The Medicare Shared Savings Program (MSSP) launched in 2012. For a variety of details regarding the MSSP, including all previously released regulations, FAQs and other guidance, visit the CMS website devoted to the program.
On January 10, 2013, CMS announced 106 new ACOs participating in the Shared Savings, Advanced Payment Model or Pioneer ACO programs. Additional information about the Shared Savings Program is available here. In a related event, note that CMS, as part of its Medicare & Medicaid Research Review (MMRR) Group collaborative, hosted between February 4-11 an online discussion forum with Rutgers University health economist, Derek DeLia, on how ACOs share savings with Medicare. Details are available here.
On April 5, 2013, the Medicare Payment Advisory Commission (MedPAC) received an update on CMS’s current ACO initiatives. Commissioners discussed these models’ designs, as well as ACOs’ strengths, weaknesses and geographic distribution relative to Medicare Advantage (MA) plans.
On June 13, Sen. Ron Wyden (D-OR) delivered a keynote address at a National ACO Summit in which he discussed ACO reforms, noting, for instance, “the attribution rule needs to be changed to allow providers to specialize in chronic care.”
On July 8, CMS released the CY 2014 Physician Fee Schedule proposed rule, part of which, among other ACO-related issues, addresses ACO quality benchmarking issues. On this note, “CMS proposes to includ[e] data submitted by the Shared Savings Program and Pioneer ACOs to set the benchmark for the 2014 performance period.” Also see the accompanying quality-focused fact sheet. Comments are due on September 6, 2013.
On August 9, SAMHSA issued a 10-part technical assistance report, Medicaid Handbook: Interface with Behavioral Health Services, that broadly examines Medicaid’s role in financing mental health and substance abuse care. Several “modules” that comprise the handbook – which span such topics as Medicaid State Plans and behavioral health service providers – relate to ACA implications; for example, the Medicaid expansion under section 2001; health home initiatives under section 2703; and Accountable Care Organizations under section 3022.
On a related note – but specific to Medicaid – on August 30, CMS disseminated a letter to state officials providing guidance on Medicaid shared savings reimbursement models intending to incentivize improved quality and outcomes while reducing Medicaid program costs. In particular, the letter providers guidance regarding a number of details states should consider in implementing these models, including: background on standard shared savings reimbursement models; methodologies for distributing payments; actuarial analysis to determine bona fide changes in cost trends; risk- and gain-sharing arrangements; and targeting of specific providers and patient populations. The letter concludes with a directive to ensure the standard State-Federal share of Medicaid-related expenses is maintained throughout these programs.
On December 20, 2013, CMS announced the Pioneer ACO Model RFI (see here). On January 28, 2014, CMS convened an eHealth provider webinar to provide information on ACOs, with a more extensive discussion of the various ACO models (Pioneer, Advance Payment, Comprehensive ESRD Initiative; and MSSP). See here. On January 30, CMS released interim findings on a number of delivery system reforms underway – including the MSSP and Pioneer ACOs (first-year evaluation report here). A CMS blog post and a press release on these findings are available here and here, respectively.
On January 30, 2014, CMS released interim findings on a number of delivery system reforms underway, including those related to Medicare ACOs, including Pioneer ACOs, as well as (the pre-ACA) Physician Group Practice (PGP) demonstration and the Bundled Payments for Care Improvement (BPCI) initiative. For more information, see here (CMS fact sheet); here (CMS blog post); and here (Pioneer ACO interim evaluation).
CMS intends to hold a National Provider Call (registration) on April 8, 2014 on the application process for the MSSP ACOs’ January 1, 2015 start date. Among other topics, CMS will discuss key application dates (also see the agency’s MSSP homepage) and Notice of Intent to Apply submission, as well as provide time for Q&A. Additional details follow.
On May 6, CMS posted a video pertaining to the Comprehensive ESRD Care Initiative, titled “Making the ACO Business Case.”
On May 8, CMS issued a revised fact sheet, exploring “what providers need to know” about ACOs. The agency also updated its fact sheets on the MSSP final rule (here); MSSP engagement for rural providers (here); CMMI’s Advance Payment Model demo (here); and the methodology for determining shared savings and losses (here).
