States and the 340B Drug Pricing Program
Spring 2012; material added November 2014
The federal 340B Drug Pricing Program provides access to reduced price prescription drugs to over 16,869 health care facilities (as of October 2011) certified by the U.S.. Department of Health and Human Services (HHS) as "covered entities". These clinics, centers and hospitals in turn serve more than 10 million people in all 50 states, plus commonwealths and territories.
Office of Pharmacy Affairs (OPA): An Overview
"The 340B Drug Pricing Program was established in response to the passage of Section 340B of U.S.. Public Law 102-585, the Veterans Health Care Act of 1992. Section 340B of this law limits the cost of drugs to certain grantees of federal agencies and other entities identified in the statute. Significant savings on pharmaceuticals may be seen by those entities who participate in this program." The program is administered by the Office of Pharmacy Affairs (OPA) of HRSA, under the federal Department of Health and Human Services (HHS).
340B Contacts: If state legislators have questions regarding the 340B Program visit the OPA web site at: http://hrsa.gov/opa. You also may contact them by calling (301) 594-4353 or 1-800-628-6297. In addition, you may write to them at this address: Office of Pharmacy Affairs, HRSA, 5600 Fishers Lane, Parklawn Bldg, Room 10C-03, Rockville, Maryland 20857.
The Office of Pharmacy Affairs established the Pharmacy Services Support Center:
OPA is under contract with the American Pharmaceutical Association (APhA) to provide, among other things, education and technical assistance on 340B issues. Lisa Scholz is in charge of the Support Center and can be reached at: HRSA Pharmacy Services Support Center, American Pharmacists Association, 2215 Constitution Ave NW, Washington DC, 20037 ; (202) 237-2742; email: email@example.com.
The 340B Prime Vendor Program (PVP) will maximize your state's participation in the 340B drug purchasing program. Click here for more info on the 340B PVP.
340B Prime Vendor Program and Preventative Health- Savings Potential Explained
The 340B Prime Vendor Program has expanded its outpatient contract portfolio to include low cost Point of Care & OTC Rapid Diagnostic Test Kits for it participating 340B eligible covered entities. States can save hundreds of millions of dollars, and tens of thousands of lives, by realizing the The Value of Diagnostics. The focus of EarlyDETECT, a 340B Prime Vendor Contract supplier, is on low cost preventive health screening tests for the nation's low-income and uninsured. According to Charles Strongo, CEO of EarlyDETECT, simple, inexpensive, rapid diagnostic tests can accurately diagnose diseases at early stages, save States from escalating costs of critical care, and help families live healthier lives.
2014 340B Program Updates:
- Hospitals and Orphan Drugs Lead to Lawsuits - In October 2014, PhRMA, the industry trade group, filed suit to strike down a 2014 rule by HRSA that allows safety net hospitals to obtain discounts when purchasing so-called orphan drugs when using them to treat non-orphan conditions or diseases through the 340B program.
- U.S. Congress Investigates 340B Website Plans - In 2013 Congress authorized funding for U.S. Health Resources and Services Administration to create a website documenting drug prices under the 340B program. In December 2014, in the enacted "CRominbus," members called for a March 2015 congressional hearing to review this project, set for March 3, 2015. One of the key provisions contained within requires HRSA to appear before Congress citing concerns that HRSA has been unable to demonstrate that the 340B program benefits vulnerable patients, the program’s ability to ensure patients' access to 340B savings for outpatient drugs and overall compliance by covered entities. The package also continued the provision on the 340B Drug Program that would require HRSA to make 340B ceiling prices available to covered entities through a secure web site.
Federal Health Reform and the 340B Program
In March 2012, The National Association of Insurance Commissioners (NAIC) issued a Bulletin, in conjunction with their statutory role under the ACA, outlining requirements for health plans operated and offered under the ACA, effective January 1, 2014. See Health Insurance Exchanges Plan Management Functions. It uses the 340B program as a core part of defining
Essential Community Providers
The criteria established by the Secretary must also ensure that provider networks include “essential community providers” that serve predominantly low-income, medically underserved individuals, as long as the provider accepts the generally applicable payment rates of the plan. The statute and the proposed Exchange establishment rule defines Essential community providers are defined to include providers that are eligible for 340B drug pricing and non-profit providers that provide the same services as those eligible for 340B pricing. These providers include:
- Consolidated Health Centers (FQHC)
- AIDS clinics and drug purchasing programs
- Black Lung Clinics
- Hemophilia Treatment Centers
- Urban Indian Clinics Tribal Centers
- Family Planning Clinics
- Sexually Transmitted Disease Clinics
- Tuberculosis Clinics
- Native Hawaiian Health Center
- Federally Qualified Health Center look-a-likes
- Certain Disproportionate Share Hospitals.
