Author Archives: Rich Bucher, JD, RPh, 340B ACE

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Telehealth and the 340B Patient Definition

Unless you have been living under a rock the past several months, you know that the COVID-19 Public Health Emergency (PHE) has dramatically impacted how both hospital and clinic providers strategize to provide healthcare to patients, including remotely via telehealth services (aka telemedicine). Given COVID-19 travel and gathering restrictions, it is obvious why the use of remote telehealth services has become an important strategy for continuing to provide healthcare to patients that do not have to be onsite. In just the last week, I have personally been engaged in telehealth related strategic discussions with at least six different 340B covered entities (CEs). These discussions have been mainly directed to inquiries about whether telehealth services can be relied upon for meeting HRSA’s patient definition used for 340B eligibility, and if so, what steps should be taken to ensure compliance. To answer these questions, it helps to first consider the acceptance and expansion of telehealth over the years.

Telehealth Acceptance

The use of telehealth in the U.S. is not a new concept. As early as the 1950s, detailed transmission of radiology images by telephone was underway. However, it was not until the late 1990s that telehealth services started to really take off, primarily due to technology changes such as more rapid data transmission and video communication. From then on, the use of telehealth has steadily grown – at least for some organizations. To put it in perspective, as far back as 2006, Kaiser Permanente’s CEO reported that it was seeing more patients online than in person. The Patient Protection and Affordable Care Act of 2010 (“ACA”) formally promotes the use of technology in health care reform as a means to increase care quality and access while reducing costs. Telehealth has become important enough that HRSA established the Office for the Advancement of Telehealth (OAT) to promote the use of telehealth technologies, especially in rural and remote areas. According to the American Hospital Association (AHA), last year, the use of telehealth in U.S. hospitals grew rapidly from approximately 35% in 2010 to 76% in 2017. This growth has also occurred in non-hospital settings (e.g., health centers) as well. For example, earlier this year the Bureau of Primary Health Care (BPHC) under HRSA even published a Program Assistance Letter (PAL) to highlight significant issues to consider when utilizing telehealth as a means to increase access to care for health center patients.

Telehealth Expansion

While the use of telehealth as an accepted treatment modality continues to grow, it has not expanded as rapidly as it could have due to barriers such as coverage and payment limitations, state and federal laws (e.g., privacy and security, provider licensure – especially across states), and limited broadband access. With respect to coverage, many argue telehealth is still not treated on parity with more traditional in-person treatment modalities. The most important example is reimbursement by CMS. Medicare has only reimbursed for interactive real-time (i.e., live-video) telehealth services. Also, there have been significant reimbursement restrictions based on the provider/ health care professional (HCP) type (only qualified health care providers), the patient’s and HCP’s location (e.g., for patients at a medical facility in rural area), and the type of service provided (e.g., for routine visits). While CMS has expanded its coverage recently to some extent (e.g., for stroke and substance abuse patients), until COVID-19 this expansion has been modest at best. Similarly, while many states have begun to expand Medicaid telehealth reimbursement, others have retracted it and/or placed other significant limitations. As with CMS, this state-based reimbursement has generally been more favorable to real-time services as compared to other telehealth modalities that are not in real-time, such as store-and-forward (e.g., digital imaging) or remote monitoring.

Parity with In-Person Care and 340B

So why is this important? Although telehealth has long been recognized by governmental agencies such as CMS, HRSA, and state Medicaid agencies, it is still not treated on parity with in-person treatment – especially with respect to coverage as discussed above. But what about 340B? Recall that as part of its omnibus guidance (aka mega-guidance) proposed back in August of 2015, although expressly stated that the use of telemedicine would be permitted (so long as authorized under state or federal law and otherwise compliant with the 340B Program), it also included language about health care services needing to be provided at a registered hospital or clinic. 340B Health was concerned enough about HRSA’s possible enforcement of this that it emphasized multiple times in its mega-guidance analysis that telemedicine was a means of health care service that could be affected. Although the mega-guidance was pulled from awaiting final approval in January 2017, the takeaway seemed to be that telehealth is a recognized modality – but enforcement was still uncertain. Other than with the mega-guidance, up until COVID-19, HRSA has been noticeably silent with respect to telehealth’s implications with 340B eligibility.