On June 16, MedPAC submitted comments to the CMS in which the Commission outlined several short- and long-term issues that it believes warrant consideration by the agency as the ACO model evolves. These issues include those that are reconcilable via both administrative action by CMS, as well as others that require a legislative change.
On June 26, CMS sent a proposed rule to the OMB for review that addresses changes to the MSSP and “contains provisions relating to Medicare payments to providers of services and suppliers participating in Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program.” These changes would apply to existing ACOs and approved ACO applicants participating in the program beginning January 1, 2016. This is the final step prior to the promulgation of the rule in the Federal Register.
On October 2, the OIG issued aproposed rule delineating revisions to Medicare and Medicaid safe harbors under the anti-kickback statute, as well as amendments to civil monetary penalty (CMP) rules pertaining to beneficiary inducements and gainsharing. Comments are due by 5pm ET on Dec. 2, 2014.
On October 8, CMS announced that in 2012, the first Medicare Pioneer ACOs performance year, Pioneer ACOs reduced expenditures for assigned Medicare beneficiaries by as much as 7.1%. Others exceeded cost benchmarks by up to 5.2%. The following year, those remaining in the program posted a similar range of between 7.0% savings and 5.6% losses relative to their benchmark. Also: year 1 and year 2 quality results.
On October 15, CMS announced (fact sheet; FAQs; online application) the availability of up to $114 million in ACA funding to support roughly 75 ACOs participating in the MSSP. This funding – made available in the form of upfront investments (or pre-paid shared savings) under the newly-launched ACO Investment Model (AIM) – builds on theAdvance Payment Model and is intended to support providers who might otherwise lack the capital to make requisite infrastructure changes to form ACOs and to spur current MSSP ACOs “to transition to arrangements with greater financial risk.” CMS clarifies that “[t]he application deadline for organizations that started in the [MSSP] in 2012 or 2013 will be December 1, 2014. Applications will be available in the summer of 2015 for ACOs that started in the [MSSP] in 2014 or will start in 2016.”
On October 16, CMS and OIG issued a joint notice announcing the continuation of the effective date – through Nov. 2, 2015 – of an interim final regulation that permits waivers of specified Medicare fraud and abuse provisions that may be necessary for providers to implement ACOs under the MSSP. Importantly, CMS confirms in the notice that it is “currently developing a proposed rule regarding the [MSSP],” acknowledging stakeholders’ concerns that “certain modifications to the [MSSP] regulations were necessary.” Some preliminary details of this forthcoming proposed rule are available here.
On October 28, the IRS issued interim guidance to healthcare facilities with tax-exempt bond financing that are participating as ACOs in the MSSP. Comments are due by Jan. 22, 2015.
On Oct. 31, CMS posted the CY 15 Medicare Physician Fee Schedule (MPFS) final rule with comment (fact sheet) addressing a number of ACA provisions related to physician payment and quality. Citing the April 1 doc fix, the Protecting Access to Medicare Act (PAMA) of 2014, CMS notes that a 0.0% update applies between Jan. 1, 2015, and March 31, 2015, for a conversion factor (CF) of $35.8013 during that period (after budget neutrality adjustments). The SGR calculation applies thereafter (April 1, 2015-Dec. 31, 2015), with the final rule conveying a 21.2% payment reduction for this period relative to the CY14 CF, with a CF of $28.2239.
On Dec. 1, CMS issued a proposed rule delineating major changes to the MSSP – methodological and payment policy changes intended to improve the program’s overall construct via a renewed emphasis on primary care and performance-based risk arrangements. In general, the provisions, once finalized and unless otherwise noted, would be applicable for the 2016 performance year for all participating organizations. A CMS fact sheet is available here and a press release here. Comments on the proposed rule are due by Feb. 6, 2015.
On Dec. 1, CMS released (announcement here) a proposal (here) to change several program areas such as beneficiary assignment, data sharing, performance risk models, eligibility requirements, participation agreement renewals, and compliance and monitoring. Also see a corresponding press release (here) and fact sheet (here).
On Dec. 22, CMS announced (blog post here) that 89 ACOs will join the Medicare Shared Savings Program in January, thus bringing the total number of organizations to 405 and increasing the number of beneficiaries impacted from 4.9 million to 7.2 million. See here, for list of new ACOs.
On Feb. 17, CMS updated the application cycle deadlines (see here) for program year 2016 of the MSSP.
