340B UNIVERSITY Las Vegas Edition. May 31, 2014

Transcription

1 340B UNIVERSITY Las Vegas Edition May 31, 2014

2 SESSION 1: THE TOP 5: 340B BASICS FOR HOSPITALS Mike Benedict

3 Objectives 1. Define the intent of the 340B Program 2. Describe the major 340B stakeholders 3. Explain how to participate in 340B 4. Identify how the Prime Vendor Program supports 340B stakeholders 5. List the program rules and explain how to follow them

4 Takeaways 1. The intent of 340B: to support entities that serve vulnerable patients so the entities stay in business 2. Major 340B stakeholders: federal government, certain drug manufacturers, certain covered entities, 340B Prime Vendor Program, managed by Apexus 3. Covered entities must register on the HRSA Database; once a year they must recertify accuracy of HRSA 340B database information

5 Takeaways 4. The 340B Prime Vendor Program provides: Truth (call center) Teamwork (contracting with distributors and suppliers) Teaching (340B University) 5. Covered entities must maintain auditable records: Only patients of the covered entity receive 340B drugs A Medicaid rebate is not paid on a 340B drug All eligibility criteria are met

6 1. 340B PROGRAM INTENT AND OVERVIEW

7 340B Intent To permit covered entities to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services. H.R. Rep. No (II), at 12 (1992)

8 Share Which examples below describe 340B program savings used in alignment with 340B program intent? Discuss at your table. A. Supporting an indigent care clinic B. Starting a patient assistance medication program C. Subsidizing medications for patients unable to pay D. Adding pharmacy staff

9 340B Statute Resulted from a 1992 federal statute Manufacturers participating in Medicaid Drug Rebate Program must sign a Pharmaceutical Pricing Agreement (PPA) with the Secretary of Health and Human Services The manufacturer agrees to charge a price for covered outpatient drugs that does not exceed the 340B price

10 340B Price Calculated quarterly 340B ceiling price = Average Manufacturer Price (AMP) Medicaid Unit Rebate Amount (URA) Manufacturer submits data to CMS

11 Relative Pricing 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 100% 79% 66% 64% 58% 53% Private Sector Pricing 51% 49% 42% Adapted from a slide by Safety Net Hospitals for Pharmaceutical Access Source: Data derived from Prices for Brand-Name Drugs Under Selected Federal Programs, Congressional Budget Office (June 2005)

12 340B Covered Outpatient Drugs* Vaccines Inpatient drugs Drug not directly reimbursed FDA doesn t require NDC Outpatient Prescription Drugs Over-the-counter drugs (with a prescription) Clinic administered drugs Biologics Insulin

13 Program Evolution Access Sub-Regulatory Integrity Regulatory

14 Have you been here?

15 340B Program Integrity Manufacturer Calculate and charge a correct 340B price Subject to HRSA audits Entity Comply with 340B statute and guidelines Subject to HRSA and manufacturer audits OPA Program Integrity Page:

16 Concerns from Peers I m afraid I ll have an audit and not be aware of a particular aspect of the program, even though I ve tried to stay on top of everything. I worry about how to apply certain policies; it seems that there are different interpretations of the right thing to do.

17 Share Please share your primary 340B program integrity concern with the person sitting next to you.

18 Review Which of the following is a 340B covered outpatient drug? a) Vaccine b) Inpatient drugs c) Over the counter drug not prescribed in writing by an authorized provider d) None of the above are covered outpatient drugs

19 Entities Take Action 1. Describe how your entity s use of the 340B program supports the intent of the 340B program. 2. Identify how your entity can document the use of 340B savings to align with the intent of the 340B program. 3. Incorporate these elements into your 340B related standard operating procedures. 4. Rely on trusted resources identified by OPA as the source of truth for 340B issues: OPA and Apexus.

20 2. MAJOR 340B STAKEHOLDERS

21 Major 340B Stakeholders Manufacturer Calculate Entity and offer Provide 340B price 340B access OPA Administer 340B program 340B Drug to Patient

22 HRSA Office of Pharmacy Affairs (OPA) Health Resources and Services Administration (HRSA) Oversees 340B program administration (enrollment, recertification, compliance) Establishes mechanism to prevent duplicate discounts OPA support The 340B Prime Vendor Program, managed by Apexus Apexus is not the same thing as HRSA; Apexus communicates HRSA policy

23 HRSA-Endorsed Resources HRSA Apexus

24 340B Eligible Entities* Federal Grantees/Designees Federally Qualified Health Center Federally Qualified Health Center Look-Alikes Title X Family Planning Grantees State Aids Drugs Assistance Programs Ryan White Care Act Grantees (A,B,C,D,F) Black Lung Clinics Hemophilia Treatment Centers Native Hawaiian Health Centers Urban Indian Organizations Sexually Transmitted Disease Grantees Tuberculosis Grantees Certain Hospitals Disproportionate Share Hospitals Children s Hospitals Critical Access Hospitals Free Standing Cancer Hospitals Rural Referral Centers Sole Community Hospitals

25 340B Hospital Eligibility Entity Type Non-profit/ Govt. Contract DSH% GPO Prohibition* Orphan Drug* Applies? Disproportionate Share Hospital (DSH) Yes >11.75% Yes No Children s Hospital (PED) Yes >11.75% Yes No Free-standing Cancer Hospital (CAN) Yes >11.75% Yes Yes

26 340B Hospital Eligibility Entity Type Non-profit/ Govt. Contract DSH% GPO Prohibition* Orphan Drug* Applies? Critical Access Hospital (CAH) Yes N/A No Yes Rural Referral Center (RRC) Yes > 8% No Yes Sole Community Hospital (SCH) Yes > 8% No Yes

27 3. PARTICIPATION IN 340B

28 To Participate in 340B, an Entity must 1. Ensure it has the capability to follow (and maintain auditable records documenting compliance with) program rules 2. Register on the HRSA 340B database 3. Recertify with HRSA annually

29 HRSA 340B Database* The HRSA 340B Database is the official source of 340B information Entities* Contract Pharmacies* Manufacturers Medicaid Exclusion File*

30 340B Database: Statistics 340B database: APR ,196 registered sites: 11,718 are hospital sites 14, 485 unique contract pharmacies >$7.5B/year in 340B drug purchases ~82% of 340B participants enrolled with Apexus

31 340B Database: Statistics, continued APR % of covered entity sites utilize contract pharmacies 89% of covered entity sites use only in-house or inhouse and one contract pharmacy Of sites using contract pharmacy, 73% have five or fewer contract pharmacy arrangements

32 Working with the HRSA 340B Database Entities DO NOT need to log into the 340B database All links referenced on the homepage are accessible without a username & password

33 Working with the HRSA 340B Database When searching for your covered entity s profile - LESS IS MORE The 340B ID is the most reliable search criteria

34 Working with the HRSA 340B Database Covered entity data is divided between tabs on the 340B profile The information about your facility can be found under the applicable tabs

35 HRSA 340B Database: Medicaid

36 Working with the HRSA 340B Database Important Notifications & What s New o Great resource for important notifications about: Registration Recertification Change requests Database changes

37 Registration Process* New entities, entity sites, contract pharmacies, Medicaid information 2 week registration periods, quarterly updates made to OPA Database Update Official October 1 January 1 April 1 July 1 Registration Period July 1 15 October 1-15 January 1 15 April 1-15 Change requests: changes to existing information, rolling basis

38 Apexus Answers What types of documentation must a hospital supply to HRSA to register?

39 Hospital Cost Report A 340B Eligible clinics should be reimbursable ( on lines ) E Part A S2 340B Eligibility if line 33 shows DSH% >11.75 or 8%, depending upon hospital type Hospital ownership /control on line 21 S Date and Time of eligibility-signature block C Shows outpatient charges

40 Worksheet A

41 Worksheet E, Part A

42 Worksheet S2

43 Worksheet S

44 Worksheet C

45 Outpatient Clinics Use 340B only in clinics that: Appear as reimbursable on the most recently filed Medicare Cost Report Are integral parts of the hospital Use 340B for patients that meet the 340B patient definition

46 Apexus Answers Which outpatient facilities are hospitals required to register on the 340B database?

47 Recertification*: Entities are required to recertify information in the HRSA 340B database annually HRSA sends a notification to Authorizing Official and Primary Contact The Authorizing Official performs the recertification online

48 Recertification Statements*: Database entry is complete, accurate, correct Entity meets 340B eligibility requirements Compliance with 340B requirements/restrictions Maintenance of auditable records Systems in place to ensure compliance Contract pharmacy compliance, entity obtains sufficient information Entity contacts OPA for any breach of the above Entity acknowledges possibility of payment to manufacturers for failure to notify OPA in timely fashion

49 Review Updates sent to OPA during its registration period of October 1-October 15 will be reflected on the OPA database and active as of: a) January 1 b) October 1 c) April 1 d) July 1

50 Review In order to be 340B eligible, outpatient clinics of hospitals must: a) Be listed as reimbursable on the most recently filed cost report b) Must be an integral part of the hospital c) Adhere to all 340B guidelines (i.e. patient definition, etc.) d) All of the above

51 Entities Take Action 1. If you have never seen your entity s record on the OPA database, visit the site, review the record and ensure it is accurate. 2. Identify all potentially eligible 340B areas of your entity; determine if your entity has implemented 340B in all areas that are eligible. 3. For hospitals only: talk to your CFO about the cost report worksheets discussed in this session, and ensure the CFO understands that changes to information on these forms may impact 340B eligibility.

