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1 Date: September 3, 2014 Subject: Background on Sections 401 and 403 of the Indian Health Care Improvement Act: Disregarding Certain Payments in Determining Appropriations and Reporting Requirements Note: The Office of Management and Budget (OMB) has requested that the Centers for Medicare & Medicaid Services (CMS) submit Medicare Medicaid, and CHIP provider billing numbers and collections data pursuant to Section 401 of the Indian Health Care Improvement Act (IHCIA). The reporting of this information from CMS to OMB is a concern for Tribes, since OMB has not clearly defined how it will use the data. This memorandum is intended to provide Tribal leadership with a brief background on the current sections 401and 403 of the Indian Health Care Improvement Act. Tribal technical advisors are also preparing a broader memorandum in order to offer recommendations to Tribal leadership with regard to the inquiry by CMS and (OMB on the level of revenues received by Tribal health programs under Medicare, Medicaid and CHIP. Background Section 401 of the Indian Health Care Improvement Act (IHCIA) is titled Treatment of Payments under Social Security Act Health Benefits Programs. In particular, section 401(a) is titled Disregard of Medicare, Medicaid and CHIP Payments in Determining Appropriations. It reads: (a) DISREGARD OF MEDICARE, MEDICAID, AND CHIP PAYMENTS IN DETERMINING APPROPRIATIONS. Any payments received by an Indian health program or by an urban Indian organization under title XVIII, XIX, or XXI of the Social Security Act for services provided to Indians eligible for benefits under such respective titles shall not be considered in determining appropriations for the provision of health care and services to Indians. Section 401 also requires that an Indian health program receiving reimbursements or payments under Medicare, Medicaid, or CHIP provide to IHS a list of each provider enrollment number (or other identifier) under which the Indian health program receives such reimbursements or payments and requires that IHS share this and other necessary information with the Centers for Medicare and Medicaid Services (CMS). 1

2 Background on Sections 401 and 403 of the Indian Health Care Improvement Act: Disregarding Certain Payments in Determining Appropriations and Reporting Requirements Page 2 September 3, 2014 Section 403 of the IHCIA (25 U.S.C. 1643) has since enactment in 1976 required a report to Congress regarding the revenue generated from Medicare and Medicaid. The current requirement says: The Secretary shall submit to the President, for inclusion in the report required to be transmitted to the Congress under section 801 an accounting on the amount and use of funds made available to the Service pursuant to this title [25 U.S.C et seq.] as a result of reimbursements through titles XVIII and XIX of the Social Security Act, as amended. The short history of these provisions is: Current IHCIA section 401 was originally split between section 401 (Medicare) and section 402 (Medicaid) as of their initial enactment in They were subsequently combined into one provision in current section 401, as well as the Children s Health Insurance Program (CHIP) was added. Section 403 has remained largely unchanged since The original congressional committee report language on these provisions made two primary points: It is the intent of the Committee that any Medicare and Medicaid funds received by the Indian Health Service program be used to supplement-- and not supplant-- current IHS appropriations. In other words, the Committee firmly expects that funds from Medicare and Medicaid will be used to expand and improve current IHS health care services and not to substitute for present expenditures. Section 403 would require the Secretary of Health, Education, and Welfare to report to the Congress annually on the use of the additional funds available to the IHS because of the Medicare and Medicaid reimbursements received by the Indian Health Service program. Other provisions in the IHCIA, and in the Indian Self-Determination and Education Assistance Act (ISDEAA), provide additional protections for Indian health programs. 2 For example, under IHCIA section 207, it states: The Service may not offset or limit any amount obligated to any Service Unit or entity receiving funding from the Service because of the receipt of reimbursements under subsection (a). In a report by the Congressional Research Service in December 2011, titled The Indian Health Care Improvement Act Reauthorization and Extension as Enacted by the Affordable Care Act: Detailed Summary and Timeline, the Congressional Research Service (CRS) described these provisions, in part, as follows:

