Medicare Part D Contract Analysis

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1 Medicare Part D Contract Analysis Presented by: H. Edward Heckman, R.Ph., PAAS National 4:15 p.m. - 5:45 p.m., Tuesday, Ft. Lauderdale, Florida Evaluation # This program is approved by NCPA for 0.15 CEUs (1.5 contact hours) of continuing education credit. NCPA is approved by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

2 Medicare Part D Contract Analysis Learning Objectives: 1. Gain an understanding of the pertinent CMS contracting requirements for pharmacies to become providers for Medicare Part D plans. 2. Learn how to evaluate reimbursement offers made to pharmacies from sponsors of Medicare Part D plans. 3. Identify the idiosyncrasies in Medicare Part D that will affect you and your pharmacy. 4. Develop a strategy to place your pharmacy in the best possible position in preparing for Medicare Part D. 5. Develop important skills to help pharmacists operate profitably with Medicare Part D plans.

3 Medicare Part D Contracts Analysis H. Edward Heckman, R.Ph. PAAS National 2 1

4 Legalese What is a Contract? A contract is a legally enforceable agreement between two or more parties. 4 Contract Basic Elements Oral Written Written Electronic OFFER CONSIDERATION ACCEPTANCE INTENT CAPACITY OBJECT 5 Bottom Line Impact Catch Damned if I do, damned if I don t Accept Scenario Reject Scenario 6 2

5 JUST SAY NO! 7 Regulatory Provisions MMA the Law Published in CFR Code of Federal Regulations CMS Requirements for Sponsors Sponsor Requirements for Providers 8 Certification of Claims Data 42 CFR (k)(3) Plan Sponsors and Providers must: Certify that Claims Data is Accurate, Complete and Truthful and acknowledge Claims Data is used to obtain Federal Reimbursement. Based on best Knowledge, Information and Belief 9 3

6 Sponsor Responsible for Providers 42CFR (i)(2), 42CFR (a)(4), 42CFR (i)(1) Sponsor Ultimately Responsible to comply w/terms CMS Contract. Sponsor Responsible to assure Providers satisfy relevant requirements. Providers are required to comply w/sponsor s s CMS obligations. Applicable to PDP and MA-PD 10 Audits to the Grave 42CFR (i)(2), 42CFR (e)(2), 42CFR (i)(2)(ii) Sponsor must require Providers to Agree: HHS, Comptroller General can Audit any pertinent Contracts, Books, Documents, Papers and Records For a Period the longest of: While a Sponsor Contract is in Effect 10 Years from Final Date of Contract 10 Years from the Completion of any Audit 11 Patient non-liability for Sponsor 42CFR (g)(1), 42CFR (i)(3)(i), 42CFR (g)(1)(i) Patient cannot be held Liable for Fees that are Sponsor s s Responsibility. Sponsor must: Ensure that Provider Contracts prevent holding the Beneficiary Liable for Sponsor. Indemnify Patient for Covered Drugs from a non- contracting pharmacy

7 Provider Unsatisfactory Performance 42CFR (i)(3)(ii), (i)(4)(ii), 42CFR (i)(3)(II), (i)(4)(ii) Sponsor delegated activities to Provider must be written and state: Sponsor or CMS may Revoke for unsatisfactory performance Sponsor monitors Providers Provider must comply with Laws & CMS 13 e-prescribing Standards 42CFR , 42CFR (b)(6) Sponsors must comply w/electronic Prescribing Standards Final Rule: Separate from Medicare Part D Deadline April 1, 2008 MA-PD can pay Doctors extra Pharmacists maybe maybe 14 Enrollee Records 42CFR , 42CFR (b)(14), 42CFR (a)(13), 42CFR Sponsor s s must establish procedures: Abide by Laws regarding PHI Safeguard PHI and Specify: What Purposes it uses PHI What Purposes it Releases PHI Ensure Disclosers follow Laws & Court Orders Maintain Accurate/Timely Records Allow Timely Enrollee Access to Records

