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340B Prime Vendor | Managed by Apexus
Pharmacy Flash
MARCH 2014
Apexus Announcements
Events and Webinars
Featured Articles
Integrity Tip of the Month
Government & Policy News
Industry News
FAQs from Apexus Answers
340B Resources
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Event Calendar
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Apexus 340B PVP Pharmacy Flash is a newsletter containing industry
news and announcements that are relevant to 340B stakeholders.
Apexus Announcements

Apexus Leads the Charge to Support AIMM

The 340B program was the common ground initially for Apexus and the Patient Safety and Clinical Pharmacy Services Collaborative (PSPC), and while many teams still have a 340B connection, Apexus sees a bigger picture. The Alliance for Integrated Medication Management (AIMM) highlights the vision and collaborative efforts of Apexus President, Christopher Hatwig, in this exclusive interview. (View Details)

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Apexus Supports and Sponsors ASHP Ambulatory Care Conference and Summit

ASHP and the ASHP Research and Education Foundation held their 2014 ASHP Ambulatory Care Conference and Summit, March 3-4, offering ambulatory care pharmacy practitioners an opportunity to influence the future of practice through consensus-building activities. This summit was a continuation of the Pharmacy Practice Model Initiative (PPMI) that began in 2010, providing participants with the opportunity to develop recommendations aiming to advance patient care and optimize pharmacists' roles in ambulatory care settings.

Apexus, as the prime vendor for the 340B program, sponsored ASHP for this summit to advance this valuable initiative. "We share the commitment to support the development of clinical pharmacy services programs. Our interest here, along with our work with the Alliance for Integrated Medication Management (AIMM), is to strengthen the role and engagement of ambulatory care pharmacists in improving the clinical and economic outcomes of the safety-net providers we serve," said Apexus President Christopher A. Hatwig, MS, RPh, FASHP. "We look forward to the seeing the recommendations that come from this summit and our continued work and support of ASHP's quality initiatives."

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Call for Advisory Committee Members

As the government's awarded 340B Prime Vendor, Apexus is responsible for securing discounts on outpatient drugs and other pharmacy-related products and services for participating public hospitals, community health centers and other safety-net health care providers electing to join the program.

Apexus maintains close working relationships with its participants through formally established councils representing active participants of Apexus. Currently, there are four formal advisory councils:
1. Hospital Advisory Council (DSH, PED, CAN, RRC, SCH)
2. Community Health Center Advisory Council (FQHC, CH)
3. Title X Family Planning Clinic Advisory Council (FP)
4. Hemophilia Treatment Center Advisory Council (HM)

Apexus is looking for additional participants to become members of our advisory councils, specifically the Community Health Center Advisory Council (FQHC,CH). The purpose of advisory councils is to serve as thought leaders in an advisory role capacity to the Apexus staff in support of its company strategies surrounding contracting, marketing and operations. Council members are selected based on geographic diversity, clinic size, complexity of pharmacy operations, technical/clinical expertise, ability to make a time commitment and more. Council members are appointed to for three-year terms. The FQHC council meets via conference-call webinars once every other month, with one in-person meeting occurring in July in conjunction with the summer 340B Coalition meeting. If you are interested in participating on the Community Health Center Advisory Council, please contact Michael Benedict at mbenedict@340bpvp.com.

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340B Recertification for HRSA and IHS Grantees Deadline March 14

The Health Resources and Services Administration (HRSA) and Office of Pharmacy Affairs (OPA) announced that recertification for Tribal and Urban Indian entities, HRSA grantees and CDC STD/TB grantees began on February 10, 2014. The deadline for the completion of the recertification process will be March 14, 2014. Each covered entity's authorizing official received an email on February 10 that included this year's username and password to access the recertification dashboard, along with instructions for the online recertification process. Any questions about recertification can be directed to Apexus Answers at 888-340-2787 or emailed to ApexusAnswers@340bpvp.com.