3 Background on Sections 401 and 403 of the Indian Health Care Improvement Act: Disregarding Certain Payments in Determining Appropriations and Reporting Requirements Page 3 September 3, 2014 IHCIA s Title IV Access to Health Services [containing section 401] authorizes IHS care facilities to receive reimbursements from SSA s Medicare and Medicaid programs. This authorization was a major component of the original IHCIA passed in These reimbursements are used to augment services received at IHS-funded facilities because IHCIA excludes Medicare and Medicaid [and now CHIP under the 2010 amendments] reimbursements from being considered when determining annual Indian health appropriations. (CRS, page 16) [Section 401] also subjects THP [Tribal Health Program] direct payments to all auditing requirements applicable to whichever programs it chooses to bill directly and to all auditing requirements applicable to the IHP [Indian Health Program]. The section requires that a THP receiving reimbursements or payments under Medicare, Medicaid, or CHIP provide to IHS a list of each provider enrollment number (or other identifier) under which the THP receives such reimbursements or payments and requires that IHS share this and other necessary information with the Centers for Medicare and Medicaid Services (CMS), the agency that administers the Medicare, Medicaid, and CHIP programs. (CRS, page 17.) Conclusion It is understood, and for good reason, that Tribes are concerned about the collection of this information. However, since it is required by statute, and opposing the collection and reporting of the data may raise additional concerns at OMB, the best approach may be not to challenge the gathering of the information, but rather assure the adequacy and accuracy of the data. The following points should be made to OMB, CMS, and IHS on this issue: 1. The statutory language makes clear that OMB, HHS, IHS, and the Congress may not offset appropriations to the IHS with any payments received under the Social Security Act. 2. OMB, CMS, and IHS must consult with Tribes about the adequacy, accuracy, and use of such data. OMB should clearly define for Tribes what their intended purpose is for collecting the data. 3. The data collected under Section 401 shall not be reported in the IHS Congressional Justification to Congress. 1 Congressional Research Service, The Indian Health Care Improvement Act Reauthorization and Extension as Enacted by the Affordable Care Act: Detailed Summary and Timeline, December 14, Other examples include: IHCIA Section 207(a) (25 U.S.C. 1621f(a)) requires all third party revenue generated under Section 206 be credited to the Service, such Indian tribe or Tribal organization, or such urban Indian organization, respectively, and maybe used as provided in section 401.

4 Background on Sections 401 and 403 of the Indian Health Care Improvement Act: Disregarding Certain Payments in Determining Appropriations and Reporting Requirements Page 4 September 3, 2014 IHCIA Section 207(a) also protects IHS Service Units by requiring that if the revenue was generated by service[s] provided by or through a Service Unit, such amounts shall be credited to such unit and used for such purposes. Also see, Section 401(c)(1)(A), (25 U.S.C. 1641(c)(1)(A)). Two sections of the ISDEAA address program income and prohibit offsetting: Sections 106(m) (25 U.S.C. 450j(m)) (self-determination) says: Program income earned by a Tribal organization in the course of carrying out a self-determination contract (2) shall not be a basis for reducing the amount of funds otherwise obligated to the contract and 508(j) (25 U.S.C. 458aaa-7(j)) (selfgovernance) says that program income, including Medicare and Medicaid income, shall not result in any offset or reduction in the amount of funds the Indian tribe [or Tribal organization] is authorized to receive under its funding agreement in the year the program income is received or for any subsequent fiscal year.