There are potential conflicts between the requirement that the plan include all essential community providers willing to accept generally applicable payment rates and other requirements governing plan reimbursement of Federally-Qualified Health Centers and Indian health providers. These conflicts will be addressed in future federal rulemaking.
|States Seek to Participate in Arguments in U.S. Supreme Court 340B Case (Archive - 2011) - Reprinted from SNHPA web site; date: January 7, 2011
Four states and the District of Columbia have asked the U.S. Supreme Court for permission to argue in person before it on Jan. 19 that safety-net providers have a right to sue drug manufacturers for allegedly charging them more for pharmaceuticals than the 340B drug discount program allows. The attorneys general of Arizona, Kansas, Missouri, West Virginia and D.C.. filed their motion to participate in arguments in the pivotal 340B case, Astra USA Inc. v. County of Santa Clara. Three days earlier, the U.S. Solicitor General's office, which represents the federal government in litigation, sought the High Court's permission to argue in person on the side of the drug companies that the 340B pricing agreements between the government and manufacturers do not grant safety-net providers the right to sue. (Case No. 09-1273), on Dec. 20, the same day they filed a joint friend-of-the-court brief backing the two California counties that have sued nine leading drug companies for what the counties claim is millions of dollars in overcharges. The federal and state governments' requests to personally argue their positions before the Court are a sign of their strong interest in the case's outcome. The justices almost always grant such motions by the federal Solicitor General but do so much less often for states. The Court is expected to announce whether the federal and state governments will take part in the arguments. (Jan., 2011.)
340B Slides from NCSL's 2008 Legislative Summit
As presented on July 23 at the NCSL Legislative Summit in New Orleans, LA. The federal 340B Drug Pricing Program helps over 13,000 qualified health centers, clinics and hospitals provide comprehensive pharmacy services for over 10 million patients. Speaker: Lisa Scholz, HRSA Pharmacy Services Support Center, Washington, DC. - [ Presentation]
The 340B Coalition's 12th Annual Conference was held at the Omni Shoreham in Washington, DC from July 14-16, 2008.
CD's of the presentation slides can be ordered online. For more information, please visit http://www.340bconferences.org/conferences/2008_annual/index.cfm
If you have any questions regarding this meeting, please contact Mike Hess at firstname.lastname@example.org or (202) 552-5869. For information on all other conference related matters, please visit their website or contact Laurinda Dennis at email@example.com or (202) 552-5854.
The 340B Coalition's Winter meeting at the Westin in Long Beach, CA was January 30-February 1, 2008. The 340B Coalition represents the thousands of providers and programs participating in the federal 340B drug discount program. The event was co-hosted by the government’s 340B Prime Vendor Program which is responsible for negotiating additional discounts and value-added services for its participants. http://www.340bwinterconference.org/
The conference was designed for providers, pharmacy service companies, the pharmaceutical industry, and other entities concerned with providing pharmaceutical care to low income and vulnerable populations while ensuring compliance with drug pricing laws. It provided an ideal opportunity for those that are new to the 340B program to learn from the experts about how to maximize pharmaceutical savings while ensuring compliance with the 340B law. It was also a great educational forum for 340B veterans who are eager to learn about new strategies for reducing costs, expanding access and ensuring compliance.
We heard from key officials from federal and state government who administer the 340B and Medicaid rebate programs, as well as from providers that have successfully implemented 340B programs in their facilities. 340B Coalition executives as well as senior officials from the Office of Pharmacy Affairs, the 340B Prime Vendor Program and the Pharmacy Services Support Center provided presentations and were available each day to answer your questions. This event and our annual July conference in Washington, D.C.. are the only events that bring together all of the stakeholders involved in the 340B program from the provider, government and industry perspectives.
• Special focus on key issues surrounding the growing use of contract pharmacies to expand pharmaceutical access
• A closer look at impending changes to how covered entities have to bill Medicaid for clinic-administered drugs bought through 340B and new rebate obligations for manufacturers including NDC collection and submission requirements
• Other changes going into effect as result of Deficit Reduction Act including nominal pricing
• Update on government’s proposed changes to the 340B definition of patient including eligibility of employees, nursing home residents, home health patients, prisoners, etc.
• Legislation to expand 340B program to new entities and extend program to inpatients
• Technical guidance on inventory management, stock replacement, patient verification, and audit preparation
• Concurrent half-day workshops on the basics of the 340B program and the latest developments with patient assistance programs
State Savings Analysis Available
Heinz Family Philanthropies has undertaken the pioneering work on 340B for a number of states, and their analysis has demonstrated significant savings to state legislators. This work is often done at no cost (or little cost) for states and the results are dramatic. The chief architect of the Heinz work is Jeffrey Lewis, president of the Heinz Family Philanthropies (firstname.lastname@example.org). For a copy of the Rhode Island state report click here: The Rhode Island 340B Analysis: Creating an Opportunity. For more information, contact: Jeffrey R. Lewis, President, Heinz Family Philanthropies, 1101 Pennsylvania Ave. NW. Suite 350, Washington, D.C.. 20004
NCSL Legislative Summit- Health Committee Session including 340B, July 23, 2008, New Orleans, LA.
Ideas at Work for Prescription Drugs
Learn about three programs in a growing number of states: Prescription Drug Monitoring Programs that help prevent abuse of prescriptions, the federal 340B Drug Pricing Program that helps provide medication to 10 million patients, and Medication Therapy Management that helps provide counseling to patients with chronic diseases.
Lisa Scholz, Senior Director of the Pharmacy Services Support Center, presented information on 340B to the NCSL Health Committee and other session attendees. Her slides will be posted here soon.
Marjorie Powell, Senior Assistant General Counsel. Pharmaceutical Research and Manufacturers of America (PhRMA), provided a response to Scholz's presentation, offering an industry's perspective on the program and compliance concerns.
NCSL Spring Forum Special Briefing on 340B, April 19, 2007 5:15-6:15pm, Columbia-C.
