HRSA Hospital Recertification

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HRSA Hospital Recertification

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It’s everyone’s favorite time of the year. No, not college football (still stings to think about that), but HRSA’s annual recertification for hospitals.  This year, HRSA has provided updated registration and recertification requirements. This blog is not intended to cover every aspect of recertification, but a few tips and thoughts as you prepare to get this off your to do list.  Below are some key points to share on the different aspects of recertification.

When:  If you are a hospital 340B covered entity, for 2020 you must recertify between August 17th and September 14th.

Who: Authorizing Officials (AO) can complete in one login session OR the Primary Contact (PC) can do the bulk of the verification with the AO logging in separately and attesting to it. AO’s must complete their attestation by September 14th.

More Info on the basics

What is new:

  • “340B OPAIS will prompt Authorizing Officials and Primary Contacts (AOs and PCs) to upload supporting documentation for the “Hospital Classification” selected at the time of registration of a parent hospital.”
  • The Medicaid billing question is modified as follows: “At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?” If the 340B covered entity site (340B ID) answers “yes” to this question, the site must also provide each Medicaid state it plans to bill and the billing number(s) it will list on the bill to the state. 
    • See Medicaid section below for more details if you Carve-In

Recertification Guidelines:  The purpose of recertification is to simply validate information in OPAIS.  Thus, you may edit database information and terminate existing child sites/contract pharmacies.  However, you may NOT register new child sites or add contract pharmacies.

Login/Communication: AO’s will get daily reminders to attest the work completed by a PC.  Don’t rely on this email to communicate the AO’s responsibility.  Be sure to communicate with the AO in other means so he/she knows of the needed task.  And most likely, the AO will need to change their password, so be prepared for that very important task (aka. waste of time). 

Documents Needed:

  1. Medicare Cost Report (MCR) signed Worksheet S: filling details
  2. MCR Worksheet E, Part A: DSH percentage
    • Worksheet S-3 for children’s hospitals
  3. MCR Worksheet S-2: hospital type
  4. MCR Worksheet A and C: outpatient facility registration
  5. Employer Identification Number (EIN)
  6. Medicaid Billing Information: NPI and state Medicaid numbers
  7. Government Contract: make sure it is effective

***If MCR data does not match OPAIS/CMS database information, be prepared to submit pdf or excel versions of the above***

Once logged in:

  • Start at the parent and then go through each child site.  This will cascade important information down vs. input at each child site.
  • Government Official: Be prepared to update this information with relevant name, phone, email of key contact. 
  • Hospital Control Type: Compare to status on MCR Worksheet S-2, Line 21
  • Verifying DSH %: MCR Worksheet E, Part A, Line 33 (S-3 for Children’s hospitals)
  • Child Sites: Verify each still exist on MCR with outpatient revenue and expenses
  • Medicaid Information:  This is the largest change from previous years.  HRSA expects that for every state you carve-in, you have that listed separately with your NPI, Medicaid, or both numbers (whichever you actually submit on the bill).  This is for each state. 
    • During recertification, you can complete this section by simply selecting the states for the NPI/Medicaid numbers you already have registered. 
    • However, if you want to get it on the next MEF as HRSA expects, you will need to do this through a change request now, during recertification or prior to September 15th.
    • Important note, your duplicate discount risk may or may not change with this requirement as states will continue with their specific policies.  For example, a state may continue to rely on the CE’s NPI number at the parent level no matter which state it is assigned to in OPAIS.  However, any omissions can be considered a database finding in the future.

***Preventing duplicate discounts is a vital aspect of program integrity and should be assessed comprehensively and separately outside of recertification***

  • Key message here is that HRSA wants you to be transparent on which states you are carving in and what numbers you bill with: NPI, Medicaid, or both.

Other Random Points:

  • Make sure you actually hit SUBMIT at the end of recertification!!
  • Pay attention to pop-ups. They are not annoying alerts, but have impactful messaging.
  • Don’t help your PC/AO over Zoom video.  It will make them uncomfortable when they search for their password and type it in wrong a few times.

As always, we are your partner and can answer any specific questions you may have!


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When Does 340B Eligibility Begin for FQHCs?

As the second largest covered entity (CE) type after hospitals, Federally Qualified Health Center (FQHC) specific 340B information and application can often lag behind. Within the last few years, Apexus begun offering 340B University OnDemand  for FQHCs, as well as periodically offering 340B University Live for FQHCs only, in conjunction National Association Community Health Center (NACHC) conferences. NACHC too provides some great resources on the program including the NACHC 340B Manual for Health Centers (2nd Edition, March 2018) and Noddlepod – Pharmacy Access for Health Centers a listserv based “peer group for sharing information and resources related to 340B and other pharmacy issues impacting health centers and their patients.” All FQHCs are welcome to join Noddlepod, even if you are not a member of NACHC and it is a great place to learn from peers. You will even see me periodically posting content there!

If you are a member of the Health Center 340B community, you may or not have noticed the flurry of communications and excitement last month as HRSA’s Office of Pharmacy Affairs (OPA) and Apexus released a variety of Frequently Asked Questions (FAQ) relating to when 340B eligibility begins for new services and offsite locations of hospital Covered Entities. The FAQs clarified that so long as policies and procedures support the practice and patient eligibility requirements are met, hospitals may consider the new service or location 340B eligible prior to its registration becoming active on the Office of Pharmacy Affairs Information System (OPAIS). Prior to this clarification hospitals could experience 340B eligibility delays of up to twenty-two months before becoming active on OPAIS. This is because hospital child site registrations cannot occur until the service is listed on a filed Medicare Cost Report (MCR).

