Skip to main content
U.S. flag

An official website of the United States government

Here’s how you know

Dot gov

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

HTTPS

Secure .gov websites use HTTPS
A lock (LockA locked padlock) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Freedom 250 banner logo Join HHS in Celebrating Freedom 250
    • About HHS

      HHS is a U.S. executive department that touches the lives of nearly all Americans by protecting your rights, research, food safety, health care, aging, and much more.

    • Explore About HHS
    • About the Department
      • Leadership
      • HHS Divisions
      • Organizational Chart
      • Priorities
      • Budget in Brief
      • Contact Us
    • Press Room
      • Press Releases
      • Request for Comment
      • Request for Interview
      • Connect on Social Media
      • HHS Live
      • Podcasts
    • Careers
      • Working at HHS
      • Opportunities for Attorneys
      • Join the Health Workforce
      • I am HHS
      • New Employee Orientation
      • Transportation Services
    • Standards and Compliance
      • Gold Standard Science
      • Accessibility
      • Plain Writing
      • Digital Communications Standards
      • Records Management
    • Accountability and Transparency
      • Freedom of Information Act (FOIA)
      • Open Government
      • No Fear Act
      • Privacy at HHS
    • NUTRITION IN AMERICA

      HHS is advancing the Make America Healthy Again agenda by putting nutrition at the center of health. President Trump and Secretary Kennedy flipped the food pyramid to encourage Americans to Eat Real Food.

    • Explore Nutrition in America
    • Advancing Nutrition Education
    • Make Hospital Food Healthy Again
    • Eat Real Food
  • MAHA
    • Programs & Services

      HHS is responsible for public health, health care, and human/social services for the United States of America. This includes administering over 100 programs and services.

    • Explore Programs & Services
    • Health Care
      • Find a Health Center
      • Find an Indian Health Service Facility
      • Find Support for Mental Health, Drugs, or Alcohol
      • Find a Cancer Center
      • Dental Care Options
      • Telehealth
    • Health Insurance
      • Medicare – 65+ or With Disability
      • Medicaid - Low-Income, With Disability, or Pregnant
      • Children’s Health Insurance Programs (CHIP)
      • Find Health Insurance Coverage
      • Insurance Help for Mental Health and Substance Use
      • No Surprise Medicals Bills
    • Social Services
      • Programs for Children and Families
      • Programs for People with Disabilities
      • Programs for Older Adults
      • Resources for Caregivers
    • Public Health and Prevention
      • Emergency Preparedness and Response
      • Healthy Lifestyle
      • Mental Health and Substance Use
      • Food Safety and Nutrition
      • Drug and Product Safety
    • Health Research and Information
      • National Library of Medicine
      • Surgeon General Reports
      • Health Data
      • National Center for Health Statistics
      • Medline Plus
      • Clinical Research Studies
      • Volunteering to Participate in Research
    • Laws & Regulations

      HHS protects and helps you understand the laws and regulations, also known as "rules," that govern the nation. You also have the power to voice your opinion on these laws and regulations.

    • Explore Laws & Regulations
    • Regulatory Information
      • What is a Rule?
      • Find Rules by Division
      • Comment on Open Rules
      • Suggest Deregulatory Actions
      • Understand Key Federal Laws
    • Civil Rights
      • Your Civil Rights
      • Civil Rights Laws Enforced by HHS
      • Health Information Privacy
      • Substance Use Disorder Patient Confidentiality
      • Conscience and Religious Freedom
    • Laws and Regulations by Topic
      • HIPAA Privacy Rule
      • Health Insurance Protections
      • Health IT Legislation
      • Food and Drug Safety
      • Public Health Emergencies
    • Human Research Protections
      • The Belmont Report
      • Regulations, Policy, and Guidance
      • Human Subjects Regulations (45 CFR 46)
      • Register IRBs and Obtain FWAs
      • Trainings, Tutorials, and Workshops
      • International Research
    • Complaints and Appeals
      • File a Medicare Complaint
      • File a HIPAA Complaint
      • File a Civil Rights Complaint
      • Appeal an Insurance Company Decision
      • Report Fraud, Waste, and Abuse to OIG
      • Report a Problem to the FDA
      • Report a Tip on the Chemical and Surgical Mutilation of Children
    • Grants & Contracts

      HHS gives the most money in grants of any federal agency in the U.S. Find out about our grants and how your organization can apply for them. We also provide information on how you can work with us and our support of small businesses.

