The document provides information about the 340B Drug Pricing Program. It describes the program as originating from legislation in 1992 that limits drug costs for certain healthcare facilities. Safety-net providers can save 20-50% on drug costs by participating. To qualify, a disproportionate share hospital must meet requirements like having an 11.75% DSH percentage and maintaining separate drug inventories for 340B and non-340B patients. The Affordable Care Act expanded eligibility for the program and increased compliance monitoring.
SUNRx can lower the cost of drugs for patients and generate profit and cash flow for 340B eligible entities such as FQHC\'s and DSH Hospitals). We also have a Payor model which provides savings to Medicaid Managed Care organizatins. Contact me for more details!
The 340B Program and Implications of the Mega GuidanceCompleteRx
As the 340B Drug Pricing Program continues to undergo changes, our team has been following all the recent updates and how they impact hospital pharmacies. This presentation goes through the latest on the long awaited guidance of proposed changes that was posted by the Federal Register on August 28, 2015.
Translating compliance requirements into action items 340BCompliatric
With constant changes in HRSA’s “expectations”, “recommendations” and audit focus, implementation and ongoing compliance of hospital and grantee’s 340B programs can be an arduous task, and also a moving target. RPh Innovations (RPHI), a 340B Program Support and Independent Auditor established in 2011, will re-center the focus around core statues and regulatory concepts of the program, and outline action items to help attendees start implementing structure, policy, and delegation of responsibilities within their respective institutions.
SUNRx can lower the cost of drugs for patients and generate profit and cash flow for 340B eligible entities such as FQHC\'s and DSH Hospitals). We also have a Payor model which provides savings to Medicaid Managed Care organizatins. Contact me for more details!
The 340B Program and Implications of the Mega GuidanceCompleteRx
As the 340B Drug Pricing Program continues to undergo changes, our team has been following all the recent updates and how they impact hospital pharmacies. This presentation goes through the latest on the long awaited guidance of proposed changes that was posted by the Federal Register on August 28, 2015.
Translating compliance requirements into action items 340BCompliatric
With constant changes in HRSA’s “expectations”, “recommendations” and audit focus, implementation and ongoing compliance of hospital and grantee’s 340B programs can be an arduous task, and also a moving target. RPh Innovations (RPHI), a 340B Program Support and Independent Auditor established in 2011, will re-center the focus around core statues and regulatory concepts of the program, and outline action items to help attendees start implementing structure, policy, and delegation of responsibilities within their respective institutions.
Providing a good overview of the 340B Program, this slide presentation outlines the benefits of 340B compliance as well as the ramifications of non-compliance.
Pharma Uptoday Monthly Magazine Volume 21; Issue Dec 2015Sathish Vemula
News Uptoday
New Guidance
Audit Findings
- Diabetes Corporation of America
- Pine Pharmaceuticals
Warning Letters
- Warning letter: American Family Pharmacy
- Warning letter: Dr. Reddy's Laboratories Limited
- Warning letter: Sandoz Private Limited
Article of the Month
- Data Integrity Checklist related to Electronic Records and Electronic Signatures.
Regulations of the Month
- Sec. 211.46 Ventilation, air filtration, air heating and cooling
- Sec. 211.48 Plumbing
To recap the previous month's pharma highlights to Pharma Uptoday followers, Monthly magazine Volume 17 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
EU Non Compliance Report
- INTEGRA LIFE SCIENCES CORP, United States
- JINAN JINDA PHARMACEUTICAL CHEMISTRY CO., LTD., China
- WUXI JIDA PHARMACEUTICAL CO., LTD, China
- PARABOLIC DRUGS LIMITED, India
Warning Letters
- Mahendra Chemicals, India
Regulations of the Month
- Sec. 211.25 Personnel qualifications
- Sec. 211.28 Personnel responsibilities
There are three main strategies for billing: becoming credentialed as a provider, obtaining preauthorization before submission, and submitting the claim without prior authorization. If a pharmacist is credentialed with the insurance carrier, he or she is already authorized to submit claims to the insurance company for those patients using the pharmacist’s program.
3 News Uptoday
22 New Guidance
28 Audit Findings
483 Observations
- Caraco Pharmaceutical Laboratories
- Hospira Inc
- Novartis Consumer Health
- McNeil Consumer Healthcare
Warning Letters
- Hikma Farmaceutica, (Portugal) S.A.