On Mar. 19, CMS announced two National Provider Calls to be held on Apr. 7 and 21 (details here) to help providers with the Medicare Shared Savings Program Application process.
On Apr. 1, CMS issued a memo delineating the Notice of Intent to Apply (NOI) process for to prospective MSSP applicants, as well as ACOs renewing for the next three-year agreement period.
On June 4, CMS released a final rule updating the Medicare Shared Savings Program, which, among other changes, establishes a new performance-based risk option (Track 3).
On June 25, CMS updated its eligibility criteria for its ACO Investment Model to allow for large rural Shared Savings Program ACOs and ACOs that have started in 2015 or will start in 2016.
On July 8, CMS posted the CY 16 Medicare Physician Fee Schedule (MPFS) proposed rule, which delineates payment policies impacting over one million physicians and other practitioners paid under the MPFS each year (see fact sheet here). Citing the latest doc fix (P.L. 114-10), the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), CMS effectuates the statutory 0.5% increase. The proposed rule addressed this provision of the ACA. Comments are due Sept. 8.
On Jan. 28, CMS released a proposed rule delineating revisions to the MSSP’s financial benchmarking approach, including the process for trending, adjusting, and updating MSSP accountable care organizations’ (ACOs) expenditure benchmarks and using regional – rather than national – cost trends. The proposals build on CMS’ June 2015 ACO final rule, which sought to encourage ongoing participation in the MSSP, though indicated that additional proposals would be forthcoming on benchmarking issues. Comments are due by Mar. 28.
On May 31, the period for organizations to submit a Notice of Intent to Apply (NOIA) closed for the Medicare Shared Savings Program.
On June 6, CMS released its final rule on incorporating regional fee-for-service expenditures into its approach for establishing, updating, and rebasing the historical benchmarks of Medicare Shared Savings Program (MSSP) Accountable Care Organizations (ACOs) following their initial three-year agreement periods. CMS says the changes make the benchmarks, which are the basis for shared savings or losses, “more independent of [an ACO’s] historical expenditures and more reflective of FFS spending in its region” over time. The final rule also addresses the administrative finality of financial reconciliation calculations and provides a new pathway for MSSP participants at one-sided risk to remain in that track for a fourth year – with no rebasing of the benchmark – before transitioning to two-sided risk.
On July 7, CMS released its calendar year (CY) 2017 Medicare Physician Fee Schedule (MPFS) proposed rule delineating wide-ranging Medicare Part B policies that would take effect on Jan. 1, 2017. The proposed rule also would expand the Medicare Diabetes Prevention Program Model, require transparency of certain Medicare Advantage (MA) data, continue the implementation of appropriate use criteria for advanced diagnostic imaging services, and make selected refinements to the Medicare Shared Savings Program, among other policies.
On Aug. 25, CMS released the 2015 performance year (PY) results on MSSP and Pioneer ACOs’ financial and quality performance.
On Oct. 25, CMS said it will reopen the application period for the Next Generation ACO model for the 2018 performance year, allowing more providers to participate in the model, which qualifies as a MACRA Advanced APM.
On Nov. 2, CMS released its CY 2017 Medicare Physician Fee Schedule (MPFS) final rule delineating wide-ranging Medicare Part B payment policies. CMS finalized a fee schedule conversion factor of 35.89 for physicians participating in Medicare Part B. CMS further notes that the policies contained in the rule would improve how Medicare pays for services for patients with multiple chronic conditions and mental and behavioral health issues.
On Dec. 20 CMS announced a new Innovation Center model, the Medicare ACO Track 1+ Model, beginning in 2018, that will test a payment design that incorporates more limited downside risk than is currently present in Tracks 2 or 3 of the Shared Savings Program.
On Jan. 18, CMS announced over 359,000 clinicians are confirmed to participate in four of CMS’ APMs in 2017: The Medicare Shared Savings Program (Shared Savings Program), Next Generation ACO Model, Comprehensive ESRD Care Model (CEC) and Comprehensive Primary CarePlus (CPC+) Model.
In Dec. 2018, CMS released a final rule (press release; fact sheet; blog post) affecting ACOs participating in the MSSP by offering only two tracks, BASIC and ENHANCED, for participating ACOs. The redesigned program, called “Pathways to Success,” encourages a transition to two-sided models and significantly limits opportunities for ACOs to continue in one-sided models.
