Susan Coultrip:

SSM Health dispenses neutral inventory.  That is to say it is not 340b, WAC nor GPO drug at the time of dispense.  The qualification happens in the days after dispense. The qualifications become accumulated drug for the next purchase of inventory.  Even if we waited until the qualification engine ran, we would have to build a process that would link our TPA to our billing system to put a modifier on the bill pursuant to this request.  The logistics of such an endeavor are cost prohibitive and time consuming if possible at all.

OHCA Response:

Per federal Medicare guidance regarding "Billing 340B Modifiers under the Hospital Outpatient Prospective Payment System (OPPS)," providers should already have a mechanism in place that determines if a particular drug qualifies as a 340B drug or not during Medicare's timely filing window. Therefore, the rule change will only require similar accommodations to Medicare federal regulations. If you have additional concerns, or questions, please contact our office at (405) 522-7031 or DrugRebateUnit@okhca.org.   

Jeff Thompson:

Hospital providers are already submitting these identifiers for Medicare claims.  If you stick to the same modifiers and units of measure/charge this shouldn't be difficult.  Stay away from requiring billing AAC.  That number is nearly impossible to settle on.  For retail, some systems can support POS 340B eligibility, but many do not.  This will require significant cost on the retail pharmacies part.  I don't see how that could be done for contract pharmacy.

OHCA Response:

Thank you for your comments/questions. The OHCA takes every comment under advisement. At this time, we do not intend to require billing of AAC and will maintain our current invoicing process for shared savings with 340B providers carved-in for OK. Additionally, all pharmacy claims submitted by carved-in pharmacies will continue to be considered 340B purchased drugs. The requirement to distinguish between 340B and non 340B purchased drugs will only apply to outpatient and hospital claims with this rule change.

Dana Berryhill:

Oklahoma has one of the best systems in place to prevent duplicate discount. Carve-in status is publicly available at OPAIS for each 340B entity.  OHCA reviews this, and for Medicaid carve-in entities, for every drug we've dispensed to a Medicaid patient they bill the entity for the rebate they would have gotten.  It's very automatic, no modifiers needed.  If modifiers are needed, please use the same Medicare modifiers so that our EMR systems will handle this. This is not a good time to review a change and request comments, because we're in crisis staffing across the state in hospitals.  Impacted parties most likely don't have have resources to investigate and respond.  

OHCA Response:

Thank you for your comments/questions. The OHCA takes every comment under advisement. OHCA will be sending out communications to providers detailing the requirements associated with our updated 340B rules.

David LaVecchia:

I like the idea of inputting the codes and not having to pay back each quarter. This is the way all of the other Medicaid and Medicaid managed care companies operate. W have bene doing this for several years and have been audited by HRSA and have never any any findings. 

OHCA Response:

Thank you for your comments/questions. The OHCA takes every comment under advisement. OHCA will require the use of these codes however the current invoicing system will remain the method by which we will adjust reimbursement "by the 340B ceiling price".

Mike Loftus:

Thank you for the opportunity to provide comments Section (b) 3 – Execute a contract addendum with the OHCA in addition to the provider contract. 

• Without additional information it is unclear what this requirement entails, but it does concern us if OHCA is imposing additional registration requirements that fall outside of the requirements in the Office of Pharmacy Affairs Information System required for 340B participation.   Please clarify what this contract addendum will require from the covered entities.

Section c) (1) – All pharmacy claims submitted by covered entities shall be adjusted by the 340B ceiling price whether purchased through the 340B Program or otherwise.

• DSH Hospital’s often operate at a loss in the entity owned pharmacy retail space if most of their claims do not qualify for 340B eligibility.   Entity owned ambulatory pharmacies are required to abide by the GPO prohibition when carving in Medicaid Claims.  In this scenario if a pharmacy fills a claim for an employee’s prescription, but they do not meet the patient definition for 340B eligibility, we purchase that medication at Wholesale Acquisition Cost and under your policy would be reimbursed at 340B Ceiling Price.   This is not a sustainable model that allows a hospital owned pharmacy to service its own employees.  This scenario would force the pharmacy to request a different provider number for the retail pharmacy and carve out 340B from their retail entity owned pharmacy.  This is not a win-win scenario for the state or the 340B covered entity.   I would propose a monthly report that we could submit for OHCA claims that were considered 340B eligible and an invoice in the difference your policy sets to offset the reimbursement.    This is much like the invoicing you do today, but would allow pharmacy claims that are not 340B eligible to be reimbursed at the normal rate and provide you the information where you are able to go after a rebate from the manufacturer.   

Section c) (2) -- Medical claims submitted by covered entities with procedure code modifiers indicating the use of the 340B purchased drugs shall be adjusted by the 340B ceiling price. OHCA will adjust each claim by subtracting the 340B ceiling price from the amount reimbursed and multiplying the difference by the quantity submitted. OHCA will use the 340B ceiling price applicable to the quarter in which the claim is paid. Medical claims submitted by covered entities with a procedure code modifier indicating the use of non 340B purchased drugs will not be adjusted by the 340B ceiling price and will be submitted for federal rebates as required by CMS. Covered entities are required to use an appropriate procedure code modifier on all physician administered drug lines when submitting medical claims.

