Edward J.S. Picardi, MD, DAB CR5764 (2020)

DECISION

The Medicare enrollment application of Petitioner is denied pursuant to 42 C.F.R. § 424.530(a)(3).1

I.  Background

CGS Administrators, LLC, a Medicare administrative contractor (MAC) for the Centers for Medicare & Medicaid Services (CMS), notified Petitioner by letter dated May 19,

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2020, that his application to enroll in Medicare was denied.  The MAC cited 42 C.F.R. § 424.530(a)(3) as the basis for the denial.  CMS Exhibit (Ex.) 1 at 10-12.

Petitioner submitted a corrective action plan (CAP) and requested reconsideration on June 12, 2020.  CMS Ex. 1 at 13-73.  On July 20, 2020, a CMS hearing officer rejected Petitioner’s CAP and issued a reconsidered determination upholding the denial of enrollment pursuant to 42 C.F.R. § 424.530(a)(3).  CMS Ex. 1 at 1-9. 

Petitioner filed a request for hearing (RFH) before an administrative law judge (ALJ) postmarked August 3, 2020.  On August 11, 2020, the case was assigned to me for hearing and decision; the request for hearing was acknowledged, and my standing order was issued (Standing Order). 

On September 10, 2020, CMS filed a prehearing brief and motion for summary judgment (CMS Br.) with CMS Ex. 1.  On October 8, 2020, Petitioner filed his prehearing brief and opposition to the CMS motion for summary judgment (P. Br.) with no exhibits.  Petitioner advised me that he elected to rely upon the evidence marked CMS Ex. 1.  P. Br. at 12.  CMS filed a reply brief (CMS Reply) on October 22, 2020.  Petitioner does not object to my consideration of CMS Ex. 1, which is admitted as evidence.    

II.  Discussion

A.  Applicable Law

Section 1831 of the Social Security Act (Act) (42 U.S.C. § 1395j) establishes the supplementary medical insurance benefits program for the aged and disabled known as Medicare Part B.  Administration of the Part B program is through the MACs.  Act § 1842(a) (42 U.S.C. § 1395u(a)).  Payment under the program for services rendered to Medicare-eligible beneficiaries may only be made to eligible providers of services and suppliers.2   Act §§ 1835(a) (42 U.S.C. § 1395n(a)), 1842(h)(1) (42 U.S.C. § 1395u(h)(1)).  Petitioner, a physician, is a supplier under the Act.

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The Act requires the Secretary of Health and Human Services (Secretary) to issue regulations that establish a process for the enrollment in Medicare of providers and suppliers, including the right to a hearing and judicial review of certain enrollment determinations, such as denial of enrollment and revocation of enrollment and billing privileges.  Act § 1866(j) (42 U.S.C. § 1395cc(j)).  Pursuant to 42 C.F.R. § 424.505, a supplier such as Petitioner must be enrolled in the Medicare program and be issued a billing number to have billing privileges and to be eligible to receive payment for services rendered to a Medicare-eligible beneficiary.

The Secretary has delegated the authority to accept or deny enrollment applications to CMS.  Pursuant to the Secretary’s regulations, CMS may deny a provider’s or supplier’s enrollment application for any of the reasons set out in 42 C.F.R. § 424.530(a).  In this case, CMS has denied Petitioner’s application under 42 C.F.R. § 424.530(a)(3), which provides in pertinent part:  

(a)  Reasons for denial.  CMS may deny a provider’s or supplier’s enrollment in the Medicare program for the following reasons:

* * * *

(3)  Felonies.  The provider, supplier, or any owner or managing employee of the provider or supplier was, within the preceding 10 years, convicted (as that term is defined in 42 CFR 1001.2) of a Federal or State felony offense that CMS determines is detrimental to the best interests of the Medicare program and its beneficiaries. 

