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6401 - Provider Screening and Other Enrollment Requirements under Medicare, Medicaid and CHIP

 
Implementation Status 
Statutory Text 

Summary

Amended by section 10603 of the Senate Manager’s Amendment and section 1304 of HCERA. Directs the Secretary of HHS to, not later than September 23, 2010, establish procedures for
conducting provider and supplier screenings (according to the risk of fraud, waste, and abuse for each provider/supplier category) under Medicare, Medicaid, and CHIP.  Such screening is to include a licensure check, and as determined by the Secretary, potentially other screening mechanisms.  Subject to certain exceptions, imposes a fee of $500 in 2010 (adjusted thereafter based on the CPI-U) on institutional providers and suppliers for such screening (but not to individual physicians).  Specifies certain requirements relative to the application of the screening to new and current providers and suppliers.  Calls for a provisional period of enhanced oversight for new providers and suppliers, including a temporary moratorium on enrollment of new providers and suppliers if the Secretary determines it appropriate to prevent or combat fraud, waste, or abuse.  Authorizes the Secretary of HHS to impose a 90-day period of enhanced oversight of initial claims of DME suppliers.  Sets forth increased disclosure requirements such that any new or revalidating providers
or suppliers must disclose any current or previous affiliation (directly or indirectly) with a provider or supplier that has uncollected debt, has been or is subject to a payment suspension under a federal health care program, or has had its billing privileges denied or revoked. Calls for the establishment of compliance programs that contain certain core elements for providers or suppliers.

Last updated: (October 31, 2016)  

Implementation Status

 
Summary 
Statutory Text 

Prior to January 2013, in February 2011, CMS published a final rule effectuating this provision, followed by the issuance later that fall of an information collection request that sets forth a Medicaid SPA preprint for use by states when implementing this provision.  CMS issued a subsequent informational bulletin in December 2011, followed by another in August 2012, on this provision.  More information regarding the implementation of this provision, including as it pertains to the application fee as well as revalidation efforts, is available on CMS’ webpage for this initiative.

2013

On April 24, 2013, CMS issued a proposed rule increasing rewards for whistle blowers to report instances of fraud and abuse in the Medicare program.  The rule would also tighten provider enrollment standards by, for example, allowing CMS to reject enrollment of providers affiliated with an entity that has unpaid Medicare debts.  CMS could also deny billings from individuals with felony convictions and ban providers who have demonstrated a pattern of abusive billing practices.  A fact sheet regarding the rule is available here. Comments are due by 5pm ET on June 28.

On June 6, as part of a broader announcement around newly redesigned Medicare Summary Notices (MSNs), CMS highlighted several developments in the realm of program integrity improvements spurred by provisions under the ACA, including the release of new Medicare provider/supplier revocation data.  A press release is available here.

On July 26, 2013, CMS issued a notice, effective July 30, 2013, leveraging its authority under this section to impose temporary (six-month) enrollment moratoria in certain fraud-prone areas.  Under this notice, the temporary enrollment moratoria will apply to newly-enrolling home health agencies (in Miami and Chicago) and ground ambulance suppliers (in Houston). A CMS press release is available here.

On December 16, 2013, CMS posted a revised MLN Matters article (SE1126).

2014

On January 30, 2014, CMS issued a notice announcing the extension and establishment of temporary moratoria on the enrollment of new ground ambulance suppliers and home health agencies in designated geographic locations. The agency’s latest action, which leverages authority provided under section 6401 of the Affordable Care Act (ACA), reflects CMS’ “second wave” of enrollment moratoria for these providers/suppliers as a means to further “prevent and combat fraud, waste, and abuse” in Medicare, Medicaid, and CHIP. A CMS Survey & Certification letter is available here that delineates further information regarding the imposition of the HHA Phase 2 enrollment moratoria criteria.

On April 14, CMS issued a MLN Matters article regarding the phased-in implementation of the ACA-required fingerprint-based background checks for certain providers and suppliers enrolling in Medicare. The screenings will apply to newly enrolling DMEPOS suppliers and HHAs, specifically individuals with at least a 5% ownership interest, as well as “providers and suppliers who have been elevated to the high risk category in accordance with enrollment screening regulations.”