    • Explore Grants & Contracts
    • Grants
      • Get Ready for Grants Management
      • Grant Policies and Regulations
      • Research Grants and Funding from NIH
      • Search Grants.gov
      • Avoid Grant Scams
      • Contact HHS Grant Officials
    • Contracts
      • Get Ready to Do Business with HHS
      • Programs for Businesses
      • Contract Policies and Regulations
      • Search Opportunities on SAM.gov
      • Contact HHS Contracting Managers
    • Small Business
      • Contract Opportunities
      • Small Business Programs
      • Small Business Resources
      • Contact Small Business Staff
    • Radical Transparency

      HHS protects and helps you understand the laws and regulations, also known as "rules," that govern the nation. You also have the power to voice your opinion on these laws and regulations.

    • Explore Radical Transparency
    • CDC’s ACIP Conflicts of Interest
    • Ending Anti-Semitism on College Campuses
    • Ending Wasteful Spending
    • Keeping Food Ingredients Safe
    • Chemical Contaminants Transparency Tool
Breadcrumb
  1. Home
  2. About HHS
  3. Agencies
  4. DAB
  5. Decisions
  6. ALJ Decision…
  7. 2026 ALJ Decisions
  8. David Smith, M.D., DAB, CR6928, (2026)
  • Departmental Appeals Board (DAB)
  • About DAB
    • Organizational Overview
    • Who are the Judges?
    • DAB Divisions
    • Contact DAB
  • Filing an Appeal Online
    • DAB E-File
    • Medicare Operations Division (MOD) E-File
  • Different Appeals at DAB
    • Appeals to DAB Administrative Law Judges (ALJs)
      • Forms
      • Procedures
    • Appeals to Board
      • Practice Manual
      • Guidelines
      • Regulations
      • National Coverage Determination Complaints
    • Appeals to the Medicare Appeals Council (Council)
      • Forms
      • Fully Integrated Duals Advantage (FIDA) Demonstration Project
  • Alternative Dispute Resolution Services
    • Mediation
    • ADR Training
    • Other ADR Services
  • DAB Decisions
    • Board Decisions
    • DAB Administrative Law Judge (ALJ) Decisions
    • Medicare Appeals Council (Council) Decisions
  • Stakeholder Feedback
  • Careers
    • Open Career Opportunities
    • Internships & Externships

David Smith, M.D., DAB, CR6928, (2026)


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division

David Smith, 
(PTANs: GG599Z, V59432, V64410, NPI No.: 1811930357), 
Petitioner,

v.

Centers for Medicare & Medicaid Services.

Docket No. C-25-942
Decision No. CR6928
July 7, 2026

DECISION

The Centers for Medicare & Medicaid Services (CMS) revoked the Medicare enrollment of David Smith, M.D. (Dr. Smith or Petitioner) pursuant to 42 C.F.R. § 424.535(a)(13) based on the Drug Enforcement Administration’s (DEA’s) issuance of an order suspending Dr. Smith’s Certificate of Registration (COR).  CMS also imposed a five-year reenrollment bar and added Dr. Smith’s name to CMS’s preclusion list.  For the reasons set forth below, I affirm CMS’s actions. 

I.  Background and Procedural History

Petitioner is a physician who was enrolled in the Medicare program as a supplier.  On May 17, 2024, Noridian, a CMS contractor, issued initial determinations revoking Petitioner’s Medicare enrollment and billing privileges based on the following reason: 

42 C.F.R. § 424.535(a)(13) – Prescribing Authority

On April 12, 2024, your Drug Enforcement Administration (DEA) Certificate of Registration was suspended. 

Page 2

CMS Ex. 2 at 1 (for PTAN No. GG599z); 4 (for PTAN Nos. V59432, V64410).  Noridian also established a five-year bar to enrollment and added Petitioner’s name to the CMS Preclusion List.  Id. at 1, 4. 

On July 19, 2024, Petitioner requested reconsideration and filed several exhibits in support of that request.  CMS Ex. 4; CMS Ex. 5 at 2-3.  On July 15, 2025, a CMS Hearing Officer issued an unfavorable reconsidered determination.  CMS Ex. 5. 