5 TRIBAL HEALTH PROGRAMS AND THE 340B PROGRAM This white paper has been developed to call attention to a potential rule change to restrict the definition of patients served by tribal health programs and that will result restrict their ability to access discount prices for drugs under the 340B program. Tribes and tribal organizations are concerned that the Health Resources and Services Administration (HRSA), which administers the 340B program, has developed a proposed mega regulation currently under review by the Office of Management and Budget (OMB), which would significantly restrict access to 340B pricing for drugs by tribal health programs. Although the authors have not actually seen the proposed regulation, it is reported to redefine the relationship between a patient and prescriber of drugs (provider) to require that all prescriptions must be issued by a staff provider at a facility. Unless Indian health facilities are exempt from such a rule, this would make prescriptions issued by providers serving patients of tribal health programs outside tribal clinic facilities under referral or contractual arrangements, or under tribal health plans contracting with provider networks, ineligible for 340B pricing. This would vastly curtail tribal access to 340B pricing under the current system and add to the expense of providing health care to American Indians and Alaska Natives (AI/AN). We understand that the purpose of the proposed mega-regulation is to rein in use of 340B pricing by all the covered entities and to correct perceived abuses of the 340B program. Indian tribes and tribal organizations could be swept into the regulatory changes because HRSA views them as having FQHC look-alike status. However, Indian tribes and tribal organizations carrying out health services programs under Indian Self-Determination and Education Act (ISDEAA) contracts and compacts have an entirely different status under Federal law than other FQHCs, such as community health centers funded by grants under 330 of the PHS Act. 1 As described below, the fact that tribal health programs are deemed FQHCs under 1905(l)(2)(B) of the Social Security Act (SSA) does not convert their status into FQHC lookalike status so that HRSA may redefine what it means to be a patient of a tribal health program. The 340B Drug Discount Program The 340B drug discount program is authorized by 340B of the Public Health Service (PHS) Act, 42 U.S.C. 256b. Subsection 340B(a)(1) requires the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish the amount that a covered entity must pay for a covered outpatient drug. Essentially, 340B extends the Medicaid rebate as a discount percentage applicable to the purchase of covered outpatient drugs by certain covered entities. Covered entities include Federally Qualified Health Centers (FQHCs) defined in 1905(l)(2)(B) of the SSA; 2 community health centers funded by grants under 330 of the PHS Act; urban Indian organizations funded under Title V of the Indian Health Care Improvement Act (IHCIA); and various other federally assisted health programs and facilities. Fifteen covered entities are listed in 340(a)(4) U.S.C. 254b U.S.C. 1396d(l)(2)(B) U.S.C. 256b(a)(4).

6 Indian tribes and tribal organizations contracting or compacting with the Indian Health Service (IHS) to operate outpatient health programs under the ISDEAA are covered entities because the definition of an FQHC in 1905(l)(2)(B) of the SSA includes an outpatient health program or facility operated by a tribe or tribal organization under the [ISDEAA]... for the provision of primary health services. Requirements for Covered Entities Covered entities must meet two requirements set out in 340B(a)(5). The first prohibits duplicate discounts or rebates. Under 340B(a)(5)(A), a covered entity may not request payment under Medicaid for a covered outpatient drug that is subject to a 340B agreement if the drug is subject to the payment of a rebate to the state under 1927 of the SSA. 4 The Secretary is required to establish a mechanism to ensure that covered entities comply with this requirement. Secondly, under 340B(a)(5)(B), covered entities shall not resell or otherwise transfer a covered outpatient drug subject to a 340B agreement to a person who is not a patient of the entity. A covered entity is subject to audits by the Secretary and the manufacturer pertaining to the covered entity s compliance with these two requirements. If the Secretary finds, after an audit, that the covered entity is in violation of either of these two requirements, the covered entity is liable to pay back the 340B discount to the manufacturer. In order to improve compliance by covered entities with the two requirements mentioned above (the prohibitions against duplicate Medicaid discounts and resale of drugs), the Secretary is tasked to make certain administrative improvements. These include: (1) enabling covered entities to update their information on the Department s 340B website; (2) verifying the information on the website; (3) providing guidance for billing state Medicaid agencies in a manner to avoid duplicate discounts; (4) establishing a standardized system to facilitate ordering, purchasing, and delivery of outpatient drugs; 5 and (5) imposing additional sanctions on covered entities for the intentional or egregious violation of the prohibition against reselling drugs in 340B(a)(5)(B). 6 The Proposed Mega-Regulation Section 340B does not impose any requirements on covered entities to change how they deliver services or how they structure their health service delivery programs. Nor does 340B authorize the Secretary to impose such requirements. The two requirements discussed above target only (1) receipt of duplicate discounts in billing for Medicaid services, and (2) resale or transfer of 340B priced drugs to persons who are not patients of the entities, i.e., individuals who may not legitimately be served by the covered entity under governing federal law and regulations. Who covered entities may serve under federal law and regulations, and how they serve them, are not matters for the Secretary to regulate in administering the 340B drug pricing program U.S.C. 1396r-8. 5 The Secretary is also required to develop a prime vendor program under 340B(a)(8). 6 See 340B(d)(2), 42 U.S.C. 256b(d)(2).