- Cadila Pharmaceuticals Limited
- Sharp Global Limited
- Wells Pharmacy Network LLC
EMA Non-Compliance Reports
- Taishan City Chemical Pharmaceutical Co. Ltd., China
- Zhejiang Apeloa Kangyu Bio-Pharmaceutical Co. Ltd., China
- MANUEL RIESGO S.A., Spain
- Ranbaxy Laboratories Limited, Dewas, India
36 Regulations of the Month
§ 211.186 Master production and control records
§ 211.188 Batch production and control records
Kalderos describes how compromised data associated with MDRP affects inaccurate Pharma Mfr payments to States leading to overpayments and compliance issues with 340B Covered Entities
Navigating manufacturer designations for 340 b contract pharmacies compliatricCompliatric
RPh Innovations, LLC (RPHI) delivers customized pharmacy, healthcare, and 340B solutions to safety net organizations.
In this webinar, RPHI will be discussing each manufacturer block and the steps to designate contract pharmacies. We will be focused on navigating these blocks and creating a roadmap to recoup some, if not all, of the savings that were lost. We have put significant time and effort into understanding the challenges, implications, and alternative options related to the actions Manufacturers have taken over the past year. In this webinar, we share our findings, actions, and results with members.
1. Review of Manufacturer Actions
2. Steps required to designate a Contract Pharmacy
3. Challenges faced
4. Real case scenario
5. Tips and Tricks
All participants are provided a Contract Pharmacy Designation Checklist
Quick Sccess Guide: Top 25 Questions Answered by the New FDA Q&A DraftAngela Carver
Supply chain businesses nationwide are rushing to implement operational changes in order to meet upcoming FDA Drug Supply Chain Security Act deadlines. This process has been a struggle for many due to the complexity of this legislation. Different business types must follow different portions of the rule in regards to reporting, registering and much more. The Food and Drug Administration released a new draft to answer some of the most frequently asked questions from third party logistics and wholesale distribution operations. This report is an update to a previously published 2014 draft. It is the intention of the FDA that these drafts are viewed together. This Q&A supplemental provides clarification based on the most frequently asked questions and comments received after the publication of the Annual Reporting draft guidance.
It is critical to clearly understand how these changes will affect your operation as any error in reporting or filing can result in significant penalties. Take advantage of these detailed tools provided by the FDA to ensure your operation is prepared before reported deadline dates. For more information on technologies to aid in pharmaceutical regulatory compliance contact Datex experts today at marketing@datexcorp.com or 800.933.2839 ext. 243.
Providing a good overview of the 340B Program, this slide presentation outlines the benefits of 340B compliance as well as the ramifications of non-compliance.
Pharma Uptoday Monthly Magazine Volume 21; Issue Dec 2015Sathish Vemula
News Uptoday
New Guidance
Audit Findings
- Diabetes Corporation of America
- Pine Pharmaceuticals
Warning Letters
- Warning letter: American Family Pharmacy
- Warning letter: Dr. Reddy's Laboratories Limited
- Warning letter: Sandoz Private Limited
Article of the Month
- Data Integrity Checklist related to Electronic Records and Electronic Signatures.
Regulations of the Month
- Sec. 211.46 Ventilation, air filtration, air heating and cooling
- Sec. 211.48 Plumbing
To recap the previous month's pharma highlights to Pharma Uptoday followers, Monthly magazine Volume 17 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
EU Non Compliance Report
- INTEGRA LIFE SCIENCES CORP, United States
- JINAN JINDA PHARMACEUTICAL CHEMISTRY CO., LTD., China
- WUXI JIDA PHARMACEUTICAL CO., LTD, China
- PARABOLIC DRUGS LIMITED, India
Warning Letters
- Mahendra Chemicals, India
Regulations of the Month
- Sec. 211.25 Personnel qualifications
- Sec. 211.28 Personnel responsibilities
There are three main strategies for billing: becoming credentialed as a provider, obtaining preauthorization before submission, and submitting the claim without prior authorization. If a pharmacist is credentialed with the insurance carrier, he or she is already authorized to submit claims to the insurance company for those patients using the pharmacist’s program.
3 News Uptoday
22 New Guidance
28 Audit Findings
483 Observations
- Caraco Pharmaceutical Laboratories
- Hospira Inc
- Novartis Consumer Health
- McNeil Consumer Healthcare
Warning Letters
- Hikma Farmaceutica, (Portugal) S.A.