Since the Electronic Handbook (EHB) is updated in real-time, the registration delays experienced by FQHCs are significantly shorter, but can stretch to up to eight and a half months in a worst-case scenario. The time between opening a clinic location, and it becoming active on OPAIS can result in significant 340B savings opportunity loss. While HRSA periodically offers the opportunity to register outside of the first 15 days of each quarter (as they are now related to the COVID-19 state of emergency), there can still be a two month delay before the associated site becomes active on OPAIS.

Having said all of this, FQHCs should not feel excluded from the recent attention shed in this area by OPA and Apexus. The nature of FAQs is that they raise a specific question to be answered which has applicability beyond the exact scenario raised to other similar situations. FQHCs and hospital covered entity types are similar in the eyes of HRSA, in that the covered entity is inclusive of all of the eligible locations that make up the organization. Outside of FQHC-Lookalikes, this is not the case for the other types of 340B eligible Federal grantees, where HRSA considers each 340B registration to be a separate and distinct covered entity.

Because of the aggregate covered entity registration models used for both hospitals parent and child sites and FQHCs (associated sites), logic would suggest that the newly published FAQs (included for reference below) would also be applicable to health centers registered as covered entities. To validate this reasoning, we reached out to Apexus and posed this question:

Turnkey Question: For hospitals, FAQ 4301 makes it clear that 340B eligibility may begin prior to OPAIS registration, can we also conclude that this logic applies to the FQHC associated sites? That once they are active on the EHB, they would be able to consider patients 340B eligible, so long as patient definition is met, and then register the location on OPAIS in the next registration window?

Needless to say, we were very appreciative and excited for the impact this would have for our FQHC clients when Apexus confirmed our logic answering:

Apexus Answer:  Yes, the patients could be eligible. As stated in the FAQ, the covered entity should evaluate whether the patients of the new site would be considered eligible patients with the patient definition and defined in your policies and procedures.

Knowing that with the right supporting policies, procedures, and processes are in place, OPA permits 340B utilization to begin prior to an associated site becoming active on OPAIS, you are likely wondering what policy language would look like. Policy and procedure must outline this new consideration and how auditable records must be maintained. When updating your policy, be sure to address necessary changes to definitions, as well as procedures for determining eligibility and enrollment.

Turnkey has drafted potential policy language to address the clarification made by the HRSA and Apexus FAQs:

340B Eligible Location:  A clinic location that is an integral part of a 340B federally qualified health center (FQHC) covered entity, is within scope of the grant and actively listed on the EHB. Both associated sites actively registered on  the OPAIS and new locations that are not yet actively registered as associated sites on OPAIS but are within Covered Entity’s scope of grant and actively listed on the EHB, are 340B Eligible Locations where 340B drugs can be purchased and/or used. 340B Eligible Locations shall be registered as associated sites on OPAIS during the OPA registration window which follows the site becoming active on the EHB.

Associated Site Participation: New associated site approval: CE ensures that each new associated site (i.e. new service delivery site) is assessed/approved internally before beginning participation in the 340B Program:

  • FQHC’s 340B Oversight Committee evaluates a new service delivery site of CE to determine if the location is eligible for participation in the 340B Program as an associated site of CE. 
  • The 340B Oversight Committee validates that the new service delivery site is added to the Electronic Handbook (EHB) prior to being enrolled as a new associated site of “FQHC” on the OPAIS.
  • At the 340B Oversight Committee’s recommendation, the Authorizing Official documents his/her approval of the new associated site’s participation in the 340B Drug Pricing Program in writing to the 340B Oversight Committee, including to CE’s accountable 340B staff member.

New Associated Site Participation: The 340B Oversight Committee validates that each new associated site approved by CE is enrolled and listed on the EHB before participating in the 340B Drug Purchasing Program.

New Associated Site Enrollment/Registration:

  • The Authorizing Official enrolls each new associated site approved by CE on the HRSA/OPA 340B database during the next available online OPA registration period.
  • The 340B Oversight Committee validates that each new associated site participating in the 340B Program is registered as associated sites on OPAIS during the OPA registration window which follows the site becoming active on the EHB.
  • For example, if a new associated site is enrolled/registered on January 1-15, 2021, the next available active OPAIS listing date is April 1, 2021. 

It is important to note that information regarding 340B eligibility is not a new policy from OPA but is instead a clarification of existing policy.

Turnkey’s Suggested New Associated Site 340B Eligibility Determination Process

Here are the newly approved FAQs:

Unpublished FAQ 1318 (5/29/20) Question:  Hospitals that have only ‘costs’ associated with that cost center/dept have been rejected from 340B registration because they had to wait for revenue to be on the MCR for that cost center/dept. Does worksheet A (and/or C) have to show costs, revenue, or both? For example, a clinic might just be opened and have costs, but has not seen patients (no revenue on cost report). Would such a clinic be eligible?
Answer:  HRSA is not able to register and list this site on 340B OPAIS at this time.  In order to be registered and listed on the 340B Office of Pharmacy Affairs Information System (OPAIS), the site must have reimbursable outpatient costs and charges on the most recently filed Medicare cost report.  However, until such time the site is listed on the cost report, you should evaluate whether the patients of the site would be considered eligible patients of the hospital and defined in your policies and procedures. More information on HRSA’s patient definition guidance can be found by reviewing the October 24, 1996 Federal Register Notice on Patient and Entity Eligibility.

