Challenges in High Dollar Drugs. Suzanne Francart, PharmD, BCPS Manager Infusion Services & Medication Assistance Program UNC HealthCare

Transcription

1 Challenges in High Dollar Drugs Suzanne Francart, PharmD, BCPS Manager Infusion Services & Medication Assistance Program UNC HealthCare

2 Disclosure I have no relevant conflicts of interest to disclose

3 Learning Objectives Identify patient and institutional challenges in providing high dollar outpatient infusion drugs Describe the patient and institutional obstacles which contribute to delays in oral chemotherapy initiation Recommend strategies to mitigate the patient and institutional financial risk associated with high dollar drugs Assess current personal and institutional readiness to successfully overcome these challenges

4 Audience Response How many of you have experienced the following situations? You have to tell a patient their drug requires prior authorization and they end up with a delay in starting therapy A patient tells you they can t afford the drug prescribed to treat their disease A patient contacts you or your institution because they received a letter from their insurance company indicating their treatment was not covered

5 Challenges

6 Why is this happening? Increased Specialty Drug Utilization Payer Cost Management Strategies Challenges

7 Medical vs. Pharmacy Benefit Medical Pharmacy Injectable or IV drugs HCPCS billing system Post-service coverage determination Oral and selfadministered drugs NDC level billing Real time coverage determination Payer and patient costs may vary dramatically depending on medical or pharmacy benefit utilization

8 Medical Benefit: Pre-Certification Medical Benefits Investigation (BI) Prior Authorization (PA) Check payer prior plan approval (PPA) list Submit request through payer online portal Fax paper forms Directly calling a payer representative Pre-determination (Pre-D) Evaluation of medical necessity policies Medicare Local Coverage Determination (LCD) check Select drugs / drug classes have a list of associated ICD-10 codes Medicare has determined they will cover

9 Oncology Management Outsourcing Oncology Pre-Certification to third parties Cigna: Integrated Oncology Management Program, administered by evicore Healthcare BCBS NC: Medical Oncology Program, administered by AIM Specialty Health Focus is on the entire treatment plan rather than each medication individually Prior Authorization for any drug requires review of the entire treatment plan including supportive care drugs Increases process complexity and number of initial prior authorization denials

10 Site of Service Office Home Off Campus- Outpatient Hospital On Campus- Outpatient Hospital Independent Clinic Cost savings initiative to move patients out of outpatient hospital sites

11 Site of Service

12 Site of Service North Carolina

13 Restriction to Pharmacy Benefit / White Bagging

14 Pre- Certification Prior Auth Site of Service Drug Access Drug Administration Billing Requirements Denials Management Who stops here?

15 Medical Billing Requirements Appropriate HCPCS code Must align with code used in Prior Authorization Provide Drug Name and NDC level details Required by certain payers Appropriate Claim Coding Requires alignment of provider clinical documentation, ICD-10 code associated with the drug PA, and ICD-10 code on the claim Appropriate Drug Modifiers Ex: JG modifier for drug or biologic acquired with the 340b drug pricing program discount Appropriate Billing Units Guidance/Guidance/Manuals/downloads/clm104c17.pdf

16 Denials Management When denial is received Type of denial Appeal options Timely filing window Turn around time for final determination

17 Patient Copay High deductible plans Medicare A/B only High cost drug regimens $$$ Limited & complex assistance programs

18 Challenges Summary Pre-Certification Process Site of Service Restrictions Restriction to the Pharmacy Benefit White Bagging Medical Billing Requirements Denials Management High Patient Copay

19 Self Assessment Question A site of care restriction is when a payer restricts coverage to a preferred location, in an attempt to lower infusion costs. Preferred locations include the patient home and hospital outpatient facilities. A. True B. False B. False

20 Pharmacy Benefit

21 Pharmacy Benefit: Prior Authorization Required prior to drug dispensing PA completion requires knowledge of patient specific disease and treatment history Ownership for PA completion is variable Provider s office staff Specialty pharmacy staff May be completed through epa systems, payer portals, faxed forms or over the phone Denials require written appeal or peer-to-peer with payer representative and provider Communication between the dispensing pharmacy and PA owner may not be optimized Result: Patient may experience delays in starting treatment or may not start it at all

22 Limited Distribution Drugs (LDD) Manufacturers limit drug access to certain pharmacies Strategy based on desire for controlled patient access to pharmacies who can offer specialized patient support Preference is for a pharmacy who can provide optimal medication adherence tracking, clinical follow-up, patient education and financial assistance Manufacturers require robust reporting from in network pharmacies and in their preferred format Adding specialty pharmacies to a distribution network can be expensive for manufacturers Local pharmacies have to refer these prescriptions to a specialty pharmacy partner who has access Result: Patient may experience delays in starting treatment and medication follow-up is managed outside of primary team