52 4. THE PRIME VENDOR PROGRAM

53 Apexus Focus TEAMWORK Contract Services TEACHING 340B University & 340B OnDemand TRUTH Apexus Answers Call

54 Teamwork: Contracted Supplier Agreements (by year) 120 C o n t r a c t s

55 Teaching: 340B University National experts share leading practices at this one or two day live educational program Aligned with HRSA policy, compliance-focused Only HRSA-endorsed compliance training CE for pharmacists and technicians offered Interactive, opportunities to network, leave with tools to equip your entity 10+ Sessions in 2014 Online, on-demand modules under development

56 Truth: Apexus Answers National 340B source of truth, communicates HRSA policy Staff in constant communication with HRSA to ensure messaging is consistent FAQs available here: Average monthly interactions ~2,000 Tiered levels of response: can handle from basic to complex

57 5. 340B PROGRAM RULES

58 Forces Impacting OPA 340B Participants (Entities and Manufacturers) Advocacy 340B Stakeholders* OPA Government (OIG, GAO, CMS, etc.)

59 Why 340B is like an onion

60 340B Policy Options* Policy Releases Guideline Regulation Statute

61 Do you see a musician or a woman s face?

62 340B Policies* Guidelines Patient Definition* Contract Pharmacy* Audits* Dispute Resolution* Outpatient Facilities Duplicate Discounts* Regulations (proposed**) Manufacturer Civil Monetary Penalties** Administrative Dispute Resolution** Orphan Drugs*

63

64 Major 340B Compliance Areas 1. Duplicate Discount Prohibition* 2. No Diversion (Patient Definition)* 3. Certain Hospitals Only Group Purchasing Organization (GPO) Prohibition* Orphan Drug Exclusion

65 Duplicate Discount Prohibition 340B Price Medicaid Rebate

66 Preventing Duplicate Discounts

67 Patient Definition* Records of individual s care Health care services, health care professional Employed by, under contractual or other arrangements (referral) Entity has responsibility for care Service received is consistent with funding or designation status (hospitals exempt) Services must be more than dispensing Aids Drug Assistance Program (ADAP) exception

68 GPO Prohibition* Applies to: Disproportionate Share Children s Hospitals Free Standing Cancer Hospitals Such hospitals:...will not participate in a group purchasing organization or group purchasing arrangement for covered outpatient drugs as of the date of this listing on the OPA website. OPA GPO Certification Form

69 Orphan Drug Exclusion Final Rule Published July 23, 2013, effective October 1, 2013 Free-standing cancer hospitals, Rural Referral Centers, Sole Community Hospitals, and Critical Access Hospitals Excluded from 340B: drugs used for the indication for which they received an orphan designation but not when the drug is used for indications independent of that designation Both HRSA and manufacturers may audit this exclusion OPA published the orphan drug list here in 9/2013: Lawsuit filed from PhRMA 9/27/13

70 Entities Take Action 1. Apply the brief tool 340B Compliance Self- Assessment Policy to your entity type 2. Review FAQs on specific policy topics for more information 3. Contact Apexus Answers to help you resolve any questions or concerns

71 Takeaways 1. The intent of 340B: to support entities that serve vulnerable patients so the entities stay in business 2. Major 340B stakeholders: federal government, certain drug manufacturers, certain covered entities, 340B Prime Vendor Program, managed by Apexus 3. Covered entities must register on the HRSA Database; once a year they must recertify accuracy of HRSA 340B database information

72 Takeaways 4. The 340B Prime Vendor Program provides: Truth (call center) Teamwork (contracting with distributors and suppliers) Teaching (340B University) 5. Covered entities must maintain auditable records: Only patients of the covered entity receive 340B drugs A Medicaid rebate is not paid on a 340B drug All eligibility criteria are met

73 Tips for Pharmacy Technicians Remind leadership they are not required to log in to the HRSA 340B database for change forms or to view profiles Check your 340B standard operating procedures to make sure they reflect your entity s operations If a new location/contract pharmacy are added to the HRSA database, remember the quarterly deadlines Keep the contact number for Apexus Answers handy

74 Questions

75 SESSION 1: THE TOP 5: 340B BASICS FOR NON-HOSPITALS Debra Demers

76 Objectives 1. Define the intent of the 340B program 2. Describe the major 340B stakeholders 3. Explain how to participate in 340B 4. Identify how the 340B Prime Vendor Program supports 340B stakeholders 5. List the program rules and explain how to follow them

77 Takeaways 1. The intent of 340B: to support entities that serve vulnerable patients so the entities stay in business 2. Major 340B stakeholders: federal government, certain drug manufacturers, certain covered entities, 340B Prime Vendor, managed by Apexus 3. Covered entities must register on the HRSA Database; once a year they must recertify accuracy of HRSA 340B database information

78 Takeaways 4. The 340B Prime Vendor Program provides: Truth (call center) Teamwork (contracting with distributors and suppliers) Teaching (340B University) 5. Covered entities must maintain auditable records: Only patients of the covered entity receive 340B drugs A Medicaid rebate is not paid on a 340B drug All eligibility criteria are met

79 1. 340B PROGRAM INTENT AND OVERVIEW

80 340B Intent To permit covered entities to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services. H.R. Rep. No (II), at 12 (1992)

81 Share Which examples below describe 340B program savings used in alignment with 340B program intent? Discuss at your table. a) Supporting an indigent care clinic b) Starting a patient assistance medication program c) Subsidizing medications for patients unable to pay d) Adding pharmacy staff

82 340B Statute Resulted from a 1992 federal statute Manufacturers participating in Medicaid Drug Rebate Program must sign a Pharmaceutical Pricing Agreement (PPA) with the Secretary of Health and Human Services The manufacturer agrees to charge a price for covered outpatient drugs that does not exceed the 340B price

83 340B Price Calculated quarterly 340B ceiling price = Average Manufacturer Price (AMP) Medicaid Unit Rebate Amount (URA) Manufacturer submits data to CMS

84 Relative Pricing 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 100% 79% 66% 64% 58% 53% Private Sector Pricing 51% 49% 42% Adapted from a slide by Safety Net Hospitals for Pharmaceutical Access Source: Data derived from Prices for Brand-Name Drugs Under Selected Federal Programs, Congressional Budget Office (June 2005)

85 340B Covered Outpatient Drugs* Vaccines Inpatient drugs Drug not directly reimbursed FDA doesn t require NDC Outpatient Prescription Drugs Over-the-counter drugs (with a prescription) Clinic administered drugs Biologics Insulin

86 Program Evolution Access Sub-Regulatory Integrity Regulatory

87 Have you been here?

88 340B Program Integrity Manufacturer Calculate and charge a correct 340B price Subject to HRSA audits Entity Comply with 340B statute and guidelines Subject to HRSA and manufacturer audits OPA Program Integrity Page:

89 Concerns from Peers I m afraid I ll have an audit and not be aware of a particular aspect of the program, even though I ve tried to stay on top of everything. I worry about how to apply certain policies; it seems that there are different interpretations of the right thing to do.

90 Share Please share your primary 340B program integrity concern with the person sitting next to you.

91 Review Which of the following is a 340B covered outpatient drug? a) Vaccine b) Inpatient drugs c) Over the counter drug not prescribed in writing by an authorized provider d) None of the above are covered outpatient drugs

92 Entities Take Action 1. Describe how your entity s use of the 340B program supports the intent of the 340B program. 2. Identify how your entity can document the use of 340B savings to align with the intent of the 340B program. 3. Incorporate these elements into your 340B related standard operating procedures. 4. Rely on trusted resources identified by OPA as the source of truth for 340B issues: OPA and Apexus.

