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Just being on the database means that HRSA validated that the CE, or its child sites, all met the basic requirements for 340B eligibility. _>lA/%S";9Lra*Z*"3#R&HP_^%0[(D630YSeIi[\L*KeW4O"KU$\lP"ZkQpZ1.6g"
The 2011 GAO report recommended that HRSA clarify its patient definition, which was established in 1996. HRSA has provided further guidance in correspondence to 340B Health, so we recommend contacting 340B Health if your hospital has questions regarding specific applications of the 340B patient definition. /Q$]g#S41E(=\XYa4Y:7VkUE
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340B Patient Definition Notice (PDF) - Federal Register Notice that addresses the definition of an eligible 340B patient (1996). 0000015842 00000 n
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However, whether the family planning user meets the other two prongs (concerning services received) would need to be determined on a … .&7$7TTSI`UOj#VH39s@(SeQUWHqL>BB4N21SU=;0%s$uH?l;I@A[6rTV?ZVRp! Just the rumor we planned a 340B blog that would relate to another Aesop fable has the Curmudgeons at Large (and they know who they are) emailing us with righteous complaints about ‘click tricks’ (tricks to have more people ‘click’ on your blog). refill. Let's break it down. However, the Cath Lab is ready, and the patient is admitted and transferred to Cath Lab for an interventional Cath, where the Integrilin is administered while they are an inpatient. 6A;6Z)%u8YI\DOa7WJpn2*__9_IEa
Friday, December 20, 2019, 340B Patient Eligibility and Aesop's Fable 35, Ambulatory & Specialty Pharmacy Solutions, not trust someone who blows hot and cold with the same breath’, http://340bexperts.com/compliance?gclid=CjwKCAjwrO_MBRBxEiwAYJnDLMZG9mWVIoeFGl3nT5rolrqGRuhwShoJZJembPVQeiPiNNOgS666YBoC9BcQAvD_BwE. Increased regulatory and manufacturer scrutiny of the program has heightened the need for robust, audit-ready reporting with claim-level inventory tracking. 9h\Ch-(tSR:tZ@?lY?]J-Mhr4;Zc:Kq. G#\!-Tr+
The CPS and the CPS logo are trademarks of Comprehensive Pharmacy Services, Inc. All other product names are trademarks, registered trademarks, or service marks of their respective owners. endstream
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`8kDF;Iq=K5[,/lc4!SPGu$c0.Ah3?M]S]OZVbiR:?\6@i_8DX0In@p%n. They were able to simply reverse the 340B purchases. EU7-q!$q)Y/X.5RJ9[2WV%V=X+F0utZ@T@LY"p\&?cTH%Yr4QBOh5VMsFC.U=oSF(kMu`?3
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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). Patient Eligibility is extremely complex. Updates to the definition of a “patient.” Federal regulations implementing the 340B program prohibit the “diversion” of drugs purchased under program discounts, including the provision of such drugs to individuals who are not “patients” of the 340B-eligible entity. i=Tgg?_O\^54DCCO^XZ;lcl"SENP?KA%6gs7i5mRa0_4WDD
340B Eligible Drugs and Orphan Drugs. Is that appropriate? 6QFo)`&bFIg;=5]C'>I%5_T[\]K'#f\WF_>E;p#rIZ1^b\U7`9rB+`?3Q. Is the drug 340B eligible? 340B, ":D?YN+=Qr]I/Y\c(*S1]\pm3N!c5R$@n3D^X(.UOH:R.V6$30*:V+D'u/Pu^]YJX
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Areas for special attention include: Following the last spat of Child Site entries we received a number of questions related to this topic. @LeoP%jh.JA4K?B5Y/TZg
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But it’s a fair comparison. In 2010, ensuing guidelines removed the limitation on the number of contract pharmacies a covered entity can have. /Q$]g#S41E(=\XYa4Y:7VkUE
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Start now in collecting your data and documentation to file your submissions. The 340B community is largely in agreement that … '$r>7%1>AJ56IDSrMH_gS0SDm&
and finally, documentation of post-administration care, 'Removed IV catheter, vitals signs normal, patient discharged after observation.'. C(h_sE-3n^;"E3YA@3ZQ,],UC=MPb#E[hqqZTgk;sQ9V@-"!H
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55156 (Oct. 24, 1996)]. Patient Eligibility/ Definition of Patient 1. Start adding off-site clinics, child hospitals with off-site clinics, and contract pharmacies, and it starts to get complicated fast. . Program sponsors must keep up with 340B regulatory guidance from the Health Services Administration (HRSA) and the Office of Pharmacy Affairs (OPA), including the patient and provider definition. Maybe. )/