On July 29, CMS issued a six-month extension of its temporary moratoria on newly enrolling HHAs in the Chicago, Fort Lauderdale, Detroit, Dallas, Houston and Miami metropolitan areas, as well as on new ground ambulance suppliers in the Houston and Philadelphia areas. The moratoria extension takes effect on July 30 and can be lifted earlier than 6 months (or further extended in 6-month increments) via publication of a Federal Register notice. A CMS press release is available here.

On August 1, CMS issued a reinstatement of an existing program integrity-related information collection pursuant to this provision of the ACA titled, “Letter Requesting Waiver of Medicare/Medicaid Enrollment Application Fee; Submission of Fingerprints; Submission of Medicaid Identifying Information; Medicaid Site Visit and Re-screening. Also, on a related note, in August, CMS released a MLN Matters article to educate Medicare providers and suppliers providers subject to fingerprint-based background check on these requirements. Finally, in August, CMS issued a MLN Matters article delineating the applicability of new provider enrollment moratoria criteria for certain HHAs and Part B ambulance suppliers in select geographic locations.

In the October 2 edition of MLN Connects, CMS underscores the need for provider/supplier compliance with MACs’ request for fingerprint-based background checks for certain providers/suppliers pursuant to a requirement effective on August 6, 2014 (details).

On Dec. 3, CMS issued a final rule to implement new safeguards intended to reduce Medicare fraud through enhanced provider oversight and beneficiary protections.

2015

On Jan. 29, 2015, CMC announced the extension of the ACA-imposed temporary moratoria on enrollment of new ambulance suppliers and HHAs in select metropolitan areas (announcement here).

On June 1, CMS released guidance on the implementation of Fingerprint-Based Criminal Background Checks for Medicaid providers.

On July 16, CMS released a proposed rule that revises the requirements that long-term care facilities must meet to participate in the Medicare and Medicaid programs. The rule addressed this provision of the ACA. Comments are due Sept. 14.

On Dec. 30, CMS issued a final rule delineating the prior authorization process for certain DMEPOS. 

2016

On Feb. 2, CMS released a notice announcing the extension of temporary moratoria on the enrollment of new Medicare Part B ground ambulance suppliers and Medicare home health agencies, subunits, and branch locations in certain specified locations.

On Feb. 11, CMS released a final rule that requires Medicare Parts A and B health care providers and suppliers to report and return overpayments made to them by the program. A separate final rule, published in 2014, addresses overpayments to Part C and D participants.

On Feb. 22, CMS in a blog post discussed recent program integrity efforts under this provision.

On Feb. 25, CMS released a proposed rule outlining new program integrity-focused screening and enrollment requirements of Medicare, Medicaid and CHIP providers and suppliers.

On Apr. 26, HHS OIG released a report evaluating early implementation for a program that enhances enrollment screening of Medicare providers.

On May 6, GAO released a report finding that improved guidance is needed to support efforts for Medicaid Managed Care providers.

On May 23, HHS released its spring 2016 Regulatory Agenda. The semi-annual agenda provides a non-exhaustive inventory of proposed and final rules the agency plans to release in the foreseeable future, along with generally non-binding “target dates” for issuing those rules via the Federal Register.

On May 25, the House Energy and Commerce Subcommittee on Oversight and Investigations held hearing on combating improper payments and ineligible providers.

On May 25, the HHS Office of Inspector General (OIG) released a report addressing provider ownership and enrollment Medicaid.

On May 25, the HHS OIG released a report addressing provider ownership and enrollment Medicare.

On May 25, HHS OIG released a report addressing provider enrollment screening in Medicaid.

On May 25, GAO released a report highlighting CMS progress in implementing previous recommendations related to oversight of providers enrolling in the agency’s Provider Enrollment, Chain and Ownership System (PECOS).