Attendees found out how the 340B Federal Drug Pricing Program can save state funds and increase access to quality pharmaceutical services for citizens. There was a brief overview of the program, followed by Q&A and discussion about how Office of Pharmacy Affairs, Pharmacy Services Support Center and NCSL can help states maximize a state's federally qualified entities' utilization of the program, quality and savings potential. Please click here to request a copy of the slides.
Jimmy Mitchell, R.Ph., M.P.H., M.S., Director, Office of Pharmacy Affairs, HRSA, Rockville, Maryland
Harry Hagel, R.Ph., M.S., Director, HRSA Pharmacy Services Support Center, Washington, D.C.
Web conference on "340B in the States" held September 28, 2006 1pm-2pm ET.
To view the archive, go to http://www.vcall.com/replay then enter replay # 31124645
- Harry Hagel, R.Ph.- Senior Director, HRSA Pharmacy Services Support Center. Download Slides Only
- William (Bill) Wood, R.Ph.- Manager, 340B Programs, University of Utah Department of Pharmacy Services.
- Moderated by Karmen Hanson - Senior Policy Specialist, NCSL. Download slides only
Types of Health Providers approved for prescription discounts
Federal Grantee covered entity sites as of October 1, 2011* Total sites = 16,869
340B Participation Statistics - October 1, 2011
|Number of Active Registered Covered Entity Sites
|Number of Active Contract Pharmacy Records
|Number of Active Manufacturers Records
|Total Number of Active Registered DSH sites
| Number of Active Registered DSH organizations
|Total Number of Active Registered Community Health sites
| Number of Active Reg. Community Health organizations
Entity Type (10/1/2011)
|Consolidated Health Centers (FQHC)
| AIDS clinics and drug purchasing programs (Ryan White Title I-IV)
|Black Lung Clinics
|Hemophilia Treatment Centers
|Urban Indian Clinics
| Tribal Centers
|Family Planning Clinics, Title X
|Sexually Transmitted Disease Clinics
|Native Hawaiian Health Center
|Federally Qualified Health Center look-a-likes
|Certain Disproportionate Share Hospitals (DSH)
*For more information like this chart, please see 340B website at: http://opanet.hrsa.gov/opa/Login/MainMenu.aspx
Recent State Laws About Expanding Pharmaceuticals through 340B
Although safety net health facilities have existed for decades, states' searches for solutions to high prescription drug costs have led to new laws authorizing expanded use of the 340B programs. Examples include:
NOTE: Some hyperlinks below may not be active, depending on the state's archive/database system. We try to keep these links as up to date as possible. We appreciate your feedback.
2005-2006 Legislative Session Bills (not enacted)
- California AB 76 Among other things, would authorize establishing "a formulary or formularies for state programs"; Pursuing "all opportunities for the state to achieve savings through the federal 340B program including the development of cooperative agreements with entities covered under the 340B program that increase access to 340B program prices for individuals receiving prescription drugs through state programs. It would "develop an outreach program to ensure that hospitals, clinics, and other eligible entities participate in the program. (Passed by both chambers; vetoed by governor.)
- Colorado HB 1052 Among other things, would require state agencies to “maximize prescription drug discounts within the programs administered by the departments through the utilization of the federal 340B drug pricing program” in order to receive the maximum state budget savings. (Passed by both chambers; vetoed by governor.)
2004 Legislative Session Bills (not enacted)
Additional References and Sources*
* Reduced cost or free copies of these publications may be made available to legislators and legislative staff at the discretion of the publishers. Please contact them directly for more information.
Arkansas HB 2498 of 2001 authorizes expanded use, creation or designation of federally qualified health centers to get "substantially discounted prescription drug prices."
California AB 77 Would authorize the Department of Corrections to establish a pilot project to determine whether the department may reduce the cost of providing health care to inmates, including the furnishing of prescription drugs to inmates at the 340B discounted price, by contracting for the provision of those health care services from certain covered entities. (Signed by governor as Chapter 503, 10/4/05)
California SB 340 of 2001. Expands dispensing options for California safety net clinics; §4126 authorizes 340B eligible clinics to contract with a community pharmacy to dispense 340B drugs. (As of January 2004, 59 clinics have contract pharmacy agreements.) (Signed by Governor Davis as Chapter 631, 10/8/01)
California SB 708 of 2005 Requires the State Department of Health Services to develop a standard contract for private nonprofit hospitals whereby a hospital agrees to provide medical care to indigent patients, as a condition of participation in the 340B drug discount program established under federal law.
Connecticut SB 1123 of 2003. Provides loans to federally qualified health centers for the cost of establishing a pharmacy facility or a partnership with a community pharmacy to serve as a centralized prescription drug distributor for federally qualified health centers that have established affordable pharmaceutical drug programs for qualified low income patients of such centers. The Commissioner of Social Services will assist any federally qualified health center that is applying for a loan by providing non-individual identifying information concerning potential participants in the affordable pharmaceutical drug program.