23 Payer Restricted Drug Access Payer restricts coverage by only allowing dispensing from a specific specialty pharmacy Occasionally, first fills and emergency fills may be done at a non-preferred pharmacy May be aligned with a manufacturer LDD restriction Allows the payer to control costs Preferred pharmacy may require the prior authorization process be restarted Result: Patient may experience delays in starting treatment and medication follow-up is managed outside of primary team

24 Patient Copay Highest formulary tier Medicare D only Limited & complex assistance programs High cost drug regimens $$$ Expensive generics Result: Patient may experience delays in starting treatment or may not start it at all

25 Challenges Summary Prior Authorization Limited Distribution Drugs Payer Restricted Drug Access High Patient Copay

26 Self Assessment Question Which of the following are obstacles which may prevent or delay a patient from starting a new oral chemo drug? A. Prior Authorization requirement and prescription copay B. Limited Distribution Drug status C. White bagging requirement D. A and B only E. All of the above D. A and B only

27 Challenge Accepted

28 Strategies

29 Change the Culture Acknowledge the challenges associated with high dollar drugs Address the direct impact on patient care Understand the financial implications Ensure commitment from the top leadership, physicians and front line staff Kotter s 8 Step Change Model

30 Prior Authorization: Establish a Clear Process Infusion treatment ordered Patient informed about BI /PA process BI completed PA outcome confirmed prior to patient scheduling or drug dispensing PA outcome documented and communicated PA completed

31 Establish Process Owners Oral chemo erx sent to patient s pharmacy Patient informed about PA process Pharmacy adjudicates claim Copay assistance obtained PA completed PA required Copay assistance needed Communication to dispensing pharmacy Final prescription adjudication

32 Develop Content Experts Medical Benefits HCPCS language Medicare LCDs Payer medical policies Navigating patient records Navigating payer portals Appeal opportunities Prescription Benefits Embrace an epa system (eg: CoverMyMeds) Train to navigate patient records Consider disease specific alignment Train to navigate Part D vs. Part B billing and split billing

33 Streamline Communication Manage process in a centralized workflow Document and communicate consistently Be transparent when possible Communicate findings to the customer

34 Collaborate Providers Medical Coding Nurses and Navigators Revenue Cycle Pharmacists Managed Care Clinical Specialists Retail / Specialty Sterile Products Area Drug Company Representatives Payer Representatives Process Owners

35 Optimize Assistance Programs Copay Cards / Rebate Programs Commercially insured patients Some Health Exchange plans allowed Independent Grants Often diagnosis specific No proof of income required for enrollment, however may be audited and rescinded Manufacturer free drug programs Infusion / Clinic Administered drugs Proactive enrollment and recoup programs Self-administered drugs Frequently allow direct ship to the patient s home

36 Optimize Assistance Programs Manufacturer Applications Patient Demographics Signature Waiver from the patient Physician Signature Copies of Insurance Cards if applicable Proof of Income Taxes, Bank statements Household size Hardship letter Include drug / medical out of pocket spend Medicaid denial letters / Medicare LIS application Hard copy prescription if applicable Planned infusion dates

37 Optimize Assistance Programs Tips: For an insured patient, get a prior auth denial for both brand and generic before applying to MFG programs Have a patient signature waiver signed early and with no expiration date Send in complete application packets, not pieces Access pharmacy print outs showing patient out of pocket expenses For copay cards, know the monthly / annual maximum In a bind, ask MFG representative the following? Do you offer a free trial program? Do you offer a bridge supply or gratis fills?

38 Self Assessment Question Optimizing patient enrollment into manufacturer assistance programs is a strategy to expand drug access and alleviate financial toxicity. A. True B. False A. True

39 Planning Ahead Focus on value from the patient s perspective Institutional Considerations: Formulary decision making Home infusion services Non-hospital based infusion sites Clear Bagging Pharmacy payer access expansion LDD network inclusion Contract relationships

40 Audience Response Does my institution have. Engagement from the entire healthcare team Staff readiness to make change Financial data showing opportunities and vulnerabilities Established lines of communication Clearly defined workflows Process owners Content experts Collaborative relationships outside of pharmacy Pharmacist involvement in all settings A patient centered plan

41 Self Assessment Question An oncology physician comes to you, the oncology pharmacist, for help in getting a patient immediately started on nivolumab. Which of the following is the most appropriate response? A. No problem, send them to the infusion center and we ll get the patient started right away. B. Put them on tomorrow s infusion schedule. We ll have lab results back by then. C. Let me contact our financial assistance team to see if the patient is covered for this therapy and determine if there is a prior authorization requirement. I ll let you know something shortly so they can be appropriately scheduled. D. We just mix and dispense here. I don t know what to tell you. C

42 Questions Suzanne Francart, PharmD, BCPS Manager Infusion Services & Medication Assistance Program UNC HealthCare