Unpublished FAQ 1648 (5/29/20) Question: Our hospital subject to the GPO Prohibition moved a clinic outside the four walls but didn’t register it on the 340B OPAIS. It is not on the most recently filed cost report at that location but will be on our next cost report as a reimbursable clinic. Will OPA consider the site “continuously eligible?”
Answer:  HRSA is not able to register and list this site on 340B OPAIS at this time.  In order to be registered and listed on the 340B Office of Pharmacy Affairs Information System (OPAIS), the site must have reimbursable outpatient costs and charges on the most recently filed Medicare cost report.  However, until such time the site is listed on the cost report, you should evaluate whether the patients of the site would be considered eligible patients of the hospital and defined in your policies and procedures. More information on HRSA’s patient definition guidance can be found by reviewing the October 24, 1996 Federal Register Notice on Patient and Entity Eligibility.

Published FAQ ID: 4301 (06/04/2020) Question: Are hospital covered entities able to register offsite, outpatient facilities before being listed as reimbursable on their Medicare Cost Report?
Answer: In order to register for the 340B Program and be listed on the 340B Office of Pharmacy Affairs Information System (340B OPAIS), HRSA must first verify that the offsite, outpatient facility is listed as reimbursable on the hospital’s most recently filed Medicare cost report and has associated outpatient costs and charges as outlined in HRSA’s 1994 Outpatient Hospital Facilities GuidelinesHRSA notes that for hospitals who are unable to register their outpatient facilities because they are not yet on the most recently filed Medicare Cost Report, the patients of the new site may still be 340B eligible to the extent that they are patients of the covered entity. More information on HRSA’s patient definition guidance can be found by reviewing the October 24, 1996 Federal Register Notice on Patient and Entity Eligibility. These situations should be clearly documented in the covered entity’s policies and procedures. In addition, a covered entity is responsible for demonstrating compliance with all 340B Program requirements and ensure that auditable records are maintained for each patient dispensed a 340B drug.

Published FAQ ID: 1193 (06/02/2020) Question: May an outpatient facility that is reimbursed by CMS as a provider-based facility, but not included on the most recently filed Medicare cost report, participate in the 340B Program?
Answer: A facility must be both reimbursable and included in the hospital’s most recently filed Medicare cost report with associated outpatient costs and charges to access the 340B Program and register in 340B OPAIS. HRSA’s outpatient facility guidelines can be found at in HRSA’s 1994 Outpatient Hospital Facilities Guidelines.

Please don’t hesitate to reach out if you have specific questions on this new development.


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HRSA Allows for Immediate 340B Use at PBDs/HOPDs

Several Apexus frequently asked questions (FAQs) have been released recently that have been interpreted to mean hospital 340B CEs will no longer need to wait to use 340B drugs at new or relocated provider-based clinics. Turnkey is just as pleasantly surprised as you are! Below is an attempt to clarify implications of these FAQs and highlight some important considerations. This much needed good news for hospitals means that there appears to be a renewed focus by HRSA to rely on the statutory definition of a patient, as Medicare would, and consider individuals to be patients of the hospital even though the service or department has not yet appeared on a filed Medicare Cost Report (MCR). A new provider-based location may begin to use 340B drug immediately, so long as provider-based requirements of CMS are met.  The following are some caveats to consider.

1. Policy and Procedure must outline this new consideration and how auditable records must be maintained. When updating your policy, be sure to address necessary changes to definitions, as well as procedures for determining eligibility and enrollment.

Turnkey has drafted potential policy language to address the clarification made by these FAQs:

340B Eligible Location Definition:  An onsite or offsite service area or facility (location) that is an integral part of a 340B hospital covered entity, as evidenced by the fact that it has reimbursable outpatient revenue and expense allocated to the hospital’s Medicare Cost report.

  • New locations that are not yet registered with OPA, but that are either (i) listed on the CE’s most recently-filed Medicare cost report with reimbursable outpatient costs and charges or (ii) will be listed with such on the next filed MCR, are 340B Eligible Locations where 340B drugs can be purchased and/or used.
  • Offsite 340B Eligible Locations shall be registered with OPA as soon as possible once listed on the hospital’s filed MCR. All clinics/services of an offsite 340B Eligible Location must be registered as a child site, regardless of whether they are in the same offsite building.

2. Once registered, a ship to address would be available for wholesalers to open a 340B account and ship 340B drugs to the off-site location. Until that occurs, alternate arrangements would need to be made to have 340B drug shipped to an already registered location (e.g., the parent).

3. Consider duplicate discount prevention strategies for an off-site clinic that carves-in Medicaid and uses a different NPI than the parent NPI to bill.  The new clinic’s NPI would need to be added to the parent registration, and subsequently the MEF, prior to utilizing 340B drug to prevent duplicate discount.

4. This new interpretation of statute does not appear to reflect HRSA’s flexibility during the COVID-19 health emergency and is expected to continue after the emergency ends.

Turnkey has drafted potential policy language to address the clarification made by these FAQs:

Here are the newly approved FAQs:

Unpublished FAQ 1318 (5/29/20) Question:  Hospitals that have only ‘costs’ associated with that cost center/dept have been rejected from 340B registration because they had to wait for revenue to be on the MCR for that cost center/dept. Does worksheet A (and/or C) have to show costs, revenue, or both? For example, a clinic might just be opened and have costs, but has not seen patients (no revenue on cost report). Would such a clinic be eligible?
Answer:  HRSA is not able to register and list this site on 340B OPAIS at this time.  In order to be registered and listed on the 340B Office of Pharmacy Affairs Information System (OPAIS), the site must have reimbursable outpatient costs and charges on the most recently filed Medicare cost report.  However, until such time the site is listed on the cost report, you should evaluate whether the patients of the site would be considered eligible patients of the hospital and defined in your policies and procedures. More information on HRSA’s patient definition guidance can be found by reviewing the October 24, 1996 Federal Register Notice on Patient and Entity Eligibility.

