Bloomberg BNA’s Medicare Report, October 3, 2014

Health-care professionals, facilities and equipment suppliers must be enrolled in the Medicare program to receive payment for covered items and services. In 2006, the Centers for Medicare & Medicaid Services adopted a comprehensive set of enrollment rules intended to ensure that Medicare payments are made only to qualified providers and suppliers.[1]

Since then, CMS has continued to revise and supplement the enrollment regulations in order to further protect the integrity of program payments.

Failure to apply for enrollment or report updated enrollment information in a timely fashion, refund an overpayment or comply with other rules governing Medicare enrollment may risk the denial, deactivation or revocation of Medicare billing privileges, potentially leading to the complete denial of claims for payment.

This article reviews some of the fundamental rules governing Medicare enrollment, which may help providers and suppliers avoid certain traps for the unwary and their potentially harsh consequences.[2]

Basic Enrollment Requirements

The Social Security Act authorizes the Secretary of the Department of Health and Human Services to promulgate regulations governing the process for enrollment of providers and suppliers in the Medicare program.[3] The Medicare enrollment regulations are set forth at 42 C.F.R. Part 424, subpart P.[4]

To be initially enrolled in the Medicare program, a provider or supplier must submit an enrollment application to the Medicare fee-for-service contractor that is designated for the provider or supplier’s geographic area (or “jurisdiction”). The applicant must use the current version of the appropriate Form CMS-855 application or the Internet-based Provider Enrollment, Chain and Ownership System (PECOS).

The application requires the provider or supplier to certify the accuracy and completeness of the application with the signature of an authorized official who has the legal authority to bind the provider or supplier, both legally and financially, to compliance with the Medicare regulations. All applicants must agree via Form 588 to receive Medicare payment via electronic funds transfer.

Enrollment requires payment of an application fee, unless the enrolling supplier is a physician, nonphysician practitioner or group practice, or unless request is made for a hardship exception.[5] Providers enter into a provider agreement and suppliers enter a participation agreement with CMS.

Certain providers and suppliers must be surveyed by the applicable state survey agency or a CMS-approved accreditation organization prior to enrollment to verify their compliance with conditions of participation or other standards.

The Medicare contractor will perform additional screening procedures based on whether the provider or supplier type is designated in the regulations as “limited risk,” “moderate risk” or “high risk.”[6] For moderate and high risk applicants, these procedures include a site visit from the Medicare contractor.

If the applicant is a newly enrolling home health agency or supplier of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS), the applicant is designated as “high risk” and must submit a set of fingerprints and undergo a fingerprint-based criminal background check for all individuals who have at least a five percent or greater ownership interest in the applicant.[7]

CMS otherwise has the discretionary authority to perform an on-site inspection of any provider or supplier to verify the accuracy of the information set forth in the application, and the applicant’s operational status and compliance with other enrollment requirements.[8]

In general, each legal entity that is subject to survey and certification must separately enroll in Medicare and is considered a Medicare provider. A provider may include subparts which are themselves not separate entities, but which must be surveyed and certified and separately enroll in Medicare.

Suppliers are enrolled on the basis of their tax identification number (TIN). If a supplier has operations at separate locations, each location must be separately enrolled, unless each one operates under the same TIN.[9]

Enrollment Effective Date and Retrospective Billing Privileges

Most providers must be surveyed and certified by a state survey agency or CMS-approved accrediting organization before they are approved for enrollment. Medicare providers include skilled nursing facilities, hospitals, critical access hospitals, home health agencies, rehabilitation agencies (for outpatient physical therapy, speech therapy), comprehensive outpatient rehabilitation facilities, hospices, community mental health centers and religious non-medical health care institutions.

A supplier is subject to survey and certification if it is an ambulatory surgical center, portable X-ray supplier, independent clinical laboratory, rural health center or federally qualified health center.

Such applicants must submit a Medicare enrollment application to the Medicare contractor, which reviews the application, performs the required validations of the information set forth in the application and, if a recommendation for approval is made, refers the recommendation to the state survey agency.

The state agency or CMS-approved accrediting organization will conduct a survey to determine whether the applicant provider or supplier is in compliance with the applicable conditions of participation, coverage or certification.