(Signed by Governor as Public Act 03-166, 6/10/03)
Maine HP 1591 / LD 2231 of 2008 by Rep. Treat requires the Governor's Office of Health Policy and Finance to "coordinate with the Department of Health and Human Services and other state agencies and representatives of state employees, health care providers and federally qualified health centers to identify opportunities no later than July 1, 2009 to provide prescription drugs through Section 340B for the following, if the costs of implementing such a plan are less than the current cost of providing prescription drugs: 1) State-funded managed care plans; 2) MaineCare (Medicaid); 3) State bulk purchasing initiatives and 4) Populations using high-cost chronic care and specialty drugs. Also requires the Department of Corrections to convene a working group to maximize use of the 340B. The effective date is April 16, 2008. (Filed 2/26/08; passed House and Senate 4/15/08; signed by governor as PS Chapter 43, 4/16/08)
Maine HP 923 / LD 1324 Among other things, Would establish the Pharmacy Cost Management Council to develop and implement measures to control the cost of prescription drugs and expand the State's purchasing power, pooled purchasing for public sectors and including employers, use of PBMs, PDLs, disease management, and research purchasing and coordination of benefits related to maximizing use of federal programs (Medicare, 340B) and purchasing from outside the US. (Signed into law by governor as Chapter 343, 6/8/05)
Maine LD 711 of 2003. Legislative resolve requires the Department of Human Services to study and report on "the feasibility of providing discounted prescription drugs to Maine's most vulnerable patient populations through the use of Section 340B" by January 1, 2004. [text below] (Signed by governor as chapter 29, 5/19/03)
Maine LD 46 of 2003. Allows certain health care facilities that provide primary and preventive care services to purchase through state agencies or state contracts, prescription drugs and medical supplies for patients to whom they provide free care.
(signed by governor as Chapter 79, 4/25/03)
Maryland HB 6 of 2001 requires the state to study the feasibility of purchasing prescription drugs through federally qualified health centers.
New Mexico SJM 35 of 2002 requests the state Medicaid, Human Services Department and others to "identify all avenues to maximize prescription drug discounts that may be achieved by using the federal 340B program."
New Mexico SB 338, now Chapter 315 of 2003. Requires Medicaid to "identify entities that are eligible to participate in 340B. "The department shall make a reasonable effort to assist the eligible entities to enroll in the program and to purchase prescription drugs under the federal drug pricing program. The department shall ensure that entities enrolled in the federal drug pricing program are reimbursed for drugs purchased for use by Medicaid recipients at acquisition cost and that the purchases are not included in a rebate program." Range of General Fund Savings $500,000-$1.5 million.
New Mexico HB 88 of 2004 ensures that all eligible entities participate in the federal drug pricing program under Section 340B of the federal Public Health Service Act. Allows entities receiving greater discounts to opt out.
New York A 7298 of 2005 implements the 340B pharmacy savings program. Prohibits state Medical Assistance payments to 340B covered entities or to contracted pharmacies for drugs that are eligible for purchase through 340B by outpatients. (Filed, passed House, passed Senate 4/12/05; signed by governor 4/13/05 as Chpt. 63)
Texas HB 2292 of 2003 among other things, provides that "community mental health centers may form a referral relationship with community health centers, federally qualified health centers, disproportionate share hospitals, and/or other eligible entities for the purpose of obtaining federal 340B pricing for pharmaceuticals." Allows such referrals to "other lower cost drug programs regardless of any statewide preferred drug list or vendor drug program which may be adopted." (§ 2.152.)
Texas HB 915 of 2001 creates the Interagency Council on Pharmaceuticals Bulk Purchasing, which must investigate options for using the 340B program: "The council shall investigate any and all options for better purchasing power, including ... using rebate programs, hospital disproportionate share purchasing, and health department and federally qualified health center purchasing."
Texas SB 347 of 2001 authorizes the Texas Department of Criminal Justice to provide prescription drug services to the Texas prison population through the 340B Prescription discount program. The law establishes a contract with two university hospital pharmacy systems that are qualified as providers within the 340B program. The law became effective October 1, 2001.
Utah H 74 text of 2008 by Rep. Litvack requires the Department of Health and Human Services to explore the feasibility of expanding the use of 340B drug pricing programs in the state Medicaid program, which limits the cost of covered outpatient drugs to federally qualified health centers including consolidated health centers, migrant health centers, health care for the homeless, Healthy Schools/Healthy Communities and Tribal Programs.
(Prefiled 12/14/07; passed House 1/23/08; passed Senate 2/7/08; signed into law by governor 3/14/08 )
Utah HB 33 of 2005 creates a five-year pilot program within the Comprehensive Health Insurance Pool Act for disease and pharmaceutical management of bleeding disorders; permits enrollees in the pilot program to participate in a federal 340B discounted drug pricing program; requires the Pool to report pharmaceutical costs under the pilot program.
Vermont H 768 (Appropriations bill) of 2004 among other things, would study the use and potential expansion of using 340B purchasing in the state for correctional facilities, state funded managed care plans and state bulk purchasing initiatives. (Signed by the governor 6/10/04) http://www.leg.state.vt.us/docs/legdoc.cfm?URL=/docs/2004/acts/ACT122.HTM see Sec. 128g. 33 V.S.A. § 2008
Colorado HB 1252
Among other things, would require the administering entity to maximize prescription drug discounts through the use of the federal 340B drug pricing program. (Did not pass House Committee 5/1/06.)
Connecticut SB 648
Among other things, would allow any Federally Qualified Health Center that has received Department of Social Services funds to establish a “§ 340B” affordable pharmaceutical drug program for qualified low-income patients or expand an existing drug program to include qualified low-income patients according to “§ 340B,” to use these funds for administrative, operational and capital costs associated with the programs. (Passed Senate, but did not pass House by end of 2006 session.)
Hawaii HB 1058 and SB 868 Would appropriate funds to the DOH for federally qualified health centers and the Medicine Bank to provide pharmacy services and supplies to low-income patients by using the 340B program. (Did not pass before end of 2006 session.)