Unpublished FAQ 1648 (5/29/20) Question: Our hospital subject to the GPO Prohibition moved a clinic outside the four walls but didn’t register it on the 340B OPAIS. It is not on the most recently filed cost report at that location but will be on our next cost report as a reimbursable clinic. Will OPA consider the site “continuously eligible?”
Answer:  HRSA is not able to register and list this site on 340B OPAIS at this time.  In order to be registered and listed on the 340B Office of Pharmacy Affairs Information System (OPAIS), the site must have reimbursable outpatient costs and charges on the most recently filed Medicare cost report.  However, until such time the site is listed on the cost report, you should evaluate whether the patients of the site would be considered eligible patients of the hospital and defined in your policies and procedures. More information on HRSA’s patient definition guidance can be found by reviewing the October 24, 1996 Federal Register Notice on Patient and Entity Eligibility.

Published FAQ ID: 4301 (06/04/2020) Question: Are hospital covered entities able to register offsite, outpatient facilities before being listed as reimbursable on their Medicare Cost Report?
Answer
: In order to register for the 340B Program and be listed on the 340B Office of Pharmacy Affairs Information System (340B OPAIS), HRSA must first verify that the offsite, outpatient facility is listed as reimbursable on the hospital’s most recently filed Medicare cost report and has associated outpatient costs and charges as outlined in HRSA’s 1994 Outpatient Hospital Facilities Guidelines. HRSA notes that for hospitals who are unable to register their outpatient facilities because they are not yet on the most recently filed Medicare Cost Report, the patients of the new site may still be 340B eligible to the extent that they are patients of the covered entity. More information on HRSA’s patient definition guidance can be found by reviewing the October 24, 1996 Federal Register Notice on Patient and Entity Eligibility. These situations should be clearly documented in the covered entity’s policies and procedures. In addition, a covered entity is responsible for demonstrating compliance with all 340B Program requirements and ensure that auditable records are maintained for each patient dispensed a 340B drug.

Published FAQ ID: 1193 (06/02/2020) Question: May an outpatient facility that is reimbursed by CMS as a provider-based facility, but not included on the most recently filed Medicare cost report, participate in the 340B Program?
Answer: 
A facility must be both reimbursable and included in the hospital’s most recently filed Medicare cost report with associated outpatient costs and charges to access the 340B Program and register in 340B OPAIS. HRSA’s outpatient facility guidelines can be found at in HRSA’s 1994 Outpatient Hospital Facilities Guidelines.

Please don’t hesitate to reach out if you have specific questions on this new development.


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340B/HRSA EMERGENCY ENROLLMENT

Some call it Novel Coronavirus SARS-CoV-2.  Others call it Corona Virus disease of 2019. Many like to say Covid-19 or just plain Corona. Anyway you say it, it brings up many emotions for nearly every American. Everyone in our society has been impacted in some way. The virus has thrown the Healthcare industry into near chaos since the virus reached our shores earlier this year.  

To the shock and dismay of many, the AHA is estimating that American hospitals alone are losing $50 Billion a month.  Yep, that is billion…with a capital B.  The impact is being felt especially hard by our Safety Hospitals, who already run on razor thin margins.

Since we do not have a genie in a bottle (or a vaccine), what can our 340B community do to help our facilities?  HRSA is now allowing several options and opportunities  to provide help to our Safety Net Providers. 

  1. Entity/Child Site Registration: They are allowing immediate enrollment into the 340B program.  Several of our clients have taken advantage of this, and can make a huge impact to the entity, especially in the short term.  What does an entity have to do?   
    • Reach out to Apexus (apexusanswers@340Bpvp.com) to answer a few simple questions regarding the reason for the off-cycle registration, and the impact Covid-19 is having on the entity.  The questions and the reason for the off-cycle enrollment must be related to the hardships incurred from Covid-19.  
    • Explain the urgency of the request for the enrollment.  Confirm the clinic/location is under the reimbursable section of the latest filed Medicare Cost Report.
    • All other enrollment requirements are still required ( i.e., DSH%, and GPO prohibition, if applicable etc.).
  2. Contract Pharmacy Registration:  HRSA is also allowing off-cycle contract pharmacy enrollment.
    • Similar process, reach out to Apexus (apexusanswers@340Bpvp.com) to answer a few simple questions.

HRSA has been supportive of allowing entities to shift, expand, and reorganize departments and locations in order to accommodate the influx of Covid-19 patients.  For example, some entities are creating new clinics just for Covid patients.  Several have separated their Emergency departments into two,  one for Covid patients and one for non-Covid patients.  

As usual, it is critical that these changes/moves/updates are documented in your policies (did you receive a copy of Turnkey’s Emergency Policy last month?  If not, reach out)!  Also, auditable records demonstrating 3430B compliance for each patient must be kept.  

Over the last two months, we have had several entities reach out to see if and how Telemedicine encounters could be counted as qualified 340B encounters.  The short answer is yes, but again, it   must be in your policies, and auditable records must be maintained.  Also, see Rich Buchers’ Blog from last month!  As he says, “it reads like a John Grisham novel”.

These are unprecedented times for our 340B hospitals, clinics and safety net providers.  From the Turnkey and Elevate340B team, a big THANK YOU to all of the front line Healthcare workers.  


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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.