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 Sept. 29, CMS issued a final rule delineating major reforms to Medicare and Medicaid conditions of participation (CoPs) impacting long-term care (LTC) facilities. In particular, the rule stipulates new prohibitions on the use of pre-dispute binding arbitration agreements as a condition of admission to the facility, among other reforms. The rule addresses these provisions of the ACA.

November: As part of the 2017 Medicare Physician Fee Schedule final rule released on Nov. 2, CMS made modifications to the notice requirements when CMS or a Medicare contractor has decided to put into effect an offset or recoupment.  The change ensures that a Medicare contractor does not have to provide separate notice to both the obligated provider and the “applicable provider” when the two share the same Taxpayer Identification Number (TIN).

Statutory Text

 
Implementation Status 
Summary 

SEC. 6401. PROVIDER SCREENING AND OTHER ENROLLMENT REQUIREMENTS UNDER MEDICARE, MEDICAID, AND CHIP. (a) MEDICARE.—Section 1866(j) of the Social Security Act (42 U.S.C. 1395cc(j)) is amended— (1) in paragraph (1)(A), by adding at the end the following: ‘‘Such process shall include screening of providers and suppliers in accordance with paragraph (2), a provisional period of enhanced oversight in accordance with paragraph (3), disclosure requirements in accordance with paragraph (4), the imposition of temporary enrollment moratoria in accordance with paragraph (5), and the establishment of compliance programs in accordance with paragraph (6).’’; (2) by redesignating paragraph (2) as paragraph (8); and øReplaced by section 10603(b)¿ (3) by inserting after paragraph (1) the following: ‘‘(2) PROVIDER SCREENING.— ‘‘(A) PROCEDURES.—Not later than 180 days after the date of enactment of this paragraph, the Secretary, in consultation with the Inspector General of the Department of Health and Human Services, shall establish procedures under which screening is conducted with respect to providers of medical or other items or services and suppliers under the program under this title, the Medicaid program under title XIX, and the CHIP program under title XXI. ‘‘(B) LEVEL OF SCREENING.—The Secretary shall determine the level of screening conducted under this paragraph according to the risk of fraud, waste, and abuse, as determined by the Secretary, with respect to the category of provider of medical or other items or services or supplier. Such screening— ‘‘(i) shall include a licensure check, which may include such checks across States; and ‘‘(ii) may, as the Secretary determines appropriate based on the risk of fraud, waste, and abuse described in the preceding sentence, include— ‘‘(I) a criminal background check; ‘‘(II) fingerprinting; ‘‘(III) unscheduled and unannounced site visits, including preenrollment site visits; ‘‘(IV) database checks (including such checks across States); and ‘‘(V) such other screening as the Secretary determines appropriate. ‘‘(C) APPLICATION FEES.—øAs revised by section 10603(a)¿ ‘‘(i) INSTITUTIONAL PROVIDERS.—Except as provided in clause (ii), the Secretary shall impose a fee on each institutional provider of medical or other items or services or supplier (such as a hospital or skilled nursing facility) with respect to which screening is conducted under this paragraph in an amount equal to— ‘‘(I) for 2010, $500; and ‘‘(II) for 2011 and each subsequent year, the amount determined under this clause for the preceding year, adjusted by the percentage change in the consumer price index for all urban consumers (all items; United States city average) for the 12- month period ending with June of the previous year. ‘‘(ii) HARDSHIP EXCEPTION; WAIVER FOR CERTAIN MEDICAID PROVIDERS.—The Secretary may, on a caseby-case basis, exempt a provider of medical or other items or services or supplier from the imposition of an application fee under this subparagraph if the Secretary determines that the imposition of the application fee would result in a hardship. The Secretary may waive the application fee under this subparagraph for providers enrolled in a State Medicaid program for whom the State demonstrates that imposition of the fee would impede beneficiary access to care. ‘‘(iii) USE OF FUNDS.—Amounts collected as a result of the imposition of a fee under this subparagraph shall be used by the Secretary for program integrity efforts, including to cover the costs of conducting screening under this paragraph and to carry out this subsection and section 1128J. ‘‘(D) APPLICATION AND ENFORCEMENT.