Massachusetts H 2700
Would require “all programs, clinics, hospitals and other health-related centers and entities that are eligible under Section 340B” to participate in the federal prescription drug price discount program, unless they demonstrate greater savings through other purchasing. (Accompanied a study order H 4830
Minnesota HF 1422
Among other things, would require Hemophilia drugs to be obtained from a 340B approved health facility. (Did not pass by end of 2006 regular session.)
New Mexico SB 11
Would appropriate funds to pharmacy services in primary care clinics in rural and medically underserved areas of the state, pursuant to the Rural Primary Health Care Act. (Which would lead to an increase in patients using 340B pricing in federally qualified/rural health centers.)
- Rhode Island SB 806 Would create a "Pharmaceutical Prudent Purchasing and Accountability Act," directing five departments to make various state drug benefit programs more cost effective, including a coordinated preferred drug list for RIPAE and state employees, a coordinated pharmaceutical contracting system or multi-state Rx program on behalf of all individuals served or covered by state programs and expanded use of 340B discounted pricing.
- Colorado HJR 1070 Would encourage all health care facilities that may qualify as covered entities under the federal 340B drug pricing program to maximize the utilization of the program, and have all state agencies explore all avenues with 340B "to receive maximum state budget savings."
- Connecticut HB 5040 of 2004 would have directed federally qualified health centers to enroll in 340B, but the language was stricken from an amended version.
- Kentucky HJR 38 of 2004 would have directed the Cabinet for Health Services to study the expansion of the federal 340B prescription drug discount program and require a report to Legislative Research Commission by October 30, 2004. *Died at end of session.
- Maryland HB 1271 and SB 715 of 2004 would develop a revolving loan program to assist Community Health Centers in obtaining prescription drugs through the 340B program.
- Maryland HB 290 & SB 189 would create the Federally Qualified Health Centers Grant Program; authorizes the Board of Public Works to provide grants under the Program for the conversion of public buildings to Federal Qualified Health Centers for specified purposes; authorizes specified entities to apply to the Department of Health and Mental Hygiene for grants.
- Minnesota HF 2280/SF 1760 would require a study of the feasibility of expanded use of the 340B drug pricing for targeted populations. Would authorize contracted use for hemophilia disease management; also requires compilation and description of "all health care providers and facilities in the state potentially eligible" for 340B discount pharmaceuticals.
- Vermont S 288 of 2004 among other things, would study the use and potential expansion of using 340B purchasing in the state for correctional facilities, state funded managed care plans and state bulk purchasing initiatives. (Passed Senate, 3/18/04)
- Virginia HB 359 of 2004 would require the state to establish a mechanism by 2005 so that all clinics that maintain pharmacy services "shall continue to provide free or low-cost prescription drugs (on a sliding fee scale) to any low-income patients who do not have any prescription drug benefit and whose primary and specialty health care services have been transferred to a community health clinic", also requires use of manufacturer free drug programs where available.
(Filed and sent to committee 1/14/04; tabled, did not pass House 1/27/04)
AN “OLDIE BUT GOODIE”: THE 340B PROGRAM, from NCSL's State Health Notes by Kory Mertz, Volume 28, Issue 491, May 14, 2007.
RX at NCSL's Annual Meeting in Boston: Achieving Pharmaceutical Access: The Roles of Disclosure and Privacy
August 6, 2007 - 3:00 - 5:00 PM, hosted by the Health Committee
Most Americans rely on the private market for their medicines. This session will examine two hotly-debated prescription drug policies facing states and pharmacists. First, should states set standards for Pharmacy Benefit Managers (PBMs), the middlemen that negotiate prices and transactions for 200 million Americans? Second, should prescription records identifying doctors or patients be available for marketing purposes by industry professionals?
Welcome/Introduction: Senator Leticia Van de Putte, Texas Senate; NCSL President
Presiding: Senator Durell Peaden, Florida; Vice-Chair, NCSL Health Committee
, Hogan & Hartson, Washington DC | PowerPoint
Representative Cindy Rosenwald
, New Hampshire; Chair, NH Health and Human Services Committee | PowerPoint
, Pharmaceutical Care Management Association (PCMA) | PowerPoint
, Vice President, National Community Pharmacists Association (NCPA), Arkansas | PowerPoint
340B Coalition's 4th Annual Winter Conference: Update on Key Operational and Compliance Issues: January 30-February 1, 2008
For slides, click here: http://www.drugdiscountmonitor.com/2008_winter/index.html
The conference will address several vital areas of the 340B drug discount program including:
- The use of contract pharmacies to dispense 340B-discounted drugs.
- The 340B impact of state Medicaid changes under the Deficit Reduction Act of 2005 (DRA).
- Compliance with 340B inventory management and anti-diversion standards.
- Legislative and regulatory update from Washington, DC.
The conference agenda has been organized into two tracks to meet the interests of conference attendees. Track One is designed for covered entities and other parties that are interested in learning about how to operationalize the 340B program. Track Two will appeal to the broader community of 340B stakeholders, including the pharmaceutical industry, that might be more interested in hearing about recent developments involving 340B policy and compliance and expert analysis of such developments. All attendees are free to attend any Track One or Track Two session that interests them.
For more information: http://www.340bconferences.org/conferences/2008_winter/agenda.cfm
HRSA: Medicare Part D Rx Information for 340B Providers
Survey of rural hospitals and their use and understanding of the 340B program.