The 340B statute prohibits covered entities from transferring or reselling a 340B-acquired drug to an individual who is not a patient of the covered entity. [6Di__Fj%)k[GkXTMf[89gr:nt$]8`agp
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For more information, current patient definition guidelines, see 61 Fed. *lk4@JN9FjHbY-O"%=ImQ4?s&oU<>Cc
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Patient receives health care service(s) from a provider employed by the covered entity (or providing services for the covered entity under contractual or other formal arrangement 3. In order to purchase, administer or dispense 340B drugs, a hospital outpatient clinic must be an integral part of a 340B eligible hospital, have patients that meet the 340B patient definition guideline, be listed on the HRSA 340B Database as eligible, submit to HRSA the most recently filed cost report to verify clinic eligibility and be designated as a reimbursable clinic above line 96 on Worksheet A of the cost report. D2NsX#cYDaX5'^h30b[S;5NUga:*LHbRC]15!WA*)%8E6N(8-[6N@gq!-!aG66[Wb
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#u-C6hBt0k[9]L^it/"V>[t;B'+>!V#hV$Ej1?#[La. When you do your own internal audits, try to find an observation patient and audit them specifically every now and then - be sure your systems work. )Ud
Covered entity Anticipating the need, a nurse pulls Integrelin from the ADC while the patient is classed as an ED outpatient. Bundled Charges and non-340B Drugs: We're not going to cover this topic in detail in this blog today, as it deserves it's own blog. Now add a child hospital - one under the overarching umbrella of the parent facility. '$r>7%1>AJ56IDSrMH_gS0SDm&
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You may also find 340B Health’s principles on how to comply with the prohibition on diversion here. That Director fixed the problem literally the same day, but the inappropriate locations had been passing through for quite some time. But be sure to include a clear explanation of bundled charges, and if at all possible, include a list in your P&P appendices. 6IE0OPKKo\2]1"C";a[nJe",`"+m7L4_KICf\gh+
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YruW^1M"F\"]'sXK>Le[]gHdK;WZcCF. Disproportionate share hospitals are exempt from this requirement. @l)sq$KJG+Udts5+YGQ:i*t2A0,*=]\`)X=%U9qb4Wi^uGD+Bti4`s"`'@.j@^Q:S
340B Patient Definition. In practice, however, 340B eligibility determinations are made on a prescription-by-prescription basis, as opposed to a patient-by-patient basis. :Lp269A,UEW\CcT`'3[5'JsK/>jmq+@&`ofi?DA7uX7s[:L-893._.Yqp.t6rGd6
An individual receiving 340B drugs must be a patient of the covered entity as defined by HRSA (PDF - 32 KB). trailer
)mH+WiHZ1C"m^k/OKQD3lIJ%j\D;g3"E2,->q]h$$4tYQ]1Ec0/*. 340B supports another key local program, created to address how frequently patients failed to fill prescriptions or take them correctly. 0000015612 00000 n
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uuid:4d5db44b-c31a-4b5c-b7f9-c9c6c0d2b59f 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. Fortunately, the Director of Pharmacy used our suggested constant readiness calendar, and caught this in less than a month of the change. Links are below. ]mn1-uENR1WJ>c16C\'O+1g)@=dL*Z4s@k0Yl*1?_R+)3u]S0aD+U5a=)oEoL/Q1BI,`-U\@fT=m0%ga<1Ml$1
The pivotal term “patient,” however, is not defined in the 340B statute. Story time: A new Director was reviewing their Split Billing Software and noticed a lot of ineligible locations were not filtered out. 0000013666 00000 n
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The last area we'll discuss is not the least important! 0000000000 00000 f
Even so, we know of places that bundle drugs in one location but not another. In late August 2015, the Health Resources and Services Administration (HRSA) released highly anticipated proposed guidance for its 340B Drug Pricing Program, which has caused uncertainty for the program’s thousands of participants—including Critical Access Hospitals—if it finalizes the proposed Omnibus Guidance. ?Hp?Wb[Wmp9[%qom+EM?X-F9I[3DVq0SkIC&E;34KPkjIfZZ=!$e8LIQg"tn>+/:Uc1L/c)d+G54)\lmsa?tY]4D4E&,SCHoHUDPaM
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Interpreting the 340B Patient Definition When there is clear documentation demonstrating that the covered entity (CE) owns patient care, CEs can include prescriptions generated via patient referrals to an outside provider in the 340B program. 16. ;Z";7/-\Vn(i!kt8*((1SA:dI0H(q]&Pt=g^tuED$FWh
