Peter Nwoke, MD, DAB CR5856 (2021)

DECISION

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

I.  Background

WPS Government Health Administrators, a Medicare administrative contractor (MAC) for the Centers for Medicare & Medicaid Services (CMS), notified Petitioner by letter dated December 13, 2019, that his application to enroll in Medicare was denied.  The

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MAC cited 42 C.F.R. § 424.530(a)(3) as the basis for the denial.  CMS Exhibit (Ex.) 3 at 8-9.

Petitioner submitted a corrective action plan (CAP) and requested reconsideration on January 9, 2020.  CMS Ex. 3 at 10-12.  On March 12, 2020, a CMS hearing officer denied 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. 3 at 1-7.

On October 30, 2020, Petitioner filed a request for hearing (RFH) before an administrative law judge (ALJ).  On November 2, 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 November 20, 2020, CMS filed a motion to dismiss the request for hearing with CMS Exs. 1 and 2.  The motion to dismiss was denied December 8, 2020.  On December 1, 2020, CMS filed a prehearing brief and motion for summary judgment (CMS Br.) with CMS Ex. 3.  On December 9, 2020, Petitioner filed his prehearing brief and opposition to the CMS motion for summary judgment (P. Br.) with no exhibits.  CMS filed a reply brief (CMS Reply) on January 11, 2021.  Petitioner filed a sur-reply brief (P. Reply) on February 2, 2021.  CMS stated in its brief that only CMS Ex. 3 is offered in support of its motion for summary judgment.  CMS Br. at 1 n.1.  Petitioner did not object to my consideration of CMS Ex. 3, and it 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 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.

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(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 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

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(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).

A prospective supplier, such as Petitioner, 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

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appearance at an oral hearing but must do so affirmatively in writing.  42 C.F.R. § 498.66.  Petitioner has not waived an oral hearing and this matter may not be decided on the documents and arguments, unless the motion for summary judgment is meritorious.

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 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

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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).

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 Medicaid fraud, a Michigan state felony offense.

3.  The Secretary has determined and provided by regulation that CMS may deny the Medicare enrollment of a supplier who, within the 10 years preceding the filing of an enrollment application, was convicted of any state or federal felony that CMS determines is detrimental to the best interests of Medicare and it 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 state 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.

6.  Petitioner has no right to review and I have no authority to review the denial of a CAP.

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a.  Undisputed 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 on or about May 18, 2012, in the 30th Judicial Circuit Court of the State of Michigan.  Petitioner does not dispute that he was convicted of three felony counts of Medicaid fraud.  RFH at 1; P. Br. at 1-2; P. Reply at 1-2; CMS Ex. 3 at 10, 56, 70-74.

Petitioner does not dispute that he was excluded from participating in Medicare, Medicaid, and all federal health care programs, by the Inspector General, US Department of Health and Human Services (IG).  The IG exclusion was pursuant to section 1128(a)(1) of the Act.  The exclusion was for five years and became effective January 20, 2013.  RFH at 2; CMS Ex. 3 at 11, 52, 54-55, 64.

On September 18, 2019, Petitioner filed an application to enroll in Medicare (CMS-855I).  CMS Ex. 3 at 57-63.  Petitioner responded "no" to the question in the application about whether any adverse legal actions had been imposed against him.  CMS Ex. 3 at 59.  Petitioner attached documents to the application related to his conviction, which apparently the MAC found to be an acceptable disclosure of the conviction.  CMS Ex. 3 at 62.

The MAC issued an initial determination on December 13, 2019, denying Petitioner enrollment pursuant to 42 C.F.R. § 424.530(a)(3) based on his May 18, 2012 state felony conviction.  The MAC informed Petitioner that he could file a CAP and request reconsideration.  CMS Ex. 3 at 8-9.

Petitioner submitted a CAP and requested reconsideration on January 16, 2020.  CMS Ex. 3 at 1, 10-12.

On March 12, 2020, the CMS hearing officer denied Petitioner's CAP and upheld denial of enrollment pursuant to 42 C.F.R. § 424.530(a)(3).  CMS Ex. 3 at 1, 5.

b.  Analysis  

Petitioner seeks review of the denial of his CAP and the adverse reconsidered determination.  RFH; P. Br.; P. Reply.