— ‘‘(i) NEW PROVIDERS OF SERVICES AND SUPPLIERS.— The screening under this paragraph shall apply, in the case of a provider of medical or other items or services or supplier who is not enrolled in the program under this title, title XIX , or title XXI as of the date of enactment of this paragraph, on or after the date that is 1 year after such date of enactment. ‘‘(ii) CURRENT PROVIDERS OF SERVICES AND SUP- PLIERS.—The screening under this paragraph shall apply, in the case of a provider of medical or other items or services or supplier who is enrolled in the program under this title, title XIX, or title XXI as of such date of enactment, on or after the date that is 2 years after such date of enactment. ‘‘(iii) REVALIDATION OF ENROLLMENT.—Effective beginning on the date that is 180 days after such date of enactment, the screening under this paragraph shall apply with respect to the revalidation of enrollment of a provider of medical or other items or services or supplier in the program under this title, title XIX, or title XXI. ‘‘(iv) LIMITATION ON ENROLLMENT AND REVALIDA- TION OF ENROLLMENT.—In no case may a provider of medical or other items or services or supplier who has not been screened under this paragraph be initially enrolled or reenrolled in the program under this title, title XIX, or title XXI on or after the date that is 3 years after such date of enactment. ‘‘(E) EXPEDITED RULEMAKING.—The Secretary may promulgate an interim final rule to carry out this paragraph. ‘‘(3) PROVISIONAL PERIOD OF ENHANCED OVERSIGHT FOR NEW PROVIDERS OF SERVICES AND SUPPLIERS.— ‘‘(A) IN GENERAL.—The Secretary shall establish procedures to provide for a provisional period of not less than 30 days and not more than 1 year during which new providers of medical or other items or services and suppliers, as the Secretary determines appropriate, including categories of providers or suppliers, would be subject to enhanced oversight, such as prepayment review and payment caps, under the program under this title, the Medicaid program under title XIX. and the CHIP program under title XXI. ‘‘(B) IMPLEMENTATION.—The Secretary may establish by program instruction or otherwise the procedures under this paragraph. ‘‘(4) 90-DAY PERIOD OF ENHANCED OVERSIGHT FOR INITIAL CLAIMS OF DME SUPPLIERS.—øAs added by section 1304 of HCERA¿ For periods beginning after January 1, 2011, if the Secretary determines that there is a significant risk of fraudulent activity among suppliers of durable medical equipment, in the case of a supplier of durable medical equipment who is within a category or geographic area under title XVIII identified pursuant to such determination and who is initially enrolling under such title, the Secretary shall, notwithstanding sections 1816(c), 1842(c), and 1869(a)(2), withhold payment under such title with respect to durable medical equipment furnished by such supplier during the 90-day period beginning on the date of the first submission of a claim under such title for durable medical equipment furnished by such supplier. øSubsequent paragraphs reflect redesignation by section 1304 of HCERA¿ ‘‘(5) INCREASED DISCLOSURE REQUIREMENTS.— ‘‘(A) DISCLOSURE.—A provider of medical or other items or services or supplier who submits an application for enrollment or revalidation of enrollment in the program under this title, title XIX, or title XXI on or after the date that is 1 year after the date of enactment of this paragraph shall disclose (in a form and manner and at such time as determined by the Secretary) any current or previous affiliation (directly or indirectly) with a provider of medical or other items or services or supplier that has uncollected debt, has been or is subject to a payment suspension under a Federal health care program (as defined in section 1128B(f)), has been excluded from participation under the program under this title, the Medicaid program under title XIX, or the CHIP program under title XXI, or has had its billing privileges denied or revoked. ‘‘(B) AUTHORITY TO DENY ENROLLMENT.—If the Secretary determines that such previous affiliation poses an undue risk of fraud, waste, or abuse, the Secretary may deny such application. Such a denial shall be subject to appeal in accordance with paragraph (7). ‘‘(6) AUTHORITY TO ADJUST PAYMENTS OF PROVIDERS OF SERVICES AND SUPPLIERS WITH THE SAME TAX IDENTIFICATION NUMBER FOR PAST-DUE OBLIGATIONS.