7 Tribal health programs provide services to American Indian and Alaska Native (AI/AN) beneficiaries, not just through clinic facilities (some do not have clinic facilities), but also through contract health services (CHS) providers 7 and tribal health plans under arrangements with service provider networks. Many I/T/U facilities include pharmacies that offer prescription drugs at no cost to IHS beneficiaries. The definition of a FQHC in 1905(l)(2)(B), which is the basis for including tribal health programs as covered entities, includes an outpatient health program or facility operated by a tribe or tribal organization under the [ISDEAA]... for the provision of primary health services (emphasis added). Tribal health programs are defined in 4(25) as meaning an Indian tribe or tribal organization that operates any health program, service, function, activity or facility funded, in whole or in part, by the Service through, or provided for in, a contract or compact with the Service under the [ISDEAA] (emphasis added). These statutory provisions, as well as ISDEAA agreements, recognize that tribal health programs are not limited to providing services just at clinic facilities. Under the proposed HRSA mega-regulation, as we understand it, 340B pricing would only be available to tribal health programs for covered outpatient drugs used to fill prescriptions issued by an employee of a tribal clinic for patients receiving services at the clinic. This would substantially curtail the availability of 340B pricing under current HRSA guidelines, which define the term patient for purposes of the resale prohibition in 340B(a)(5)(B) as follows: 8 An individual is a patient of a covered entity... only if (1) the covered entity has established a relationship with the individual, such that the covered entity maintains records of the individual s health care; (2) the individual receives health care services from a health care professional who is either employed by the covered entity or provides health care under contractual or other arrangements (e.g., referral for consultation) such that responsibility for the care provided remains with the covered entity; and (3) the individual receives a range of services from the covered entity which is consistent with the service or range of services for which grant funding or [FQHC look-alike status] has been provided to the entity.... An individual will not be considered a patient of the entity for purposes of 340B if the only health care service received by the individual from the covered entity is the dispensing of a drug or drugs for subsequent self-administration in the home setting. Emphasis added. The emphasized language in the current guideline can be reasonably read to include 340B pricing for drugs used to fill prescriptions issued not only by tribal employees for patients served at tribal clinics, but also prescriptions issued by CHS or network providers in the course of providing services to AI/AN beneficiaries under contractual or other arrangements with the tribal health program. The proposed mega-regulation would change this. 340B pricing would no longer be available to a tribal health program for drugs used to fill prescriptions issued by CHS or network providers C.F.R , et seq. 8 See, HRSA guidelines published in the Federal Register on August 3, 1995 (60 FR 39764).

8 Rulemaking Authority In Pharmaceutical Research and Manufacturers of America (PhRMA) v. U. S. Department of Health and Human Services, No RC (D.D.C. May 23, 2014), the U.S. District Court for the District of Columbia held that the Secretary s authority to issue legally binding regulations governing the 340B program is limited to three distinct matters: (1) establishing an administrative dispute process between covered entities and manufacturers; (2) defining a standard methodology for calculating ceiling prices; and (3) imposing civil monetary penalties. Although this case involved the Secretary s orphan drug rules, it s holding applies generally to the Secretary s rulemaking authority under 340B. Under the PhRMA decision, the Secretary has no rulemaking authority to issue a mega regulation establishing legally binding rules for the 340B program covering other matters. Thus, the Secretary has no rulemaking authority to restrict 340B pricing to use of drugs by tribal health programs to fill prescriptions issued by tribal employees serving patients at tribal clinics. Furthermore, this would be an attempt to arbitrarily limit the patient/provider relationship under which tribal health programs administer the delivery of services authorized by federal law. Furthermore, tribal health programs conducted under ISDEAA agreements are not subject to regulation by the Secretary or HRSA in the same manner as PHS grantees. The fact that tribal health programs are included in the definition of FQHCs does not make them subject to regulation by HRSA or the Secretary based upon a notion of FQHC look-alike status. Thus, tribal health programs should not be swept into a mega-regulation applicable to other FQHCs based upon a false notion of FQHC look-alike status. Rather, they should be exempted. We recognize that the patient requirement in 340B(a)(5)(B) is statutory. We are not suggesting that tribal health programs be exempt from the statutory requirement that they not resell or transfer 340B priced to persons who are not patients. However, the mega-regulation could restrict what it means to be a patient in a manner that conflicts with how tribal health programs deliver services to patients under their ISDEAA agreements. The government-togovernment relationship inherent in ISDEAA contracts and compacts is very different from the federal grant relationship governing funding and regulation of other FQHCs such as community health center grantees under 330 of the PHS Act. The notion of FQHC look-alike status does not bridge this gap to allow HRSA to redefine by regulation or policy guidance who is a patient of a tribal health program. Serving Non-Eligible Individuals At the same time that HRSA may seek to restrict use of the 340B program by tribal health programs, the IHS is also discouraging use of the VA prime vendor drug discount program by tribes and tribal organizations serving non-eligible individuals under 813(c)(2) of the Indian Health Care Improvement Act (IHCIA). 9 The 340B program and the VA prime vendor discount program are the two primary ways that tribes and tribal organizations purchase prescription drugs at a discount, saving the federal government millions of dollars in drug costs 9 The VA prime vendor program is authorized under 38 U.S.C