If the survey indicates that the applicant is in compliance, the state agency or accrediting organization will make its recommendation to the CMS Regional Office for review. If the Regional Office determines that the provider or supplier has met all federal requirements for Medicare participation, the Regional Office will issue an effective date for Medicare participation and billing privileges will be conferred.[10]

Notably, no effective date of approval or billing privileges will be issued until the Medicare contractor has completed its review and verification of the provider or supplier’s Form CMS-855 application, even if the applicant has already passed its survey.[11]

For a newly enrolling independent diagnostic testing facility, the effective date of billing privileges is the date on which the testing facility files a Medicare enrollment application that is subsequently approved by a Medicare fee-for-service contractor or, if later, the date on which the testing facility first started furnishing services at its new practice location.[12]

For DMEPOS suppliers, the effective date of Medicare enrollment and billing privileges is the date on which the supplier has submitted a complete application to CMS to furnish Medicare-covered items and meets other conditions for payment.[13]

For physicians, nonphysician practitioners, nonphysician organizations and nonphysician practitioner organizations (collectively referred to here as a “physician supplier”), the effective date of enrollment is the date on which the Medicare contractor receives a signed provider enrollment application that it is able to process to approval or, if later, the date on which the physician supplier first began furnishing services at the new practice location.[14]

If the physician supplier meets all of the Medicare program’s enrollment requirements, and circumstances precluded enrollment in advance of providing services to Medicare beneficiaries, the physician supplier is permitted to retrospectively bill for services at the enrolled practice location with dates of service up to thirty (30) days prior the effective date of enrollment.[15]

In the event that a specified presidentially-declared disaster precludes the physician supplier from enrolling in advance of providing services to Medicare beneficiaries, retrospective billing is permitted for dates of service up to ninety (90) days prior to the effective date of enrollment.[16]

CMS provides the following illustration of the legal distinction between a physician supplier’s effective date of enrollment and the retrospective billing date:

Suppose that a non-Medicare enrolled physician begins furnishing services at an office on March 1. She submits a Form CMS-855I initial enrollment application on May 1. The application is approved on June 1.

The physician’s effective date of enrollment is May 1, which is the later of: (1) the date of filing, and (2) the date she began furnishing services. The retrospective billing date is April 1 (or [thirty] days prior to the effective date of enrollment), assuming that the requirements of 42 C.F.R. § 424.521(a) are met.[17]

In this example, any claims submitted for the physician’s services rendered prior to April 1 would not be paid.

Application Returns, Rejections and Denials

Return

Medicare contractors are instructed to return applications that bear any of the defects listed below. These policies apply to a Form CMS-855 initial application for enrollment, change of information request, change of ownership (CHOW) application, revalidation, reactivation, Form 855O Registration for Eligible Ordering and Referring Physicians and Non-Physician Practitioners, and Form 588 Electronic Funds Transfer Authorization Agreement.[18]

• The application is submitted to the wrong Medicare fee-for-service contractor.
• A CHOW application is submitted more than ninety days in advance of the anticipated date of a provider’s sale to a new owner.
• An initial Form 855B application is submitted by an ambulatory surgical center or portable x-ray supplier or any initial 855A application is submitted more than 180 days prior to the effective date shown on the application.
• An initial enrollment application was submitted prior to the expiration of the deadline for the applicant to appeal the denial of a previously submitted application, or prior to the expiration of a bar against re-enrollment.
• An applicant submits a Form 855A initial or change of ownership (CHOW) application, and subsequently submits a CHOW application prior to the Medicare contractor’s receipt of an approval or tie-in notice from the CMS Regional Office.
• The application is not needed for the transaction, e.g., an enrolled physician wishes to change his or her reassignment of benefits from one group practice to another one with operations in the same Medicare contractor’s jurisdiction, and the physician submits Forms 855I and 855R. The contractor will return the Form 855I because only Form 855R is required.

If the Medicare contractor returns an application, it effectively means the application was never submitted.