- Cadila Pharmaceuticals Limited
- Sharp Global Limited
- Wells Pharmacy Network LLC
EMA Non-Compliance Reports
- Taishan City Chemical Pharmaceutical Co. Ltd., China
- Zhejiang Apeloa Kangyu Bio-Pharmaceutical Co. Ltd., China
- MANUEL RIESGO S.A., Spain
- Ranbaxy Laboratories Limited, Dewas, India
36 Regulations of the Month
§ 211.186 Master production and control records
§ 211.188 Batch production and control records
Kalderos describes how compromised data associated with MDRP affects inaccurate Pharma Mfr payments to States leading to overpayments and compliance issues with 340B Covered Entities
Navigating manufacturer designations for 340 b contract pharmacies compliatricCompliatric
RPh Innovations, LLC (RPHI) delivers customized pharmacy, healthcare, and 340B solutions to safety net organizations.
In this webinar, RPHI will be discussing each manufacturer block and the steps to designate contract pharmacies. We will be focused on navigating these blocks and creating a roadmap to recoup some, if not all, of the savings that were lost. We have put significant time and effort into understanding the challenges, implications, and alternative options related to the actions Manufacturers have taken over the past year. In this webinar, we share our findings, actions, and results with members.
1. Review of Manufacturer Actions
2. Steps required to designate a Contract Pharmacy
3. Challenges faced
4. Real case scenario
5. Tips and Tricks
All participants are provided a Contract Pharmacy Designation Checklist
Quick Sccess Guide: Top 25 Questions Answered by the New FDA Q&A DraftAngela Carver
Supply chain businesses nationwide are rushing to implement operational changes in order to meet upcoming FDA Drug Supply Chain Security Act deadlines. This process has been a struggle for many due to the complexity of this legislation. Different business types must follow different portions of the rule in regards to reporting, registering and much more. The Food and Drug Administration released a new draft to answer some of the most frequently asked questions from third party logistics and wholesale distribution operations. This report is an update to a previously published 2014 draft. It is the intention of the FDA that these drafts are viewed together. This Q&A supplemental provides clarification based on the most frequently asked questions and comments received after the publication of the Annual Reporting draft guidance.
It is critical to clearly understand how these changes will affect your operation as any error in reporting or filing can result in significant penalties. Take advantage of these detailed tools provided by the FDA to ensure your operation is prepared before reported deadline dates. For more information on technologies to aid in pharmaceutical regulatory compliance contact Datex experts today at marketing@datexcorp.com or 800.933.2839 ext. 243.
Digital-агентство ДАЛЕЕ провело воркшоп, посвященный digital закупкам. Рассматривались вопросы стоимости часа, обоснования количества часов и причины использования тех или иных сотрудников в командах
Estacionamento Companhia Docas - Diário Oficial da UniãoTransvias
http://www.transvias.com.br/8484/noticias/Porto-de-Santos-ganhara-estacionamento-de-caminhoes - Infraestrutura: Também poderá ser usada parte da área para atividades auxiliares à operação portuária, como armazenagem de contêineres e operação ferroviária -
https://www.udemy.com/vlsi-academy
http://vlsisystemdesign.com/need_for_decap.php
A decoupling capacitor is a capacitor, which is used decouple the critical cells from main power supply, in order to protect the cells from the disturbance occuring in the power distribution lines and source. The purpose of using decoupling capacitors is to deliver current to the gates during switching. Herein, we would peep inside the reasons for the distrubance occuring in the power distribution lines.
Monikanavaisuuden ja digin mahdollisuudet työyhteisöviestinnässäHanna P. Korhonen
Monikanavaisuuden ja digin mahdollisuudet sisäisessä viestinnässä
- Työtehtävät ja työvälineet ovat monipuolisemmat kuin koskaan aiemmin – Miten viestintä ja HR tavoittavat sekä siivoojan että tietotyöläisen?
- Älypuhelin mullisti jo vapaa-ajan – Tippuivatko työnantajat kelkasta?
- Palveleeko digitaalisten työvälineiden kehitys vain tietotyöläistä?
Hanna P. Korhonen, Intranet & Web Communications Specialist, Partner, North Patrol
Esitys 25.11.2015 Talentum Eventsin tilaisuudessa Työyhteisöviestintä 2015 24.-25.11.2015
Asiasanat: sisäinen viestintä työyhteisöviestintä viestintä organisaatioviestintä intranet digitaalinen työympäristö
Five Pharmacy Rules Hospitals Can't Afford To Ignore In 2016CompleteRx
With each new year comes increased regulations that affect the hospital ecosystem. This webinar will take a look at the approved and proposed regulatory requirements for hospital pharmacies that have been published to be proactive and ensure compliance.