8 POS (on-line) Adjudication 42CFR 505(b)(17) Sponsors must administer claims via POS Adjudication Timely Efficient Exceptions Underserved Areas Long Term Care I/T/U Pharmacies 16 Marketing Rules Impartiality 42CFR (f)(1)(v) Plan Sponsors may not use a Pharmacy to distribute printed information unless the Pharmacy accepts and displays materials from all Sponsors. Sponsors are Downloading Responsibility to Pharmacies 17 Access to Negotiated Prices 42CFR (g)(1) Enrollees must have access to Negotiated Prices for Covered Drugs even if 100% Co-pay Deductibles Coinsurance Cover Gap = Donut Hole

9 Lowest Prices for Generics 42CFR (a) and (b) Sponsors must Require Pharmacies to inform Enrollees of the Lowest Cost Generic Therapeutically Equivalent and Bioequivalent Unless Drug Dispensed is the Lowest Exeptions include LTC inform in EOBs 19 Quality Assurance 42CFR (c)(1) Sponsor must establish Quality Assurance Systems and Measures that Reduce Medication Errors Reduce Adverse Drug Interactions 20 Drug Utilization Review 42CFR (c)(2) Drug Utilization Review Therapeutic Duplication Age/Gender Contraindications Over/Under-Utilization Utilization Drug-Drug/Drug Drug/Drug-Allergy Incorrect Dosage/Duration of Therapy Clinical Abuse/Misuse

10 Posting Notices in Pharmacy 42CFR (a)(3) Sponsors must arrange with Pharmacies to Post or Distribute Notices for Patient to Contact Plan to Obtain: Coverage Determinations Request an Exception 22 Patient Counseling 42CFR 206(a)(2) Offer Patient Counseling Culturally Competent Manner Ensure Patients with Disabilities have Effective Communications 23 Exclusion/Suspension from Programs 45 CFR Part 76 Provider, Employees, Sub-Contractors cannot have been Excluded/Suspended from Participating in any program w/federal Funds. Medicare/Medicaid

11 Long-Term Care LTC Facility Definition Network LTC Pharmacies (NLTCPs( NLTCPs) Performance and Service Criteria Comprehensive Inventory Capacity Pharmacy Operations & Rx Orders Special Packaging IV Medications RPh on Call Delivery Service Emergency 25 Boxes Evaluating Reimbursement Basics Cost of Dispensing 30-Days Average Brand AWP = $ WAC = AWP 17.2% = $87.39$ 90-Days Average Brand AWP = $ WAC = AWP 17.2% = $262.16$ Generic Reimbursements Fair MAC Evaluation Board 26 Approved Sponsors A look at some of the idiosyncrasies found in Part D Contracts offered by Approved Plan Sponsors

12 Medicare Part D Contract Analysis Learning Assessment Questions: T F 1. The any willing provider provisions of MMA guarantee that a pharmacy won t be locked out of participating in Medicare Part D plans as long as they sign every contract they receive. T F 2. The regulatory rules for Medicare Part D are published in the CFR Code of Federal Regulations. T F 3. The Department of Health and Human Services is limited to six years from the date of service to audit pharmacy records. T F 4. During those times when Enrollees must pay 100% of their drug costs (deductibles, coinsurance, coverage gap donut hole), a pharmacy may not charge their Usual and Customary price and must charge the negotiated price. T F 5. Pharmacies must agree to accept and distribute or display printed materials from all the Part D plans they accept.

13 Medicare Part D Contract Analysis Learning Assessment Answers: F 1. The any willing provider provisions of MMA guarantee that a pharmacy won t be locked out of participating in Medicare Part D plans as long as they sign every contract they receive. T 2. The regulatory rules for Medicare Part D are published in the CFR Code of Federal Regulations. F 3. The Department of Health and Human Services is limited to six years from the date of service to audit pharmacy records. T 4. During those times when Enrollees must pay 100% of their drug costs (deductibles, coinsurance, coverage gap donut hole), a pharmacy may not charge their Usual and Customary price and must charge the negotiated price. T 5. Pharmacies must agree to accept and distribute or display printed materials from all the Part D plans they accept.

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