— ‘‘(A) IN GENERAL.—Notwithstanding any other provision of this title, in the case of an applicable provider of services or supplier, the Secretary may make any necessary adjustments to payments to the applicable provider of services or supplier under the program under this title in order to satisfy any past-due obligations described in subparagraph (B)(ii) of an obligated provider of services or supplier. ‘‘(B) DEFINITIONS.—In this paragraph: ‘‘(i) IN GENERAL.—The term ‘applicable provider of services or supplier’ means a provider of services or supplier that has the same taxpayer identification number assigned under section 6109 of the Internal Revenue Code of 1986 as is assigned to the obligated provider of services or supplier under such section, regardless of whether the applicable provider of services or supplier is assigned a different billing number or national provider identification number under the program under this title than is assigned to the obligated provider of services or supplier. ‘‘(ii) OBLIGATED PROVIDER OF SERVICES OR SUPPLIER.—The term ‘obligated provider of services or supplier’ means a provider of services or supplier that owes a past-due obligation under the program under this title (as determined by the Secretary). ‘‘(7) TEMPORARY MORATORIUM ON ENROLLMENT OF NEW PROVIDERS.— ‘‘(A) IN GENERAL.—The Secretary may impose a temporary moratorium on the enrollment of new providers of services and suppliers, including categories of providers of services and suppliers, in the program under this title, under the Medicaid program under title XIX, or under the CHIP program under title XXI if the Secretary determines such moratorium is necessary to prevent or combat fraud, waste, or abuse under either such program. ‘‘(B) LIMITATION ON REVIEW.—There shall be no judicial review under section 1869, section 1878, or otherwise, of a temporary moratorium imposed under subparagraph (A). ‘‘(8) COMPLIANCE PROGRAMS.— ‘‘(A) IN GENERAL.—On or after the date of implementation determined by the Secretary under subparagraph (C), a provider of medical or other items or services or supplier within a particular industry sector or category shall, as a condition of enrollment in the program under this title, title XIX, or title XXI, establish a compliance program that contains the core elements established under subparagraph (B) with respect to that provider or supplier and industry or category. ‘‘(B) ESTABLISHMENT OF CORE ELEMENTS.—The Secretary, in consultation with the Inspector General of the Department of Health and Human Services, shall establish core elements for a compliance program under subparagraph (A) for providers or suppliers within a particular industry or category. ‘‘(C) TIMELINE FOR IMPLEMENTATION.—The Secretary shall determine the timeline for the establishment of the core elements under subparagraph (B) and the date of the implementation of subparagraph (A) for providers or suppliers within a particular industry or category. The Secretary shall, in determining such date of implementation, consider the extent to which the adoption of compliance programs by a provider of medical or other items or services or supplier is widespread in a particular industry sector or with respect to a particular provider or supplier category.’’. (b) MEDICAID.— (1) STATE PLAN AMENDMENT.—Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)), as amended by section 4302(b), is amended— (A) in subsection (a)— (i) by striking ‘‘and’’ at the end of paragraph (75); (ii) by striking the period at the end of paragraph (76) and inserting a semicolon; and (iii) by inserting after paragraph (76) the following: ‘‘(77) provide that the State shall comply with provider and supplier screening, oversight, and reporting requirements in accordance with subsection (ii);’’; and (B) by adding at the end the following: ‘‘(ii) PROVIDER AND SUPPLIER SCREENING, OVERSIGHT, AND RE- PORTING REQUIREMENTS.—For purposes of subsection (a)(77), the requirements of this subsection are the following: ‘‘(1) SCREENING.—The State complies with the process for screening providers and suppliers under this title, as established by the Secretary under section 1886(j)(2). ‘‘(2) PROVISIONAL PERIOD OF ENHANCED OVERSIGHT FOR NEW PROVIDERS AND SUPPLIERS.—The State complies with procedures to provide for a provisional period of enhanced oversight for new providers and suppliers under this title, as established by the Secretary under section 1886(j)(3). ‘‘(3) DISCLOSURE REQUIREMENTS.