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including the prohibition of diverting 340B drugs to individuals who are not patients under 340B Program patient definition. ;YlRc^$U48LrC1;T"19C88
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But these in-house clinics do not need to be registered as child sites on the OPA database. 2/56^Ffs@U%Il@-nkEV]`]7IKWTbTh-f^jH#7V
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Ed"if9&NQAU! Permissible use and prescribing of 340B drugs at such offsite locations will continue to be subject to the 340B program definition of “eligible patient” of the hospital, and hospitals remain required to register offsite locations in OPAIS once the location is reported on a filed Medicare cost report. Manufacturers provide steep, mandatory discounts on medicines to certain types of clinics and hospitals as a condition of their drugs being covered by Medicaid. Regardless of insurance type or lack of insurance coverage, covered entities can provide all of their patients with 340B drugs. JQ58jAg"o]FN\6l39sMr53AZG')sB1JC2gt410u.o//!TQVlth](,ATbAIKk8
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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). U39"H)G&-k`^JmWJs=Pg[7H+VOV8q#OiZ&laf!QcTB+lRi4'bnoBL'9XS%1NV@MGkW\NM(lD,j0@=TPdM;mMBQ"]Rl"
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If policy covers presumptive removal of Integrelin prior to the actual order, you're still OK with 340B. The definition gets a little more cloudy when a Consulting Physician is called in to see a patient, or if a patient is referred to a specialist who is not on your medical staff. (7@3*s0G;Hd
2J]26;HQe2K^,e<=7Q/aF/r-]02WCu1\Hp.ZT/4`6! If you'd like more information on this, or any aspect of 340B, please email or call us at any time. Patient eligibility's complexity creates challenges due to the multiple areas it involves. m?UP4Nch74&IoYq/.adWg7Zb7XU&\54geK-4lWQ$-H`XjUGe46/GNEGT7bp7#0DB;
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prongs of the 340B patient definition (having an established relationship as demonstrated by the maintaining of a medical record). We suggest not less than quarterly. 2003-08-28T08:31:04 0000015509 00000 n
What Is The 340B Drug Pricing Program? Call or emal for more discussion if this is as clear as mud. A: STD (318 grantee) clinics that participate in the 340B Program may purchase 340B drugs (including prescribed contraceptives), for grantee patients that meet the patient definition criteria [61 Fed. >OellE?`hm9'cs. Xq(6H"Q! In such a location, each patient receiving care meets all aspects of the 340B patient definition. ,8$Y7O(`&5#9*&GQR=^u+NSXFb&:V^1"p!fdht1%GN5E6'0,
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The approved list of eligible sites was signed off by both the TPA and the CE. 0000016064 00000 n
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If your P&P is clear in stating 'the patient's admission status at the time of dispense', then you are likely OK with 340B. b;C#2`s'9(I7JH8UE!JA8kuS:F(G&Bar:#8:tO15=!]F$! :mR3^tkgSnWF;]nECgS
It depends on your ability to justify why and how you do that.If your P&P describes the process in what is known as a 'defensible way' then you are OK. J3XD@hJrmlbo(/+Im!/K*,'&Pu-Sl6J&G!G'd##Q[)JHHPJCqMUe.! 31454
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Search Results; A; A; A; Print; Search. Your split billing software drifves your 340B coimpliance, and it's critical to have it properly maintained. Consequently, many 340B pharmacy contracts do not cover Medicaid patients. records of the individual’s health care dfJ&.J7cFii//G\QM(h3>0KRP1/^_B2qhH1c;DC6%=,Zg/+dP6@U#Va#bm1W637~>
We work diligently to limit these blogs to under 1,500 words. )P`E+gY/+>els7&Wq4e0#V:L-c!PJ7AX-L^ReH&X!JX)MeUX6(ib_"WEATngP]3
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The federal 340B Program is a drug price control program that allows qualifying providers, generally hospitals, specialty clinics and their associated outpatient facilities serving uninsured and low-income patients in rural communities, to purchase outpatient drugs from manufacturers at discounted prices. d]0YWUeC(076A>H+s2N)Ol*?>[BCl1Wc/4d-:.a8J$WRBEnD/M:rCokS? In a lot of situations, a provider outside of the CE's medical staff refers a patient to an infusion center. _?uL[Ed5^,(``@CSmpQR;a.0D_/-HZr(U>Q@j5GMee#tc5TDAf)&,@X_dUkIp*V)6rM/r&TGte5e#m\$2[:1#+0;! Patient Definition: Not all patients that seek care from a covered entity are qualified to receive outpatient prescription drugs at 340B discounted prices. Y:g? 340B Patient Definition. J. -Vob`dN_6NVZ\),@=lT43!RpOWn4Rp("0m>K+PU2C,^L],A&3VaO1mB'?g5VO4HU,?bM8]2Ctf.M=Sf?dno-rMZ'2