SEC. 3022. MEDICARE SHARED SAVINGS PROGRAM. Title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) is amended by adding at the end the following new section: ‘‘SHARED SAVINGS PROGRAM ‘‘SEC. 1899 ø42 U.S.C. 1395jjj¿. (a) ESTABLISHMENT.— ‘‘(1) IN GENERAL.—Not later than January 1, 2012, the Secretary shall establish a shared savings program (in this section referred to as the ‘program’) that promotes accountability for a patient population and coordinates items and services under parts A and B, and encourages investment in infrastructure and redesigned care processes for high quality and efficient service delivery. Under such program— ‘‘(A) groups of providers of services and suppliers meeting criteria specified by the Secretary may work together to manage and coordinate care for Medicare fee-forservice beneficiaries through an accountable care organization (referred to in this section as an ‘ACO’); and ‘‘(B) ACOs that meet quality performance standards established by the Secretary are eligible to receive payments for shared savings under subsection (d)(2). ‘‘(b) ELIGIBLE ACOS.— ‘‘(1) IN GENERAL.—Subject to the succeeding provisions of this subsection, as determined appropriate by the Secretary, the following groups of providers of services and suppliers which have established a mechanism for shared governance are eligible to participate as ACOs under the program under this section: ‘‘(A) ACO professionals in group practice arrangements. ‘‘(B) Networks of individual practices of ACO professionals. ‘‘(C) Partnerships or joint venture arrangements between hospitals and ACO professionals. ‘‘(D) Hospitals employing ACO professionals. ‘‘(E) Such other groups of providers of services and suppliers as the Secretary determines appropriate. ‘‘(2) REQUIREMENTS.—An ACO shall meet the following requirements: ‘‘(A) The ACO shall be willing to become accountable for the quality, cost, and overall care of the Medicare feefor-service beneficiaries assigned to it. ‘‘(B) The ACO shall enter into an agreement with the Secretary to participate in the program for not less than a 3-year period (referred to in this section as the ‘agreement period’). ‘‘(C) The ACO shall have a formal legal structure that would allow the organization to receive and distribute payments for shared savings under subsection (d)(2) to participating providers of services and suppliers. ‘‘(D) The ACO shall include primary care ACO professionals that are sufficient for the number of Medicare feefor-service beneficiaries assigned to the ACO under subsection (c). At a minimum, the ACO shall have at least 5,000 such beneficiaries assigned to it under subsection (c) in order to be eligible to participate in the ACO program. ‘‘(E) The ACO shall provide the Secretary with such information regarding ACO professionals participating in the ACO as the Secretary determines necessary to support the assignment of Medicare fee-for-service beneficiaries to an ACO, the implementation of quality and other reporting requirements under paragraph (3), and the determination of payments for shared savings under subsection (d)(2). ‘‘(F) The ACO shall have in place a leadership and management structure that includes clinical and administrative systems. ‘‘(G) The ACO shall define processes to promote evidence-based medicine and patient engagement, report on quality and cost measures, and coordinate care, such as through the use of telehealth, remote patient monitoring, and other such enabling technologies. ‘‘(H) The ACO shall demonstrate to the Secretary that it meets patient-centeredness criteria specified by the Secretary, such as the use of patient and caregiver assessments or the use of individualized care plans. ‘‘(3) QUALITY AND OTHER REPORTING REQUIREMENTS.— ‘‘(A) IN GENERAL.—The Secretary shall determine appropriate measures to assess the quality of care furnished by the ACO, such as measures of— ‘‘(i) clinical processes and outcomes; ‘‘(ii) patient and, where practicable, caregiver experience of care; and ‘‘(iii) utilization (such as rates of hospital admissions for ambulatory care sensitive conditions). ‘‘(B) REPORTING REQUIREMENTS.—An ACO shall submit data in a form and manner specified by the Secretary on measures the Secretary determines necessary for the ACO to report in order to evaluate the quality of care furnished by the ACO. Such data may include care transitions across health care settings, including hospital discharge planning and post-hospital discharge follow-up by ACO professionals, as the Secretary determines appropriate. ‘‘(C) QUALITY PERFORMANCE STANDARDS.