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340B Peer-to-Peer: Summer 2014 Applications Are Now Being Accepted

Are you a 340B entity that may be interested in becoming a HRSA recognized 340B Leading Practice Site? Do you still have questions about the application process or the program? The American Pharmacists Association (APhA) has opened the application period for the Summer 2014 class of Leading Practice Sites. All 340B entity types are encouraged to apply. Sites that are selected for this recognition will receive a stipend for two years of participation as well as other benefits, such as off-site training, APhA association membership, and financial support for select conference attendance. Limited spots are available. Don't miss out on this opportunity—apply today! Apply here.

Email the Peer-to-Peer team at p2pcommunication@aphanet.org if you have any questions.

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Provider Status Legislation Introduced

Apexus supports H.R. 4190, introduced March 11 by Reps. Brett Guthrie (R-KY), G.K. Butterfield (D-NC), and Todd Young (R-IN). The legislation will amend the Social Security Act to recognize pharmacists as providers under Medicare Part B. This legislation is anticipated to greatly increase access to pharmacists' services for patients who live in medically underserved communities and obtain their primary medical care from 340B eligible safety-net facilities.

The legislation is supported by both ASHP and APhA, which are both members of the Patient Access to Pharmacists' Care Coalition—a group of organizations representing patients, pharmacists, and pharmacies, as well as other interested stakeholders—which is leading efforts to garner support for the bill. Currently, the coalition has 22 members, including pharmacy associations, pharmacy chains, and other stakeholders.

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Updates from 340B University in Dallas



A successful session of 340B University was held March 2 in Dallas, TX. More than 150 people attended, representing 33 states and 127 organizations from 18 various stakeholder groups.

At 340B University, the faculty provides a curriculum that equips attendees with facts, tools, and resources. Networking with peers helps support entities on ways to maximize the intent and value of the program. One participant commented: "This was really great. So much information, and we were so well taken care of. I was impressed by the expertise of the speakers." Another attendee said, "Great information, well organized. Thank you! I learned a lot and look forward to future sessions."

Each 340B University is uniquely designed to incorporate the latest information to ensure that entities have what they need to run a compliant 340B program.

If you have not attended 340B University yet, you don't want to miss the next one. Sign up today for the next open session!

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ISMP February Newsletter Now Available

Log in to the www.340BPVP.com secure site for access to this exclusive newsletter, a peer-reviewed newsletter published by the Institute for Safe Medication Practices (ISMP). Once you log in, navigate to the NEWS tab of the top main navigation bar, and from the drop-down menu, click on "ISMP."

In this month's issue:
Oral vaccine mistakenly given by injection
How FDA can help reduce dabigatran (PRADAXA) bleeding risks
Welcome new subscribers!
Middle four strike again
ID please
Standardized concentrations for pediatric oral liquids
Welcome action by CVS
Share your stories with us

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Events and Webinars

Register for a 340B University Session Near You

Registration is now open for additional 340B University sessions! 340B University sessions fill up quickly—therefore, early registration is encouraged.

Upcoming 2014 sessions and open registration:

March 27 .......................................... Orlando, FL
(prior to APhA Annual Meeting)
Register
March 28 .......................................... Alexandria, VA
(special session for manufacturers, in conjunction with the Government Pricing (GP) Summit)
Register
May 31 .......................................... Las Vegas, NV
(prior to ASHP Summer Meeting)
Register
July 13–14 .......................................... Washington, DC

(prior to 340B Coalition Conference)

August 21 .......................................... San Diego, CA

(prior to NACHC CHI Meeting)

October 19 .......................................... Chicago, IL

(prior to ASHP Leadership Conference)

December 6 .......................................... Anaheim, CA

(prior to ASHP Midyear Meeting)


For additional information and questions regarding 340B University events, please contact 340BUniversity@340BPVP.com or call (888) 340-2787 and press option 3.

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Network with Apexus Experts at Upcoming Industry Events

Apexus experts will be presenting on 340B hot topics and various Apexus staff members will be available and exhibiting during industry conferences. We look forward to meeting you in person at the Apexus 340B booth and addressing the most complex 340B-related questions. View our event calendar we look forward to seeing you at the next conference!