In response to COVID-19, federal agencies such as CMS and HRSA have provided important additional information regarding telehealth. With respect to coverage, federal legislation has been recently signed into law that significantly expands telehealth coverage and implementation during the COVID-19 PHE. Recently, the law firm of Powers Pyles Sutter & Verville held a Telehealth and COVID-19 webinar that provided a good summary of this legislation and its implications. Also, many government administrative websites with telehealth information have been provided, including a CMS Medicare Telehealth FAQ website, a HRSA BPHC COVID-19 FAQ website and Office of Pharmacy Affairs (OPA) COVID-19 340B resources FAQ website, and an Office of Civil Rights (OCR) website regarding its enforcement discretion of privacy and security laws during the COVID-19 PHE.

Regarding 340B in particular, the OPA COVID-19 340B resources FAQ website states that HRSA recognizes telemedicine as merely a mode by which health care services can be delivered and recommends that CEs outline the modalities they utilize in policies/procedures and maintain auditable 340B records. Also, recently we reached out to Apexus and received the following guidance and internal Apexus FAQ below:

  • Guidance: The guiding principles are the patient must meet the patient definition, the physical location of service for patient or physician does not necessarily have to be a registered location, as long as the Service for grantees is consistent with the scope of grant, and for hospitals, reimbursable on the most recently filed MCR. An eligible site/location (e.g. Cardiology Clinic) of the CE has to be responsible for the service. For hospitals, this would mean that any sites/clinics outside the 4 walls (Cardiology Clinic) would need to be registered separately on OPAIS, even if that is not the physical location of where the patient/physician is.
  • Apexus Internal FAQ: Question: Is telemedicine an eligible service to qualify for 340B drug pricing in a covered entity? Answer: In the case of eligible hospitals, the clinic at which the covered entity provides healthcare services must be an integral part of the hospital, listed as reimbursable on its Medicare cost report. In the case of all other covered entities, the patients must be provided healthcare services by the covered entities that are within the scope of the grant or other statutory basis for eligibility. The entity is responsible for meeting the definition of a patient.

340B and Telehealth: Moving Forward

Based on above, it is clear that telehealth is a recognized healthcare modality that can be applicable to 340B eligibility, and this is not limited to only during the COVID-19 PHE. In other words, there does not appear to be any reason that a telehealth encounter cannot be relied upon for establishing 340B eligibility where the patient and/or treating HCP are not physically at the CE’s 340B eligible location, so long as auditable records show that:

  • The CE documented the telehealth care provided to the patient in the patient’s medical record,
  • The documentation clearly shows that:
    • The care provided by the CE to the patient during the encounter was tied to the CE’s 340B eligible location (and within the scope of grant if the CE is a grantee), and
    • The care was provided by an HCP that had a documented arrangement with the CE such that the CE remained responsible for the care.

To further help support such an argument, it is prudent to follow HRSA’s recommendation that this telehealth modality be outlined/supported in the CE’s policies and procedures. This is consistent with our experience in which we have seen HRSA often defer to a CE’s policies/procedures to support practices that are not clearly delineated in law or HRSA’s guidance. Turnkey Pharmacy Solutions recently sent a template emergency policy/procedure to its clients with example language that may be helpful during the COVID-19 PHE. Also, please feel free to reach out to us if you have specific questions!

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Inpatient Discharge Prescription Clarification

Inpatient Discharge Prescriptions

Traditionally, hospital discharge prescriptions written for eligible patients at eligible locations have generally been understood to be 340B eligible – regardless of whether they were written in connection with a hospital outpatient service ultimately billed as an outpatient service (i.e., outpatient discharge prescription) or with a hospital inpatient service ultimately billed as an inpatient service (i.e., inpatient discharge prescription). This is because after discharge, these prescribed drugs are to be used on an outpatient basis.

This general understanding was challenged by the Health Resources and Services Administration (HRSA) proposed Omnibus Guidance (a.k.a. “Mega Guidance”) in August 2015. Among other changes, the Mega-Guidance proposed changes to the current patient definition, including that only outpatient discharge prescriptions would be eligible. In a 2016 survey by 340B Health of hospital covered entities regarding the loss of inpatient discharge prescriptions, 81% of the respondents indicated they would lose discounts, with 57% saying they would struggle and 11% saying they could be forced to drop 340B altogether.