Rejection

Medicare contractors have discretionary authority to reject an application for enrollment if, within thirty days of the contractor’s request, the applicant fails to furnish items or information missing from the application or supporting documentation.[19] Following below are examples of circumstances in which the contractor may reject an application:

• The Form 855 or PECOS certification statement is unsigned, undated, bears a copied or stamped signature, or a signature that is dated more than 120 days prior to the date on which the contractor received the application.
• A paper Form 855I or Form 855O is signed by someone other than the applicant physician or non-physician practitioner.
• The paper application is submitted on an outdated version of Form 855.
• The applicant has submitted the wrong application form, e.g., Form 855A instead of Form 855B.
• The application form is completed in pencil.
• The provider applicant failed to include the required application fee.

The Medicare contractor may, but is not required, to extend the thirty-day period if it determines that the applicant is actively working with the contractor to resolve outstanding issues.[20]

The contractor thus may choose whether to make a follow-up request for missing information or reject the application if the applicant fails to furnish all missing and clarifying data requested by the contractor within the thirty-day timeframe.[21]

Consequences of Rejection

A provider or supplier whose enrollment application is rejected has no right of appeal and must complete and submit a new Form 855 (either via paper or PECOS), including all supporting documentation.[22]

Denial

In accordance with Section 424.530 of the enrollment regulations, CMS instructs its contractors to deny an enrollment application under the following circumstances:[23]

• Not in compliance with Medicare enrollment rules – The provider or supplier is determined to be out of compliance with Medicare enrollment requirements and has not submitted a corrective action plan pursuant to Section 488 of the Medicare regulations. Grounds for denial of an application for non-compliance with enrollment criteria include, among others, failure to have a business address or mobile unit where services can be rendered; no facility for the storage of patient records; lack of appropriate licensure as a provider or supplier to perform the services which the applicant intends to render; no valid social security number or employer identification number for the applicant or another individual or organization disclosed on the application, e.g., an owner, partner, managing organization or employee, officer, director, medical director or authorized or delegated official.[24]
• Exclusion or debarment – The provider or supplier, or any owner, managing employee, authorized or delegated official, medical director or other health care personnel of the provider or supplier who is required to be reported on Form 855 is excluded from Medicare, Medicaid or any other federal health care program, or is debarred, suspended or otherwise excluded from participation in a federal procurement or non-procurement program or activity.[25]^{, [26]}
• Felony conviction – The provider, supplier, or any owner of the provider or supplier was, within the ten years preceding enrollment or revalidation of enrollment, convicted of a federal or state felony offense that CMS has determined to be detrimental to the best interests of the program and its beneficiaries.[27] Under the current version of the rule, the types of felonies that may cause the agency to deny enrollment include felony crimes against persons, financial crimes, offenses that place the Medicare program or its beneficiaries at immediate risk (such as malpractice resulting in conviction for criminal neglect), and felony convictions that trigger mandatory or permissive exclusion under Section 1128 of the Social Security Act. However, the denial may be reversed if the provider or supplier submits proof within thirty days of the denial notification that it has terminated its business relationship with the individual or organization.[28]

CMS has proposed to eliminate the list of felonies included in the text of Section 424.530, so that a Medicare contractor would be authorized to deny enrollment based on any felony conviction that CMS has determined to be detrimental to the best interests of the Medicare program and its beneficiaries. The agency has also proposed to expand the authority for denial of enrollment to include the felony conviction of any managing employee of the applicant provider or supplier.[29]

• False or misleading information. The provider or supplier has certified as “true” any false or misleading information on the enrollment application.[30]
• On-Site Review – Upon on-site review or other reliable evidence, CMS determines that the provider or supplier is not operational to furnish Medicare covered items or services, or does not meeting Medicare enrollment requirements.[31]
• Overpayment – The enrolling physician or nonphysician practitioner, or a current owner of the enrolling provider or supplier has an existing Medicare overpayment at the time of filing the application.[32] An “owner” is defined as any individual or entity with a partnership interest in a provider or supplier that is organized as a partnership, or otherwise any individual or entity that has a five percent or greater direct or indirect ownership interest in the provider or supplier.[33]

The current version of the rule governing denial on the basis of an existing overpayment does not address situations where an enrolling provider or supplier, other than a physician or non-physician practitioner, has a current Medicare overpayment. It also does not apply where the overpayment was incurred by an entity with which the enrolling provider, supplier or owner had a previous affiliation.[34]

If changes proposed by CMS in 2013 become final, enrollment could be denied if the provider or supplier, regardless of type, or any owner of the provider or supplier, has an existing debt to the Medicare program, be it an overpayment or some other type of financial obligation.[35]

Enrollment could also be denied if the applicant provider, supplier, or any owner, was previously the owner of a provider or supplier that had a Medicare debt and the debt existed at the time when the debtor’s enrollment was revoked or voluntarily or involuntarily terminated, and if three additional criteria were met: the owner left the debtor provider or supplier within one year of the debtor’s voluntary or involuntary termination or revocation of enrollment, the Medicare debt remains unpaid in full and CMS determines that the uncollected debt poses an undue risk of fraud, waste or abuse.