On September 15, 2025, Petitioner filed a request for hearing.  The following day the Civil Remedies Division (CRD) acknowledged the hearing request and assigned the matter to Administrative Law Judge (ALJ) Jacinta Alves and issued her Standing Order, which included the dates by which the parties were to submit their prehearing exchanges.1  The deadlines were extended on multiple occasions, once due to a lapse in appropriated funding and twice at the request of Respondent’s counsel.  DAB E-File Entry Nos. 4, 7, and 10.  CMS filed its prehearing exchange, which included a Prehearing Brief and Motion for Summary Judgment (CMS Br.), along with five proposed exhibits (CMS Exs. 1-5) on May 14, 2026. 

Following an Order to Show Cause that was issued on May 4, 2026, Petitioner filed a Response (P. Response) along with its Prehearing Exchange (P. Exchange), Opposition to CMS’s Motion for Summary Judgment and Prehearing Brief (P. Br.) and 15 proposed exhibits (P. Exs. 1-15).  In accordance with ALJ Alves’s Standing Order, Petitioner identified two potential witnesses.  P. Exchange at 5.  Finally, Petitioner objected, in part, to all of CMS’s proposed exhibits.  Id. at 6-7. 

By my direction, the CRD Attorney-Advisor assigned to assist me in this matter notified the parties that the Order to Show Cause was discharged based on Petitioner’s response, which demonstrated that he was not abandoning his hearing request.  CMS was also permitted an opportunity to reply to Petitioner’s submission.  DAB E-File Entry No. 17.  CMS timely filed its reply.  CMS Reply.  CMS did not argue that Petitioner failed to show good cause for his untimely submission of his prehearing exchange or object to any of Petitioner’s proposed exhibits.  Id. 

II.  Rulings and Admission of Evidence

Petitioner has established good cause for filing his prehearing exchange untimely.  Petitioner explains that this case has had an unusual procedural history with multiple extensions, including two requested by CMS.  P. Response at 2.  Petitioner further

Page 3

proffers that accepting its filing will help me decide the case based on a complete record.  Id.  CMS, in its reply, does not object to me accepting the late filing.  CMS Reply.  Absent objection, I find that Petitioner has shown good cause for filing late, and I admit his exchange into the record. 

I also admit Petitioner’s proposed exhibits into the record as P. Exs. 1-15.  For the revocation issue, the applicable regulation directs me to “examine any new documentary evidence” submitted for the first time at the ALJ level of review and to determine whether Petitioner had good cause for submitting the evidence for the first time, at this level.  42 C.F.R. § 498.56(e); see also Standing Order ¶ 7 (explaining that Petitioner may not offer new documentary evidence absent a showing of good cause for failing to present that evidence previously to CMS).  Unless I find good cause, I must exclude the evidence and may not consider it in reaching a decision.  42 C.F.R. § 498.56(e)(2)(ii).  This rule about excluding newly submitted evidence does not apply to my review of the preclusion list determination. 

Many of the exhibits Petitioner submitted are duplicates of documents that CMS has already provided.  It also appears that Petitioner previously submitted several of these exhibits to CMS with his reconsideration request.  Compare, e.g., P. Exs. 8-11, with CMS Ex. 5 at 2 (documents listed as Exhibit 3).  As for the newly submitted evidence, Petitioner states that the documents “concern collateral proceedings and status developments that bear directly on CMS’s reliance on disputed underlying allegations, the alleged immediacy of risk, and the proportionality and accuracy of the preclusion-list determination.”  P. Exchange at 4.  CMS does not object to the admission of Petitioner’s proposed exhibits.  CMS Reply.  Because most of the new evidence is relevant to the preclusion‑list issue, I admit Petitioner’s newly submitted evidence.  Although duplicative exhibits do not need to be admitted, I am admitting all of Petitioner’s exhibits for administrative convenience. 

