AMP

Medicaid 340BState Pharmacy

Assistance Programs

Supplemental Rebates/Subceiling Pricing

Best Price

Page 12: State Opportunities under the 340B Drug Discount Program by Bill von Oehsen Counsel Public Hospital Pharmacy Coalition Phone: 202-872-6765 Email: william.vonoehsen@ppsv.com

340B OPPORTUNITIES FOR STATES: SOLE SOURCE CONTRACTS

• To meet patient definition requirements, 340B provider must provide other services than pharmacy – case management and disease management are possibilities

• For Medicaid, a 1915(b) waiver is required to waive the patient’s freedom of choice

• Utah Medicaid program has a sole source contract with University of Utah for providing factor products and case management services to hemophilia population statewide (although not using 340B pricing)

Powers Pyles Sutter & Verville, PC Bill von Oehsen(202) 466-6550 [email protected]