93 2. MAJOR 340B STAKEHOLDERS

94 Major 340B Stakeholders Manufacturer Calculate Entity and offer Provide 340B price 340B access OPA Administer 340B program 340B Drug to Patient

95 HRSA Office of Pharmacy Affairs (OPA) Health Resources and Services Administration (HRSA) Oversees 340B Program administration (enrollment, recertification, compliance) Establishes mechanism to prevent duplicate discounts OPA support The 340B Prime Vendor Program, managed by Apexus Apexus is not the same thing as HRSA; Apexus communicates HRSA policy

96 HRSA-Endorsed Resources HRSA Apexus

97 340B Eligible Entities* Federal Grantees/Designees Federally Qualified Health Center Federally Qualified Health Center Look-Alikes Title X Family Planning Grantees State Aids Drugs Assistance Programs Ryan White Care Act Grantees (A,B,C,D,F) Black Lung Clinics Hemophilia Treatment Centers Native Hawaiian Health Centers Urban Indian Organizations Sexually Transmitted Disease Grantees Tuberculosis Grantees Certain Hospitals Disproportionate Share Hospitals Children s Hospitals Critical Access Hospitals Free Standing Cancer Hospitals Rural Referral Centers Sole Community Hospitals

98 3. PARTICIPATION IN 340B

99 To Participate in 340B, an Entity must 1. Ensure it has the capability to follow (and maintain auditable records documenting compliance with) program rules 2. Register on the HRSA 340B Database 3. Recertify with HRSA annually

100 HRSA 340B Database* The HRSA 340B Database is the official source of 340B information Entities* Contract Pharmacies* Manufacturers Medicaid Exclusion File*

101 340B Database: 340B Statistics 340B database: APR ,196 registered sites: 11,718 are hospital sites 14, 485 unique contract pharmacies >$7.5B/year in 340B drug purchases ~82% of 340B participants enrolled with Apexus

102 340B Database: 340B Statistics, continued APR % of covered entity sites utilize contract pharmacies 89% of covered entity sites use only in-house or inhouse and one contract pharmacy Of sites using contract pharmacy, 73% have five or fewer contract pharmacy arrangements

103 Working with the HRSA 340B Database Entities DO NOT need to log into the 340B database All links referenced on the homepage are accessible without a username & password

104 Working with the HRSA 340B Database When searching for your covered entity s profile - LESS IS MORE The 340B ID is the most reliable search criteria

105 Working with the HRSA 340B Database Covered entity data is divided between tabs on the 340B profile The information about your facility can be found under the applicable tabs

106 HRSA 340B Database: Medicaid

107 Working with the HRSA 340B Database Important Notifications & What s New o Great resource for important notifications about: Registration Recertification Change requests Database changes

108 Registration Process* New entities, entity sites, contract pharmacies, Medicaid information 2 week registration periods, quarterly updates made to OPA Database Update Official October 1 January 1 April 1 July 1 Registration Period July 1 15 October 1-15 January 1 15 April 1-15 Change requests: changes to existing information, rolling basis

109 Electronic Handbook HRSA/OPA uses it for validation of site information EHB data incorporated as part of recertification in FEB 2014 Importance of EHB changes and timing, especially changes of scope Possibility of chargeback denial and/or wholesaler delivery issues if EHB doesn t match HRSA and entity s wholesaler information

110 Apexus Answers A CHC uses employed healthcare professionals to provide elderly care services at a non-entity owned clinic. The CHC owns the records of care. Should the CHC register this location on the 340B database? Is 340B use permissible?

111 Recertification*: Entities are required to recertify information in the HRSA 340B database annually HRSA sends a notification to Authorizing Official and Primary Contact The Authorizing Official performs the recertification online

112 Recertification Statements*: Database entry is complete, accurate, correct Entity meets 340B eligibility requirements Compliance with 340B requirements/restrictions Maintenance of auditable records Systems in place to ensure compliance Contract pharmacy compliance, entity obtains sufficient information Entity contacts OPA for any breach of the above Entity acknowledges possibility of payment to manufacturers for failure to notify OPA in timely fashion

113 Review Updates sent to OPA during its registration period of October 1-October 15 will be reflected on the OPA database and active as of: a) January 1 b) October 1 c) April 1 d) July 1

114 Entities Take Action 1. If you have never seen your entity s record on the OPA database, visit the site, review the record and ensure it is accurate 2. Identify all potentially eligible 340B areas of your entity; determine if your entity has implemented 340B in all areas that are eligible

115 4. THE PRIME VENDOR PROGRAM

116 Apexus Focus TEAMWORK Contract Services TEACHING 340B University & 340B OnDemand TRUTH Apexus Answers Call

117 Teamwork: Contracted Supplier Agreements (by year) 120 C o n t r a c t s

118 Teaching: 340B University National experts share leading practices at this one or two day live educational program Aligned with HRSA policy, compliance-focused Only HRSA-endorsed compliance training CE for pharmacists and technicians offered Interactive, opportunities to network, leave with tools to equip your entity 10+ Sessions in 2014 Online, on-demand modules under development

119 Truth: Apexus Answers National 340B source of truth, communicates HRSA policy Staff in constant communication with HRSA to ensure messaging is consistent FAQs available here: Average monthly interactions ~2,000 Tiered levels of response: can handle from basic to complex

120 5. 340B PROGRAM RULES

121 Forces Impacting OPA 340B Participants (Entities and Manufacturers) Advocacy 340B Stakeholders* OPA Government (OIG, GAO, CMS, etc.)

122 Why 340B is like an onion

123 340B Policy Options* Policy Releases Guideline Regulation Statute

124 Do you see a musician or a woman s face?

125 340B Policies* Guidelines Patient Definition* Contract Pharmacy* Audits* Dispute Resolution* Outpatient Facilities Duplicate Discounts* Regulations (proposed**) Manufacturer Civil Monetary Penalties** Administrative Dispute Resolution** Orphan Drugs*

126

127 Major 340B Compliance Areas 1. Duplicate Discount Prohibition* 2. No Diversion (Patient Definition)* 3. Certain Hospitals Only Group Purchasing Organization (GPO) Prohibition* Orphan Drug Exclusion

128 Duplicate Discount Prohibition 340B Price Medicaid Rebate

129 Preventing Duplicate Discounts

130 Patient Definition* Records of individual s care Health care services, health care professional Employed by, under contractual or other arrangements (referral) Entity has responsibility for care Service received is consistent with funding or designation status (hospitals exempt) Services must be more than dispensing Aids Drug Assistance Program (ADAP) exception

131 Entities Take Action 1. Apply the brief tool 340B Compliance Self- Assessment Policy to your entity type 2. Review FAQs on specific policy topics for more information 3. Contact Apexus Answers to help you resolve any questions or concerns

132 Takeaways 1. The intent of 340B: to support entities that serve vulnerable patients so the entities stay in business 2. Major 340B stakeholders: federal government, certain drug manufacturers, certain covered entities, 340B Prime Vendor, managed by Apexus 3. Covered entities must register on the HRSA Database; once a year they must recertify accuracy of HRSA 340B database information

133 Takeaways 4. The 340B Prime Vendor Program provides: Truth (call center) Teamwork (contracting with distributors and suppliers) Teaching (340B University) 5. Covered entities must maintain auditable records: Only patients of the covered entity receive 340B drugs A Medicaid rebate is not paid on a 340B drug All eligibility criteria are met

134 Tips for Pharmacy Technicians Remind leadership they are not required to log in to the HRSA 340B database for change forms or to view profiles Check your 340B standard operating procedures to make sure they reflect your entity s operations If a new location/contract pharmacy are added to the HRSA database, remember the quarterly deadlines Keep the contact number for Apexus Answers handy

135 Questions

136 SESSION 2: 340B PRICING Chris Hatwig Chris Shain George Kenny

137 Objectives Identify the activities of the manufacturer and wholesaler in 340B pricing Explain 340B price calculation for covered outpatient drugs Discuss the manufacturer and wholesaler perspectives on policy issues

138 Takeaways Manufacturers and wholesalers have important roles in supporting program integrity Manufacturers have 340B compliance responsibilities The 340B price file is one of the most complex Actions entities take can impact a manufacturer s calculations and ultimately impact the manufacturer s compliance

139 Panel Question What are the 340B-related roles and responsibilities for you and your organization?

140 Manufacturer: Role/Responsibilities Uphold responsibilities in the Pharmaceutical Pricing Agreement Calculate and charge a correct PHS Price Ensure that you charge the price to valid 340B entities Validate customers on indirect sales (chargebacks) to the OPA database (eligibility)

141 Pharmaceutical Pricing Agreement HRSA Responsibilities Public list of 340B entities, including Medicaid information Require entities to maintain purchasing/dispensing records for covered outpatient drugs and Medicaid reimbursement for these drugs for not less than 3 years Manufacturer Responsibilities Charge 340B entities a price that does not exceed the 340B ceiling price Retain necessary records for not less than 3 years from date of creation Afford Secretary (or designee) reasonable access to records relevant to compliance Permit CMS to share AMP and URA with Secretary in order to carry out agreement Participate with HRSA 340B Prime Vendor Program (voluntary)

142 Wholesaler: Role/Responsibilities Open accounts with only eligible entities Deliver correct price to 340B entities Process chargebacks with manufacturer correctly

143 Manufacturer Question How is the 340B price calculated?

144 Manufacturer: 340B Calculation 340B Price based on quarterly Medicaid metrics which are based on commercial contracting practices AMP: Average Manufacturer Price Weighted average price (net of discounts) to retail community pharmacies BP: Best Price Lowest price to US customers, certain federal pricing, such as 340B, excluded URA: Unit Rebate Amount Brand: Greater of [(AMP * 231%) or (AMP BP)] plus inflation penalty Generic/OTC: 13% of AMP