Finally, I overrule Petitioner’s objections and admit CMS’s proposed exhibits, CMS Exs. 1–5, into the record.  Petitioner raises partial objections to each exhibit, but most of these objections simply challenge CMS’s legal arguments rather than the admissibility of the exhibits themselves.  A disagreement with the legal conclusions in the documents is not a valid basis to exclude them.  Petitioner was free to, and in fact did, contest CMS’s interpretation and use of those documents in his response to CMS’s motion for summary judgment.  Under 42 C.F.R. § 498.60(b), I must fully consider all issues and admit any evidence that is relevant and material.  Petitioner does not, and indeed cannot, argue that CMS’s exhibits are irrelevant or immaterial, particularly because Petitioner included some of the same documents in his own submission.  For these reasons, CMS’s exhibits are admitted into the record. 

Page 4

III.  Issues

The issue in this case is whether CMS is entitled to summary judgment.  On the merits the issues are: 

1.  Whether CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment under 42 C.F.R. § 424.535(a)(13). 

2.  Whether CMS had a legitimate basis to place Petitioner’s on CMS’s Preclusion List under 42 C.F.R. §§ 422.2 and 423.100. 

IV.  Jurisdiction

I have jurisdiction to hear and decide the issues presented in this case.  42 C.F.R. §§ 498.3(b)(17), (20); 498.5(l)(2), (n)(2). 

V.  Discussion

My legal conclusions are set forth below in italics, followed by undisputed facts and analysis. 

A.  Summary judgment in CMS’s favor is appropriate. 

When appropriate, ALJs may decide a case arising under 42 C.F.R. Part 498 by summary judgment.  See Civil Remedies Division Procedures § 19.a; Livingston Care Ctr. v. U.S. Dep’t of Health & Human Srvcs., 388 F.3d 168, 172 (6th Cir. 2004) (citing Crestview Parke Care Ctr. v. Thomson, 373 F.3d 743 (6th Cir. 2004)).  Summary judgment is appropriate if “the record shows that there is no genuine issue as to any material fact, and the moving party is entitled to judgment as a matter of law.”  Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300, at 3 (2010) (citations omitted).  The moving party must show that there are no genuine issues of material fact requiring an evidentiary hearing and that it is entitled to judgment as a matter of law.  Id. 

If the moving party meets its initial burden, the non-moving party must “come forward with ‘specific facts showing that there is a genuine issue for trial . . . .”’  Matsushita Elec. Industrial Co. v. Zenith Radio, 475 U.S. 574,587 (1986).  “To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact — a fact that, if proven, would affect the outcome of the case under governing law.”  Senior Rehab., DAB No. 2300, at 3. 

To determine whether there are genuine issues of material fact for hearing, an ALJ must view the evidence in the light most favorable to the non-moving party, drawing all

Page 5

reasonable inferences in that party’s favor.  Id.  When ruling on a motion for summary judgment, an ALJ may not assess credibility or evaluate the weight of conflicting evidence.  Holy Cross Vill. at Notre Dame, Inc., DAB No. 2291, at 5 (2009).  However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non-moving party’s legal conclusions.  W. Tex. LTC Partners, DAB No. 2652 at 6-7; cf. Guardian, DAB No. 1943 at 11 (“A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed and there is only one reasonable conclusion that can be drawn from those facts.”); see Green Valley Healthcare & Rehab. Ctr., DAB No. 2947 at 8 (2019), quoting Johnson v. Perez, 823 F.3d 701, 705 (D.C. Cir. 2016) (noting that a genuine factual dispute does not exist “when a putatively disputed body of evidentiary material could not, even assuming a sympathetic factfinder, reasonably support a finding crucial to the nonmoving party’s legal position.”). 

Even when viewing the evidence in the light most favorable to Petitioner and drawing all inferences in Petitioner’s favor, I conclude that no genuine disputes of material fact exist regarding revocation under 42 C.F.R. § 424.535(a)(13)(i) or the addition of Petitioner’s name to CMS’s preclusion list that would require a hearing.  CMS is entitled to judgment as a matter of law; therefore, summary judgment is appropriate. 

B.  CMS had a legitimate basis to revoke Petitioner’s enrollment in the Medicare program because his DEA COR was suspended. 

As a physician, Petitioner is a supplier of health care services for purposes of the Medicare program.  42 U.S.C. § 1395x(d), (r)(1); 42 C.F.R. § 400.202 (definition of supplier).  The Social Security Act authorizes the Secretary of Health and Human Services (Secretary) to create regulations governing the enrollment of suppliers in the Medicare program.  42 U.S.C. § 1395cc(j). 