(i)  Offenses include, but are not limited in scope or severity to —

(A) Felony crimes against persons, such as murder, rape, assault, and other similar crimes for which the individual was convicted, including guilty pleas and adjudicated pretrial diversions.

(B) Financial crimes, such as extortion, embezzlement, income tax evasion, insurance fraud and other similar crimes for which the individual was convicted, including guilty pleas and adjudicated pretrial diversions.

(C) Any felony that placed the Medicare program or its beneficiaries at immediate risk, such as a malpractice

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suit that results in a conviction of criminal neglect or misconduct.

(D) Any felonies that would result in mandatory exclusion under section 1128(a) of the Act.

(ii)  Denials based on felony convictions are for a period to be determined by the Secretary, but not less than 10 years from the date of conviction if the individual has been convicted on one previous occasion for one or more offenses.

42 C.F.R. § 424.530(a)(3); Act §§ 1842(h)(8), 1866(b)(2)(D). 

Regarding the definition of “convicted,” 42 C.F.R. § 1001.2 provides in pertinent part:

Convicted means that—

(a) A judgment of conviction has been entered against an individual or entity by a Federal, State or local court, regardless of whether:

(1) There is a post-trial motion or an appeal pending, or

(2) The judgment of conviction or other record relating to the criminal conduct has been expunged or otherwise removed;

(b) A Federal, State or local court has made a finding of guilt against an individual or entity;

(c) A Federal, State or local court has accepted a plea of guilty or nolo contendere by an individual or entity; or

(d) An individual or entity has entered into participation in a first offender, deferred adjudication or other program or arrangement where judgment of conviction has been withheld.

42 C.F.R. § 1001.2 (italics in original).

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A prospective supplier whose enrollment application has been denied may request reconsideration and review as provided by 42 C.F.R. pt. 498.  42 C.F.R. § 424.545(a).  A prospective supplier submits a written request for reconsideration to CMS or its contractor.  42 C.F.R. § 498.22(a), (b).  CMS or its contractor must give notice of its reconsidered determination to the prospective supplier, giving the reasons for its determination, specifying the conditions or requirements the prospective supplier failed to meet, and advising of the right to an ALJ hearing.  42 C.F.R. § 498.25.  If the decision on reconsideration is unfavorable to the prospective supplier, the prospective supplier has the right to request a hearing by an ALJ and further review by the Board.  Act § 1866(j)(8) (42 U.S.C. § 1395cc(j)(8)); 42 C.F.R. §§ 424.545, 498.3(b)(17), 498.5.  A hearing on the record, also known as an oral hearing, is required under the Act.  Crestview Parke Care Ctr. v. Thompson, 373 F.3d 743, 748-51 (6th Cir. 2004).  The prospective supplier bears the burden to demonstrate that it meets enrollment requirements with documents and records.  42 C.F.R. § 424.545(c).

B. Issues

Whether summary judgment is appropriate; and

Whether there was a basis for the denial of Petitioner’s application to enroll in the Medicare program. 

C.  Findings of Fact, Conclusions of Law, and Analysis

My conclusions of law are set forth in bold text followed by my findings of undisputed facts and analysis. 

1.  Summary judgment is appropriate.

CMS requests summary judgment.  Petitioner opposes summary judgment.  Petitioner, a supplier denied enrollment in Medicare, has a right to a hearing and judicial review, and a hearing on the record is required under the Act.  Act §§ 205(b), 1866(h)(1), (j); 42 C.F.R. §§ 498.3(b)(17) and 498.5(l); Crestview, 373 F.3d at 748-51.  A party may waive appearance at an oral hearing but must do so affirmatively in writing.  42 C.F.R. § 498.66. 