—The Secretary shall establish quality performance standards to assess the quality of care furnished by ACOs. The Secretary shall seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both for purposes of assessing such quality of care. ‘‘(D) OTHER REPORTING REQUIREMENTS.—The Secretary may, as the Secretary determines appropriate, incorporate reporting requirements and incentive payments related to the physician quality reporting initiative (PQRI) under section 1848, including such requirements and such payments related to electronic prescribing, electronic health records, and other similar initiatives under section 1848, and may use alternative criteria than would otherwise apply under such section for determining whether to make such payments. The incentive payments described in the preceding sentence shall not be taken into consideration when calculating any payments otherwise made under subsection (d). ‘‘(4) NO DUPLICATION IN PARTICIPATION IN SHARED SAVINGS PROGRAMS.—A provider of services or supplier that participates in any of the following shall not be eligible to participate in an ACO under this section: ‘‘(A) A model tested or expanded under section 1115A that involves shared savings under this title, or any other program or demonstration project that involves such shared savings. ‘‘(B) The independence at home medical practice pilot program under section 1866E. ‘‘(c) ASSIGNMENT OF MEDICARE FEE-FOR-SERVICE BENEFICIARIES TO ACOS.—The Secretary shall determine an appropriate method to assign Medicare fee-for-service beneficiaries to an ACO based on their utilization of primary care services provided under this title by an ACO professional described in subsection (h)(1)(A). ‘‘(d) PAYMENTS AND TREATMENT OF SAVINGS.— ‘‘(1) PAYMENTS.— ‘‘(A) IN GENERAL.—Under the program, subject to paragraph (3), payments shall continue to be made to providers of services and suppliers participating in an ACO under the original Medicare fee-for-service program under parts A and B in the same manner as they would otherwise be made except that a participating ACO is eligible to receive payment for shared savings under paragraph (2) if— ‘‘(i) the ACO meets quality performance standards established by the Secretary under subsection (b)(3); and ‘‘(ii) the ACO meets the requirement under subparagraph (B)(i). ‘‘(B) SAVINGS REQUIREMENT AND BENCHMARK.— ‘‘(i) DETERMINING SAVINGS.—In each year of the agreement period, an ACO shall be eligible to receive payment for shared savings under paragraph (2) only if the estimated average per capita Medicare expenditures under the ACO for Medicare fee-for-service beneficiaries for parts A and B services, adjusted for beneficiary characteristics, is at least the percent specified by the Secretary below the applicable benchmark under clause (ii). The Secretary shall determine the appropriate percent described in the preceding sentence to account for normal variation in expenditures under this title, based upon the number of Medicare fee-for-service beneficiaries assigned to an ACO. ‘‘(ii) ESTABLISH AND UPDATE BENCHMARK.—The Secretary shall estimate a benchmark for each agreement period for each ACO using the most recent available 3 years of per-beneficiary expenditures for parts A and B services for Medicare fee-for-service beneficiaries assigned to the ACO. Such benchmark shall be adjusted for beneficiary characteristics and such other factors as the Secretary determines appropriate and updated by the projected absolute amount of growth in national per capita expenditures for parts A and B services under the original Medicare fee-forservice program, as estimated by the Secretary. Such benchmark shall be reset at the start of each agreement period. ‘‘(2) PAYMENTS FOR SHARED SAVINGS.—Subject to performance with respect to the quality performance standards established by the Secretary under subsection (b)(3), if an ACO meets the requirements under paragraph (1), a percent (as determined appropriate by the Secretary) of the difference between such estimated average per capita Medicare expenditures in a year, adjusted for beneficiary characteristics, under the ACO and such benchmark for the ACO may be paid to the ACO as shared savings and the remainder of such difference shall be retained by the program under this title. The Secretary shall establish limits on the total amount of shared savings that may be paid to an ACO under this paragraph. ‘‘(3) MONITORING AVOIDANCE OF AT-RISK PATIENTS.