Confusion Regarding Unregistered Offsite Locations

In January 2017, the proposed Mega-Guidance was withdrawn and thus the common understanding continued that both inpatient and outpatient discharge prescriptions were eligible –when written in connection with a hospital service at an eligible location. However, based on our experience, until recently there has been a lot of concern over just what constitutes an eligible location. More particularly, for many it has not always been clear if an offsite inpatient location that is an integral part of the hospital, but that is not registered as a child site on Office of Pharmacy Affairs Information System (OPAIS), can be considered an eligible location. This general concern was reflected in an April 14, 2016 letter from 340B Health to HRSA. This letter explained that there was no guidance requiring registration of inpatient locations in order to use 340B drugs for discharge prescriptions from those locations. This letter also detailed the long history of HRSA approving such use. Later, 340B Health indicated that HRSA had informed it that 340B could be used for discharge prescriptions written following care that was delivered in an inpatient location. For many, the question of whether offsite inpatient locations had to be registered remained. Based on our experience supporting numerous clients during formal HRSA audits, 340B discharge prescriptions from unregistered offsite inpatient locations continued to be questioned and treated with skepticism by auditors, though no formal findings for these clients were issued to our knowledge. As a result, many of our hospital clients have been hesitant to qualify discharge prescriptions from unregistered offsite inpatient locations.

Recent Apexus Guidance

Because of the general confusion regarding discharge prescriptions from unregistered offsite locations, we reached out to Apexus on several occasions seeking guidance. Recently, we received guidance that confirmed that 340B eligible discharge prescriptions may include those originating from a location considered to be an integral part of the covered entity and having either inpatient or outpatient costs/charges on the covered entity’s most recently filed Medicare cost report (MCR). Very recently, Apexus released an FAQ (FAQ 2693, Last Modified 05/21/2019) that appears to formally confirm the guidance we received:

FAQ ID: 2693

Last Modified: 05/21/2019

Q:  Can a covered entity use 340B for discharge prescriptions from a child site hospital that does not have outpatient clinics to register?

A:  Discharge prescriptions are allowed as long as the prescription originated from a location that is considered an integral part of the covered entity and has reimbursable costs and charges on the covered entity’s Medicare Cost Report.

Although the question of this FAQ is directed to “a child site hospital, the answer appears to confirm the traditional understanding that discharge prescriptions written for eligible patients can be 340B eligible – regardless of whether they are inpatient or outpatient discharge prescriptions. This interpretation appears to be supported by 340B Health, which has stated that this FAQ clarifies that hospitals can use 340B discharge prescriptions that originate from all locations with reimbursable costs and charges on its MCR, and not just outpatient locations.

Apexus also recently released another related FAQ 2692, Last Modified 05/21/2019confirming that inpatient locations with observation beds do not have to necessarily be registered and acknowledging that 340B eligible patients may receive healthcare services in observation beds located in inpatient sections of the hospital. This FAQ indicates hospitals must be able to explain how they remain responsible, maintain auditable records, and have 340B policies/procedures defining inpatient/outpatient and how it relates to observation patients.

We encourage hospital covered entities to become familiar with these FAQs and to review the comments made by 340B Health and to reach out to Apexus with further questions. Of course, we are available for consultation as well.

Note: For clarification, if you do not register the child site hospital inpatient/observation locations, then you can only capture discharge prescriptions. 340B is not available for administered drugs for patients at unregistered locations, including observation patients of unregistered inpatient locations.

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Your 340B Universe Narrative

When HRSA sends a data request to a covered entity (CE) being audited, the request includes a description of the CE’s 340B universe that includes a narrative, by which the data was gathered, and any limitations or exclusions. Based on our experience supporting HRSA audits, auditors often rely on this narrative to some extent when planning and conducting their onsite audit. Therefore, creating a 340B universe narrative provides you with an excellent opportunity to help facilitate and guide these and other external and internal audits in a manner that promotes efficiency and appropriate focus. Perhaps more importantly, however, creating a narrative is a critical step that you can take to help ensure that you have sufficient oversight of your program. Managing your program should start with being able to accurately describe it in sufficient detail. If you do not understand your program and cannot accurately describe it, you cannot effectively manage it. Drafting a 340B universe narrative forces you to describe your program, and it can be a catalyst for addressing and clarifying confusing or unfamiliar locations and practices, engaging key stakeholders, and developing comprehensive and more detailed documentation.

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Mitigating Risks of Indirect Referrals

Sometimes, reliance on a referral request to an outside prescriber (e.g., specialist) to qualify a prescription as 340B eligible can be relatively straightforward. For instance, when a direct referral request to the actual prescriber is documented in the patient’s medical record along with a referral visit summary back closing the loop, the covered entity’s responsibility of care can be clearly demonstrated.