Summary judgment is not automatic but is limited to certain specific conditions.  The procedures applicable to the adjudication of this case are at 42 C.F.R. pt. 498.  The regulations do not establish or recognize a summary judgment procedure.  However, the Board has long accepted that summary judgment is an acceptable procedural device in cases adjudicated pursuant to 42 C.F.R. pt. 498.  See, e.g., Ill. Knights Templar Home, DAB No. 2274 at 3-4 (2009); Garden City Med. Clinic, DAB No. 1763 (2001); Everett Rehab. & Med. Ctr., DAB No. 1628 at 3 (1997).  The Board has also recognized that the

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Federal Rules of Civil Procedure do not apply in administrative adjudications such as this, but the Board has accepted that Fed. R. Civ. P. 56 and related cases provide useful guidance for determining whether summary judgment is appropriate.  Furthermore, a summary judgment procedure was adopted as a matter of judicial economy within my authority to regulate the course of proceedings and made available to the parties in the litigation of this case by my Standing Order.  The parties were given notice by the Standing Order that summary judgment is an available procedural device and that the law as it has developed related to Fed. R. Civ. P. 56 will be applied.  Standing Order ¶¶ D. & G.

Summary judgment is appropriate when there is no genuine dispute as to any issue of material fact for adjudication and/or the moving party is entitled to judgment as a matter of law.  In determining whether there are genuine issues of material fact for trial, the reviewer must view the evidence in the light most favorable to the non-moving party, drawing all reasonable inferences in that party’s favor.  The party requesting summary judgment bears the burden of showing that there are no genuine issues of material fact for trial and/or that it is entitled to judgment as a matter of law.  Generally, the non-movant may not defeat an adequately supported summary judgment motion by relying upon the denials in its pleadings or briefs but must furnish evidence of a dispute concerning a material fact, i.e., a fact that would affect the outcome of the case if proven.  Mission Hosp. Reg’l Med. Ctr., DAB No. 2459 at 4 (2012) (and cases cited therein); Experts Are Us, Inc., DAB No. 2452 at 4 (2012) (and cases cited therein); Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 3 (2010) (and cases cited therein); see also Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).

The standard for deciding a case on summary judgment and an ALJ’s decision-making in deciding a summary judgment motion differs from that used in resolving a case after a hearing.  On summary judgment, the ALJ does not make credibility determinations, weigh the evidence, or decide which inferences to draw from the evidence, as would be done when finding facts after a hearing on the record.  Rather, on summary judgment, the ALJ construes the evidence in a light most favorable to the non-movant and avoids deciding which version of the facts is more likely true.  Holy Cross Vill. at Notre Dame, Inc., DAB No. 2291 at 5 (2009).  The Board also has recognized that on summary judgment it is appropriate for the ALJ to consider whether a rational trier of fact could find that the party’s evidence would be sufficient to meet that party’s evidentiary burden.  Dumas Nursing & Rehab., L.P., DAB No. 2347 at 5 (2010).  The Secretary has not provided in 42 C.F.R. pt. 498 for the allocation of the burden of persuasion or the quantum of evidence required to satisfy the burden.  However, the Board has provided some persuasive analysis regarding the allocation of the burden of persuasion in cases subject to 42 C.F.R. pt. 498.  Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005).

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In this case, I conclude that there is no genuine dispute as to any material fact pertinent to a denial of enrollment under 42 C.F.R. § 424.530(a)(3) that requires a trial.  The undisputed material facts establish a basis for the denial of Petitioner’s enrollment in Medicare under 42 C.F.R. § 424.530(a)(3) as a matter of law.  Accordingly, I conclude that summary judgment is appropriate.  

2.  Petitioner was convicted, within the meaning of 42 C.F.R. § 1001.2, of tax evasion, a federal felony offense.

3.  The Secretary has given broad discretion to CMS to determine which state or federal felony convictions are detrimental to the Medicare program or its beneficiaries.  42 C.F.R. § 424.530(a)(3); 79 Fed. Reg. 72,500, 72,531-32 (Dec. 5, 2014).