—The State requires providers and suppliers under the State plan or under a waiver of the plan to comply with the disclosure requirements established by the Secretary under section 1886(j)(4). ‘‘(4) TEMPORARY MORATORIUM ON ENROLLMENT OF NEW PROVIDERS OR SUPPLIERS.— ‘‘(A) TEMPORARY MORATORIUM IMPOSED BY THE SEC- RETARY.— ‘‘(i) IN GENERAL.—Subject to clause (ii), the State complies with any temporary moratorium on the enrollment of new providers or suppliers imposed by the Secretary under section 1886(j)(6). ‘‘(ii) EXCEPTION.—A State shall not be required to comply with a temporary moratorium described in clause (i) if the State determines that the imposition of such temporary moratorium would adversely impact beneficiaries’ access to medical assistance. ‘‘(B) MORATORIUM ON ENROLLMENT OF PROVIDERS AND SUPPLIERS.—At the option of the State, the State imposes, for purposes of entering into participation agreements with providers or suppliers under the State plan or under a waiver of the plan, periods of enrollment moratoria, or numerical caps or other limits, for providers or suppliers identified by the Secretary as being at high-risk for fraud, waste, or abuse as necessary to combat fraud, waste, or abuse, but only if the State determines that the imposition of any such period, cap, or other limits would not adversely impact beneficiaries’ access to medical assistance. ‘‘(5) COMPLIANCE PROGRAMS.—The State requires providers and suppliers under the State plan or under a waiver of the plan to establish, in accordance with the requirements of section 1866(j)(7), a compliance program that contains the core elements established under subparagraph (B) of that section 1866(j)(7) for providers or suppliers within a particular industry or category. ‘‘(6) REPORTING OF ADVERSE PROVIDER ACTIONS.—The State complies with the national system for reporting criminal and civil convictions, sanctions, negative licensure actions, and other adverse provider actions to the Secretary, through the Administrator of the Centers for Medicare & Medicaid Services, in accordance with regulations of the Secretary. ‘‘(7) ENROLLMENT AND NPI OF ORDERING OR REFERRING PROVIDERS.—The State requires— ‘‘(A) all ordering or referring physicians or other professionals to be enrolled under the State plan or under a waiver of the plan as a participating provider; and ‘‘(B) the national provider identifier of any ordering or referring physician or other professional to be specified on any claim for payment that is based on an order or referral of the physician or other professional. ‘‘(8) OTHER STATE OVERSIGHT.—Nothing in this subsection shall be interpreted to preclude or limit the ability of a State to engage in provider and supplier screening or enhanced provider and supplier oversight activities beyond those required by the Secretary.’’. (2) DISCLOSURE OF MEDICARE TERMINATED PROVIDERS AND SUPPLIERS TO STATES.—The Administrator of the Centers for Medicare & Medicaid Services shall establish a process for making available to the each State agency with responsibility for administering a State Medicaid plan (or a waiver of such plan) under title XIX of the Social Security Act or a child health plan under title XXI the name, national provider identifier, and other identifying information for any provider of medical or other items or services or supplier under the Medicare program under title XVIII or under the CHIP program under title XXI that is terminated from participation under that program within 30 days of the termination (and, with respect to all such providers or suppliers who are terminated from the Medicare program on the date of enactment of this Act, within 90 days of such date). (3) CONFORMING AMENDMENT.—Section 1902(a)(23) of the Social Security Act (42 U.S.C. 1396a), is amended by inserting before the semicolon at the end the following: ‘‘or by a provider or supplier to which a moratorium under subsection (ii)(4) is applied during the period of such moratorium’’. (c) CHIP.—Section 2107(e)(1) of the Social Security Act (42 U.S.C. 1397gg(e)(1)), as amended by section 2101(d), is amended— (1) by redesignating subparagraphs (D) through (M) as subparagraphs (E) through (N), respectively; and (2) by inserting after subparagraph (C), the following: ‘‘(D) Subsections (a)(77) and (ii) of section 1902 (relating to provider and supplier screening, oversight, and reporting requirements).’’.

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