COVID-19

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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340B Program Legislative & Regulatory Update

For those of us in the 340B program trenches, it feels like we are constantly under assault from our legislatures (e.g., Senate and House bills with detrimental effects on 340B), regulatory agencies (e.g., CMS reimbursement, HHS/HRSA interpretations of the law), drug manufacturer groups (e.g., PhRMA doing anything possible to dismantle the program), and even the judicial system (e.g., courts considering the viability of the ACA). I don’t know about you, but as we have gone about our work to keep the 340B program functional for the last 28 years, there is this gnawing in the back of my head that something big could happen to 340B. Oddly enough, we have not seen a significant change in the program in quite some time. The question is, are we due for a big change or with everything else going on in the country and world, are we likely to maintain 340B in its current state? My crystal ball is currently broken, but let’s break down what we do know and where the biggest risks are today.

Judicial: The Affordable Care Act (ACA) was determined to be invalid by the lower Federal courts in December of 2018. This was a lawsuit filed in February 2018 by 20 states and led by Texas (2 states have since dropped off the case, Wisconsin and Maine). In December of 2019, the 5th Circuit Court of Appeals affirmed the lower court’s decision on the unconstitutionality of the individual mandate but did not decide on whether the rest of the ACA should also be struck down. Instead, they referred the case back to the lower courts. In an interesting turn of events, the Supreme Court has stepped in and has agreed to review the case. A request was made for an expedited review, but in January, the Supreme Court said no to an expedited review and will likely hear arguments for the case in October 2020. It is highly likely that a decision will not be made until after the presidential election. If you have read this far, and are now wondering, “okay, so what does this mean for 340B,” then let me remind you of the various changes the ACA made to 340B:

  • Most Importantly: It added the rural hospitals to 340B qualification. This includes our critical access hospitals (CAH), rural referral centers (RRC), and sole community hospitals (SCH) and of course their lower (or none for CAH) DSH% thresholds for entering the program. A repeal would mean a loss of these covered entity (CE) types.
  • Medicaid Expansion: At least for the states that took the Medicaid Expansion, this increased DSH percentages and likely allowed for additional hospitals to qualify. If we see a decrease in DSH percentage, we will see a decrease in qualified hospitals (in addition to the loss of the rural hospitals).
  • MCO Medicaid: It was the ACA that allowed state Medicaid agencies to seek Medicaid rebates on MCO Medicaid paid claims in addition to the FFS Medicaid paid claims. At least this would clear up how we handle MCO Medicaid, but it will be a large budget loss for the Medicaid program.
  • Annual Recertification: Hmm, I think this was a good thing (albeit a pain sometimes). I remember when some hospitals would lose their DSH percent but “forget” to tell HRSA. I am not sure why they would stop this, but technically it was added as part of the ACA.
  • 340B Pricing Oversight: Both the HRSA ceiling price website and monetary penalties were likely the result of the ACA. Again, I hope they wouldn’t stop the website now, but it is thanks to the ACA.

As you can see, losing the ACA will have a significant impact on the 340B program. Not a ton we can do about it, I suppose hoping the RBG (i.e., Ruth Bader Ginsburg) can maintain her health through the year would be good. Many pundits believe the current Supreme Court would likely keep the ACA intact (mostly), but a switch of one of the liberal justices for a more conservative one could change the dynamics of the Supreme Court such that a full repeal of the ACA becomes more likely.

I think I used up most of my time on that one, so what else . . .

Legislative: Although we saw a slew of bills from both the Senate and House in 2019 regarding 340B, nothing actually passed. Yes, NOTHING! To be fair, some of the bills were pro-340B, so it would have been nice to see some of them come through. However, here we are in 2020, a re-election year. The House and Senate are split Democratic and Republican, respectively, and it is unlikely we will see 340B bills being passed in this session either. One area of potential risk is around drug pricing legislation. This is a hot topic and people on both sides of the aisle have an appetite to do something. Where 340B has some risk is if any of the drug pricing bills affect the 340B ceiling price calculation and/or provide exemptions to manufacturers on 340B for participating (e.g., one of the international pricing index bills had some provisions on 340B exemptions).

Regulatory: I think this is where we will continue to see an erosion of 340B savings. On both a Federal and State level. CMS is still decreasing drug reimbursement with an ASP minus 22.5% on status indicator K drugs for most hospitals (i.e., they left out CAH and SCH that are rural for now). This is in addition to the reduction in clinical payments for off-site clinics, often referred to as “site neutrality.” States, such as California, are pushing all retail prescriptions to FFS Medicaid, where an actual acquisition cost (AAC) plus a fee is required. This is where it is critical to work with your states and ensure they are aware of the impact these decisions can have on patients and the healthcare system.

I tried to not take too many sides, rather just share what we are hearing and seeing. I would like to end on a positive note. In 2019, West Virginia, Minnesota, South Dakota, Montana, and Oregon all passed laws prohibiting discriminatory reimbursement by health plans. Nice work to those states, and there are additional states working on similar legislation for 2020. I would love to see all states pass a similar law in order to protect 340B from payors harvesting 340B savings for themselves. If your state isn’t already working on it, then maybe they should be. Now is a good time (it is always a good time) to reach out to your legislatures and ensure they are aware of how important the 340B program is to hospitals, clinics, and patients in their communities.


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A Difference Made

We hear negative goings-on in the world so often that we gloss over what happened and keep reading down the page.  We are engrossed in our work and don’t always respect why we continue to do the daily grind.  Some work for a paycheck.  Some work for the difference they make.  I believe that most do it for a combination of both.  It is easy to get absorbed in your work and not think about how you are making a difference.  