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Hear from 340B Industry Experts at the GP Summit

IIR's 6th Annual Government Programs Summit is just 3 weeks away! Join Cmdr. Krista Pedley, PharmD, MS, CDR, USPHS, Director, Office of Pharmacy Affairs, HRSA; Chris Hatwig, President of Apexus; and other industry experts to learn about the latest developments to the 340B Program.

Sessions throughout the conference will emphasize the role of the manufacturer in ensuring the integrity of the 340B program and will focus on:
Updates regarding HRSA audits and other integrity initiatives
Pricing and contracting strategies with the prime vendor
Medicaid and duplicate discounts
Orphan Drug Exclusion
GPO Prohibition
Contract Pharmacies

On Friday, March 28, join Chris, along with other 340B experts in the sessions:
Update on the 340B Program
Latest Developments for the 340B Orphan Drug Rule

Chris will also be available for a Parking-lot Q&A session on Friday at the end of the track—340B Summit for Manufacturers, in collaboration with Apexus' 340B University.

Register with code XP1951LINL and receive 15% off of the standard rate: http://bit.ly/1dncAkp.
If you have any questions about the event, please contact Kate Devery (Kdevery@iirusa.com). View more information.

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Peer-to-Peer Webinar: The Making of a Leading Practice Site in the HRSA/OPA Peer-to Peer-Program—An Insider's View

March 12, 2014
2:00–3:00 p.m. (Eastern)


All 340B participating organizations are required to meet 340B integrity standards and uphold 340B program requirements. A number of organizations have integrated the benefits of the 340B program into their operations to a high level of success, achieving the status of a Leading Practice Site. Having done this, they are eager to help others find their success implementing a 340B pharmacy project. The purpose of this webinar is to highlight the aspects of the 340B peer-to-peer (P2P) Leading Practice that make them successful within the 340B program and share with the audience the process of becoming a HRA/OPA P2P Leading Practice Site.

Continuing Pharmacy Education (CPE) credit will not be offered for this webinar.

More information and registration.

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Featured Articles

HRSA Funding Priorities for 340B Integrity Emerge

In its annual budget justification to Congress, HRSA provided the four key areas on which the Office of Pharmacy Affairs funding priorities will focus.

Non-compliance with the 340B pricing requirements
Support the 340B pricing system
Publish policies for 340B ceiling price computation
Establish systematic quarterly comparison: 340B ceiling prices vs. 340B selling prices (offered by manufacturers and drug wholesalers)
Provide follow-up efforts to resolve problems wherever they arise in the data supply chain

Errors and omissions in HRSA's covered entity database
Continue to require the verification of eligibility of entity types in FY 2015 (annual online verification of records in the 340B database).

Program Regulations and Guidance
Support implementation of program regulations and guidance (to provide oversight/integrity)

Office of Pharmacy Affairs Information System (OPAIS) IT Investment
Supports the strategic and performance outcomes of the program, ensuring stakeholders have accurate 340B Program data on which to base their sales projections or other business decisions.
The 340B online public access database
The pricing module to be used to validate manufacturers' calculations of the 340B ceiling price

Apexus commends HRSA for its incredible strides in recent years to improve program integrity. Such improvements include modernization of the HRSA 340B Database and mandatory recertification for all entities. In fact, HRSA just completed the largest recertification period to date, which included over 5,000 entities and will result in a database with more accurate data. HRSA has also issued policy clarifications and even its first regulation to guide stakeholders toward compliant practices. The additional funding recently appropriated to HRSA is likely to further strengthen these integrity initiatives, as it will empower HRSA with the resources necessary to promote integrity. These changes have raised the bar for compliance and set a clear expectation for best practices.

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HRSA Describes Proposed 340B User Fee

In its annual budget justification to Congress, HRSA provided a summary of attributes of a possible 340B User fee.