4.  There is a basis for denial of Petitioner’s enrollment in Medicare pursuant to 42 C.F.R. § 424.530(a)(3) based upon Petitioner’s federal felony conviction which CMS has determined is detrimental to Medicare and its beneficiaries.

5.  The issue to be decided is whether there is a basis for denial of Petitioner’s Medicare enrollment and, if there is a basis for denial, my jurisdiction does not extend to review of whether CMS properly exercised its discretion to deny Petitioner’s Medicare enrollment application.

a.  Facts 

The material facts are undisputed, or for purposes of summary judgment, Petitioner’s averred facts are accepted as true and all favorable inferences are drawn in favor of Petitioner.  I advised the parties in the Standing Order that a fact alleged and not specifically denied may be accepted as true for purposes of a motion or cross-motion for summary judgment.  I also advised them that any evidence will be considered admissible and true, unless specific objection is made to its admissibility and accuracy.  Standing Order ¶ G. 

Petitioner does not dispute that he was convicted by a jury on or about October 5, 2012, in the United States District Court of South Dakota.  Petitioner does not dispute that he was convicted of 13 felony counts of income tax evasion; making and subscribing a false tax return, statement, or other document; and failure to keep or disclose records and reports on foreign financial or agency transactions.  P. Br. at 4; CMS Ex. 1 at 92, 101, 118-19.  Petitioner was sentenced to 60 months in prison and served 38 months.  P. Br. at 4; CMS Ex. 1 at 97-98, 102. 

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On February 18, 2020, Petitioner submitted a CMS-855I enrollment application to enroll in Medicare.  Petitioner reported his felony conviction in his application.  CMS Ex. 1 at 124-32. 

The MAC issued an initial determination on May 19, 2020, denying Petitioner enrollment pursuant to 42 C.F.R. § 424.530(a)(3) based on his 2012 felony conviction.  CMS Ex. 1 at 10-12.

Petitioner submitted a CAP and requested reconsideration on June 12, 2020.  CMS Ex. 1 at 13.

On July 20, 2020, the CMS hearing officer rejected Petitioner’s CAP and upheld denial of enrollment pursuant to 42 C.F.R. § 424.530(a)(3).  CMS Ex. 1 at 1. 

Petitioner asserts and I accept as true for purposes of summary judgment, that he paid approximately $2 million in back taxes, penalties, interest, court costs, and civil fines.  P. Br. at 4.  Petitioner states that he regained his licenses to practice medicine in South Dakota, Nebraska, and Ohio; he was newly licensed in Iowa; and the Drug Enforcement Administration granted him an unrestricted registration.  He states that multiple insurers have approved Petitioner as a network provider, but those approvals will be withdrawn based on the denial of Petitioner’s enrollment in Medicare.  Petitioner states that he was certified by the American Board of Surgery.  P. Br. at 4-6.  I am willing to accept all these asserted facts as true on summary judgment.  However, none of these facts are material to the decision in this case as they do not negate or rebut the facts that are material.  Further, as Petitioner recognizes (P. Br. at 6), I have no authority to consider these facts as bases for fashioning equitable relief.  Petitioner asserts that these facts are material because there is no indication the CMS hearing officer actually reviewed the facts and “truly considered the severity (or lack thereof)” of Petitioner’s conviction.  P. Br. at 6.  I construe Petitioner’s argument to be that I should consider the facts he avers and substitute my judgment for that of CMS.  As discussed more fully hereafter, I have no authority to substitute my judgment for that of the CMS hearing officer if the undisputed facts constitute a basis for denial of enrollment in Medicare, which they do.  Furthermore, contrary to Petitioner’s argument (P. Br. at 10), the reconsidered determination shows that the CMS hearing officer was aware of these facts and considered them when making the reconsidered determination.  CMS Ex. 1 at 4.  Petitioner offers no evidence to rebut the reasonable inference arising from the detailed recitation of the facts asserted by Petitioner in the reconsidered determination, namely, that they were considered by the hearing officer.  Although the weight assigned by the hearing officer cannot be determined, after reading the reconsidered determination (CMS Ex. 1 at 4-7), it is clear that the hearing officer was aware of all of Petitioner’s assertions of fact and exercised the discretion to uphold the denial of Petitioner’s enrollment.