Case 13340B Drug Pricing Program OversightSection 602 of the Vet.docxketurahhazelhurst
Case 13340B Drug Pricing Program Oversight
Section 602 of the Veterans Health Care Act of 1992 was titled “Limitations on Prices of Drugs Purchased by Certain Clinics and Hospitals.”It amended the Public Health Services Act by adding a new section, Section 340B, to that act. Section 602 of the Veterans Health Care Actread in part:
Part D of title III of the Public Health Service Act is amended by adding the following subpart: “SUBPART VII – DRUG PRICINGAGREEMENTS” LIMITATION ON PRICES OF DRUGS PURHASED BY COVERED ENTITIES “Sec. 340B (a) Requirements for Agreement withSecretary – “(1) In general. The Secretary shall enter into an agreement with each manufacturer of covered drugs under which theamount required to be paid … to the manufacturer for covered drugs … does not exceed an amount equal to the average manufacturerprice for the drug under title XIX of the Social Security Act in the preceding quarter, reduced by the rebate percentage described inparagraph (2). “Rebate percentage defined. – (A) In general. For a covered outpatient drug … the ‘rebate percentage’ is the amount equalto – “(i) the average total rebate required under Section 1927(c) of the Social Security Act … for a unit of the dosage form and strengthinvolved during the preceding quarter divided by “(ii) the average manufacturer price for such a unit of the drug during such quarter….”
Section 340B applied Medicaid drug discounts to drugs purchased for clinics that served many outpatients who were not eligible forMedicaid at qualified safety-net institutions. For the most part, eligible clinics were associated with hospitals receiving disproportionateshare payments under Medicare, pediatric hospitals, and community health centers. Also included were specialized clinics and projects forHIV/AIDS, hemophilia, black lung, tuberculosis, and family planning, as well as those serving Native Americans and Native Hawaiians.Hospitals were required to be governmental or nonprofit with a contractual commitment to provide services supported by governments,have a disproportionate share percentage greater than 11.75, and not obtain the covered drugs through a group purchasing agreement. Thedrugs had to be used for patients of the covered entity and could not be resold.
A key provision of Section 340B read “(10) No prohibition on larger discount. Nothing in this subsection shall prohibit a manufacturer fromcharging a price for a drug that is lower than the maximum price that may be charged under paragraph (1).” The Patient Protection andAffordable Care Act (ACA or PPACA) increased the 340B discount to 13% on generic drugs and 23.1% on branded drugs. Specific discountshave been reported to range from 15–60% on prescription drugs. The law prohibits getting both a state Medicaid rebate and a 340Bdiscount on a drug.
BACKGROUND
In the 1980s, Congress established a discount drug purchasing program for the Veterans Administration. In 1990, it extended this discountprogram to Medicaid purchases on beh ...
With constant changes in HRSA’s “expectations”, “recommendations” and audit focus, implementation and ongoing compliance of hospital and grantee’s 340B programs can be an arduous task, and also a moving target. RPh Innovations (RPHI), a 340B Program Support and Independent Auditor established in 2011, will re-center the focus around core statues and regulatory concepts of the program, and outline action items to help attendees start implementing structure, policy, and delegation of responsibilities within their respective institutions.
TGA Presentation: Medicines scheduling and scheduling policy ad hoc working g...TGA Australia
TGA Scheduling Working Group Meeting One February 2018. Role of the Working Group including Reforms to the advertising of S3 pharmacist only medicines, Reviewing what current S3 substances should be advertised, Proactively identifying S4 medicine substances for consideration for down-scheduling, Adding a new appendix to the poison standard to provide additional safeguards when down-scheduling
Here's what bio-pharma organizations need to know when transforming the promotional material review and approval process from a transactional requirement to a competitive advantage.
NAPM is a Section 21 Trade Association which was established in 1977. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. NAPM has a diverse membership comprising of 24 companies. Some of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.
Helping Pharmas Manage Compliance Risks for Speaker ProgramsCognizant
To avoid stiff fees, reputation damage and the imposition of corporate integrity agreements (CIAs), pharmaceuticals companies need to monitor their speaker programs carefully for compliance to a suite of regulations. We identify those rules and outline a rigorous process based on relevant key performance indicators (KPIs) that will enable pharmas to head off these potential major hits to their bottom line.