Purpose: The user fee provides the resources needed to improve program integrity and implement statutory provisions while reducing the government expenditure of taxpayer dollars. It will also help address recommendations by the Office of Inspector General (OIG) and Government Accountability Office (GAO) to make major improvements in program integrity. Rationale: The user fee will create a sustainable funding source generated by those who benefit from the program to meet the demands of the existing growth of the Program, the changing marketplace, and the new statutory program requirements. The fee will allow HRSA to better monitor compliance among both manufacturers and covered entities.

Description: 0.1 percent (or one cent for every thousand dollars) of the total 340B drug purchases paid by participating covered entities. The collected user fee is in addition to the entity's cost to purchase the drug at the 340B price, and does not impact the 340B ceiling price calculation. The user fee would not affect the calculation of the entity's total acquisition cost of a 340B drug.

Implementation:
1. The fee will be collected from the covered entities into a no-year account established by the Secretary for use by the Secretary and designees in administering operations of the 340B Program (i.e., integrity provisions, access to covered drugs and services for 340B eligible entities.)
2. The manufacturers will periodically report purchases by entities under the 340B program.
3. The fee will be paid by and collected from the entity, and remitted to the Secretary.

Benefit:
The user fee collected will address areas of concern that include:
1. Developing/implementing a system to verify the accuracy of the 340B ceiling prices (including policies regarding 340B ceiling price calculation, verification/spot checks of covered entity transactions, sharing via a secure website, etc.)
2. Selective auditing of manufacturers and wholesalers
3. Inquiring into the cause of any pricing discrepancies and take necessary corrective actions (i.e. ensuring manufacturers issue timely refunds for routine retroactive adjustments, erroneous or intentional overcharges)
4. Developing a user fee system (standards, methodology, verification of payments, etc.)
5. Establishing/implementing an administrative process for entity overcharge claims as well as manufacturer claims of violations
6. Imposing civil monetary penalties (manufacturers and entities)

Status: A legislative proposal has also been presented, but there has not been action yet.

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Integrity Tip of the Month

The entity is ultimately responsible for 340B compliance; entities should not consider "turning over" compliance to a third party as an option.

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Government & Policy News

CMS OK's California's 340B Medicaid Carve-Out Ban and AAC Billing Requirement

The federal Centers for Medicare and Medicaid Services (CMS) has approved California Medicaid's 2009 policy requiring 340B covered entities to "carve in" their Medicaid purchases and to pass their 340B discounts on to Medicaid by billing such drugs at no more than actual acquisition cost (AAC) plus a dispensing fee. The state and the AIDS Healthcare Foundation (AHF) are now sparring in a federal appeals court over what CMS's January 30 action means for a lower court's permanent injunction last year barring the policy's enforcement. Full (paid subscription required)

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FDA Initiates Secure Supply Chain Pilot Program with 13 Prequalified Pharmaceutical Distributors

Michael Johnsen (Drug Store News, 2/19) reports, "The Food and Drug Administration on Tuesday announced the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs....The goal of the program is to enable the FDA to evaluate resource savings that will allow the agency to focus imports surveillance resources on preventing the entry of high-risk drugs that are the most likely to compromise the quality and safety of the U.S. drug supply." Full

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Study Warns of Rising Prices of Generic Medicines Under New FDA Rule

The Hill (2/27) reports in its "Regwatch" blog that the price "of generic drugs would skyrocket under a proposal" from the FDA "that would open manufacturers to lawsuits for failures to warn consumers about the potential side effects," citing a new report. In the study unveiled "earlier this month that contradicts the FDA's numbers, conservative economic consulting firm Matrix Global Advisors" noted "the cost of producing generic drugs would" jump by about $4 billion a year for the industry, "or $1.16 per prescription, which would be passed down to consumers." Industry groups argue that the FDA may not have weighed the full impact of the rule, noting that some manufacturers and insurers may be forced out of market because of the rule. That could hurt the consumers because they may not be able to get the generic medicines and may also raise their prices.

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Obama Administration Proposes Medicaid Prescription Monitoring

CQ (Young, Subscription Publication, 3/5) reports that the US Department of Health and Human Services estimates that an Obama administration proposal could save the Medicaid program up to $540 million over 10 years by monitoring drug prescription patterns among its recipients to detect waste, fraud and abuse. The proposal was contained in the president's budget, which was released March 4. CQ notes the budget's uncertain future calls into question whether or not the proposal will actually be implemented.