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340B Summer ’17 Coalition Meeting

We had a great time in DC for the 340B Coalition Meeting. Thank you to everyone who stopped by the booth to say hello, or to learn more about our services. We thought the conference did well with keeping the 340B community updated on what is potentially coming with 340B changes, of course, it is still speculation in most cases. Rich Bucher and Rob Nahoopii will try to hit the highlights below.
Ted Slafsky, President and CEO of 340B Health, spoke about the state of 340B, and looking back and moving forward. Ted noted recent scrutiny of disproportionate share hospitals (DSHs) and pointed out that while 36% of this nation’s hospitals are DSHs, they provide close to 60% of this nation’s uncompensated care. He also pointed out that many rural hospitals would most likely have to shut their doors if not for the 340B program. For perspective, it was also noted that manufacturers spend four times as much on advertising as they do on the 340B program.

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Are you ready for a mock audit with Turnkey?

For those who have had an audit from Turnkey, you already know how important it is to have a strategy in place for every drug in every location that ensures 340B compliance. At the very least, this should include ensuring that patient-specific and drug-specific auditable records are maintained and available, that 340B drugs are only qualified for 340B eligible patients, and that duplicate discount violations are prevented.

Furthermore, if you are a disproportionate share hospital (DSH), children’s hospital, or freestanding cancer hospital subject to the GPO prohibition (GPO affected entity), you’d better also have a strategy in place for every such drug and location that ensures against possible GPO prohibition violations.

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Is it a 340B Drug?

Covered entities are often faced with trying to decide whether or not a particular product is a 340B drug for which PHS/340B pricing benefits and regulations apply. Sometimes this can be confusing and tedious. 340B Drug Pricing Program under section 340B of the Public Health Services Act (PHS) only applies to covered outpatient drugs (CODs), as defined under section 1927(k) of the Social Security Act (SSA). Also, the product’s manufacturer must have entered into a pharmaceutical pricing agreement (PPA) with Health and Human Services (HHS) (i.e., with the Secretary of HHS) for the labeler code that applies to the product’s NDC. The labeler code is represented by the first 5 digits of the product’s NDC.

While reaching out to the manufacturer is generally the recommended process for determining whether a product is a 340B drug, there are some initial steps that can be taken to either eliminate having to do this, or at least to facilitate and expedite the process:

  • Step 1: Confirm the product is a COD under section 1927(k) of the Social Security Act (SSA). HRSA has general summarized the following outpatient drugs as being included as CODs under the 340B Program:
    • FDA-approved prescription drugs;
    • Over-the-counter (OTC) drugs written on a prescription;
    • Biological products that can be dispensed only by a prescription (other than vaccines); or
    • FDA-approved insulins
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Update Days 1 and 2: Health Care Compliance Association (HCCA) 19th Annual Compliance Institute

340B UpdateThis is Turnkey’s first year participating in the HCCA Compliance Institute annual meeting. Interestingly, I spoke about 340B at this conference two years ago and while there was a fair amount of interest at that time, 340B was still relatively unknown to most attendees. That was not surprising, however, given that the HCCA institute is really directed to health care compliance in general, with topics like patient privacy /protected health information (PHI), Stark Law, Fraud, Waste & Abuse, physician compliance, and quality of care auditing getting most of the attention from the compliance officers, health care leaders, and compliance professionals in attendance. While this focus has not changed significantly, it is interesting to see that there is more focus on the 340B program this year. For example, today there is a session specifically directed to enforcement of 340B by HRSA. Given the number of HRSA audits that our team has been on-site for in the last 18 months (approximately 50 covered entity audits and 10 HRSA audits), this should prove to be an interesting discussion for us to participate in. So far, we have been hard pressed to find anyone (other than HRSA auditors themselves!) that has been involved with as many HRSA audits as we have. In addition to the 340B enforcement session this afternoon, later this week there are a couple of sessions directed to 340B in general planned. These should be interesting, and of course there will be more to come from us reflecting on these sessions.