Compliatric is excited to host the first of a two part 340B webinar series, presented by Ryan DiGiovanni, an Apexus Certified Expert (ACE) Pharmacist, President of EPL Health, and 340B Program Manager, Rush University Medical Center.
This webinar will provide evaluation tactics, operational considerations and planning required for covered entities before, and potentially after, participating in the 340B ESP platform. For the C-suite, this webinar will provide an overview of impact and implications of participation. For those involved in daily 340B program management, a more detailed breakdown of 340 ESP app usage, requirements, and resources will be discussed.
This presentation discusses the key elements of a Corporate Compliance program allowing an organization to self-monitor operations on an ongoing basis to ensure compliance with supportive documentation to adhere to applicable laws and the organization’s own policies and procedures.
Appropriate for CEOs, CFOs, Administrators, Nursing Management, Direct Care Nurses in a SNF, MDS Coordinators and Business Office Managers.
RPh Innovations, LLC (RPHI) delivers customized pharmacy, healthcare, and 340B solutions to safety net organizations.
In this webinar, RPHI will be discussing each manufacturer block and the steps to designate contract pharmacies. We will be focused on navigating these blocks and creating a roadmap to recoup some, if not all, of the savings that were lost. We have put significant time and effort into understanding the challenges, implications, and alternative options related to the actions Manufacturers have taken over the past year. In this webinar, we share our findings, actions, and results with members.
1. Review of Manufacturer Actions
2. Steps required to designate a Contract Pharmacy
3. Challenges faced
4. Real case scenario
5. Tips and Tricks
Mastering Pharmacy Medical Billing + Claims Submissionkendall100
Claim your free access to invaluable pharmacy billing guides and streamline your processes with confidence. Pharmacy billing encompasses submitting claims to insurance payers for reimbursement for pharmacy services. These services range from dispensing medications to providing medication therapy management (MTM) and other clinical interventions you can bill for!
1. rom posts to ACCCExchange to questions
asked at ACCC meetings, it is clear that our
member programs want more information about
the 340B Drug Pricing Program. Here is the infor-
mation you’ve been asking for: a description of the
340B Drug Pricing Program; how to qualify and apply
fortheprogram;implicationsofparticipatingintheprogram;
and clarification on how the Patient Protection and Afford-
able Care Act of 2010—universally known as the Healthcare
Reform Law—has impacted the program.
What is the 340B Drug Pricing Program?
The 340B Drug Pricing Program resulted from enactment
of the Veterans Health Care Act of 1992, which is in Section
340B of the Public Health Service (PHS) Act. Sometimes
referred to as PHS Pricing, the program is managed by the
Health Resources and Services Administration (HRSA)
Office of Pharmacy Affairs (OPA) (http://www.hrsa.gov/
opa). Section 340B of this legislation limits the cost of cov-
ered outpatient drugs to certain federal grantees, federally-
qualified health center look-alikes, and qualified dispropor-
tionate share hospitals. The purpose of the 340B Program is
to enable these entities to stretch scarce federal resources,
reaching more eligible patients and providing more compre-
hensive services. For safety-net providers, participation in
the 340B Drug Pricing Program results in significant sav-
ings—between 20 to 50 percent—on the cost of pharmaceu-
ticals.1
Who Qualifies for the 340B Drug Pricing
Program?
Several healthcare entities qualify for this program. For
ACCC members, the most relevant entity would be a dis-
proportionate share hospital. There are five key require-
ments to qualify for the 340B Drug Pricing Program and
all must be met to qualify. Healthcare entities must:
1. Be a disproportionate share hospital with a dispro-
portionate share hospital (DSH) percentage of at least
11.75 percent.
2. Own and operate participating outpatient clinics.
3. Opt out of using Group Purchasing Organizations
(GPOs) for the purchase of these drugs.
4. Maintain a separate inventory (real or virtual) of drugs
prescribed to 340B patients versus non-340B patients.
5. Ensure that 340B drugs are only used by appropriate
patients.
While most private practice and for-profit entities do not
qualify for the 340B Drug Pricing Program, other qualified
entities include critical access hospitals, freestanding can-
cer hospitals, and sole community hospitals. The full list of
qualified entities can be found online at: http://www.hrsa.
gov/opa/introduction.htm.
How Does My Program Apply for the 340B
Program?