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FDA's Move to End Age Restriction for Generic Contraceptive Discussed

CQ (Young, Subscription Publication, 3/5) reported that the FDA's move to "effectively end the age restriction" for purchasing "generic versions of the Plan B One-Step morning-after contraceptive is drawing mixed reactions." Planned Parenthood President Cecile Richards "hailed last week's decision," allowing "generic versions of the one-pill forms of Plan B to women younger than 17." However, the conservative group Concerned Women of America criticized the FDA's move. "This means literally anyone can step up to the counter and buy this powerful drug even though the fine print says it is for those 17 and older," said Janice Shaw Crouse, director and senior fellow at the Beverly LaHaye Institute, a think tank at the Concerned Women for America.

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340B User Fee Proposed for FY 2015 budget

The Obama administration's proposed budget for FY 2015 includes $17 million for the 340B program: $10 million in appropriated funds and $7 million from a 0.1% user fee on 340B drug purchases. The Department of Health and Human Services states in its Budget in Brief booklet that the $7M increase over FY 2014 is intended "to establish a cost recovery fee to improve program integrity and oversight." A 340B user fee has been proposed for several years, with mixed support; the combination of mixed support for this issue and elections in November do not point to certain enactment of a 340B user fee.

Other 340B-noteworthy proposed issues in the administration's proposed budget include the following:

Potential reduction in Medicare disproportionate share hospital (DSH) percentage for some hospitals, possibly removing them from 340B eligibility: The administration proposes to include patients who have exhausted inpatient benefits (Medicare Part A), or who have enrolled in Medicare Part C, in the calculations of the Medicare fraction of the DSH patient percentages.

Possible reduced reimbursement for critical access hospitals (CAHs) and reduction in the number of CAHs: The administration proposes to reduce cost-based Medicare payments from 101% to 100% of reasonable costs; the administration proposes to reduce CAHs' enhanced cost-based Medicare payments from 101% of reasonable costs to 100%, and to prevent hospitals within 10 miles of another hospital from maintaining CAH designation.

Part D drug rebates: The administration proposes to permit Medicare to receive the same rebates that Medicaid receives, starting in 2016. It is noteworthy that the OIG 2014 Workplan also states: "We will determine how much Medicare Part B spending could be reduced if Medicare were able to share in the savings for 340B-purchased drugs."

A summary of the FY 2015 budget may be found here: http://www.washingtonpost.com/wp-srv/special/politics/presidential-budget-2015/.

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Obama Administration Paying Hospitals More than Many Community Cancer Centers for Same Treatment

Jim Angle (Fox News, 3/5) reports that Dr. Daniel Kantor, a neurologist in Florida, "says, 'one of the interesting quirks of health care in America is that hospitals really get paid a lot more than individual physicians, or even physician groups. It has to do partially with lobbying power, right, so hospitals are bigger corporations.' But hospitals argue their costs are greater, so they have to be paid more. A bipartisan House bill, however, would force equal payments no matter where a patient is treated." Full

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Industry News

Google Teams Up With Federal Government to Tackle Illegal Online Pharmacies

The National Journal (3/6, Novack, Subscription Publication) reported on how the search engine giant Google is working with the Federal government in its bid to tackle the growing problem of illegal online pharmacies. The Journal noted that attempts to locate and "verify every alleged online pharmacy" is virtually impossible, "so the focus is instead on limiting their use through consumer education, restricting their appearance in Internet searches, and enforcing harsher punishment." Google and others such as Microsoft and Facebook are member of the nonprofit Center for Safe Internet Pharmacies, which aims to promote secure online pharmacies. "Internet companies are working to report and remove illegal pharmacies from Internet search results, while payment networks aim to prevent payment transactions for illegal drugs," the article noted.