Regarding compliance in general, one of the most interesting sessions here so far was the Office of the Inspector General (OIG) update during the general session. Speaking was Inspector General Daniel Levinson, of the U.S. Department of Health & Human Services (HHS). Mr. Levinson’s discussion focused on the concept of a “knowledge worker” and Peter Drucker’s work regarding our shift to a knowledge society. Of particular interest was Mr. Levinson’s focus on a knowledge worker’s ability to take raw data and transform it into meaningful information that can be put to practical use with respect to maintaining compliance. In the context of 340B, this is very relevant to what covered entities often struggle with. All too often our clients are faced with the dilemma of having a great deal of information about their 340B operations, whether it be from vendors or their own internal processes, that they are unable to put to practical use. This is not surprising, however, given the fact that transforming these data into meaningful information typically requires 340B-dedicated resources with significant experience and training. While this may include internal resources, such as pharmacy and compliance staff, an outside perspective that can be provided by 340B-focused is essential. This is where Turnkey comes in; with close to 50 covered entity audits and on-site support of 10 actual HRSA audits, we can help transform your 340B data into meaningful information and strategies for compliance. More to come as this HCCA conference progresses!

Thank you, -Rich Bucher (from the HCCA Conference in Lake Buena Vista, FL)

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340B Audits (OPA and Manufacturers)

340B Audits Are Increasing, Are You Ready?

340B Audit Letter340B Audits by Manufacturers: While formal audits of 340B covered entities by manufacturers are less common than those conducted by the Health Resources and Services Administration (HRSA), they are nevertheless a reality. As with government audits, there is a statutory basis for manufacturer audits, and in 1996 HRSA set forth certain guidelines for how these manufacturer audits should be conducted. A brief overview of these guidelines is provided below followed by some interesting points and comments that were recently expressed by a manufacturer and two recently-audited covered entities. Finally, some basic manufacturer audit tips are provided.

Audit Guidelines: In 1996, HRSA (under the Department of Health and Human Services (DHHS)) set forth a Compliance Audit Guide for manufacturers that was provided by DHHS. (61 Fed. Reg. 65406 12/12/1996). Generally speaking, this guide indicates that a manufacturer must first notify a covered entity (CE) in writing when it believes the CE has violated a provision of the 340B statute by allowing either 340B-purchased drugs to be diverted or the manufacturer to be subjected to duplicate discounts. The CE and manufacturer then have at least 30 days to make a good faith attempt to resolve the matter. If the matter is not resolved during this “informal process”, the manufacturer can proceed with formal dispute resolution steps if it believes it has enough evidence without having to conduct an audit. If it needs to gather more evidence, the manufacturer can proceed with initiating an audit by first submitting an audit plan to the Office of Pharmacy Affairs (OPA) under HRSA. The audit plan must include a clear explanation of why the manufacturer believes a violation has occurred along with supportive evidence.

If within 15 days after receiving the audit plan the OPA/HRSA finds that reasonable cause exists, it may then review the plan to ensure that certain auditing elements are present. If the elements are not present in the plan, the OPA/HRSA may work with the manufacturer to ensure that the necessary elements are included. The manufacturer may then, after giving 15 days notice to the CE, commence with the audit. This notice is typically provided to the CE’s authorizing official and contact official of record.

Once approved by the OPA/HRSA, the audit must be conducted by an independent public accountant that is employed by the manufacturer specifically for this task. The auditor must adhere to current official government auditing standards and must observe patient confidentiality. As an initial step, the auditor may request various records and other data associated with the alleged violation. In the above-mentioned 1996 audit guidelines, HRSA provided suggested audit steps to be followed.

At the completion of its audit, the manufacturer must provide the CE with an audit report that includes findings and recommendations. The manufacturer must also provide this audit report to both HRSA and the Office of Inspector General (OIG) of Audit Services. The CE then has 30 days from receiving the audit report to respond. If the CE agrees with the report, it must include actions that it has taken, or will take, to address the findings and recommendations. If the CE disagrees with the report, it must provide the manufacturer with its rationale. The parties may then file a request for dispute resolution through the DHHS.

Manufacturer Points/Comments:
• Rather than denying or approving a submitted audit plan, the OPA/HRSA has been known to request that the manufacturer and CE again try to reach a resolution through an informal process.

• If a resolution between the CE and manufacturer can be reached during an informal process, the manufacturer is not required to notify the OPA/HRSA. However, once the formal auditing process begins, the manufacturer must notify the OPA/HRSA.

• Manufacturer audits are usually narrower in scope than government 340B audits and typically last 2-3 days.

• One manufacturer voiced the opinion that most manufacturers would prefer to first be contacted by a CE if the CE suspects a violation rather than simply first receiving a check from the CE or finding out about a credit/re-bill.