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b.  Analysis  

The CMS hearing officer upheld the denial of Petitioner’s enrollment on reconsideration pursuant to 42 C.F.R. § 424.530(a)(3), based on the fact that he was convicted within the 10 years prior to his enrollment application of income tax evasion, an offense listed in 42 C.F.R. § 424.530(a)(3)(i)(B) as one CMS has determined is detrimental to Medicare and its beneficiaries.  I conclude that there is a prima facie showing of a basis for denial of Petitioner’s enrollment in Medicare pursuant to 42 C.F.R. § 424.530(a)(3) based on the following undisputed facts: 

1.  Petitioner was convicted within the meaning of 42 C.F.R. § 1001.2, of the federal felony offense of tax evasion on about October 5, 2012;

2.  The conviction occurred within the 10 years preceding the MAC’s receipt of Petitioner’s enrollment application on February 18, 2020 (CMS Ex. 1 at 124); the initial determination to deny enrollment on May 19, 2020; the reconsidered determination on July 20, 2020; and the date of this decision;

3.  The felony offense of tax evasion is an offense that CMS has determined is detrimental to the best interests of the Medicare program and its beneficiaries as that offense is listed in 42 C.F.R. § 424.530(a)(3)(i)(B). 

The Secretary has delegated virtually unfettered discretion to CMS to decide what constitutes a felony offense detrimental to the best interests of the Medicare program and its beneficiaries under 42 C.F.R. § 424.530(a)(3).  79 Fed. Reg. 72,500, 72,531-32 (Dec. 5, 2014).  Effective February 3, 2015, 42 C.F.R. § 424.530(a)(3) was amended to make clear that CMS or the MAC has discretion to determine that a felony is detrimental to Medicare or its beneficiaries even if it is not an offense listed in 42 C.F.R. § 424.530(a)(3)(i).  The preamble3 to the revised regulation states: 

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First, we proposed to modify the list of felonies in each section such that any felony conviction that we determine to be detrimental to the best interests of the Medicare program and its beneficiaries would constitute a basis for denial or revocation.  We stated that considering the very serious nature of any felony conviction, our authority in §§ 424.530(a)(3)(i) and 424.535(a)(3)(i) should not be restricted to the categories of felonies identified in (a)(3)(i); this was especially true considering that the types of felony offenses often vary from state to state.

79 Fed. Reg. at 72,509-10 (emphasis added).  The list of offenses in 42 C.F.R. § 424.530(a)(3)(i) is clearly a list of examples of the types of offenses that may be found detrimental to Medicare or its beneficiaries.  Tax evasion is one of the specifically listed felony offenses that CMS has determined is presumptively detrimental.  42 C.F.R. § 424.530(a)(3)(i)(B). 

Petitioner argues that summary judgment is improper because it is unclear that CMS or the MAC recognized it had discretion to grant or deny Petitioner’s enrollment application.  The only determination subject to my review is the reconsidered determination dated July 20, 2020 (CMS Ex. 1 at 1-9).  Neb Grp., DAB No. 2573 at 7. 

Tax evasion, the offense of which Petitioner was convicted, is specifically listed by CMS in 42 C.F.R. § 424.530(a)(3)(i)(B).  Therefore, tax evasion is an offense that is presumptively detrimental to the Medicare program or its beneficiaries and no separate case-specific determination needed to be done by the CMS hearing officer.  John A. Hartman, D.O., DAB No. 2911 at 14-17 (2017).  Nevertheless, the CMS hearing officer did a thorough review of the evidence and arguments that Petitioner submitted when requesting the reconsidered determination.  The CMS hearing officer did a case-specific determination that Petitioner’s offense of tax evasion was detrimental to the Medicare program and its beneficiaries.  CMS Ex. 1 at 5-7.  The reconsidered determination shows that the CMS hearing officer clearly understood she had the discretion to grant or deny Petitioner’s enrollment.  Hartman, DAB No. 2911 at 17-20 (reconsidered determination was good evidence of the awareness of discretion and the exercise of discretion).  