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Protect the 340B Program

Hospital CEO and former emergency room physician, Dr. Charles E. Hart of Safety Net Hospitals for Pharmaceutical Access (SNHPA), makes a strong case for benefits of the 340B to vulnerable patients, noting, "Without 340B savings, many systems would have to close pharmacies and oncology clinics and cut other healthcare services significantly." Full

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US Raises Concerns Over Patent Protections In India

Reuters (Busvine, 3/7) reported the US raised concerns over protection of patents on advanced medicines in India as that country prepares to evaluate allowing more medicines for local firms to copy. India is seeking to produce generic copies of medicines under a compulsory licensing process, which allows a government to approve production of generic copies while they are still protected by patents. "I understand that India has issued one compulsory license, but there's a lot of concern about what additional licenses are being considered," US Assistant Secretary of State Nisha Biswal told journalists in New Delhi.

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ACA Provision Leads Major Pharmaceutical Companies To Reduce Physician Payments

The Newark (NJ) Star-Ledger (Friedman, 3/5) reports that "drugmaker giants like Eli Lilly and Novartis" have reacted to the Affordable Care Act provision requiring disclosure of the money they pay physicians to promote their products by "substantially" reducing such payments. An investigation by the nonprofit news organization ProPublica found that "the sharp declines coincide with increased attention from regulators, academic institutions and the public to pharmaceutical company marketing practices."

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Some Insurance Companies Seek State Help Paying For Hepatitis C Medication

Reuters (Humer, 3/5) reports that health insurance companies are looking for assistance from state Medicaid officials in paying for an expensive new generation of treatments for hepatitis C. Some estimate the cost of the new treatment at $200 billion over the next five years, prompting private insurance companies that administer Medicaid plans to ask for help paying.

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Blog: 2013 Pharmacy Market Share for Specialty Drugs—and the Biggest Players

Adam J. Fein (Drug Channels, 3/4) comments, "In 2013, retail, mail, and specialty pharmacies dispensed about $63 billion in specialty pharmaceuticals...Specialty drugs accounted for 22% of total pharmacy industry revenues...Three companies—Express Scripts, CVS Caremark, and Walgreens—accounted for 63% of revenues from pharmacy-dispensed specialty drugs. The next three largest players had a combined share of about 5%." Full

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Promising Hepatitis C Treatment's Cure Rates, Costs Highlighted

The Denver Post (Draper, 3/5) reported that Sovaldi (sofosbuvir) is being seen as a blockbuster medicine after studies show that it cured 90 percent of hepatitis C patients in just 12 weeks. However, a major issue with the therapy is its exorbitant cost: $1,000 a day. Insurers still have not decided about the coverage options, as more than 3 million infected patients look toward the treatment, the Post noted. The therapy received FDA approval in December.

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Blog: The Rural Health Impact of the President's FY 2015 Budget

President Obama's budget proposal, released March 4, continues to be a source of concern for many rural health providers. Even though the non-binding budget proposal is unlikely to be adopted by Congress, the president again proposes cuts to the Critical Access Hospital (CAH) system and other members of the rural health safety net. Full

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FAQs from Apexus Answers

What's Trending in the Call Center This Month?

Q: May 340B drugs be used for Medicaid patients as part of a 340B contract pharmacy?

A: 340B drugs may not be used for Medicaid patients at a contract pharmacy, absent an arrangement between the entity and state to prevent duplicate discounts. HRSA should be notified of this arrangement. View additional information.

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Q: Our hospital has a clinic (within the four walls of the parent) that does not appear on the hospital's most recently filed cost report. Is this an eligible 340B area?

A: No. Although HRSA does not require separate registration of clinics within the four walls of the parent, onsite clinics that are not included as reimbursable on the most recently filed Medicare cost report will not be eligible. View additional information.

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Q: Is the orphan drug list from the FDA dosage–form-specific (in other words, does the designation apply to ALL of the sponsor's NDCs of the chemical name or just one specific dosage form?)

A: The FDA does not designate orphan drugs for approval by dosage form. The FDA confirmed that it provides a designation and marketing approval for orphan drugs based on condition. There may be multiple NDCs from one sponsor tied to an individual orphan drug designation.

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