The Oregon Blueprint: Coordinated Contracting of Prescription Drugs - A Fiscal and Policy Strategy for the State of Oregon - A report by the Heinz Family Philanthropies about OR and the use of 340B in the state. July, 2006.
"Prescription Drug Discounts: from 340B to Consumer Cards." NCSL Annual Meeting session, August 16, 2006: - For the 40+ million Americans not on Medicare or comprehensive private insurance, access to prescription drugs remains a visible concern. The federal 340B drug discount program provides one significant option - including a fast-expanding network of clinics and pharmacies in every state. In addition, user-friendly industry-sponsored assistance cards and new state discount laws keep pharmaceuticals near the top of policymakers' priority lists.
* Harry Hagel, Senior Director, HRSA Pharmacy Services Support Center, Washington, DC
340B Coalition's 3rd Annual Winter Conference: Major Changes on the Horizon for the 340B Drug Discount Program
The winter 340B Coalition Conference was held February 26-28, 2007 at the Hilton Salt Lake City Center in Salt Lake City, UT. To download the conference brochure or visit the conference Web site at http://www.340bconferences.org/conferences/index.htm.
To see some of the presentations, go here: http://www.drugdiscountmonitor.com/2007_winter/index.html
- 340B Coalition's 11th Annual Conference was held July 23-25, 2007 at the Wardman Park Marriott in Washington, DC. For copies of the slides and more information, please see: www.340Bconferences.org or http://www.340bconferences.org/conferences/2007_annual/index.htm#orders
The Safety Net Hospitals for Pharmaceutical Access (SNHPA), formerly known as the Public Hospital Pharmacy Coalition has a new name and website. Please see: http://www.safetynetrx.org/public/index.cfm for more information.
340B Coalition's 10th Annual Conference on Improving Access to Pharmaceutical Care and Ensuring Compliance with Federal and State Laws was held July 17-19, 2006 at the Omni Hotel in Washington, DC. This conference provided timely information on how to provide high quality pharmaceutical care and handle various compliance issues related to the Public Health Service 340B Drug Discount Program. Sessions included strategies for encouraging 340B participation in your state; pharmacy reimbursement models that create savings for Medicaid by incentivizing 340B pharmacies to serve more Medicaid patients; pricing investigations with recovery implications for both Medicaid and 340B; and innovative partnerships that qualify state-funded populations (Medicaid, corrections, mental health, etc.) for 340B-priced drugs. For more information click here: www.340Bcoalition.org
To view the presentation slides, please go here: http://www.drugdiscountmonitor.com/2006_July/index.html
2005 340B Audioconference Archive
NCSL and the National Governors Association hosted a webconference on August 5, 2005 regarding 340B Drug Purchasing Options for states. States can benefit from the 340B program when Medicaid clients or other state programs purchase discounted pharmaceuticals through participating federally qualified community health centers (FQHCs). Further, many states and communities have used 340B to expand access to prescription drugs and improve patient safety. 340B also uses a Prime Vendor to negotiate pharmaceutical pricing below the 340B price as well as improving access to affordable medications by establishing a distribution network for pharmaceuticals to covered entities. This allows health care organizations participating in the 340B Prime Vendor program to recognize additional savings and value. For more information on the 340B Drug Pricing Program, please read this webpage or see NGA’s fact sheet at the following link: http://preview.nga.org/Files/pdf/032503FACTS340B.pdf Presenters provided the states with the basics on 340B, as well as some innovative actions that states have taken so far. Presenters were:
Diane Goyette, RPh, JD- Senior Director, HRSA Pharmacy Services Support Center, American Pharmacists Association
Karmen Hanson, MA- Senior Policy Specialist, Health Care Program, NCSL
Senator Dede Feldman, New Mexico State Legislature
Todd D. Sorenson, PharmD, Associate Professor, University of Minnesota College of Pharmacy
To hear the archive of the session, please click here: mms://media.nga.org/Webconf340B2005/Track01.wma
- The 340B Prime Vendor Information - In September 2004, the Health Resources and Services Administration (HRSA) signed a competitively awarded agreement with HealthCare Purchasing Partners International (HPPI) to be the Prime Vendor for entities participating in the 340B Drug Pricing Program. The Prime Vendor negotiates sub-340B pricing on pharmaceuticals, establishes distribution solutions and networks that improve access to affordable medications and provides other value-added products and services. The program is voluntary, free and risk-free to 340B-covered entities. A participant may continue to use its existing drug distributor or select one of the program’s authorized distributors. The program has recruited over 1600 participating entities and has secured sub-ceiling discounts on over 2000 pharmaceuticals. For more information on how to participate, visit the Prime Vendor’s Web site at www.340bpvp.com or call (888) 340-2787.
- *Rx for Access: Drug Cost Management and Value for Vulnerable Populations: http://www.rxforaccess.org/.. This newsletter addresses many topics other than the 340B program and may be of interest to a wide range of readers.
- *Sign up for the Federal Drug Discount and Compliance Monitor: The Inside Source on the Public Health Service 340B Drug Discount Program. The Monitor is the definitive source for the latest news on the Public Health Service 340B drug discount program and related developments in the federal drug discount arena. The Monitor's Washington DC-based staff has the inside scoop on 340B, a program that affects over 11,000 health care providers and over 500 pharmaceutical manufacturers. From new developments in the regulatory front to the latest news from Capitol Hill, you can count on the Monitor as your guide to the 340B program. The Monitor will also track the latest developments in drug pricing litigation impacting 340B and the Medicaid drug rebate programs.