Petitioner points to no evidence that raises a genuine dispute that the authorization to exercise discretion was not understood and exercised by the hearing officer.  Petitioner’s reliance on the decision of an appellate panel of the Board in Brian K. Ellefsen, D.O., DAB No. 2626 (2015) is misplaced as that case is readily distinguishable.  P. Br. at 7-8.  In Hartman, the Board made clear that its concern in Ellefsen was that it was not clear from the language of the reconsidered determination in Ellefsen that the MAC understood it had discretion and that denial of enrollment of Ellefsen was not mandated by the regulation.  Hartman, DAB No. 2911 at 17-18 (citing Ellefsen, DAB No. 2626 at 4.)  As

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in Hartman, there is no language in the reconsidered determination in this case suggesting that the hearing officer did not understand her discretionary authority.  CMS Ex. 1 at 1-9.

Petitioner argues that the MAC failed to comply with CMS policy related to the processing of Petitioner’s CAP.  P. Br. at 11.  Petitioner advances this argument despite clearly recognizing that Petitioner had no right to submit a CAP under 42 C.F.R. § 424.530(a)(3).  P. Br. at 8, 11.  Petitioner argues that the notification in the initial determination of his right to request review and appeal was inaccurate because the notice advised him that he could submit a CAP.  Petitioner also argues that he was not notified by letter that his CAP was denied.  The initial determination includes the line “Right to Submit a Corrective Action Plan (CAP) and Reconsideration Request.”  CMS Ex. 1 at 11.  However, the letter only describes in detail the right to request reconsideration and the procedure for doing so.  The letter does not state that Petitioner has a right to submit a CAP or the procedures for doing so.  CMS Ex. 1 at 11.  The inclusion of the words “Corrective Action Plan (CAP)” in the one line of the initial determination is clearly a scrivener’s error and cannot be construed to confer any right on Petitioner to submit a CAP when submitting a CAP is not provided for by 42 C.F.R. § 424.530(a)(3).  Petitioner specifically acknowledges before me that he had no such right.  P. Br. at 8, 11.  The hearing officer also specifically advised Petitioner in the reconsidered determination that his CAP could not be accepted.  Out of an abundance of caution, the hearing officer also stated that “even if CAP rights did extend to [Petitioner’s] denial, CMS does not believe the issue underlying the denial has been corrected for the reasons discussed . . . .”  CMS Ex. 1 at 3-4.  The refusal of CMS or the MAC to accept Petitioner’s CAP is not an initial determination subject to my review.  42 C.F.R. §§ 405.809, 424.545(a), 498.3(b); Conchita Jackson, M.D., DAB No. 2495 at 5-7 (2013).

Further, to the extent that Petitioner’s arguments may be construed as requests for equitable relief, I have no authority to grant such relief.  US Ultrasound, DAB No. 2302 at 8 (2010).  I am bound to follow the Act and regulations, and I have no authority to declare statutes or regulations invalid or ultra vires.  1866ICPayday.com, L.L.C., DAB No. 2289 at 14 (2009).  As the Board stated in Sentinel Medical Laboratories, Inc.,

It is well established that administrative forums, such as this Board and the Department’s ALJs, do not have the authority to ignore unambiguous statutes or regulations on the basis that they are unconstitutional.  A legislative rule is binding on the agency that issues it.  1 Kenneth Culp Davis and Richard J. Pierce, Jr., Administrative Law Treatise, § 6.5 (3rd ed. 1994), (citing U.S. v. Nixon, 418 U.S. 683 (1974) (where the court noted that the executive branch was bound by the terms of a regulation it had issued, even though it was within its power to change that regulation)).  Federal courts have