Once you have ascertained that your organization is an
eligible entity, you must submit the appropriate registra-
tion form and supporting documents to participate to the
Office of Pharmacy Affairs (OPA) 5600 Fishers Lane,
Everything
YouWanted
toKnow
Aboutthe
340BDrug
PricingProgram
by Matt Sherer, MBA, MHA, and
Teri U. Guidi, MBA, FAAMA
)
38 O I May/June 2011
2. O I May/June 2011 39
Mailstop 10C-03, Rockville, MD 20857. Or fax the infor-
mation to: 301.594.4982. Registration forms are available
online: https://opanet.hrsa.gov/OPA/Registration/Regis-
trationMain.aspx.
The key factor is being able to demonstrate the DSH
percentage. (The DSH percentage is reported annually on
all Medicare Cost Reports submitted by hospitals.) The
application process is not overly complicated, but it can take
time—particularly if the agency has questions about your
application. Once your facility is approved, you will receive
notification from HRSA that your program is now eligible.
HRSA will also list your program as an eligible entity on
the agency’s website so that drug manufacturers can con-
firm eligibility.
What are the Benefits of Using the Program?
As stated previously, an outpatient infusion clinic can see a
reduction of 20 to 50 percent off of their drug costs. These
savings go straight to your bottom-line and could allow
your program to provide services that previously were cost
prohibitive. These savings could also be reinvested in tech-
nology, staff, etc. Particularly as reimbursement amounts
continue to decline, participation in the 340B Drug Pricing
Program can be a competitive advantage.
How is the 340B Drug Pricing Program Managed?
Once enrolled in the program, hospitals and cancer centers
must maintain detailed records of their qualified patients
and how the drugs purchased under the 340B Program are
used. The term “qualified patient” is critical as these drugs
cannot be used on any non-qualified patients. A qualified
patient is someone who:
1. Has an established relationship with the provider (i.e.,
with the DSH institution)
2. Has been seen by the provider at least once in the past
12 months
3. Has their health record maintained by the organization
4. Receives healthcare related to a condition for the medi-
cation received from a provider that is either employed
by the organization or is under contract to provide
services for the organization. (A private practice could
potentially contract with a qualified DSH hospital to
provide care but, again, many legal requirements must
be met for this option to work.)
Diversion of these drugs to other locations and inpatient
use are strictly forbidden.
What Changed in the Program because of
Healthcare Reform?
TheAffordableCareActof2010expandedthetypesofenti-
ties qualifying for participation in the program; expanded
integrity and enforcement provisions, and mandated devel-
opment of regulations to address complaints and dispute
resolution.
Specifically, the law expanded the 340B Drug Pricing
Program to include certain children’s hospitals, freestand-
ing cancer hospitals, critical access hospitals, rural refer-
ral centers, and sole community hospitals. For these cov-
ered entities, the term “covered outpatient drug” does not
include orphan drugs (drugs designated for rare conditions
by the Secretary under section 256 of the Food, Drug, and
Cosmetic Act).2
The law requires HRSA to improve compliance by
covered entities by developing:
1. Procedures to enable and require covered entities to
regularly (at least annually) update their information in
the HRSA database.
2. A system for HRSA to verify the accuracy of informa-
tion in the database.
3. More detailed guidance to covered entities describing
methodologies and options available for billing cov-
ered drugs to state Medicaid agencies in a manner that
avoids duplicate discounts.
4. A single, standardized system by which covered
entities can be identified by the drug companies,
distributors, other covered entities, and HRSA for
purposes of facilitating the procurement of covered
drugs.
The law included new penalties that can be levied against
covered entities that divert drugs to individuals who are
not patients of the covered entity. Basically, the covered
entity would be liable to the drug company for the amount
equal to the reduction in the price of the diverted drug
plus the amount of interest due, depending upon the cir-
cumstances.
The revisions in the Affordable Care Act of 2010 are
the most significant since the inception of the 340B Drug
Pricing Program.
Matt Sherer, MBA, MHA, is Service line administra-
tor, Oncology, Tallahassee Memorial Cancer Center,
Tallahassee, FL. Teri U. Guidi, MBA, FAAMA, is
president and CEO, Oncology Management Consulting
Group, Pipersville, PA.
References
1
U.S. Department of Health and Human Services Administration.
Introduction to the 340B Drug Pricing Program. Available online at: http://
www.hrsa.gov/opa/introduction.htm. Last accessed March 23, 2011.
2
Morgan Lewis. Healthcare Reform Law Leads to Significant Changes
to the 340B Program. Available online at: http://www.morganlewis.com/
pubs/WashGRPP_340BProgram_LF_14apr10.pdf. Last accessed March
23, 2011.