9 to serve AI/AN. In the attached statement entitled IHCIA Section 813; Services to Ineligibles, IHS apparently disagrees with how Congress amended 813 to allow tribes and tribal organizations to serve otherwise non-eligible individuals. IHS advises tribes and tribal organizations not to use the VA prime vendor program to serve non-eligible individuals under 813(c)(2). The reason given is that tribes accessing the Prime Vendor program for use by a large number of ineligibles under section 813 could place the Prime Vendor access at risk for tribes and the IHS because this may constitute diversion from federal purposes. Subparagraph 813(c)(2) delegates to the governing bodies of Indian tribes and tribal organizations the authority to determine whether health services should be provided under their ISDEAA agreements to otherwise non-eligible individuals. 10 It also provides that [a]ny services provided by the Indian tribe or tribal organization pursuant to a determination made under this subparagraph shall be deemed to be provided under the agreement entered into by the Indian tribe or tribal organization under the [ISDEAA]. This makes 102(d) of the ISDEAA applicable, extending FTCA coverage for medical torts to tribes, tribal organizations, and their employees providing services to non-eligible individuals under 813(c)(2). 11 It also extends access to discount drug pricing under 340B and the VA prime vendor programs, because the services to non-eligible individuals are deemed as a matter of law to be provided under their ISDEAA agreements. Subsection 105(k) of the ISDEAA 12 authorizes tribes and tribal organizations carrying out ISDEAA agreements to access federal prime vendor drug discount programs. IHS is authorized under 813(c)(1) to serve otherwise non-eligible individuals at its directly operated facilities. IHS is listed in 38 U.S.C. 8126(b)(3) as a federal agency which can access the VA discount program. Indian tribes and tribal organizations may serve otherwise non-eligible individuals under 813(c)(2) and may access the VA prime vendor program under 105(k) of the ISDEAA. How, then, does serving non-eligible individuals under these federal authorities constitute diversion from federal purposes? The IHS statement does not answer this question. The IHS statement also insists that tribal health programs must charge non-eligible individuals served under 813(c)(2) Secretarial rates for pharmacy services based on 813(c)(3), which makes non-eligible individuals receiving health services provided by the Service liable for payment according to a schedule of charges prescribed by the Secretary. This schedule of charges, however, does not apply to non-eligible individuals served by tribal health programs; only to non-eligible individuals served by the IHS under 813(c)(1). The IHS statement attempts to bridge this gap by asserting that tribes step into the shoes of the Secretary when they make determinations under 813(c)(2) to serve non-eligible individuals. This is incorrect. Subparagraph 813(c)(2) delegates this authority to tribal governments without IHS approval U.S.C. 1680c(c)(2). 11 Subparagraph 813(c)(2) also specifically extends FTCA coverage for non-medical torts by making 314 of Public Law applicable U.S.C. 450j(k).

10 Conclusion Tribal health programs rely on 340B drug discount pricing in providing pharmacy services to their service populations. If HRSA restricts tribal access to 340B pricing, it could have serious repercussions for tribal health programs. Neither HRSA nor the IHS has afforded tribes and tribal organizations consultation on these proposals, which must take place under the Department s and HRSA s tribal consultation policies, before any significant changes to the 340B program affecting tribal health programs are proposed. The purpose of this paper is to call attention to this problem and request that tribes and tribal organizations be exempt from any forthcoming regulations of 340B drugs or, if they are not exempt, that tribal consultation on these issues take place.

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