145 Manufacturer: 340B Calculation 340B Ceiling Price WAC AMP minus URA equals 340B Unit Price BP times Units per Package equals 340B Ceiling Price

146 Manufacturer: 340B Implementation Quarterly Pricing 340B prices change quarterly Manufacturers upload to authorized wholesalers days prior to beginning of a quarter 340B pricing lags behind Medicaid by 2 quarters Q1 Q2 Q3 Sales transactions occur Q1 AMP and BP calculated, submitted to CMS; 340B ceiling price calculated, submitted to wholesalers 340B ceiling price becomes effective (based on Q1 transactions)

147 Apexus Answers Why is my 340B price different from another 340B entity s price?

148 Panel Question How do you implement a chargeback?

149 Manufacturer: Chargeback Process B price is established 2. Wholesaler purchases at WAC ($10) 3. Covered entity places 340B order with wholesaler 4. Wholesaler reviews OPA database, then sells to covered entity at 340B price ($6) 5. Wholesaler sends manufacturer a 340B chargeback ($4) 6. Manufacturer verifies 340B eligibility of covered entity (reviews OPA database) 7. Manufacturer pays wholesaler the chargeback Potentially significant Medicaid implications if a manufacturer provides the 340B price to a non-participating entity

150 Manufacturer: Chargeback Comments Manufacturer MUST validate entity on the chargeback to confirm 340B eligibility Manufacturer will deny the chargeback if they can not validate eligibility Bill-to address on the chargeback identifies eligibility Correct information is critical

151 Wholesaler: Chargeback Comments B Pricing changes quarterly: Unique and Challenging 340B is the most challenging price file to administer in the pharmaceutical industry 2. No verified central file of all 340B pricing Wholesale distributors receive more than 100 different notices from manufacturers, 4 times per year PVP does provide a comparative price file to Participants which shows the Big 3 and one regional wholesaler s 340B pricing for comparison

152 Wholesaler: Chargeback Comments 3. Contract Pharmacy and Entity Identification: HIN, DEA, 340B ID 4. Returns: The correct invoice must be chosen when returning a product

153 Manufacturer Question What types of adjustments do manufacturers make to prices?

154 Manufacturer: Pricing Adjustments Standard procedures Routine Medicaid restatements Standard Best Price true-ups Medicaid restatements resulting from audits/investigations Reclassification/banking

155 Apexus Answers What steps does an entity take to resolve what it believes to be an incorrect 340B price?

156 Apexus Answers What is the procedure used by manufacturers that wish to refund payment to covered entities who are overcharged for 340B?

157 Panel Question What are special situations or challenges for you specific to 340B?

158 Manufacturer: Special Situations Penny pricing Sub-Ceiling prices (voluntary) Through 340B Prime Vendor Program (non-famp exempt) Not through 340B Prime Vendor Program (include in non-famp) Inpatient pricing Product allocation systems 340B customers can be subject to product allocation systems just like commercial customers Non-discrimination guidance Timing issues Concern about hoarding

159 Apexus Answers If a drug is only available through a specialty pharmacy, how would a 340B patient access that drug?

160 Wholesaler: Contract Pharmacy Challenges Complex 340B contract pharmacy relationships present additional challenges Manufacturer requirements are not consistent regarding 340B sales reporting for 340B contract pharmacy Process: 1. Confirm accurate bill-to 340B covered entity and ship-to (contract pharmacy) information specific to the relationship on the OPA website 2. Request HIN (5-7 business days) 3. Account Set Up (Multi-Ship To Form/Customer Application) 4. Set ordering/delivery options 5. Covered Entity Authorization 6. Complete Credit Application if new customer 7. Verify licenses, CSMP setup 8. Set up EDI specific to 340B vendor

161 Entities Take Action Keep OPA database information accurate/current to avoid chargeback issues Check the OPA website for manufacturer updates

162 Takeaways Manufacturers and wholesalers have important roles in supporting program integrity Manufacturers have 340B compliance responsibilities The 340B price file is one of the most complex Actions entities take can impact a manufacturer s calculations and ultimately impact the manufacturer s compliance

163 Tips for Pharmacy Technicians Remember: you have resources to check pricing! Log in to the Apexus 340BPVP.com website to verify pricing, run customized reporting, and keep up-todate with new contracts Communicate pricing changes to leadership; significant price changes may impact purchasing decisions

164 Questions

165 SESSION 3: 340B IMPLEMENTATION Todd Karpinski

166 Objectives Describe 340B delivery models: Contract Pharmacy In-House Pharmacy Mixed-Use Areas Discuss implementation strategies of compliant programs

167 340B Pharmacy Options

168 Pharmacy Options Mixed-Use Single Contract Pharmacy Services Contract Pharmacy In-house Pharmacy Contracty Multiple Contract Phcy Supplement with Contract Clinic Administered Drugs Other Central Fill, Telepharmacy or Specialty Pharmacy

169 Share 1. Your current model for getting 340B drugs to patients 2. One thing you are interested in expanding or changing about your current 340B model

170 CONTRACT PHARMACY

171 Froedtert Hospital 550 bed academic medical center 24,000 annual admissions >140,000 patient days Disproportionate share hospital 17.25% (FY2011) Affiliated with Medical College of Wisconsin Only Level I trauma center in Southeastern Wisconsin Major referral center: 40 specialties and subspecialties >220 Pharmacy FTE s Administration, Pharmacists, Technicians, EPIC team

172 Affiliation with the Medical College of Wisconsin Froedtert Hospital is the major teaching affiliate of the Medical College of Wisconsin (the Medical College ) A majority of Froedtert Hospital s medical staff is comprised of Medical College faculty members (816 faculty) 330 full-time equivalent residents at Froedtert Hospital 413 medical students Close working affiliation between the two organizations Froedtert Hospital and the Medical College jointly operate and own a network of clinical sites for primary care and outpatient clinical initiatives

173 Froedtert Pharmacy Fun Facts Inpatient 3,700 orders per day; 12,000 total doses dispensed daily; 4.3 million doses yearly 2,000 admission histories per month Discharge reconciliation and education Hospital Outpatient Departments (HOD) 70,000 doses dispensed yearly 60,000 injection/iv dispenses yearly Over 30 Ambulatory Clinics Outpatient Pharmacies 170,000 prescriptions/year

174 How do we support the intent of the 340B program? Froedtert Hospital s community benefit framework is to improve the quality of life in the communities we serve through health care programs and services that are measureable, accessible and culturally appropriate; recognizing the greatest impact is in Milwaukee s underserved, urban population. The Setting: US 2010 Census: Milwaukee is #4 in poverty among nation s cities In Milwaukee County, 30% are on Medicaid and 15% are uninsured Our Investments in 2011: $34 million uncompensated care $41 million in government shortfalls Over 10,000 patient accounts adjusted for charity care $400,000 annual support to FQHC s and a $2 million pledge for capital support Over $58 million in health professions education, including college and high school scholarships/internships for underrepresented students

175 Community Benefit from Pharmacy Charity Care Medication Management Home Delivery Diabetes Smart Start Program Medication Collection Program Sharps Collection Program Medication Repository Discharge Program (implemented 9/2011) Ambulatory Care pharmacists Blood pressure cuffs (Newly Transplanted Patients)

176 Froedtert Hospital 340B Timeline AUDIT

177 Takeaways Do not outsource your 340B compliance responsibilities to another party Entities can negotiate the terms of their contract pharmacy agreements The intent of 340B is to stretch scarce federal resources as far as possible to help entities and their patients

178 340B Contract Pharmacy - Overview HRSA guidance permits entities to partner with outside pharmacies to provide eligible patients with 340B medications Identification via shared patient and provider data Inventory via "Bill To - Ship To wholesale arrangements Entity-Contract Pharmacy relationship types Direct Contracting with Pharmacy Contracting through 340B vendor with Pharmacy

179 What is a 340B Vendor? A company providing 340B contract pharmacy program implementation and management Not a HRSA requirement Minimizes impact on retail pharmacy workflow Collects data from retail pharmacy at the switch Provides the interface to identify eligible claims (matches entity data and pharmacy data) Manages inventory replenishment Establishes contracts with pharmacies Provides reports and transparency for auditing

180 340B Contract Pharmacy 1. Contract Pharmacy dispenses drug (non-340b inventory) to 340B entity s eligible patient 2. When a full package size of the Rx is reached, the pharmacy or vendor orders a 340B drug to replace it 3. Replacement 340B drugs are billed to the entity and shipped to the contract pharmacy 4. Entity pays contract pharmacy for its services

181 340B Contract Pharmacy - Data Eligibility data feeds sent 2. Patient presents Rx to pharmacy (or entity sends electronically to pharmacy) 3. Pharmacy submits claim via switch 4. Switch communicates with PBM 5. Claim payer eligibility sent 6. Periodic 340B eligibility determination 7. Periodic 340B replenishment order placed B replenishment order shipped

182 340B Contract Pharmacy - Financial Patient receives Rx, pays co-copay 2. PBM pays pharmacy (3rd party) 3. Pharmacy keeps dispensing fee, pays vendor entity s 3rd party collections 4. Vendor pays entity 3rd party collections, less vendor administrative fees B replenishment order paid

183 Reality of the Complexity

184 Apply It: Patient/Prescriber Data Updates Scenario 1: Pharmacy will update the patient and prescriber data once monthly, per data receipt from entity Is this frequency of updating appropriate? What kinds of data files could the entity use as sources for eligible prescribers/patients?