Covered entity; patient; eligible entities; definition of a “patient�; drug assistance program; employee of a covered entity; records of the individual’s health care; refill. CPS Blog Posts, dfJ&.J7cFii//G\QM(h3>0KRP1/^_B2qhH1c;DC6%=,Zg/+dP6@U#Va#bm1W637~>
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Apexis website provides answers regarding patient definition (website link was provided). definition of a “patient� [c'mRt))r3+'U)<5F5St'5k.2gatFHe
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Also, a lot of CE's are looking at their latest MCR's this summer and considering potential additions or deletions to the OPA database. 7h!:+fkT71^u@E! bXVpW%V0%'R5mK&b$MWL$n:a@eP_e. Their P&P was not in good shape, and I referred to it one time too many. Moreover, an individual is not a “patient” under 340B if the only health care services that the individual receives from the FQHC are • Hold hospitals accountable for passing 340B savings from drugs to patients • Block Medicare Part B cuts • Orphan drug discounts • Patient definition • How should hospitals qualify for 340B • Increasing DSH % to qualify • User Fee • 340B administrator changes Legislative Updates 2017-2018 *mT>IB!XX>RClKes!MIb?rhLD*uW"
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These situations should be clearly documented in the covered entity’s policies and procedures. ED admissions: A classic audit issue we see is: A patient presents to the ED with chest pain. 340B Patient Eligibility. 13) Duplicate Discount: Manufacturers are prohibited from providing a discounted 340B price … cmd,N]fQ[? 4@c=!"GiiY!*Gj-nMQWPA/m]S=e)_Wj.6a%!G)undU7SJL9BU! Aesop's Fables, . O1>1;"W%:nPF.G:
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Interpreting the 340B Patient Definition. HRSA • Drugs purchased under the 340B program are not eligible for Medicaid rebates. The U.S. Department of Health and Human’s Services (HHS) Health Resources and Services Administration’s (HRSA) long-awaited administrative dispute resolution (ADR) final rule went into effect last week, on January 13, 2021. Unfortunately, this can become less clear if the drug is removed before the actual order is written by the provider, and then the order is written after the patient is admitted. We recommend documentation of pre-administration of the drug, such as documenting blood pressure, pulse, temperature, etc. 0000016064 00000 n
a These criteria include the following: The patient is an outpatient. o3.C54gU(Jf.PqVB?^=I'7+E?Ba*^s1Gje=9oRhI\Me3PiicTb^7N_b@%\5Gk6$m\
For example: A CE with all of its clinics housed within the four walls of the hospital (and using the same physical address) must be on the Medicare Cost Report (between lines 50 and 118) as and active outpatient cost center. &Y/t:6FHs#@/3HK:&m+'ef<183D`nXl? In 1996, the Health Resources and Services Administration (HRSA), which oversees the program, wrote guidance that allowed covered entities that did not have an in house pharmacy to contract with one outside pharmacy to provide the deeply discounted medications to the indigent patients they served. ?\gT$>&D>DsRE'Vce\=l,Il+
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One of our other 340B consultants and I worked with a director of pharmacy in a state not to be named. 01 The covered entity must have an established relationship with the patient. B^1o_#-[0LdqBq'AgW]02^0DYYp"1ndq'YZ#f)B)ZN(:SX9c7EAo3;+TRmN;M.a8G
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At least one CE calling us had a previously eligible clinic drop off the MCR. 340B Database and Recertification Information (HTML) - Government database of 340B-certified centers with information and resources on recertification and compliance. The actual arrangement varies by hospital, but so long as there is an agreement as mentioned above, these providers are eligible. 55156 (October 24, 1996). Currently, the 1996 guidance is a two-part test to determine if the individual is a patient of the covered entity for enrolled hospital qualified entity types. The Patient Definition FAQs have just been updated. 207; October 24, 1996 As anticipated, the proposed guidance seeks to clarify the qualified patient definition. 5a3]e1cWK*8&cmS]qD+6/PC3F2(+j(G#gprg9*Q!5[CHP`N4C-XLcZXqU)E+eZF/N