Under the Secretary’s regulations, a supplier must enroll in the Medicare program to receive payment for covered Medicare items or services.  42 C.F.R. § 424.505.  Once enrolled, CMS may revoke a supplier’s Medicare enrollment and billing privileges for any of the reasons stated in 42 C.F.R. § 424.535(a).  Relevant here, CMS may revoke a supplier if: 

The physician or other eligible professional’s Drug Enforcement Administration (DEA) Certificate of Registration to dispense a controlled substance is currently suspended or revoked or is surrendered in response to an order to show cause. 

42 C.F.R. § 424.535(a)(13)(i). 

Page 6

The Board has explained that “[t]he ALJ’s . . . role in an appeal of CMS’s . . . revocation of enrollment in the Medicare program is to determine whether CMS had a legal basis for its action,” and “[i]f it did, then [the ALJ is] bound to affirm the . . . revocation.”  Dr. Robert Kanowitz, DAB No. 2942 at 4 (2019).  The Board has further explained that “the right to review of CMS’s determination by an ALJ serves to determine whether CMS had the authority to revoke [the petitioner’s] Medicare billing privileges, not to substitute the ALJ’s discretion about whether to revoke.”  Letantia Bussell, M.D., DAB No. 2196 at 13 (2008); see also Eva Orticio Villamor-Goubeaux, DAB No. 2997 at 10 (2020). 

“Petitioner acknowledges that the DEA issued an immediate suspension order date April 12, 2024.”  P. Br. at 5; see also CMS Ex. 1; P. Ex. 6.  Because the DEA suspended Petitioner’s COR, CMS was authorized to revoke Petitioner’s Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(13). 

I acknowledge that Petitioner “disputes the DEA order’s characterization that he unlawfully infused or authorized unlawful infusions of controlled substances and disputes the conclusions that his continued registration constituted an imminent danger.”  P. Br. at 3; see also id. at 4 (describing the underlying conduct relied on by the DEA as stale and remediated).  However, those issues are beyond my scope of review.  The only question before me is whether CMS was authorized to revoke Petitioner’s enrollment based on the suspension of his DEA COR.  Regardless of Petitioner’s disagreements with the DEA’s (or CMS’s) characterization of the underlying conduct or allegations, the DEA’s order suspending Petitioner’s COR became effective on April 12, 2024.  Petitioner does not dispute this fact.  There is also no argument or evidence that the suspension was not in effect when CMS issued its initial determination in this case.  Therefore, CMS had the authority to revoke Petitioner’s enrollment and billing privileges in the Medicare program based on the suspension of Petitioner’s DEA COR pursuant to 42 C.F.R. § 424.535(a)(13)(i). 

C.  Petitioner is subject to a five-year bar to reenrollment. 

CMS imposed a reenrollment bar on Petitioner for five years.  CMS Ex. 5 at 4.  Petitioner challenges the length of the reenrollment bar.  P. Br. at 9-10.  However, CMS is permitted to impose a reenrollment bar that is at least one year in length and no more than ten years in length, except in certain circumstances that are not present in this case. 42 C.F.R. § 424.535(c)(1)(i).  CMS imposed a reenrollment bar that is within the permitted range.  Therefore, I have no authority to review the five-year length of the reenrollment bar.  Shah v. Azar, 920 F.3d 987, 998 (5th Cir. 2019); Frank B. Lee, M.D., DAB No. 3170 at 27-34 (2025); Vijendra Dave, M.D., DAB No. 2672 at 9 (2016). 

Page 7

D.  CMS had a legitimate basis to add Petitioner to the CMS Preclusion List. 

Petitioner disputes his inclusion on CMS’s Preclusion List.  Petitioner contends CMS erred in its conclusion that the underlying conduct was detrimental to the best interests of the Medicare program because it failed to consider several mitigating factors, mischaracterized the underlying conduct leading to the suspension of his COR and overstated the present risk.  P. Br. at 4, 6-9. 