The proposed rule would allow the applicant to avoid denial of enrollment if the debtor repays the debt in full or agrees to an approved repayment schedule, and satisfies additional specified criteria.

• Suspension of Medicare payment – CMS or a Medicare contractor has placed the applicant physician or non-physician practitioner, or any current owner of such applicant under suspension from Medicare payment.[36] Suspension of payment implies that a determination of overpayment is pending or investigation of a credible allegation of fraud remains to be resolved.[37]
• Failure to Pay the Application Fee after Denial of Hardship Exception Request – The applicant fails to submit payment of the enrollment application fee within thirty days of notification that the applicant’s hardship exception request was not approved.[38]
• Temporary Moratorium – The provider or supplier applies for initial enrollment or requests enrollment of an additional practice location in a geographic area where CMS has imposed a temporary moratorium.[39]
• Denial of Enrollment for Specific Types of Providers and Suppliers – Billing privileges may be denied for a home health agency if, within thirty days of a request from CMS or a Medicare contractor, the home health agency cannot furnish supporting documentation to verify that it meets the initial reserve operating funds requirement under Section 489.28(a) of the Medicare regulations. Billing privileges may also be denied if the home health agency otherwise fails to satisfy the initial reserve operating funds requirements.[40]

This year, CMS made final regulatory changes that authorize denial of any application submitted by a physician or other non-physician practitioner based on a suspension or revocation of the applicant’s Drug Enforcement Administration certificate of registration or the applicable state licensing agency’s suspension or revocation of the applicant’s authority to prescribe drugs.

Denial is authorized where the suspension or revocation is in effect on the date of filing the enrollment application.[41]

Consequences of Denial

• Appeal – A provider or supplier may appeal the denial of Medicare enrollment. No Medicare payments are to be made during the appeal process.[42]
• Review of CMS Files for Associates – CMS will also review its files to determine whether an enrolled provider or supplier is associated with a denied applicant, which may prompt adverse action against the enrolled provider or supplier. For example, if enrollment was denied based on the felony conviction of the applicant’s owner, and CMS’ review reveals that the same individual has an ownership interest in an enrolled supplier, CMS will determine whether the enrolled supplier failed to report adverse legal action against its owner within the applicable reporting deadline.[43]
• No bar to re-application – There is no bar to reapplication for enrollment after the denial of an application. Re-enrollment is barred only in the event of revocation, which is discussed below.[44] However, if the denied provider or supplier does not appeal the denial, the Medicare contractor is instructed to return any application that is submitted prior to the appeal deadline. Similarly, if the denial is appealed, the contractor is instructed to return any new application that it receives prior to a determination that the denial has been upheld.[45]
• Deactivation or revocation after denial of a change of information or CHOW application – If the Medicare contractor denies a Form 855 submitted by a currently enrolled provider or supplier to report a change of information or CHOW, the denial may prompt deactivation or even revocation of billing privileges.[46] Deactivation and revocation are discussed further below.
• Revocation after denial of revalidation – If a revalidation application is denied and the sixty-day deadline for submitting the revalidation application has expired, CMS has instructed its contractors to revoke billing privileges pursuant to Section 424.535(a)(1), unless a CMS instruction or directive indicates otherwise.[47] If the contractor denies the revalidation application prior to the submission deadline, it is instructed, in absence of a contrary instruction or directive, not to revoke billing privileges until the deadline expires. If another application is submitted before the deadline and that application is denied, returned or rejected, the contractor is instructed to revoke billing privileges upon expiration of the submission deadline.[48]

Revocation of Enrollment and Billing Privileges

The grounds for revocation of enrollment and billing privileges are similar to those discussed above regarding denial. There are some important differences, however, which are summarized below.