Recently, our CEO, Rob, sent the team an email with a link to an article discussing hospital closings and discussed how Turnkey has helped entities realize savings that have actually kept their doors open.  The article made me stop and reflect on the importance of the 340B program. More specifically, I reflected on how important the program is for rural communities. Each of us who works in the 340B space makes a difference.  If that statement is the only thing you take away from this piece, I have accomplished my goal.

​Hospitals closing or hospitals limiting their services occursmore often than not.  This seems due to poor (in some cases no) reimbursement from Medicare and Medicaid (M&M).  The topic of Medicare and Medicaid reimbursement is extremely complex so I will provide a very basic example of what poor reimbursement can look like.  

A patient receives a medication in the emergency room that costs $1.00 for the pharmacy to procure. The medication will be marked up to $3.00 to contain all overhead costs related to it being administered.  Now, Medicare or Medicaid comes in and only pays $0.50 for the medication.  Not only does the reimbursement not pay for the hospital to buy the medication, but none of the overhead costs are paid.  I cannot walk into the grocery store and pay for a gallon of milk that cost the grocer $1.00 and is marked up to $4.00 for only a penny!  Why? The obvious answer is because the grocer could not remain in business if they are not paid what they need to cover the costs of selling the gallon of milk.

The lack of reimbursement in hospitals does not apply to medications only, it applies to all areas of a healthcare entity. There are other reasons for poor financial performance from hospitals such as bad debts, patients not paying, etc., but a continual concern is poor reimbursement from M&M. This is where 340B folks make a difference.  The program allows the hospital to make the initial purchase of the drug at a discounted price which in turn allows the poor reimbursement to now cover the cost of the drug along with a small portion of overhead costs involved in the administration.

So why does anyone care that a hospital closes when we have so many?  The instant answer is that it creates obstacles to healthcare. We have to remember that for rural communities, the hospital not only serves as a place for inpatient care but also serves as the local clinic for family health and specialty provider services. The loss of a local hospital means our most vulnerable and in a lot of cases, our oldest patients, will have to drive quite a distance to receive even basic healthcare services. On a lighter note, I would not want anyone to get stuck behind my grandpa who drives 15 mph on the highway ON A GOOD DAY when he has to drive 45 minutes (5 hours in his way of driving) to get to the doctor.

340B betters the country and allows communities to have access to healthcare they would not otherwise have. It is important to remain compliant and for hospitals to optimize their 340B programs to continue to save money. I cannot imagine having to rush my wife 45 minutes after she goes into labor to get her to an appropriate facility.  I know because of what I have done working within 340B that my local hospital continues to be able to offer OB services.  My grandpa’s local hospital is able to provide him the services he needs and both of the hospitals’doors are still open.

You have made a difference too.  I encourage you to reflect on what you have done for your community and continue to do as much as you can to help serve our most vulnerable populations and to keep our communities happy and healthy. If you are interested in seeing how some 340B entities use their 340B savings, check out Megan Kussay’s December 2019 blog title ’Tis the Season For Giving at https://turnkeyrxsolutions.com/blog/.


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‘Tis the Season for Giving

Last weekend, my family and I made our annual trip to Philadelphia to enjoy the elaborate holiday décor and festivities, including Macy’s Christmas light show and the Comcast Holiday Spectacular. Of course, our trip to the city would not be complete without a visit to Santa. I am happy to report, I spoke with Santa personally, and all our wonderful clients are on the “Nice” list!

Turnkey is fortunate to witness the numerous ways in which the 340B Program expands access to our underserved and most vulnerable patient populations. If you have participated in an external audit with Turnkey, attended a 340B Coalition, perused 340B Health, or listened to NACHC’s Office Hours, you are aware of the importance of your Covered Entity’s (CE) ability to communicate the use of 340B savings. Apexus provides a 340B Savings and Community Benefit Template Tool to assist in this exercise. Currently, 340B statute does not require CE’s to document how savings are being utilized, however, it is considered best practice. 

Both our grantee and hospital CE type clients have developed creative and unique ways to use their 340B savings. Stories such as how our friends at Salina Family Healthcare Center and Orlando Health have developed impactful ways to utilize their 340B savings, excites us at Turnkey, equivalent to that of Buddy The Elf’s excitement when he hears “Santa is Coming”!! If you are wondering how much excitement that is, please do yourself a favor and watch Elf this holiday season!!

Salina Family Healthcare Center (Salina), a Community Health Center, is a great example of how 340B savings can be used to minimize gaps in health care, which directly affects the quality of life of their patients. Salina has seen improvements in patient care through their various programs including medication assistance programs, prescription adherence and condition management, dental services and education, mental health and substance abuse therapy. Salina has been able to take their patient care a step further by integrating savings into their community by utilizing Care Coordinators and including “learners” throughout the clinic. The Care Coordinators assistmany of their patients – from affording groceries to helping with transitional care management. Additionally, Salina hosts “learners” from the community and is also well known for their Smoky Hill Family Medicine Residency Program. Involving members of the community to understand the needs and the gaps in insurance that leave many of their patients vulnerable, in turn encourages folks to participate in the betterment of their own community. The residency program was started due to theshortage and maldistribution of physicians in Kansas. The mission of education, and its positive impact on the community,is taken seriously at Salina. 