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Regarding Petitioner's CAP, it is not clear that the MAC had authority to grant Petitioner the right to file a CAP.  If a provider's or supplier's enrollment application is denied for noncompliance with enrollment requirements, the provider or supplier is granted the opportunity to submit a CAP.  42 C.F.R. § 424.530(a)(1).  However, there is no provision for the submission of a CAP under 42 C.F.R. § 424.530(a)(3), the provision under which Petitioner was denied enrollment.  The regulatory language is clear in this regard.  Under 42 C.F.R. § 424.535, which provides for revocation of enrollment and the language of which closely tracks the language of 42 C.F.R. § 424.530, it has been concluded that the right to submit a CAP is limited to the situation where revocation is based on noncompliance rather than a felony conviction.  Abdul Razzaque Ahmed, MD, DAB No. 2261 at 17 n.10 (2009) (the opportunity to file a CAP under 42 C.F.R. § 424.535(a)(1) does not extend to 42 C.F.R. § 424.535(a)(3)).

Even if Petitioner did have right to submit a CAP, I have no authority to review the denial of the CAP.  The Board has long held that denial of a CAP is not an initial determination under 42 C.F.R. § 498.3(b) and not subject to ALJ or Board review.  DMS Imaging, Inc., DAB No. 2313 at 5-6 (2010); Conchita Jackson, MD, DAB No. 2495 at 6 (2013); Zille Shah, MD & Zille Huma Zaim, MD, PA, DAB No 2688 at 17 (2016).

There is no question, however, that Petitioner does have a right to review of the CMS hearing officer's determination that there was a basis for Petitioner's exclusion.  I conclude, based on my de novo review, 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:

1.  Petitioner was convicted within the meaning of 42 C.F.R. § 1001.2, of the state felony offense of Medicaid fraud on about May 18, 2012;

2.  The conviction occurred within the 10 years preceding the MAC's receipt of Petitioner's enrollment application on September 18, 2019 (CMS Ex. 3 at 57); and

3.  The state felony offense of Medicaid fraud is an offense that CMS has determined is per se detrimental to the best interests of the Medicare program and its beneficiaries under both 42 C.F.R. § 424.530(a)(3)(i)(B) (financial crimes such as insurance fraud) and (D) (felony conviction that results in mandatory exclusion under Act § 1128(a)).

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.

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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 specifically listed in 42 C.F.R. § 424.530(a)(3)(i).  The preamble3 to the revised regulation states:

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.

Insurance fraud is one of the specifically listed felony offenses that CMS has determined is presumptively or per se detrimental.  42 C.F.R. § 424.530(a)(3)(i)(B).  Insurance fraud is analogous to Medicaid fraud, the offense of which Petitioner was convicted.  Accordingly, I conclude that Medicaid fraud 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 review the facts underlying Petitioner's conviction and arguments in Petitioner's request for the reconsidered determination.  The CMS hearing officer did a case-specific determination that Petitioner's offense of Medicaid fraud was detrimental to the Medicare program and its beneficiaries.  CMS Ex. 1 at 3-5.  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).

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Petitioner's conviction of Medicaid fraud was also presumptively detrimental because it was a conviction for which exclusion from Medicare, Medicaid, and all federal health care programs is mandated by section 1128(a)(1) of the Act.  In fact, there is no dispute Petitioner was excluded by the IG pursuant to section 1128(a)(1) of the Act based on his conviction.  RFH at 2; CMS Ex. 3 at 11, 52, 54-55, 64.

Petitioner argues that CMS and the MAC failed to consider the circumstances surrounding his conviction.  The only determination subject to my review is the March 12, 2020, reconsidered determination (CMS Ex. 3 at 1-7).  Neb Grp., DAB No. 2573 at 7.  Petitioner asserts, and I accept as true for purposes of summary judgment, that he was not directly involved in the overbilling to the state Medicaid program and the amount at issue was merely $9.37.  P. Br. at 1-2.  Petitioner states that the Michigan Medical Board reduced his suspension from 12 months to one month, and the IG reduced his exclusion from federal health care programs from 10 years to five years.  He also states that his practice serves underserved areas of Detroit.  P. Br. at 1-2; P. Reply at 1-2.  The CMS hearing officer clearly addresses each of Petitioner's arguments in the reconsidered determination.  However, she also clearly rejected Petitioner's arguments as rebutting the basis for denial of Petitioner's enrollment application.  CMS Ex. 1 at 3-5.  The hearing officer concluded denial was appropriate pursuant to 42 C.F.R. § 424.530(a)(3) because Petitioner was convicted of offenses detrimental to Medicare or its beneficiaries.  CMS Ex. 3 at 5.  Petitioner's assertions of fact, even if accepted as true on summary judgment with all favorable inferences drawn for Petitioner, do not rebut that Petitioner was convicted of offenses that are presumptively detrimental under 42 C.F.R. § 424.530(a)(3)(i)(B) and (D) and the conviction is a basis for denial of his enrollment application.

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).

Further, to the extent that Petitioner's arguments may be construed to be 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

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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 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).

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 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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