185 Apply It: Prescriber Eligibility Scenario 2: Prescriber eligibility is determined by a match to a prescriber eligibility list Is this enough? What additional information could be used?

186 Apply It: Fees Scenario 3: Self-Pay: Pharmacy shall collect and receive a $15 dispensing fee and a $1 administrative fee from patient Insured: Pharmacy shall collect and retain 30% of the contracted rate + a $19 dispensing fee Dispensing Fee: rates will increase according to the consumer price index yearly Is this a reasonable fee structure? Does this align with 340B program intent?

187 Apply It: MCO Medicaid Scenario 4 The contract will include patients with Private Insurance. Contract Definitions of Private Insurance Private Insurance includes Managed Care Medicaid Plans. 1. How can you find out if your state collects Medicaid rebates on MCO drugs? 2. If your state collects rebates on MCO drugs, is this language appropriate to include in the contract?

188 Contract Pharmacy Reimbursement Cash Pay/Sliding Fee Reduced pricing at contract pharmacy Private Insurance Medicaid - Managed Care Medicaid Plans Check with your state Entity risk

189 C-Suite Myths This program runs it self! 340B program coordinator / manager essential The first company that approach us is the best/ only one out there! Have the conversation first We have to jump on every opportunity! Be vigilant when considering any opportunity

190 HOW DO WE STAY COMPLIANT?

191 340B Program Coordinator Responsible for day to day program maintenance Preforming compliance audits Maintaining provider list Coordinating data sharing Reporting metrics Assisting in staff training

192 Contract Pharmacy Compliance Audit 1: Patient Eligibility From the vendor s report, choose 20 patients to audit. Select patients who are filling the prescription for the first time. Select patients that have multiple first fills prescriptions written by different prescribers. Verify each patient in EPIC to ensure visit was completed by an eligible provider. Completed daily Audit 2: Hardcopy Prescription Request Request 20 prescription hardcopies from vendor. Verify patient and provider eligibility. Verify that dispenses were accumulated appropriately. Completed monthly

193 Contract Pharmacy Compliance cont d Audit 3: Vendor Prescriber Audit Evaluate each provider used to dispense 340B eligible prescriptions for inclusion on eligible provider list. Eligibility is based on NPI number. Updated provider eligibility list is sent each month Completed monthly

194 Lessons Learned Understand Work with national organizations Network with other covered entities Utilize internal resources Be proactive Review and understand Polices & Procedures Review audit process with key stakeholders Stay engaged Continue to measure and test compliance

195 Contract Negotiation, Summary Entity pays flat fee per claim Stop-loss function (prevents 3rd party transmission if loss to entity) Entity does not pay fees on claim reversals (net paid claims) Entity pays lowest of U&C, MAC, and 340B Entity has access to ALL data (including prescriptions presented vs. filled with 340B) High complexity data management systems HL7 interface Entity pays fees based on % of revenue or drug cost Entity does not keep 3 rd party reimbursement Vendor recruits patients to its mail order pharmacy Early cancellation fees Entity not permitted to select wholesaler Entity may end up purchasing partial bottles at high rates due to nonreplenishment Entity not permitted to contract with other 340b vendors

196 Entities Take Action

197 Takeaways Do not outsource your 340B compliance responsibilities to another party Entities can negotiate the terms of their contract pharmacy agreements The intent of 340B is to stretch scarce federal resources as far as possible to help entities and their patients

198 Questions Take a deep breath, take a good look, and take responsibility.

199 MIXED-USE: GPO Mike Benedict Fern Paul-Aviles Rob Nahoopii

200 Carolinas Medical Center Disproportionate Share Hospital 874-bed Level I Trauma Center in Charlotte, NC 2 infusion centers: 1 cancer, 1 non-cancer Behavioral Health Center Five outpatient retail pharmacies located in clinic buildings that provide primary care and behavioral health care

201 Carolinas Medical Center Resources within Pharmacy for 340B compliance Dedicated Enterprise audit tech (former buyer) shared among 7 facilities Enterprise 340B Director Facility Directors of Pharmacy Materials management department Inventory management software, automated dispensing machines, split-billing software and HIS system Wholesaler account representative and other wholesaler experts

202 Panel Question Describe what data you feed into your splitbilling software and the source for that data

203 Use of 340B Savings Offer meds on a sliding scale to indigent patients and numerous patient assistance programs Ambulatory clinical pharmacy services in anticog, HIV, asthma, diabetes (appropriate care) Carolinas Medical Center 340B Savings Built a primary care clinic within Behavioral Health Center using Family Medicine fellow Multidisciplinary care teams (RN, CM, PharmD, Health Advocate) to prevent readmissions

204 Use of 340B Savings 340B Charity Care Voucher Program Diabetes Clinic Family Practice Clinic Synagis (palivizumab) Clinic Pertussis Cocooning Clinic Discharge Medication Support (Cath Pts)

205 Takeaways 1. Carefully consider which options you elect if using split billing software 2. Take steps to minimize your WAC spend 3. Load correct contracts, including Apexus sub- WAC pricing 4. Define: inpatient, outpatient 5. Interpret: covered outpatient drug 6. Account: for waste and lost charges

206 Overview: Mixed-Use Mixed-Use Setting in a Nutshell In a mixed-use area, the entity dispenses/administers medications to both inpatients and outpatients from the same location (pharmacy) Examples Cardiac Cath Lab, One-day surgery, Emergency Department, Endoscopy

207 GPO Prohibition* Applies to: Disproportionate Share Children s Hospitals Free Standing Cancer Hospitals Such hospitals:...will not participate in a group purchasing organization or group purchasing arrangement for covered outpatient drugs as of the date of this listing on the OPA website. OPA GPO Certification Form

208 Entities Must Ensure 340B is limited to OUTPATIENTS Patients meet patient definition Patient status = outpatient (at time of service) Prescriber = eligible prescriber Location of service = reimbursable on cost report, registered on 340B database (if req.) No GPO use for covered outpatient drugs for DSH/PEDs/CAN No duplicate discounts on Medicaid transactions

209 Split-Billing Software to the Rescue There is one physical drug inventory serving both inpatients and outpatients This software merges data from patient visits (date/time of service, patient status, prescriber, location/clinic, Medicaid status) to help split orders into the right buckets

210 Accumulators and Eligibility Accumulator: GPO Accumulator/Default: Non-GPO/WAC Accumulator: 340B Inpatients 340B ineligible outpatients 340B eligible outpatients Medicaid carve-out Lost charges Clinics within 4-walls but not 340B eligible In-house pharmacy open to public

211 Wholesaler Account Setup -DSH/PED/CAN with GPO Prohibition Inpatient GPO GPO Contract DSH Inpatient GPO Contracts (DSH only) GPO or Wholesaler Generic Source Program Individual Hospital Agreement Outpatient (not 340B eligible) Non-GPO/WAC WAC Pricing PVP Sub-WAC (if enrolled in PVP) Apexus Generic Portfolio (AGP) (if enrolled in PVP) Individual Hospital Agreement (single entity only) Outpatient (340B eligible) 340B PHS/340B PVP Sub-340B (if enrolled in PVP) Apexus Generic Portfolio (AGP) (if enrolled in PVP) Individual Hospital Agreement (single entity only)

212 Update: Account Load Options

213 Contracting: Avoid These Pitfalls The following situations are not GPO-compliant contracting practices: - An individual DSH accessing contracts executed by a network (i.e. IDN, ACO, etc.) in which it is a member - A wholesaler s generic source program (unless offered as a subcontracted solution to the Apexus Generics Source portfolio) - A manufacturer extending a discounted price to a group of covered entities (subject to the GPO prohibition) through a wholesaler, other third party or group purchasing arrangement, that is not supported by an individual contract between the 340B covered entity and the manufacturer. Such agreements should be reproducible for review during an audit of compliant 340B

214 GPO: Special Situations GPO private label products IVIG Drug shortages

215 2 Key Questions HRSA Will Ask: What outpatient accounts do you have? How do you purchase drugs for ineligible outpatients?