If you live in Central Florida, you are aware of the numerous and amazing ways Orlando Health, a Disproportionate Share Hospital, has been able to use their 340B savings to strengthen and create a healthier community. Orlando Health shares their Community Benefit Report which highlights their community outreach efforts. I encourage all to seek out this document, it is guaranteed to make you feel empowered about your participation in the 340B program and serves as a reminder of how many patients would be gravely affected without the 340B program. A standout community partnership of Orlando Health is with The University of Central Florida’s (UCF) Go Baby Go! This initiative allows children with delayed or hindered mobility the ability to experience the independence of discovering and playing. The concept is the purchase of an off-the-shelf motorized toy car that is then rewired and retrofitted for children with unique abilities. The cars allow the children to gain confidence as many of the children taking part in the program cannot walk.  The redesigned cars allow them more freedom to explore and learn on their own.

Turnkey is privileged to consult with many CEs that are working tirelessly to ensure their patients receive the attention and empathy that is needed to care for their own health and the health of their families. There are many CEs that use the 340B savings to simply keep their doors open, this does not go unrecognized. It is important to spread the word of how your 340B program is helping your patients and to stay involved in the advocacy for the program. Allow the Holiday Season to reinvigorate your team and take the time to reflect on how important your 340B program is to the community. 


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A Game of Capture the Referral

As the 340B Program faces increasing scrutiny and possible changes that could lead to reduced savings, covered entities are looking for ways to diversify and maximize their 340B Programs.  Maximization and diversification can come in the form of, for example, implementing software solutions, expanding the range of services offered, or, the topic of today’s blog, capturing referral prescriptions.  Referral prescriptions can provide significant savings opportunities for covered entities, but identifying and qualifying referral prescriptions compliantly can be a challenge. So, what does it take to capture the referral?

What is a referral prescription? 

A covered entity’s providers may refer patients out to specialists for care at a location that is not 340B eligible (i.e. a specialist’s private office). If the specialist writes prescriptions for the patient as a result of the referral by the covered entity’s provider, those prescriptions would be considered referral prescriptions.  For more information about unique referral scenarios, check out the Indirect Referrals blog post.

How can referral prescriptions qualify for 340B if they are written at ineligible locations?

According to HRSA’s patient definition, referral prescriptions may qualify as 340B eligible in certain circumstances. A patient is eligible if:

“1. the covered entity has established a relationship with the individual, such that the covered entity maintains records of the individual’s health care; and

 2. the individual receives health care services from a health care professional who is either employed by the covered entity or provides health care under contractual or other arrangements (e.g. referral for consultation) such that responsibility for the care provided remains with the covered entity; and

3. The individual receives a health care service or range of services from the covered entity which is consistent with the service or range of services for which grant funding or Federally qualified health center look-alike status”[1]

There are several considerations when applying HRSA’s patient definition in the context of a referral prescription.  The sticking point is that, if a covered entity wishes to qualify referral prescriptions as 340B eligible, it must demonstrate that it has responsibility of care for the patient and referral prescription(s).  This can be achieved by implementing the best practice referral loop [JM1] (Figure 1). First, the covered entity must demonstrate that it has established care with the patient, typically by confirming that the patient has an associated visit at an eligible 340B location with an employed or contracted provider of the covered entity. If the patient is an established patient of the covered entity, documentation of an outgoing referral in the patient’s medical record on or prior to the written date of the referral prescription is necessary to support that the covered entity has responsibility of care for the referral prescription(s).  Finally, the covered entity must receive referral summary notes to be uploaded in the patient’s medical record in order to “close the loop”.  The covered entity’s provider should update the patient’s medical record with any new information, including medications prescribed during the referral visit.

What are the compliance risks associated with capturing referrals?

Capturing referral prescriptions can increase a covered entity’s compliance risks.  A covered entity interested in capturing referrals must first evaluate if the risk, potentially a HRSA diversion finding, is worth the benefits of increased program savings and patient care. Consider, are enough referrals being made by the covered entity’s prescribers?  Are the referral prescriptions being sent to pharmacies within the covered entity’s 340B network (i.e. contract or in-house), would a new contract pharmacy need to be added, or are the prescriptions scattered to multiple pharmacies? Keep in mind, increasing the number of contract pharmacies can introduce more program complexity (i.e new TPAs) and subsequently increase a covered entity’s chance of being selected for a HRSA audit. 

Once a covered entity determines that it is interested in capturing referral prescriptions, additional considerations need to be made.  To start, the covered entity must evaluate its referral process to determine if providers are documenting outgoing referrals consistently.  Some electronic health records (EHRs) may have standardized outgoing referral forms, while others may require manipulation by an IT department to create a template or field for free-form documentation.  Would additional provider training be required? Does the covered entity’s IT department need to be involved for EHR manipulation? Are providers reliably documenting outgoing referrals? Remember, a referral must be documented in the patient’s medical record on or prior to the written date of the referral prescription to be justifiable.

After standardizing the outgoing referral process, a covered entity must assess the risk associated with obtaining referral visit summaries promptly to corroborate the eligibility of the referral prescription. At a very minimum, the covered entity must have documented attempts for obtaining the referral documentation.  However, best practice would be to obtain the visit summaries and update the patient’s medical record prior to qualifying a referral prescription as 340B eligible. Does the covered entity share an EHR with the specialists?  Can the covered entity obtain referral consult notes and update the patient’s medical record in a timely manner?

How can a covered entity capture a referral prescription?