- U.S. Office of Pharmacy Affairs: Overview of the 340B Drug Pricing Program - Frequently Asked Questions, updated 2002.
- Review of 340B Prices (OEI-05-02-00073; 07/06) - This report reviews 340B prices charged to a subset of covered entities and compares them to the 340B ceiling prices This report’s hyperlink is http://oig.hhs.gov/oei/reports/oei-05-02-00073.pdf
- Information on HEALTH CENTERS (http://www.ncsl.org/programs/health/Communityhc.htm)
Currently, the Community Health Center federal grant program is authorized under section 330 of the Health Centers Consolidation Act of 1996. According to HHS Secretary Tommy G. Thompson, "Community health centers are the core of the health care safety net for underserved and uninsured Americans." In 2002, President Bush announced the Health Center Initiative, which plans to increase the number of health centers and increase primary health care access to more Americans.
- "State Spending on Medical Supplies and Pharmaceuticals" A detailed Virginia legislative study of 340B and other state Rx options, released by JLARC, Dec. 2002. [52 pages - see especially pages 20-24, 43]
- "Pharmaceutical Manufacturers Overcharged 340B-Covered Entities," Report by the HHS Office of the Inspector General, March 10, 2003 (A-06-01-00060)
- "Pharmaceutical Discounts Under Federal Law: State Program Opportunities," a comprehensive report by Bill von Oehsen on opportunities and obstacles for state drug assistance programs to use federal drug discount programs. NCSL participated in the editorial review. August 10, 2001 (48 pages).
- "Prescription Drug Coverage, Spending, Utilization, and Prices: Report to the President," by the U.S. Department of Health and Human Services, April 2000 (240 pages).
340B Drug Pricing Program: Practical Details *
To understand the genesis of the 340B program, one must begin with OBRA'90 and, in particular, the best price mechanism established by Congress to calculate the rebate amounts for brand name drugs. As a result of the best price mechanism, many pharmaceutical companies had a disincentive to continue giving deep discounts on drugs because they would have to extend the same discounts to the Medicaid program.
When manufacturers began raising their prices, the federal and state savings achieved through the Medicaid rebate program were being offset by increased government spending on drugs purchased by other federal- and state-supported providers. To correct this situation, Congress included in the Veterans Health Care Act of 1992 legislation intended to extend relief to other governmental payors of drugs - including the Big 4, federal agencies and other purchasers buying various safety net providers and programs funded by the Public Health Service. One area of statutory relief involved enactment of section 340B of the Public Health Service Act. This program, often referred to as the PHS drug discount program or the 340B program, is administered by the Office of Pharmacy Affairs (OPA) which was called the Office of Drug Pricing until it was renamed in early 2000. OPA is located within the Bureau of Primary Health Care (BPHC) which, in turn, is located within the Health Resources and Services Administration (HRSA). OPA, BPHC, and HRSA are all agencies within HHS. OPA is responsible for interpreting, implementing, and overseeing compliance with section 340B.
Section 340B requires pharmaceutical manufacturers whose drugs are covered by the Medicaid program to enter into an agreement with the secretary of HHS obligating manufacturers to comply with the terms of section 340B.  A parallel provision exists in the Medicaid rebate statute.  Under the 340B participation agreement, a manufacturer agrees to provide discounts on covered drugs purchased by specified PHS and government-supported facilities, called "covered entities," that serve the nation's most vulnerable patient populations. The amount of these discounts is calculated using the same rebate formulas specified in OBRA'90; however, covered entities are free to negotiate even deeper discounts than the Medicaid rebate amount .  The agreement also requires, among other things, that manufacturers check the OPA website each quarter to determine which covered entities are participating in the program. Manufacturers may not charge more than the 340B ceiling price regardless of whether the covered entity purchases pharmaceuticals through a wholesaler or directly from the manufacturer. The definition of "covered entities" includes certain nonprofit disproportionate share hospitals owned by or under contract with state or local government, as well as specified PHS grantees including certain federally qualified health centers (FQHCs), FQHC "look-alikes," state operated AIDS drug assistance programs (ADAPs), the Ryan White CARE Act Title 1, Title 11, and Title III programs, tuberculosis, black lung, family planning, and sexually transmitted disease clinics, hemophilia treatment centers, public housing primary care clinics, homeless clinics, urban Indian clinics and Native Hawaiian health centers.  Some 8,900 eligible covered entities participate in the 340B program. 
Covered entities participating in the PHS drug discount program are subject to two important restrictions. First, section 340B prohibits the resale or transfer of discounted outpatient drugs to anyone other than a patient of the covered entity.  An individual may, be considered a patient of a covered entity if he or she satisfies a test set forth in OPA guidelines.  The penalty for failing to comply with the 340B antidiversion provision is forfeiture of the discounts back to the manufacturer or disqualification from the program.  Manufacturers and OPA have the right to audit the records of covered entities to determine whether diversion has occurred.  Second, the 340B law states that a drug purchased through the 340B program shall not be subject to both a 340B discount and a Medicaid rebate.  The purpose of this restriction is to protect manufacturers from giving duplicate discounts on the same drug - a 340B discount up front when the covered entity purchases the drug, plus a Medicaid rebate paid to the state after the drug is billed to Medicaid. OPA has established two mechanisms for covered entities to comply with the 340B prohibition against duplicate discounts.  The most common procedure involves covered entities submitting their Medicaid pharmacy numbers to OPA for use by state Medicaid agencies in identifying covered entity pharmacy bills and excluding them from the rebate program. 