• Overpayment – An existing Medicare overpayment and the suspension of Medicare payment does not constitute specific grounds for the revocation of enrollment or billing privileges.[49] However, if a physician, non-physician practitioner or the owner of another provider or supplier has a delinquent overpayment, and the physician, nonphysician practitioner or other provider or supplier receives notification that it must revalidate the accuracy and completeness of its enrollment information, the Medicare contractor may discover the delinquent overpayment and deny revalidation. As discussed above, the denial of a revalidation application may ultimately prompt the revocation of enrollment and billing privileges.
• Failure to revalidate – Revocation of enrollment and billing privileges is authorized if, within sixty days of a request from CMS or its contractor, a provider or supplier fails to furnish complete and accurate enrollment information, including all supporting documentation, or to resubmit and certify the accuracy of its enrollment information.[50] However, CMS instructs its contractors not to revoke on this basis if CMS has explicitly instructed the contractor to deactivate billing privileges.[51]
• Misuse of billing number – The contractor may revoke billing privileges and any corresponding provider agreement in the event that a provider or supplier knowingly sells or allows anyone to use its billing number. (Revocation does not apply to the use of billing information by another person in connection with the reassignment of benefits or a change of ownership.)[52]
• Abuse of billing privileges – Contractors are instructed to revoke billing privileges in the event that a provider or supplier submits a claim or claims for services that could not have been furnished to a specific individual on the claim’s date of service.[53] The contractor has express authority under the governing rule to revoke billing privileges if claims are submitted for services rendered to a deceased individual or beneficiary who was not in the country on the claim’s date of service, or when equipment necessary for testing was not present where the claim states the testing occurred. CMS has proposed to expand the scope of revocation authority to include its determination that the provider or supplier has demonstrated a pattern or practice of submitting claims for services that fail to meet Medicare requirements.[54] The agency believes that it should have the authority to allow contractors to revoke privileges where services were actually furnished but did not meet reasonable and necessary criteria, so long as there is a pattern of inaccurate or erroneous claim submissions.[55]
• Medicaid termination – Termination or revocation of Medicaid billing privileges will prompt revocation of Medicare billing privileges if the provider or supplier has exhausted its appeal rights.[56]
• Improper prescribing practices – As discussed above with regard to denial of enrollment, revocation of billing privileges is authorized in the event of the revocation or suspension of a physician or non-physician practitioner’s prescribing authority. In addition, revocation is authorized by specified patterns and practices of prescribing drugs covered by Medicare Part D.[57]
• Failure to comply with reporting requirements – A physician supplier must report an adverse legal action or change in practice location to the Medicare contractor within thirty days.[58] Reportable adverse legal actions include conviction of certain state or federal misdemeanor or felony offenses, exclusion from participation in any federal or state health care program, debarment from federal procurement program, or the revocation or suspension of a professional license. The contractor is authorized to revoke billing privileges if a provider or supplier fails to comply with these reporting duties and to assess overpayments back to the date of the final adverse action or change in practice location.[59] CMS has instructed its contractors to revoke billing privileges for failure to report a change in practice location only if the contractor independently discovers the change, and not if the physician supplier provides late notification to the contractor, i.e., more than thirty days after the change occurred.[60] If a revalidation application contains new information which indicates that the provider or supplier has failed to update its enrollment information on a timely basis, CMS has stated that it generally will not take administrative action unless the failure to report the change would have caused the provider or supplier to be ineligible for enrollment in the Medicare program.[61]

Consequences of Revocation

As in the event of the denial of an application, CMS will search its files for associations of enrolled providers and suppliers, e.g., through an owner or managing employee, with the revoked provider or supplier, which may prompt adverse action against other enrolled providers and suppliers. Revocation is also subject to the same appeal rights that apply to a denial. Some of the unique consequences of revocation are set forth below.