Based on its consideration of the regulatory factors set forth in 42 C.F.R. §§ 422.2 and 423.100, CMS had a legitimate basis for upholding Petitioner’s placement on the Preclusion List.  In assessing a placement on the Preclusion List, CMS is required to consider, in the case of a revoked supplier who is under a reenrollment bar, whether the underlying conduct that led to the revocation is detrimental to the best interests of the Medicare program: 

A.  The seriousness of the conduct underlying the individual’s or entity’s revocation. 

B.  The degree to which the individual’s or entity’s conduct could affect the integrity of the Medicare program. 

C.  Any other evidence that CMS deems relevant to its determination. 

42 C.F.R. §§ 422.2 (paragraph (1)(iii) of definition of “Preclusion List”), 423.100 (paragraph (1)(iii) of definition of “Preclusion List”). 

As part of my review, I must ensure that CMS properly exercised its discretion by considering all required regulatory factors before placing Petitioner on the Preclusion List.  See Brian K. Ellefsen, D.O., DAB No. 2626 at 9 (2015).  However, my authority does not extend to second guessing CMS’s discretionary judgment.  See Abdul Razzaque Ahmed, M.D., DAB No. 2261 at 19 (2009), aff’d, Ahmed v. Sebelius, 710 F. Supp. 2nd 167 (D. Mass. 2010) (addressing the role of an ALJ in the context of reviewing CMS’s exercise of its discretion and not substituting his or her discretion when CMS had established the necessary regulatory elements). 

CMS’s reconsidered determination demonstrates that it considered all the required factors.  There is no dispute that CMS revoked Petitioner’s Medicare enrollment and Petitioner is under a reenrollment bar.  Therefore, the only question is whether the underlying basis for revocation is detrimental to the best interest of the Medicare program. 

In its reconsidered determination, CMS provided extensive support for its determination that Petitioner would be placed on its Preclusion List, stating: 

Page 8

Regarding factor (A), the suspension of Dr. Smith’s DEA COR led to the revocation of his Medicare enrollments pursuant to § 424.535(a)(13).  The facts underlying the suspension of Dr. Smith’s DEA COR fully support the revocation of his Medicare enrollments.  In the DEA’s Order to Show Cause, there was a finding that from November 2018 through April 2022, he unlawfully infused or authorized the infusion of numerous controlled substance prescriptions and violated both state and federal law by performing or authorizing such infusions “outside the usual course of professional practice and not for a legitimate medical purpose” (see Exhibit 1).  Dr. Smith does not deny these occurrences. 

Furthermore, the DEA’s suspension states that between February 4, 2022 through September 29, 2023, Dr. Smith violated the MBC’s December 22, 2021 Decision and Order on several occasions.  The Order prohibited Dr. Smith from, among others, “performing any care or treatment with patients involving the use, management, or any surgical procedure related to intrathecal pumps.”  Dr. Smith also does not deny these violations.  In fact, the MBC later revoked Dr. Smith’s probation and revoked his CA medical license because he “provided intrathecal pump treatment to three patients at a time when he was prohibited from doing so” (see Exhibit 6). 

The suspension notes indicate that Dr. Smith pled guilty to a Class A misdemeanor for adulteration of fentanyl, for having provided fentanyl compounded "under insanitary conditions" (see Exhibit 1).  While Dr. Smith qualifies the plea, distinguishing it from a plea of adulterating the drug itself, he does not deny the plea.  The suspension also notes that the DEA retained an independent medical expert to review the information regarding the alleged improper infusions, and that the medical expert concluded that Dr. Smith violated, “minimal medical standards applicable to the practice of medicine in the State of California” (see Exhibit 1). 

CMS considers the suspension of a DEA COR for numerous violations related to the improper and illegal infusion and authorizations of infusion of numerous controlled substance prescriptions to be very serious in nature.  CMS finds that Dr. Smith’s improper actions represent an extremely serious threat to the Medicare program and to the health, well-being, and safety of Medicare beneficiaries. 

Regarding factor (B), as noted previously, Dr. Smith’s DEA COR was suspended in part because as recently as April 2022, Dr. Smith violated both state and federal law by causing the infusion of controlled substances “outside the usual course of professional practice and not for a legitimate

Page 9

medical purpose,” and as recently as September 2023, he violated the MBC’s Order and Decision prohibiting him from, among others, “performing any care or treatment with patients involving the use, management, or any surgical procedure related to intrathecal pumps” (see Exhibit 1).  The MBC also found that Dr. Smith violated its probationary terms (see Exhibit 6).  CMS finds that Dr. Smith’s actions demonstrate a propensity for non-compliant behavior, as well as a complete disregard for state and federal government rules and regulations.  Furthermore, his actions call into question his ability to be a trustworthy Medicare partner. CMS is responsible for protecting Medicare beneficiaries and the Medicare Trust Funds.  The integrity of the Medicare program is dependent on the reliability, integrity, and good judgment of its partners.  As a result, Dr. Smith’s participation in the Medicare program would negatively affect the integrity of the Medicare program. 