Finally, the 340B program offers a contract pharmacy option for covered entities. When Congress enacted section 340B, Congress did not consider that some covered entities - especially FQHCs, city and county health departments, and other small facilities -would not be able to participate due to the lack of an in-house pharmacy capable of purchasing and dispensing the discounted drugs. These facilities began complaining to OPA about their inability to participate. OPA responded to these complaints by developing guidelines that allow covered entities to use contract pharmacies to dispense discounted drugs.  The guidelines essentially allow a covered entity to enter into a "ship to, bill to" arrangement with a community pharmacy or other pharmacy contractor such that the covered entity purchases the 340B drug and the manufacturer bills the entity for the drug purchased, but ships the drug to the contract pharmacy. In addition, the contractor must provide the covered entity quarterly financial statements, a detailed status report of collections, and a summary of receiving and dispensing records. The contractor is also required to establish and maintain a tracking system to prevent diversion of drugs to individuals who are not patients of the covered entity. The contract pharmacy model is primarily used by FQHCs and other smaller covered entities. It is difficult to implement in some states, such as California, because of perceived conflicts with state pharmacy laws. 
A recent study estimates that, during fiscal year 1997, 1,075 entities purchased outpatient drugs at these discounts with a total net purchase amount between $893 million and $1.2 billion.  Estimated purchases in fiscal year 2000 are approximately $1.7 billion.  On average, 340B prices are estimated to be 51 percent lower than AWP, 39 percent lower than AMP and 19 percent lower than the Medicaid net price. 
* Excerpted from "Pharmaceutical Discounts Under Federal Law: State Program Opportunities," by William von Oehsen, August, 2001. pp.13-14
Definitions and Footnotes for William von Oehsen paper
Such term does not include a wholesale distributor of drugs or a retail pharmacy licensed under state law.
49 - Veterans Health Care Act of 1992, Pub. L. No. 102-586, 106 Stat. 4943 (1992). Id § 602 (C
"Covered outpatient drug" has a lengthy statutory definition. 42 U.S.C.A. § 1396r-8(k)(2). In part, the term includes a prescribed drug (1) which is approved under the Food, Drug and Cosmetic Act; (2) which was commercially used or sold in the U.S. before enactment of the Federal Food, Drug and Cosmetic Act; and (3) which has not been the subject of a final determination by the Secretary that it is a "New Drug" under the Food, Drug and Cosmetic Act. Also included are identical, similar or related drugs, a biological product which may only be dispensed by prescription, is licensed, and produced by a licensed establishment. The term excludes any drug, biological product, or insulin provided with inpatient hospital services, hospice services, dental services (except where state plan authorizes direct reimbursement to dispensing dentist), physician office visits, outpatient hospital emergency room visits, and outpatient surgical procedures. Finally, nonprescription drugs prescribed by a physician, or other authorized prescriber, may be regarded as covered outpatient drugs.
"Manufacturer" means any entity which is engaged in -
(A) the production, preparation, propagation, compounding, conversion, or processing of prescription drug products, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, or (B) in the packaging, repackaging, labeling, relabeling, or distribution of prescription drug products. 42 U.S.C.A. § 1396r-8(k)(5) (West Supp. 2000).
odified at 42 U.S.C.A. § 256b (West Supp. 2000)
50 - Id.
51 - 42 U.S.C.A. § 256b(a)(1) (West Supp. 1999).
52 - 42 U.S.C.A. § 1396r-8(a)(1) and 8(a)(5) (West Supp. 2000).
53 - 42 U.S.C.A. § 256b(a)(2) (West Supp. 1999).
54 - Id. § 256b(a)(4).
55 - See OPA, Entity and Manufacturer's List
56 - 42 U.S.C.A. § 256b(a)(5)(B) (West Supp. 1999).
57 - 61 Fed Reg. 55,156 (1996).
58 - 42 U.S.C.A. § 256b(a)(5)(D) (West Supp. 1999).
59 - Id. § 256b(a)(5)(C).
60 - Id. § 256b(a)(5)(A).
61 - 58 Fed. Reg. 34,058 (1993) (rebate exclusion option); 65 Fed. Reg. 13,983 (2000) (Medicaid carve-out option).
62 - 58 Fed. Reg. 34,058 (1993).
63 - 61 Fed. Reg. 43,549 (1996).
64 - This problem would be remedied by legislation introduced by Senator Speier on February 20, 2001. S.B. 340.
65 - Mathematica Policy Research, Inc., Washington, D.C., "An Analysis of Purchases, Savings and Participation in the PHS Drug Pricing Program," (Sept. 30, 1999).
66 - Telephone Interview with Jim Mitchell, Director of OPA (Apr. 2, 2001).
67 - See Table 3.
Legislators and staff may obtain information from NCSL by contacting Karmen Hanson or Richard Cauchi.
This material was compiled in cooperation and consultation with the HRSA Office of Pharmacy Affairs.
Disclaimer: The opinions and/or policies expressed in non-NCSL materials are those of the authors, sponsors or sponsoring organization, and not NCSL. NCSL takes no position for or against state health legislation.