• Termination of provider agreement – If the contractor revokes the billing privileges of a provider, the provider agreement will terminate effective upon the date of revocation.[62]
• Bar to participation in the Medicare program and re-enrollment bar – A provider, supplier, delegated official or authorized official whose billing privileges are revoked is barred from participating in the Medicare program from the effective date of revocation until the end of the re-enrollment bar.[63] Depending on the basis for the revocation, reenrollment is barred for a minimum of one, but not more than three years. However, the re-enrollment bar does not apply in the event that billing privileges are revoked due to the failure of a provider or supplier to timely respond to a Medicare contractor’s revalidation request or other request for information.
• Shortened deadline to submit claims for pre-revocation services – After the revocation of billing privileges for a physician supplier or IDTF, all claims for items and services furnished prior to revocation must be submitted within sixty calendar days.[64] CMS has proposed to revise this rule so that it would apply to all revoked providers and suppliers, except for home health agencies.[65] If the proposed change is finalized, home health agencies would have to submit all pre-revocation claims within sixty days of the effective date of revocation or, if later, the date when the home health agency’s last payable episode ends.

Deactivation and Reactivation of Billing Privileges

Deactivation

The Medicare contractor may deactivate a provider or supplier’s Medicare billing privileges for any of the following reasons:

• The provider or supplier does not submit any Medicare claims for twelve consecutive calendar months.[66]
• The provider or supplier fails to report a change in the information set forth on the enrollment application within the timeframe required under Section 424.516 of the enrollment regulations. Examples of reportable changes of information are the addition of a physician supplier’s practice location, which must be reported within thirty days, and the change of business address, managing employee or billing agency for a home health agency, which must be reported within ninety days.
• The provider or supplier fails to report a change in ownership or control within thirty days.
• The provider or supplier does not respond within ninety days to a request for revalidation.[67]

Consequences of Deactivation

• Deactivation of non-billing Provider Transaction Access Number (“PTAN”) only – When a provider or supplier with multiple PTANs is to be deactivated based on non-billing, Medicare contractors are instructed to deactivate only the non-billing PTAN.[68]
• Appeal rights – A provider or supplier has no right to appeal deactivation. It may file only a statement of rebuttal.[69]
• Participation in Medicare – Deactivation of billing privileges is not tantamount to the termination of a participation or provider agreement or violation of any condition of participation.[70]

Reactivation

To reactivate the billing privileges of an enrolled provider or supplier after deactivation on the basis of an untimely revalidation, the provider or supplier must submit a new enrollment application or re-certify the accuracy of the enrollment information currently on file with Medicare.[71] If deactivation occurred due to non-submission of a claim, the provider or supplier must recertify the accuracy of its enrollment information, furnish any missing information and be prepared to submit a valid claim for payment.[72]

Except for home health agencies, reactivation does not require new certification by the state survey agency or that a provider enter into a new provider agreement.[73]

Until October 8, 2013, CMS instructed its contractors to make reactivation effective on the date when the provider or supplier filed an enrollment application that was subsequently approved.[74] That instruction required Medicare contractors to treat applications submitted for purposes of reactivation essentially as initial applications for enrollment. Consequently, some providers and suppliers lost reimbursement for claims submitted for dates of service after deactivation of billing privileges for failure to respond timely to a revalidation request.[75]

Under CMS’ modified policy, if the contractor approves a reactivation application or certification package, it is instructed to reactivate billing privileges effective as of the date of deactivation.[76] Under the new policy, a provider or supplier who submits a revalidation application that is subsequently approved should not experience an interruption in billing.

[1] See “Medicare Program; Requirements for Providers and Suppliers to Establish and Maintain Medicare Enrollment,” 71 Fed. Reg. 20754-20781 (April 21, 2006).

[2] Reference is made throughout the article to “providers” and “suppliers.” Within the Medicare program, a “provider” furnishes patient care services for those who are awaiting, receiving, or recuperating from treatment by intervening practitioners, e.g., hospitals, hospices, home health agencies and skilled nursing facilities. A “supplier” furnishes the goods and services that actually comprise patient care and treatment, e.g., physicians, physician group practices, other health care professionals, ambulatory surgery centers and portable x-ray units.

[3] Section 1866(j)(1)(A) of the Social Security Act, 42 U.S.C. §§ 1302, 1395cc(j)(1)(A).

[4] 42 C.F.R. § 424.510 to § 424.570.

[5] 42 C.F.R. § 424.514; Program Integrity Manual, CMS Pub. 100-08, Ch. 15, § 15.19.1.

[6] 42 C.F.R. § 424.518.

[7] Id.