216 Panel Question What is the biggest challenge for you regarding record-keeping/inventory management?

217 Mixed-use Inventory/Record Keeping Challenges Steps to take Pitfalls to avoid Example

218 Minimizing WAC Exposure Tool

219 Panel Question Please share a few strategies to minimize WAC exposure

220 Strategy #1: Covered Outpatient Drug Q: Can a hospital subject to the GPO Prohibition use a GPO for drugs that are part of/incident to another service and payment is not made as direct reimbursement of the drug ( bundled drugs )? A: If the entity interprets the definition of covered outpatient drug referenced in the 340B Statute (Social Security Act 1927 (k)) and decides that bundled drugs do not meet this definition, a GPO may be used for drugs that are not covered outpatient drugs. The decision the entity makes should be defensible, consistently applied in all areas of the entity, documented in policy/procedures, and auditable.

221 Strategy #2: GPO Only Clinics In certain off-site outpatient hospital facilities that meet all of the following criteria: 1. Are located at a different physical address than the parent; 2. Are not registered on the OPA 340B database as participating in the 340B Program; 3. Purchase drugs through a separate pharmacy wholesaler account than the 340B participating parent; and 4. The hospital maintains records demonstrating that any covered outpatient drugs purchased through the GPO at these sites are not utilized or otherwise transferred to the parent hospital or any outpatient facilities registered on the OPA 340B database.

222 Strategy #3: Waste/Lost Charges Expired/returns-return company policy, entity policy Waste/lost charges Multi-dose vials, insulin Mixed product, but patient doesn t get dose

223 Strategy #4: Charge Code to NDC Charge code to the correct NDC Charge quantity to the package size Procrit, e.g. Billing unit: 1000 units Vial size: 20,000 units/1 ml vial Package size: 4 vials per box How many billing units per package?

224 Takeaways 1. Carefully consider which options you elect if using split billing software 2. Take steps to minimize your WAC spend 3. Load correct contracts, including Apexus sub- WAC pricing 4. Define: inpatient, outpatient 5. Interpret: covered outpatient drug 6. Account: for waste and lost charges

225 Tips for Pharmacy Technicians Stay up to date with Apexus sub-wac price changes; sign up for Contract News brief Educate your colleagues and identify ways to capture lost charges and expired drugs, to avoid unnecessary WAC exposure Ensure the CDM to NDC crosswalk stays updated

226 Questions

227 IN-HOUSE PHARMACY Jenny Clark

228 Health Partners of Western Ohio To eliminate gaps in health outcomes for all members of our community by providing access to quality, affordable, preventive and primary health care.

229 Entity Background Slide FQHC with 5+ sites 18,000+ patients NCQA Level 3 Patient Centered Medical Home In house, owned and operated, 340B pharmacies Approximately 18 Pharmacy staff members Each pharmacy fills RX per day

230 Use of 340B Savings INTENT- The 340B Program enables covered entities to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services. HPWO Patient Rx Savings in 2013 = $1.58M

231 340B Savings Funds: Integrated Clinical Pharmacy Services Medication Therapy Management (MTM) clinic and Med Box Program Uninsured and underinsured patient services and prescriptions Free Delivery Program Continual Service Expansion

232 Takeaways 1. The entity is responsible for compliance. 2. Understand your state s Medicaid billing policy (ambulatory, physician administered). 3. Identify the key Policies and Procedures that are needed to support your 340B program. 4. Continually review 340B program and conduct self-audits to maintain program compliance.

233 Pharmacy Model Benefits In-House Owned Pharmacy Generally lower average operating costs (average $10-15 per prescription) after start up costs are covered. Pharmacy staff can contribute as part of patient care team, improving patient outcomes and meeting organizational goals. Achieve higher capture rates for pharmacy; Patients can be very loyal. Able to keep uninsured costs very low. Pharmacy can be community resource; Retail business can increase business of pharmacy and clinic. Contract Pharmacy Less staffing resources needed; Need pharmacy point person and for monthly reporting and compliance. Less risk for low volume clinics or those with very high rate of uninsured patients. Low start up costs: No need for infrastructure development or licensing. No building space requirements. Use negotiated contracts of pharmacy partner; do not need to negotiate your own.

234 Pharmacy Model Challenges In-House Owned Pharmacy Higher start up costs ($75-200K start up not including inventory). Requires space within or immediately proximate to entity site. Greater administrative resources required; Need to develop space, get licensed and hire staff. Contract Pharmacy Higher ongoing operational costs ($ per prescription) and potential need for 3 rd party administrator too. Added cost for quarterly drug reconciliation costs. Less opportunity for clinical integration of pharmacy services and improved patient outcomes. Note: Pros and Cons are offered as generalizations and are not mutually exclusive. Entities can have Owned and Contracted Pharmacy programs.

235 In-House Pharmacy Considerations What are the entity goals of creating a pharmacy program? Would your volume and payer mix support an Inhouse Pharmacy? Consider types of clinical services offered or special populations served by entity. Would your community benefit from a retail pharmacy?

236 In-House Pharmacy Operation 340B Account Retail Account In House Pharmacy 340B Inventory Retail Inventory 340B Patient Retail Patient Provider 340B Provider Retail Provider 340B Billing Retail Billing Wholesaler Patient Billing

237 Start Up Steps Planning, Design, Construction Carve-In vs. Carve-Out Pharmacy Operating System Licensing and Accreditation Insurance Contracting Pharmacy Staffing Plan and Training Inventory Model Choices Wholesaler Negotiations Policies and Procedures

238 Strategies for Growth 12 month Start-Up Plan Tracking and reporting on progress Detail strategies to achieve growth rate Educating patients and prescribers to use pharmacy Added value services for clients Sales and Marketing

239 In-House Pharmacy Keys to Success Staffing Considerations Manage Accounts Receivable Optimize Savings Control Costs Maximize Technology & Workflow Regulatory Compliance Plan

240 Maximize Technology & Work Flow Investments to increase pharmacy efficiency and improve 340B compliance Pharmacy operating system Robotic dispensing devices Bar code scanning through dispensing and check out processes Interactive voice / text response Tele-pharmacy

241 Control Costs Cost of goods reviewed at every order Cost of Goods Quarterly price changes Prime Vendor Program Perpetual Inventory System with Par Levels Monthly unused drug report Quarterly drug level check Labor as a percent of sales

242 Compliance Considerations Eligibility and Registration A grantee has a new clinic that opens March 15 th It must be added to the EHB prior to registration in the OPA database. What steps have to be taken before the clinic can begin using 340B?

243 Compliance Considerations Referral Prescriptions If we refer a patient to an outside clinic, can we fill their prescriptions from our 340B clinic?

244 Compliance Considerations Demonstrating responsibility for care Some examples of auditable records for a 340B prescription resulting from a referral prescription? Some methods to help demonstrate responsibility for care Outgoing referral from covered entity Shared EMR access with outside provider Incoming notes from outside provider Referring returning patient for follow up encounter to review outside care

245 Compliance Considerations Eligible providers who are floaters CE maintains a list of providers who could prescribe at nonentity location. Pharmacy should have means to verify entity address of floaters Use provider address check Without means to verify floaters address - NO 340B should be used340b drugs.

246 Compliance Considerations Eligibility verification at filling Retail inventory Hospital prescriptions Specialist prescriptions Real time access to patient and provider eligibility information Right inventory to right person Do you have responsibility for care? Documentation of Outgoing referral and incoming

247 Compliance and Business Reporting End of Month Reporting: Weekly Monthly Quarterly Matching return-to-stock to correct account Patient and provider eligibility Inventory to match dispensations Duplicate discounts Billing for all prescription

248 Case Discussions Thank You!

249 In-House Case #1: Patient A patient came to our pharmacy with prescriptions from a local hospital discharge. Can we fill these prescriptions with 340B drugs? 1. Is the person an active patient of the health center? 2. Is your health center provider medically responsible for the care related to these prescriptions? 3. Does your health center have a contract with prescriber?

250 In-House Case #2: Provider We have a cardiologist that sees health center patients once a month because we have no specialists in the area. Can the health center use 340B to fill these prescriptions? 1. Does the health center contract with the specialist to provide services to the patients? 2. Is the health center medically responsible for the care provided by the specialist to the patients?

251 In-House Case #3: Referral Patients The local mental health providers send uninsured patients to our pharmacy if they can t afford prescriptions. Under what circumstances can we fill them? 1. Is the person a patient of the health center? 2. Can you verify documentation of a referral from the health center to the specialist and report back from the specialist?

252 In-House Case #4: Medicaid Billing Can we use 340B for the Medicaid managed care patients and bill regular rates (U&C)? What information do you need to know to make this decision?

253 In-House Case #5: Multiple provider types Our health center provides dental and primary care. A patient presents to the pharmacy with two prescriptions, (Rx #1) is from a health center dentist for an antibiotic and (RX#2) is for birth control from a non-health center OBGYN provider. 1. Can 340b inventory be used for the antibiotic? 2. Is the health center medically responsible for the care provided by the OBGYN to the patient?