Audited CE’s Points/Comments:
• Although diversion and duplicate discounts are the formal focus of manufacturer audits, auditors have been known to ask questions concerning other types of potential violations while conducting their audit, such as enquiring about the CE’s participation in group purchasing organization (GPO) purchasing for instance.

• Auditors have been known to contact the CE’s wholesaler directly without the CE knowing beforehand.

• Manufacturers may ask details about the CE’s split-billing process, accumulation process, and/or Medicaid patient identification process to determine if diversion and/or duplicate discounts have occurred.

• Auditors will typically first ask for the CE’s 340B policies and procedures.

• When an auditor requests records and/or other data within a short time (e.g., 24 hours), CE’s are often hard-pressed to identify the correct individuals and gather the records/data within that time. This is often due to the wide variety of individuals that may need to be contacted. Examples of such individuals can include representatives from areas such as: information technology, pharmacy, compliance, legal, payroll/human resources, supply chain, physician/provider credentialing, and/or physician/provider contracting.

• Auditors do not always focus the majority of their efforts on contract pharmacy operations.

• Auditors have been known to ask for individual physician/provider contracts with the CE and to scrutinize whether individual practitioners are listed in these contracts.

• The actual formal audit process can vary. For example, one CE reported that an initial audit kick-off meeting was conducted by the auditor while another CE reported that there was no kick-off meeting held at all. As another example, the types and amounts of records and other data initially requested by an auditor can vary significantly.

Basic Audit Tips for CEs
• Proactively identify an audit-response team and process before being audited to allow for timely and accurate responses to auditor requests. Include the types of individuals mentioned above in the group and provide them with a basic understanding of what a 340B audit might entail.

• Identify a “gate-keeper” that will act as a point person for the CE to field auditor requests, coordinate responses, and ensure that the appropriate accurate information is provided in each response.

• Ensure that the gate-keeper or other audit-response team member becomes familiar with the 1996 audit guidelines set forth by HRSA.

• When necessary, it is acceptable to try and negotiate with an auditor when the response time mandated by the auditor is not realistic. For example, if 24 hours is not enough, try negotiating for more time to allow for an accurate and pertinent response to be prepared.

• Consider reviewing physician/provider contracts proactively to ensure that the appropriate providers are listed, that the contracts are current, etc.

• Try to resolve alleged violations during an informal process whenever possible.

• Make sure that the CE’s 340B policies and procedures are readily retrievable upon request by the auditor.

• Sample audit data requests from HRSA are provided by SNHPA to its members. These samples may be helpful in anticipating data requests from HRSA and manufacturer auditors.

• Obtaining the assistance of trained 340B experts to help establish a comprehensive 340B compliance plan will help ensure success when responding to HRSA and manufacturer audits.

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340B Inpatient Expansion – What Happened to it?

Inpatient discounts were in some PPACA (Obamacare) drafts, so what happened to them?

Disclosure: We choose not to affiliate with either republican or democrat views regarding 340B. We have seen both opposition and support from both parties. In this article we are attempting to share what we have found.

Background: The 340B drug discount program requires pharmaceutical manufacturers participating in the Medicaid program to agree to provide front-end discounts on covered outpatient drugs that are purchased by so called “covered entities”, as defined in Section 340B of the Public Health Service Act (42 U.S.C. §256b). Covered entities include disproportionate share hospitals (DSHs), children’s hospitals and cancer hospitals exempt from the Medicare prospective payment system, sole community hospitals, rural referral centers, and critical access hospitals (CAHs). Support for expanding these front-end discounts to inpatients of covered entities has been widely supported by groups such as the American Hospital Association, National Rural Health Association, National Association for Children’s Hospitals, and National Association of Public Hospitals and Health Systems.

What Happened: A provision intended to expand these front-end discounts to inpatients was removed from the final health reform legislation (PPACA). Some have characterized emails recently uncovered as part of an investigation by the House Energy and Commerce Committee as reflecting the White House’s opposition to expanding 340B front-end discounts, and PhRMA’s influence in Washington, despite lobbying efforts by entities such as the American Hospital Association and others. Such an interpretation would seemingly not only make the expansion of 340B front-end discounts to inpatients in the near future seem unlikely, but also call into question whether the favorable interpretation of the “orphan” drug exclusion will be able to be retained.

To see copies of the House Energy and Commerce Committee memorandums, click on the following links: memorandum 1 and memorandum 2.