Meeting the recommended guidelines for documentation of referrals and subsequent prescriptions requires significant resources.  There are a few approaches that a covered entity may choose from when deciding what best suits the needs of the covered entity.  First, the covered entity must determine how it will identify referral prescriptions.  If there is a known list of specialists, these specialists could be added to an eligible provider list, on a limiting basis, for easy identification.  Some pharmacy Third Party Administrators (TPAs) can sort prescriptions from these specialists into a separate queue for manual review by the covered entity’s staff.   If the covered entity is not using a TPA, staff may use the list to cross reference against the prescription to determine if it could be a referral prescription.  These options require significant staff resources but allow the covered entity to keep most or all of the savings.   Another option is to outsource the entire process, from identification to retrieval of documentation and communication with pharmacy TPAs, to an external party.  A consideration when using an external vendor is that a covered entity will be forfeiting some of its savings.  However, by outsourcing the labor, the covered entity would be minimizing the operational changes that would need to be made internally to accommodate the demands of capturing referral prescriptions. 

As a covered entity, the decision to capture referral prescriptions is multifaceted and may require significant resources and operational changes.  However, the benefits of adding this to your 340B portfolio may have a significant impact to program savings and ultimately, patient care.  The undertaking may be worthwhile, because at the end of the day, 340B is the bloodline for those who are providing care where it is needed most. 


[1]https://www.hrsa.gov/sites/default/files/hrsa/opa/programrequirements/federalregisternotices/patientandentityeligibility102496.pdf


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What does this have to do with me?

Many of us are so focused on our next meeting, the crisis that needs to be addressed now, or how we are going to get through all of our emails; that it is easy to read something and not think beyond the here and now.  Recently the state of Minnesota implemented an update effective August 1st that allows pharmacists to dispense a refill of a medication despite no refills remaining on the prescription. Emergency refills of prescriptions for a 30-day supply are allowable under the following circumstances:

  • The patient has been compliant with taking the medication and has consistently had the drug filled or refilled as demonstrated by records maintained by the pharmacy;
  • The pharmacy from which the legend drug is dispensed has record of a prescription drug order for the drug in the name of the patient who is requesting it, but the prescription drug order does not provide for a refill, or the time during which the refills were valid has elapsed;
  • The pharmacist has tried but is unable to contact the practitioner who issued the prescription drug order, or another practitioner responsible for the patient’s care, to obtain authorization to refill the prescription; or the drug is essential to sustain the life of the patient or to continue therapy for a chronic condition;
  • Failure to dispense the drug to the patient would result in harm to the health of the patient; and
  • The drug is not a controlled substance listed in Minnesota Statues Health section 152.02, subdivisions 3 to 6, except for a controlled substance that has been specifically prescribed to treat a seizure disorder, in which case the pharmacist may dispense up to a 72-hour supply.

Similarly, the Governor of the state of Florida, on August 28th, declared a State of Emergency, in which a pharmacist can use their judgement to refill prescriptions early for a 30-day supply provided certain criteria are met in the areas or counties affected by Hurricane Dorian.

In both states, the pharmacist must notify the practitioner who prescribed the medication.  In Minnesota it is no later than 72 hours after the drug was sold or dispensed. Florida does not define a time but rather states that the provider should be notified within a reasonable amount of time.  A record of the drug being dispensed should be maintained just as it would be for any other refills. 

Most would read these updates from the Board of Pharmacy and not think beyond the impact of the practice change.  I am challenging you to do just that and ask does this impact how we oversee our 340B Program and if so, how?  And would also argue it should be a thought every time practice change is implemented either by your State Board of Pharmacy or internally by your covered entity.  In response to the question above, the answer is, yes.  It could make it challenging to comply with the statutory requirement for auditable records.

Because there may not be auditable records for the fill (i.e., refill authorization) in the patient record at the covered entity, Turnkey is recommending that language be added to policy. Consider the following language for example: “The state of (insert applicable state) allows a one-time 30-day supply of a medication when certain requirements are met without provider authorization or documentation. In these cases, auditable records would include any documentation by the filling pharmacy to indicate the medication was refilled and the provider was contacted.” In addition, it may be wise to reference the link in which the practice change is stated in policy.  I have attached the link for both the state of Minnesota and Florida respectively, that outlines the practice change and requirements.

Just as you need to keep updated with practice changes, states can change their requirements to prevent duplicate discounts.  The state of North Carolina updated their Clinical Policy No. 9 for outpatient pharmacy on July 15th, 2019.  This update requires the use of both the ‘08’ in the basis of cost determination field via the National Council for Prescription Drug Programs (NCPDP D.0 field 423-DN) and a ‘20’ in the submission clarification field (NCPDP D.0 field 420-DK) for point of service claims.   Prior to this update a covered entity could use one or the other.  In addition, per the updated policy, only the actual purchased drug price should be submitted in the usual and customary charge field.

The state of Kentucky posted on August 2, 2019 changes to its Medicaid policies and procedures for Managed Care Organization (MCO) and Fee-for-Service (FFS) providers who participate in the 340B Drug Pricing Program.  Beginning on January 1, 2020, providers should submit 340B Medicaid FFS and MCO claims with the NCPDP D.0 value “20” in the field 420-DK submission clarification code.  This indicates to the Kentucky Department of Medicaid Services that a 340B purchased drug was used and not to collect rebates on the claim.

The following links outline the changes to the NCPDP requirements as discussed above for the states of North Carolina and Kentucky, respectively.

Key takeaway:  Stay abreast of what is happening with state requirements including changes to pharmacy practice.  One never knows when a change may impact your 340B Program.

P.S.  Although the picture above depicts a beautiful snow scene – the winters in Minnesota are long, and it gets very cold here -50 degrees with the windchill.  Okay, that is not typical, but it has been known to happen and impacting travel and one’s ability to be outside.  You need to be a lover of snow and really cold weather to live here year-round or crazy.  I think I am the latter.