254 Tips for Pharmacy Technicians Ensure your entity s policy for referrals is reflected in the 340B Standard Operating Procedure Know your state s Medicaid 340B billing policy and support it in your operations Prior to dispensing prescriptions, verify prescriber and clinic/location 340B eligibility

255 Takeaways 1. The entity is responsible for compliance. 2. Understand your state s Medicaid billing policy (ambulatory, physician administered). 3. Identify the key Policies and Procedures that are needed to support your 340B program. 4. Continually review 340B program and conduct self-audits to maintain program compliance.

256 Questions

257 SESSION 5: 340B & MEDICAID BILLING Debra Demers Fern Paul-Aviles Jennifer Hagen Jenny Clark

258 Objectives Recognize information required to avoid creation of a duplicate discount Review appropriate approaches to Medicaid billing and understand scenarios that could lead to duplicate discounts

259 Takeaways 1. Duplicate discounts are prohibited by 340B Statute 2. The entity s 340B information on the 340B Database should reflect practice 3. Contract pharmacies should carve-out Medicaid, absent an arrangement to prevent duplicate discounts

260 Medicaid 1. Requirement: Prevent duplicate discounts Medicaid Exclusion File 2. Entity decision: Use 340B for Medicaid (or not) Some states have requirements for using 340B for Medicaid Some states have very specific Medicaid billing requirements (ex. certain codes or procedures when using 340B drugs)

261 Medicaid Billing How much do you know? Review 4 question quiz at your table Discuss options among colleagues at your table and select choice you think most accurate

262 Duplicate Discounts What is the state s general policy on Medicaid rebates on 340B drugs (for example, does the Medicaid Agency use the OPA Exclusion File?) If our entity uses 340B for Medicaid, what procedure should we use to notify the state Medicaid agency that a 340B drug was unavailable? Does the State Medicaid Agency seek a Medicaid Rebate on claims from patients: 1. That are Dual Eligible (Medicaid/Medicare) 2. That received physician administered Drugs 3. That are billed from Medicaid Managed Care 4. In any other circumstance?

263 Medicaid Message State 340B policies that incentivize entities to use 340B by offering fair reimbursement will save states money and support entities

264 State Medicaid Engagement : 19 states Discussions Active Engagements

265 Medicaid 340B University for Medicaid Agencies planned for summer 2014 Apexus engagement: Providing education and connecting entities with the state during state policy development Providing analytics support to State and covered entities Challenges & Opportunities: Shrinking state budgets (+/-) Managed care policy issues, contract pharmacies Coordinating policy development and billing systems to enable entities to use 340B

266 Apexus Answers If an entity intends to have some clinics use 340B drugs for Medicaid and other clinics carve-out, then should each clinic get its own Medicaid number to distinguish them?

267 Apexus Answers My contract pharmacy said I can use 340B for Medicaid patients. Is this OK?

268 Apexus Answers We bill Medicaid in more than one state. Is it OK to have different billing policies for the different state? How do we reflect this in the database?

269 Takeaways 1. Duplicate discounts are prohibited by 340B Statute 2. The entity s 340B information on the HRSA 340B Database should reflect practice 3. Contract pharmacies should carve-out Medicaid, absent an arrangement to prevent duplicate discounts

270 Tips for Pharmacy Technicians Check your HRSA 340B database listing to ensure your Medicaid information reflects practice Ensure Medicaid patients with retroactive eligibility are accounted for in your 340B software/operations and treated consistently with your standard operating procedures)

271 Questions

272 SESSION 6: 340B HOT TOPICS Debra Demers Fern Paul-Aviles Jennifer Hagen Jennifer Clark Justin Simon

273 Objectives Apply tools available to assist entities in developing and assessing program compliance Discuss 340B compliant approaches used by leading practices to common hot topics

274 Takeaways Stakeholders are not all going to interpret policy the same way Defend your decision and document it in your policies and procedures Use free tools and resources to support your decisions: FAQs, Apexus Answers

275 340B Mega-Reg Comprehensive HRSA regulation (to replace program guidance) Expected to be a proposed rule, with comment period Expected in draft form by Summer 2014

276 Contract Pharmacy OIG Report Contract Pharmacy Arrangements in the 340B Program (OEI ) released Feb. 5, 2014 Contract pharmacy arrangements create complications in preventing diversion and duplicate discounts, and covered entities addressed the complications in different ways. Some covered entities in the study offer the 340B discount to uninsured patients at the contract pharmacy and others do not. Most covered entities in the study do not conduct all of the HRSA-recommended oversight activities.

277 Entities Take Action

278

279 Patient Definition Does the entity: Have a relationship with the individual and maintain records of the individual s health care? Provide health care services from a health care professional Employed by entity Under contractual or other arrangements (e.g. referral for consultation) with entity? Maintain responsibility for the patient s health care services? Provide services consistent with funding or designation status (hospitals exempt)

280 Apexus Answers Are employees of a covered entity eligible to receive 340B drugs?

281 Apexus Answers If we refer a patient to an outside clinic, can we use 340B for their prescriptions?

282 Apexus Answers In our outpatient pharmacy, we provide services to patients who receive prescriptions from physicians that do not have a relationship with our hospital. Is this compliant?

283 Inventory/Records Does the entity: Maintain separate, auditable records for all 340B purchasing and dispensing? Regularly evaluate 340B utilization reports to catch and correct problems?

284 Apexus Answers If I dispense a manufacturer s generic product to a 340B eligible patient, can I restock my inventory with a generic equivalent from another manufacturer?

285 Apexus Answers Can our parent entity transfer 340B drugs to a child site? Can a hospital under our umbrella organization transfer 340B drugs to another 340B hospital? What about in an emergency?

286 Apexus Answers Does the prescription have to have a fill date that matches the date of service?

287 Registration Does the entity: Have all information completely and accurately reflected in the Office of Pharmacy Affairs (OPA) and PVP (Prime Vendor Program) databases?

288 Apexus Answers How do I know which types of 340B Database information are changeable on a rolling basis vs. only at the quarterly interval?

289 Changes to 340B Database Online Change Form Changes to existing information in 340B database (e.g., addresses) Add/remove Medicaid Provider # or NPI Rolling/as required Registration: Quarterly Recertification: Annually Opt-in vs. opt-out decision Medicaid carve-in vs. carve out Add new clinics or contract pharmacies

290 Apexus Answers If my contract pharmacy has a change of information (name change, etc.) how should I notify OPA?

291 Apexus Answers Will HRSA make an exception to their registration rules? For example: My CEO deleted an from HRSA that was critical, and HRSA removed our entity We made a mistake and forgot to register a site We forgot to submit the supporting documentation on the same day we submitted our registration request

292 Takeaways Stakeholders are not all going to interpret policy the same way Defend your decision and document it in your policies and procedures Use free tools and resources to support your decisions: FAQs, Apexus Answers

293 Tips for Pharmacy Technicians Consider making a 340B eligibility checklist to keep at your workstation, if your software doesn t help you manage this don t forget to address referral prescriptions Understand the policy for transferring 340B inventory from your entity to a child site, and ensure this is documented in your 340B Standard Operating Procedures

294 Questions

295 SESSION 7: AUDIT & DISPUTE PANEL DISCUSSION Rose Babbitt Fern Paul-Aviles Robert Nahoopii George Kenny Marcy Imada

296 Objectives Explain the key points of the audit processes Describe current events in HRSA and manufacturer audits Discuss tools available to self-assess in preparation for an audit

297 Takeaways HRSA and manufacturers may both audit entities There are lessons to be learned from prior audits There are specific choices that place an entity at a higher risk of being audited

298 HRSA AUDITS Rose Babbitt

299 Audits What are the main areas of focus for a HRSA audit of an entity? How does that differ from a manufacturer audit of an entity? Entity shall permit manufacturer/government to audit records that directly pertain to entity compliance HRSA Audits Diversion, Orphan Drugs Duplicate Discounts Eligibility GPO Prohibition Auditable records Manufacturer Audits Diversion, Orphan Drugs Duplicate Discounts

300 HRSA Risk-Based/Target Audits WHO performs the audits, and WHAT is examined? HRSA Staff All covered entities considered for risk based audits Audit Focus Areas: Entity s oversight of Contract Pharmacy compliance Operations and Internal Controls Records of distribution and dispensing

301 HRSA Audit Steps What steps are involved in a HRSA audit of an entity? 1. Pre-Audit Engagement letter from HRSA 2. Onsite Audit Auditors obtain, review, examine data Exit interview, preliminary issues 3. Post-Audit Auditors provide preliminary issues to OPA OPA reviews issues found during audit, documents, and addresses concerns Entity presents corrective action plan to HRSA Results are preliminary until reviewed by OPA OPA finalizes report, posts summary on website

302 HRSA Audit: Next Steps 1 HRSA Notice and Hearing; entity has 30 days to disagree with preliminary report 2 Final report; 60 days to submit corrective action plan*; entity has 30 days to disagree with final report 3 Audit Summary and corrective action on HRSA website *If no corrective action plan within 60 days of final report, entity terminated 4 Results support education of covered entities