• Will this modifier be required on all drugs or only those with a HCPC code?   If it is all drugs, how will the State handle NDC’s submitted with a modifier that are not part of the rebate program?   We have scenarios where the same drug by different manufacturer’s may in one case have a 340B/PHS price requiring a modifier and in other instances some manufacturers may not offer a PHS price.   If a modifier is applied and not part of the rebate program, will you deny the claim or have a secondary reimbursement methodology.  Putting this into operation is complex and requires the state and covered entities to work closely on preventing duplicate discounts.  I would like to propose that a monthly or quarterly reporting structure be added so a covered entity could receive a report showing all the claims submitted to the state that were done so without a modifier (i.e. those you will seek a rebate).  The covered entity could use that as an auditing tool to insure we both understand which claims you are considering for a rebate.   Without that level of partnership, it will be difficult to know if there are areas where claims are not applying modifiers and sent through to the State.  

While many states continue to alter reimbursement to 340B facilities, it is our view that Congress did not intend for reimbursement disparities in the physician administered drug space.  It is unfortunate that CMS and some other payers are taking the benefit from the program that was intended for hospitals taking care of our most vulnerable populations to continue in that mission and expand services.

OHCA Response: 

Thank you for your comments/questions. The OHCA takes every comment under advisement. The rules regarding 340B remain largely the same as those that were implemented in 2016 (Link to our current policy https://oklahoma.gov/ohca/policies-and-rules/xpolicy/medical-providers-fee-for-service/individual-providers-and-specialties/pharmacies/340b-drug-discount-program.html), with the exception of Section c) (2) regarding medical claims. Section (b) 3 remains the same as with the previous rule. Therefore, required agreements from providers already carved-in or those seeking to carve-in will not require any additional paperwork than what is being currently required. There is no change to pharmacy billing with this rule change. 340B pharmacies have been all in or all out and we will maintain that policy with the updated rule. Modifiers will be required on medical claim lines with HCPC codes. Our invoicing system that has been in place for many years will continue to be the method by which we will "adjust by the 340B ceiling price". As part of this process, we identify all claims billed by the provider.

Roger Neal:

I agree with several of the other comments. IF we can stick with the current Medicare mods, that will make this much easier to swallow, especially at a time where no hospital has the resources to make significant change midstream to something that has worked for a long-time. 

OHCA Response:

Thank you for your comments/questions. The OHCA takes every comment under advisement. OHCA will be sending out communications to providers detailing the requirements associated with our updated 340B rules.

Stephanie Kilbourn:

OHCA 340B Drug Discount program currently in place is highly effective and a clean process.  Please review our comments regarding the proposed improved 340B shared saving methodology.

Rule Impact Statement APA WF#21-33

C. A description of the classes of persons who will benefit from the proposed rule:

The proposed rule changes will benefit 340B covered entities and the OHCA by appropriately identifying and reimbursing 340B drugs as required by federal law.

Comment: Is reimbursement is going to follow the same methodology at Medicare? Federal law, CMS, reimbursement differs from the reimbursement list below in 2c.

Rule Text: 317:30-5-87.  340B Drug Discount Program

(b) (3) Execute a contract addendum with the OHCA in addition to their provider contract.

Comment: Please provide a copy of the contract addendum. Will we need to have a new one if this Administrative code is revised? 

(c) To prevent a duplicate discount, quarterly adjustments will be made to all pharmacy or medical claims for drugs submitted by covered entities when billed using the registered SoonerCare NPI number on the MEF.

Comment: This is in disagreement with OPA/HRSA’s requirement that either Medicaid Provider Number or NPI be listed on Medicaid Exclusion File.  Please change to match OPA/HRSA requirement for MEF.

(c) (2) Medical claims submitted by covered entities with procedure code modifiers indicating the use of the 340B purchased drugs shall be adjusted by the 340B ceiling price. OHCA will adjust each claim by subtracting the 340B ceiling price from the amount reimbursed and multiplying the difference by the quantity submitted. OHCA will use the 340B ceiling price applicable to the quarter in which the claim is paid. Medical claims submitted by covered entities with a procedure code modifier indicating the use of non 340B purchased drugs will not be adjusted by the 340B ceiling price and will be submitted for federal rebates as required by CMS. Covered entities are required to use an appropriate procedure code modifier on all physician administered drug lines when submitting medical claims.

Comments: This statement would imply that procedure codes not using 340B purchased drugs will not be adjusted by the 340B ceiling price.  Currently, all claims submitted by a Medicaid Provider Number that is listed on the Medicaid Exclusion File are adjusted.  This would be a change in the current process.  Additionally, requiring a modifier on non-340B claims goes against the Federal Medicare guidance regarding "Billing 340B Modifiers under the Hospital Outpatient Prospective Payment System (OPPS), the guidance states a “340B modifier is not required for a 340B-eligible drug that was not purchased under the 340B Program." 

OHCA Response:

Thank you for your comments/questions. The OHCA takes every comment under advisement. OHCA will continue to utilize our current invoicing system as the method by which we will adjust reimbursement "by the 340B ceiling price". The rules regarding 340B remain largely the same as those that were implemented in 2016 (Link to our current policy https://oklahoma.gov/ohca/policies-and-rules/xpolicy/medical-providers-fee-for-service/individual-providers-and-specialties/pharmacies/340b-drug-discount-program.html), with the exception of Section c) (2) regarding medical claims.

This rule change will not mirror OPPS guidelines but it will require the identification of 340B drugs and non 340B drugs on medical claims through the use of procedure code modifiers. Medical claim lines with HCPC codes not using 340B purchased drugs will not be adjusted by the 340B ceiling price. Section (b) 3 remains the same as with the previous rule. Therefore, required agreements from providers already carved-in or those seeking to carve-in will not require any additional paperwork than what is being currently required.