[8] 42 C.F.R. § 424.510. To be and remain enrolled in Medicare for the first three months after the Medicare contractor approves billing privileges, a home health agency must be prepared to furnish CMS with proof that it has available initial reserve operating funds pursuant to Section 489.28 of the Medicare regulations. 42 C.F.R. § 424.510(d)(9).

[9] Program Integrity Manual, CMS Pub. 100-08, Ch. 15, § 15.3.

[10] 42 C.F.R. § 424.520(a).

[11] 42 C.F.R. § 489.13; Program Integrity Manual, CMS Pub. 100-08, Ch. 15, § 15.17.1. Although state survey agencies and accreditation organizations normally wait for a recommendation for approval before conducting a survey, but in some cases the survey may precede the recommendation. Section 489.13 makes clear that all federal requirements for participation must be satisfied prior to issuing an effective date, including the Medicare completion of the contractor’s enrollment verification activities.

[12] 42 C.F.R. §§ 424.520(b), 410.33(i).

[13] 42 C.F.R. §§ 424.520(c), 424.57(b).

[14] 42 C.F.R. § 424.520(d).

[15] 42 C.F.R. § 424.521(a)(1).

[16] 42 C.F.R. § 424.521(a)(2). The disaster must be declared pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act, Pub. L. No. 100-707, 42 U.S.C. §§ 5121- 5206.

[17] Program Integrity Manual, CMS Pub. 100-08, Ch. 15, § 15.17. CMS also notes that the effective date entered into the Provider Enrollment, Chain and Ownership System (PECOS) will be April 1. Id.

[18] Program Integrity Manual, CMS Pub. 100-08, Ch. 15, § 15.8.1.

[19] 42 C.F.R. § 424.525(a).

[20] 42 C.F.R. § 424.525(b).

[21] Program Integrity Manual, CMS Pub. 100-08, Ch. 15, § 15.8.2.

[22] 42 C.F.R. § 424.525(c)-(d).

[23] Note that the text of Section 424.530 states that “CMS may deny a provider’s or supplier’s enrollment in the Medicare program for the following reasons . . . .” (emphasis added). However, the Program Integrity Manual instructs Medicare contractors that they “must deny an enrollment application if any of the situations . . . are present.” Program Integrity Manual, CMS Pub. 100-08, Ch. 15, § 15.8.4.A (emphasis added).

[24] 42 C.F.R. § 424.530(a)(1).

[25] 42 C.F.R. § 424.530(a)(2). A “managing employee” is a general manager, business manager, administrator, director, or other individual who exercises operational or managerial control over, or directly or indirectly conducts, the day-to-day operations of the provider or supplier. A managing employee may be engaged by the provider or supplier under contract or through some other arrangement, and may or may not be a W–2 employee. 42 C.F.R. § 424.502.

[26] “Federal health care program” is defined at 42 C.F.R. § 1001.2. Authority for exclusion from participation in federal health care programs is set forth in Sections 1128, 1128A, 1156, 1842, 1862, 1867 or 1892 of the Social Security Act, 42 U.S.C. § § 1320a-7, 1320a-7a, 1320c-5, 1395u, 1395y, 1395dd, 1395ccc. Debarment, suspension or exclusion from federal procurement or non-procurement programs and activities is authorized by Section 2455 of the Federal Acquisition Streamlining Act of 1994, Pub. L. No. 103-355.

[27] 42 C.F.R. § 424.530(a)(3).

[28] 42 C.F.R. § 424.530(c).

[29] 78 Fed. Reg. at 25021-25022. See definition of “managing employee,” n. 25, supra.

[30] 42 C.F.R. § 424.530(a)(4).

[31] 42 C.F.R. § 424.530(a)(5).

[32] 42 C.F.R. § 424.530(a)(6).

[33] 42 C.F.R. § 424.502.

[34] 78 Fed. Reg. at 25019.

[35] Id. at 25019-25021.

[36] 42 C.F.R. § 424.535(a)(7).

[37] 42 C.F.R. §§ 405.370-405.372.

[38] 42 C.F.R. § 424.535(a)(9).

[39] 42 C.F.R. § 424.535(a)(10).

[40] 42 C.F.R. § 424.535(a)(8).

[41] 42 C.F.R. § 424.535(a)(11). The addition of impaired prescribing authority as grounds for the denial and revocation became effective on July 22, 2014. 79 Fed. Reg. 29844 (May 23, 2014).