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patient 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. endstream
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This time we topped out at just under 2,000. HRSA oversees much of the 340B program through sub-regulatory guidance, with perhaps no element of guidance more significant than HRSA’s 1996 patient definition guidance. 340B Database and Recertification Information (HTML) - Government database of 340B-certified centers with information and resources on recertification and compliance. [Y$J`fpDOo)K42DqMrc3eHZQe/nGbt
Patient Definition Advocates of the 340B program have consistently argued that the 1996 definition of who qualifies as a 340B patient should not be changed. %%EOF, 7gN+
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Current Definition of 340B “Patient” is Based on 1996 Guidance :tg([#V7riE75O85fl[brC/1\(BXYP?j]!H:/"*5R:\"1%H'bcWr+[k'D`[%nu?NI
That in 1996 definition is not only -of-date, but outineffectual as well, fail ing to successfully prevent diversion of discounted drugs to non340B patients. No one could explain the error. As anticipated, the proposed guidance seeks to clarify the qualified patient definition. 0000012764 00000 n
*g?6MNlgAT%WJQ1-K!/chuM! If not, they must be removed as soon as possible, and if ineligible 340B use exceeds your P&P Material breach threshold, reported. However, you might say the morale is ‘too much information can be confusing’. [*T6^mQ1Nj"p@Rp5`BE=;?QuR,(rWN^r$=@L`uh,#6LJpm&Wcd5f",*"tUQuE(GE8
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•For PrEP, should also include extragential testing (goal: STD prevention) 31. Unfortunately, it's easy to get wrapped up in local definitions of Active, Attending, Inactive, Temporary, and other definitions of a health care provider. *g?6MNlgAT%WJQ1-K!/chuM! 31454
•If the 340B patient definition is met, 340B can cover any outpatient prescription that is warranted by the visit. :Pm:NbNe5)[sCkE
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As such, it is imperative for Covered Entities to clearly state policy as to how they define and track eligibility for unregistered Child Sites. _Ubf6*t0BJE'%O:QC"2O:r)7`a7dN?3S1Og8C=6>Y*VN!G^cWm3j&P`&/$*Zdl;-p?on8ZWLF!D72#_,H5d$E_h8A=c?m-1'ATS3f71k?N8Y[
Add external clinics, and these must not only be omn the MCR as mentioned above, but registered as child sites on the OPA database. CI4R4h:k3VgOs`/Sb5Mo:0BbO2K6T%M]p^Uc;t=Vj_e8klOW0lm8'Yh9/4it&i^;c
The threshold question in any analysis of 340B Program patient eligibility is whether the recipient of the 340B drugs meets the definition of a "patient of a covered entity." 0000005270 00000 n
13) Duplicate Discount: Manufacturers are prohibited from providing a discounted 340B price and a Medicaid drug rebate for the same drug. :Lp269A,UEW\CcT`'3[5'JsK/>jmq+@&`ofi?DA7uX7s[:L-893._.Yqp.t6rGd6
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Elles sont, à elles toutes, la première cause de décès prématuré dans le monde. An individual receiving 340B drugs must be a patient of the covered entity as defined by HRSA (PDF - 32 KB). ?\gT$>&D>DsRE'Vce\=l,Il+
Sometimes that's hard to do, especially a topic as complex as Patient Eligibility. :.A#S)Ag$Kjg'
Evidence of an employer relationship or insurer relationship alone is insufficient to determine 340B patient eligibility. J. "feu'dLT*OHRhu?d-Em(%0ZA:+9^"Pd[]\_*i@;:K?QaO/*Vo?f*^\SmhN)Dph`"]
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HRSA recognizes that the circumstances surrounding disaster relief efforts warrant additional flexibility to affected 340B entities. +`hiW@*fBs_&;=%33=$g7H1L9jZSMYG_DJJL(Qa.mj`;MqpS5/TNaa(CDi1J>/Z[G
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This emphasizes the important of a routine review of all the parameters in your split billing software. /E]c%Ya#?,1O#5Ao5ec6q7#d$)+-f%Z#F=2*$"i'#\JgZjksOoL3Ld0%f6/
EPT & Patient Definition St. Clair County Health Department Q: Please define eligible patients. %*>LZ"T\lSKYWrf6?#Et!=U?/5`/U;YV;!3\h8[=L_36-$B=.h].5WH:EP-F,Qu=2
It might be different for FQHC's or grantees, but let's let that go for now.
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