—If the Secretary determines that an ACO has taken steps to avoid patients at risk in order to reduce the likelihood of increasing costs to the ACO the Secretary may impose an appropriate sanction on the ACO, including termination from the program. ‘‘(4) TERMINATION.—The Secretary may terminate an agreement with an ACO if it does not meet the quality performance standards established by the Secretary under subsection (b)(3). ‘‘(e) ADMINISTRATION.—Chapter 35 of title 44, United States Code, shall not apply to the program. ‘‘(f) WAIVER AUTHORITY.—The Secretary may waive such requirements of sections 1128A and 1128B and title XVIII of this Act as may be necessary to carry out the provisions of this section. ‘‘(g) LIMITATIONS ON REVIEW.—There shall be no administrative or judicial review under section 1869, section 1878, or otherwise of— ‘‘(1) the specification of criteria under subsection (a)(1)(B); ‘‘(2) the assessment of the quality of care furnished by an ACO and the establishment of performance standards under subsection (b)(3); ‘‘(3) the assignment of Medicare fee-for-service beneficiaries to an ACO under subsection (c); ‘‘(4) the determination of whether an ACO is eligible for shared savings under subsection (d)(2) and the amount of such shared savings, including the determination of the estimated average per capita Medicare expenditures under the ACO for Medicare fee-for-service beneficiaries assigned to the ACO and the average benchmark for the ACO under subsection (d)(1)(B); ‘‘(5) the percent of shared savings specified by the Secretary under subsection (d)(2) and any limit on the total amount of shared savings established by the Secretary under such subsection; and ‘‘(6) the termination of an ACO under subsection (d)(4). ‘‘(h) DEFINITIONS.—In this section: ‘‘(1) ACO PROFESSIONAL.—The term ‘ACO professional’ means— ‘‘(A) a physician (as defined in section 1861(r)(1)); and ‘‘(B) a practitioner described in section 1842(b)(18)(C)(i). ‘‘(2) HOSPITAL.—The term ‘hospital’ means a subsection (d) hospital (as defined in section 1886(d)(1)(B)). ‘‘(3) MEDICARE FEE-FOR-SERVICE BENEFICIARY.—The term ‘Medicare fee-for-service beneficiary’ means an individual who is enrolled in the original Medicare fee-for-service program under parts A and B and is not enrolled in an MA plan under part C, an eligible organization under section 1876, or a PACE program under section 1894. øSubsections (i)-(k) added by section 10307¿ ‘‘(i) OPTION TO USE OTHER PAYMENT MODELS.— ‘‘(1) IN GENERAL.—If the Secretary determines appropriate, the Secretary may use any of the payment models described in paragraph (2) or (3) for making payments under the program rather than the payment model described in subsection (d). ‘‘(2) PARTIAL CAPITATION MODEL.— ‘‘(A) IN GENERAL.—Subject to subparagraph (B), a model described in this paragraph is a partial capitation model in which an ACO is at financial risk for some, but not all, of the items and services covered under parts A and B, such as at risk for some or all physicians’ services or all items and services under part B. The Secretary may limit a partial capitation model to ACOs that are highly integrated systems of care and to ACOs capable of bearing risk, as determined to be appropriate by the Secretary. ‘‘(B) NO ADDITIONAL PROGRAM EXPENDITURES.—Payments to an ACO for items and services under this title for beneficiaries for a year under the partial capitation model shall be established in a manner that does not result in spending more for such ACO for such beneficiaries than would otherwise be expended for such ACO for such beneficiaries for such year if the model were not implemented, as estimated by the Secretary. ‘‘(3) OTHER PAYMENT MODELS.— ‘‘(A) IN GENERAL.—Subject to subparagraph (B), a model described in this paragraph is any payment model that the Secretary determines will improve the quality and efficiency of items and services furnished under this title. ‘‘(B) NO ADDITIONAL PROGRAM EXPENDITURES.—Subparagraph (B) of paragraph (2) shall apply to a payment model under subparagraph (A) in a similar manner as such subparagraph (B) applies to the payment model under paragraph (2). ‘‘(j) INVOLVEMENT IN PRIVATE PAYER AND OTHER THIRD PARTY ARRANGEMENTS.—The Secretary may give preference to ACOs who are participating in similar arrangements with other payers. ‘‘(k) TREATMENT OF PHYSICIAN GROUP PRACTICE DEMONSTRATION.—During the period beginning on the date of the enactment of this section and ending on the date the program is established, the Secretary may enter into an agreement with an ACO under the demonstration under section 1866A, subject to rebasing and other modifications deemed appropriate by the Secretary.’’.