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refused “to recognize in administrative officers any inherent power to nullify legislative [or executive] enactments because of personal belief that they contravene the [C]onstitution.” Gibas v. Saginaw Mining Co., 748 F.2d 1112, at 1117 (6th Cir. 1984) (citation omitted).  Thus, courts have noted that challenges to the constitutionality of an agency regulation lie outside the cognizance of that agency, and that generally, an ALJ is bound by the regulations promulgated by his administrative agency.  Howard v. FAA, 17 F.3d 1213, 1218 (9th Cir. 1994); Stieberger v. Heckler, 615 F.Supp. 1315, 1386 (S.D.N.Y. 1985), citing D’Amico v. Schweiker, 698 F.2d 903 (7th Cir. 1983).

Sentinel Med. Labs., Inc., DAB No. 1762 at 9 (2001), aff'd sub nom., Teitelbaum v. Health Care Fin. Admin., 32 F. App’x 865 (9th Cir. 2002). 

Two goals of Medicare and the law implementing the program are to protect the Medicare program and to provide health care to many Americans who are eligible.  The procedures followed in this case and the CMS decision to deny Petitioner enrollment do not show that either policy goal was violated.  Rather, the balance of the scale tipped against Petitioner. 

My review in this case is limited to determining whether CMS had a basis for denial of enrollment under 42 C.F.R. § 424.530(a)(3).  Hartman, DAB No. 2911 at 17; Letantia Bussell, M.D., DAB No. 2196 at 13 (2008).  Because I conclude that there is a basis to deny Petitioner’s enrollment in Medicare pursuant to 42 C.F.R. § 424.530(a)(3), I have no authority to review the exercise of discretion by CMS or its contractor to deny enrollment where there is a basis for such action.  Abdul Razzaque Ahmed, M.D., DAB No. 2261 at 19 (2009), aff’d, Ahmed v. Sebelius, 710 F. Supp. 2d 167 (D. Mass. 2010).  

III.  Conclusion

For the foregoing reasons, I conclude that there was a basis to deny Petitioner’s application to enroll in Medicare pursuant to 42 C.F.R. § 424.530(a)(3).

1. Citations are to the 2019 revision of the Code of Federal Regulations (C.F.R.), unless otherwise stated.  An appellate panel of the Departmental Appeals Board (Board) concluded in Mark A. Kabat, D.O., DAB No. 2875 at 9-11 (2018), that the applicable regulations are those in effect at the time of the initial determination.  The Board has also determined that the only CMS or MAC determination subject to my review in a provider and supplier enrollment case is the reconsidered determination.  Neb Grp. of Ariz. LLC, DAB No. 2573 at 7 (2014).
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2. A “supplier” furnishes services under Medicare and includes physicians or other practitioners and facilities that are not included within the definition of the phrase “provider of services.”  Act § 1861(d) (42 U.S.C. § 1395x(d)).  A “provider of services,” commonly shortened to “provider,” includes hospitals, critical access hospitals, skilled nursing facilities, comprehensive outpatient rehabilitation facilities, home health agencies, hospice programs, and a fund as described in sections 1814(g) (42 U.S.C. § 1395f(g)) and 1835(e) (42 U.S.C. § 1395n(e)) of the Act.  Act § 1861(u) (42 U.S.C. § 1395x(u)).  The distinction between providers and suppliers is important because they are treated differently under the Act for some purposes.
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3. Each agency submitting a proposed or final rule for publication in the Federal Register must provide a preamble to inform the reader of the basis and purpose of the regulation or proposal.  1 C.F.R. § 18.12.  In promulgating regulations, the Secretary must publish the proposed regulation in the Federal Register and allow no fewer than 60 days for public comment.  Act § 1871.
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