[42] 42 C.F.R. § 424.545(a). Appeal of a denial must be made in accordance with 42 C.F.R. Part 424, subpart A.

[43] 42 C.F.R. § 424.530(d).

[44] 42 C.F.R. § 424.530(b); Program Integrity Manual, CMS Pub. 100-08, Ch. 15, § 15.8.4.B.

[45] 42 C.F.R. § 424.530(b); Program Integrity Manual, CMS Pub. 100-08, Ch. 15, § 15.8.4.C.

[46] Id. at § 15.8.4.E. Section 424.540(a)(2) of the regulations authorizes deactivation of billing privileges for failure to report within the applicable timeframe a change of information supplied on the enrollment application. Section 424.516 sets forth the reporting requirements for specific providers and suppliers.

[47] Program Integrity Manual, CMS Pub. 100-08, Ch. 15, § 15.8.4.E. Revalidation is the process by which providers and suppliers are required to resubmit and recertify the accuracy of their enrollment information every five years. 42 C.F.R. § 424.515. Within sixty days of notification, the provider or supplier must submit to CMS the applicable enrollment application with complete and accurate information, including the application’s supporting documentation. § 424.515(a)(2). Failure to respond within ninety days is grounds for deactivation of billing privileges. 42 C.F.R. § 424.540(a)(3).

[48] Program Integrity Manual, CMS Pub. 100-08, Ch. 15, § 15.8.4.E.

[49] 42 C.F.R. § 424.535.

[50] Section 424.535(a)(1) sets forth the authority for revocation based on non-compliance with Medicare enrollment requirements. Failure to revalidate pursuant to Section 424.515 constitutes non-compliance with the enrollment regulations.

[51] Program Integrity Manual, CMS Pub.100-08, Ch. 15, § 15.27.2.A.

[52] 42 C.F.R. § 424.535(a)(7).

[53] 42 C.F.R. § 424.535(a)(8).

[54] 78 Fed. Reg. at 25022.

[55] Id. CMS sought comment on what should qualify as a “pattern or practice” of submitting claims that do not meet Medicare requirements.

[56] 42 C.F.R. § 424.535(a)(12).

[57] 42 C.F.R. § 424.535(a)(14).

[58] 42 C.F.R. § 424.516. Numerous additional reporting requirements apply to providers and suppliers, which are enumerated in Section 424.516 of the enrollment regulations.

[59] 42 C.F.R. §§ 424.535(a)(9), 424.565.

[60] Program Integrity Manual, CMS Pub.100-08, Ch. 15, § 15.27.2.A.

[61] CMS Frequently Asked Question #3701 (https://questions.cms.gov/ – click on Provider Enrollment and Certification link) (last accessed on 9/23/14).

[62] 42 C.F.R. § 424.535(b).

[63] 42 C.F.R. § 424.535(c).

[64] 42 C.F.R. § 424.535(h).

[65] 78 Fed. Reg. at 25023.

[66] 42 C.F.R. § 424.540(a) sets forth the grounds for deactivation of billing privileges.

[67] 42 C.F.R. § 424.540(a)(3). See n. 47, supra.

[68] Program Integrity Manual, CMS Pub.100-08, Ch. 15, § 15.27.1.D.

[69] 42 C.F.R. § 424.545(b).

[70] 42 C.F.R. § 424.540(c). Reactivation of a home health agency’s billing privileges requires an initial state survey or accreditation by an approved accreditation organization. § 424.540(b)(3)(i).

[71] 42 C.F.R. § 424.540(b)(1).

[72] 42 C.F.R. § 424.540(b)(2).

[73] 42 C.F.R. § 424.540(b)(3).

[74] Program Integrity Manual, CMS Pub.100-08, Ch. 15, former § 15.27.1.B, cited in MacCormac v. Centers for Medicare and Medicaid Services, Dept. Health & Human Servs. Dept. Appeals Board (Civil Remedies Division) Docket No. C-13-566 Ruling No. 2014-31 (May 22, 2014).

[75] See MacCormac v. Centers for Medicare and Medicaid Services, n. 74, supra.

[76] Program Integrity Manual, CMS Pub.100-08, Ch. 15, § 15.27.1.2.