303 HRSA Audits: Lessons Learned What have we learned from the HRSA audits? FY covered entities encompassing over 410 outpatient facilities/sub-grantees and 860 contract pharmacy locations All 51 audits finalized and posted on website FY audits covering 718 outpatient facilities/sub-grantees and 1,937 contract pharmacy locations In process of finalizing audits FY As of March 12, on-site audits completed 2 in process 42 covered entity audits include 796 outpatient facilities and 2,544 contract pharmacies

304 Example HRSA Audit Findings Diversion 340B drugs dispensed at ineligible sites Not spot checking inventory to check for diversions and correcting them (variance) 340B drugs dispensed at ineligible site and by an ineligible provider 340B drugs dispensed to nonpatient at contract pharmacy

305 Example HRSA Audit Findings Duplicate Discount Billing Medicaid contrary to HRSA Medicaid Exclusion File listing 340B drugs used for Medicaid patients at contract pharmacy, with no arrangement to prevent duplicate discounts Medicaid claims incorrectly coded when provided to the state Incorrect Medicaid or NPI in HRSA Medicaid Exclusion File Outpatient sites incorrectly listed on HRSA Medicaid Exclusion File

306 Example HRSA Audit Findings Eligibility, Auditable Records Incorrect Authorizing Official Primary location and contact information incorrect Closed child sites remained registered; incorrect name listed for a child site Incorrect address for facility, incorrect ship-to address, pharmacy listed as entity with 340B ID No written contract in place for contract pharmacies

307 Audits Manufacturer Conducted Authority Reasonable cause Independent auditor OPA encourages manufacturers to submit plans and we will work closely with them throughout the process Statistics: 9 received 7 approved to move forward 6 audit reports finalized Encourage manufacturers to share lessons learned

308 Audits Manufacturer Conducted Authority 340B statute, guidelines Requirements Reasonable cause Workplan to HRSA Independent auditor Limited to Diversion/Duplicate Discounts HRSA has received 8 work plans OPA works with them throughout the process *Encourage manufacturers to share lessons learned

309 ENTITY EXPERIENCE (SELF-AUDIT) Fern Paul-Aviles

310 Carolinas Healthcare System Audit-readiness review Summary of locations and 340B usage types (100% 340Beligible, hospital mixed-use, hospital-based retail) Deviations from DSH practices Table with answers to audit questions Data examined Retail prescription dispensing Inpatient and outpatient types Policies and procedures must describe what you do

311 Carolinas Healthcare System Lessons learned Audit yourself as rigorously as you expect HRSA to Policies and procedures Data extracts for split-billing software Inpatient vs. outpatient When does patient status change? Know! Bill on dispense/bill on administration Duplicate discount avoidance How Medicaid gets 340B info Self-audit

312 Self-Audit: Eligibility Frequency Monthly split-billing non-matched items report more optimization than compliance Quarterly prior to open enrollment Annually part of Corporate Compliance Workplan Sample of prescriptions in mixed-use retail High-dollar drugs (cancer, transplant, fertility) Old-way doctor list; New-way: ICD-9 match or 100% doctor list Examine Patient eligibility Prescriber eligibility Specialists (referral and follow up) Drug on formulary

313 Self-Audit: Inventory/Compliance Regular ad hoc reports from vendor Prior authorizations for specialists Reviewed by internal entity staff Contract with an outside group to audit NDC vs. replenishment Inventory management Any true-ups Reversed claims Payment of inventory value

314 Self-Audit: 340B Database Developed a policy to: Assign responsibility for monitoring/updating Direct routine review or PRN changes Address recertification annually

315 Takeaway Compliance is the entity s responsibility; do not rely on a vendor s records alone

316 ENTITY EXPERIENCE Rob Nahoopii

317 Lessons Learned-HRSA Audits Flying by the seat of your pants precedes crashing by the seat of your pants. Bill Walsh Have a solid compliance plan. Implement monthly auditing of both contract pharmacy and administered drugs. Resource staff time for compliance and program oversight.

318 Self-Reports Use Apexus resource, Self-Reporting 340B Non- Compliance. Found at: Notify HRSA, then each manufacturer impacted individually. There are multiple ways to correct non-compliance, and working with each manufacturer on its ideal mechanism works best.

319 Lessons Learned-Manufacturer Audits Avoid the costly (time and money) impact of a manufacturer audit by working together for an equitable and transparent resolution. Share data to help with transparency. As a DOP, I had four manufacturer letters. In all cases we engaged in open and honest conversation and they all ended well.

320 A Wise Person Once Said To achieve great things, two things are needed; a plan and not quite enough time. Leonard Bernstein

321 Remember A Compliance Action Plan Is Complicated Is Do-Able Is Updated Regularly Is Auditable Is the Covered Entity s Responsibility

322 Apexus Self-Audit Tool

323 MANUFACTURER AUDITS George Kenny

324 Apexus Answers As a manufacturer, what are potential compliance issues that I might observe?

325 Manufacturer Audit Issues Diversion Non-eligible entity or entity service (inpatient) Non-eligible patient Reselling of product Non-Compliance with Orphan Drug Final Rule (for RRC, SCH, CAH and Freestanding Cancer Hospitals) Medicaid Duplicate Discounts 340B discount and Medicaid rebate on same unit of utilization Covered entity responsible for avoiding duplicate discounts State Medicaid should issue rules for compliance Example: UD Modifier for Physician Administered Managed Medicaid

326 Other Issues: GPO Prohibition Definition of patient Maintenance of auditable records Correct information on OPA database Multiple ship-to sites Split billing software and credit /re-bill activity Healthcare reform impact (ACOs, integration) Some other issues (ex. GPO Prohibition) are not auditable by manufacturers, but manufacturers can inform OPA of these issues and OPA will follow-up with covered entities

327 Manufacturer Audits of Entities: Overview If informal negotiations fail, a manufacturer may seek OPA permission to conduct an audit Demonstrate reasonable cause Evidence of Duplicate Discount and/or Diversion Unsatisfactory attempt at informal dispute resolution Submit proposed audit workplan OPA response to request (within 15 days) Approval Denial Request for revision/additional information Manufacturer provides Covered Entity with notice of Audit minimum 15-day period to prepare for audit

328 Manufacturer Audits of Entities: Overview Manufacturer notifies covered entity of audit Identifies issue(s) & third party auditing firm Audit Pre-Work Document requests (policies, SOPs, etc.) Data request (inventory, billings, etc.) Identification of key individuals to be interviewed On-Site Audit Minimal time necessary to complete work (2-5 days) Conclusion of Audit Resolve any outstanding issues Covered entity comment on findings Final Audit report provided to OPA and HHS OIG Recoupment of 340B discount (discount = WAC 340B)

329 Covered Entity Self-Disclosure of Non-Compliance Covered Entity Identifies Issue(s) Corrects Issue(s) Self-Discloses issue and proposed corrective action plan (CAP) to OPA Self Discloses to manufacturer works in good faith to implement CAP Manufacturer Identifies impact to manufacturer s products Works with covered entity to resolve issue

330 Corrective Action Plans Covered entity must: Prospectively correct issue Conduct root cause analysis of underlying issue Implement Plan to correct issue moving forward Retrospectively correct issue Identify products (and units) affected Determine inappropriate discounts Repayment challenges Refund vs. Offset Work with manufacturers to determine best course

331 HRSA Audits of Manufacturers Manufacturer perspective Calculation of 340B Ceiling price AMP URA Transmission of 340B Ceiling price to distributors Resolution of inquiries regarding appropriate prices

332 AUDITOR S EXPERIENCES Marcy Imada

333 Audit Approval Manufacturer seeks OPA permission to conduct an audit Demonstrate reasonable cause Submit proposed audit work plan OPA response to request (within 15 days) Approval Denial Request for revision/additional information Manufacturer must provide covered entity with notice Minimum 15-day period to prepare for audit

334 Audit Steps and Scope Manufacturer notifies covered entity of audit Identifies issue(s) Identifies third party auditing firm Sets audit timeline (at least 15 day advance notice) Audit Pre-Work may include: Background Questionnaire Document requests (policies, SOPs, etc.) Data request (inventory, billings, etc.) Identification of key individuals to be interviewed Scope Entire period of non-compliance

335 Audit Steps and Scope cont d On-Site Audit Third party auditors (implementing GAGAS standards) Minimal time necessary to complete work Pre-work can shorten on-site requirement ~2-3 days Conclusion of Audit Resolve any outstanding issues Draft Audit report Covered entity comment on findings Final Audit report provided to OPA and HHS OIG

336 Tips From the Auditor Examples of what works well and what to avoid Most common findings

337 Takeaways HRSA and manufacturers may both audit entities There are lessons to be learned from prior audits There are specific choices that place an entity at a higher risk of being audited

338 Tips for Pharmacy Technicians Report inventory discrepancies or software malfunctions to leadership; document the issue in writing and keep records of how the situation was corrected Know your 340B policies and procedures for verifying patient, prescriber, and location eligibility Spot check that these procedures are being followed and report issues to leadership

339 Questions

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