Regarding factor (C), CMS finds that the facts that led the DEA to suspend Dr. Smith’s COR particularly egregious.  The DEA’s findings do not point to one-time violations, but to a pattern of improperly infusing or authorizing the infusion of excessive amounts of controlled substances without appropriate evaluations, medical justifications, or monitoring.  In one case, Dr. Smith infused a patient with excessive amounts of both fentanyl and ketamine on at least 13 different occasions and authorized the infusion of excessive amounts of both fentanyl and ketamine on at least 35 other occasions (see Exhibit 1). 

CMS also finds the MBC’s findings and conclusions in the July 2024 proposed decision to be relevant to our determination.  In July 2024, the MBC revoked Dr. Smith’s medical license because he violated the probationary terms established in 2022.  Specifically, the MBC found that Dr. Smith provided intrathecal pump treatment when he was prohibited from doing so, and violated his “informed consent duty to patients by knowingly making false and misleading disclosures to patients concerning his disciplinary status” (see Exhibit 6).  In determining what disciplinary remedy to impose, the MBC stated that Dr. Smith “was recalcitrant and cavalier in his dealings with the [MBC] and with his professional duty to disclose accurate information to his patients when seeking their informed consent to treat them.”  The MBC also concluded that Dr. Smith “learned nothing” from his license probation and that there was “no evidence in [Dr. Smith’s] case of his rehabilitation” (see Exhibit 6).  These findings by the MBC bolster CMS’s concerns about whether Dr. Smith can be a reliable Medicare partner, given his history of disregarding federal and state rules and regulations regarding medical treatment. 

Page 10

Furthermore, CMS finds relevant that the CMS Preclusion List was established to conform with a Congressional mandate.  This mandate intended to establish a program to prevent prescription drug abuse by Medicare beneficiaries under Medicare Parts C and D.  While Dr. Smith is a Medicare supplier and not a Medicare beneficiary, the dangerous actions by Dr. Smith that led to the suspension of his DEA COR are precisely the type of conduct that the CMS Preclusion List was intended to deter within the Medicare program.  In creating the CMS Preclusion List, CMS noted that, “the inclusion of problematic prescribers on the [P]reclusion [L]ist could reduce the amount of opioids that are improperly or unnecessarily prescribed by persons who pose a heightened risk to the Part D program and Medicare beneficiaries.”  The Medicare program is at serious risk if we allow suppliers, like Dr. Smith, to engage in improper prescribing practices while seeking to prevent and prohibit prescription drug abuse by its beneficiaries. 

CMS finds that the conduct that led to the revocation of Dr. Smith’s Medicare enrollments is detrimental to the best interest of the Medicare program and forms an appropriate basis to place him on the CMS Preclusion List.  Therefore, CMS upholds the determination to place Dr. Smith on the CMS Preclusion List, effective the date of this decision. 

CMS Ex. 5 at 5-7 (footnotes omitted). 

Petitioner does not assert that CMS neglected to consider any regulatory factors when it exercised discretion and affirmed his inclusion on the Preclusion List.  Rather, Petitioner’s arguments primarily center on contesting the characterization of his alleged misconduct as outlined in the DEA’s Order, stating that the actual conduct does not meet the alleged level or seriousness or pose the risk to program integrity attributed by CMS.  Id. at 3-5; 6-9.  The Petitioner maintains that the only uncontested fact is the issuance of an immediate suspension order by the DEA, while the veracity, relevance, and legal implications of the allegations contained within that order remain subject to dispute.  Id. 

Even assuming Petitioner’s disputes as to the underlying allegations are true, Petitioner points to no authority that requires CMS to adjudicate, in the first instance, whether the DEA Administrator’s order was erroneous.  Rather, pursuant to 42 C.F.R. §§ 422.2 and 423.100, CMS evaluates “the conduct underlying the revocation,” which was the prescribing practices that led to the revocation of his COR.  CMS considered this conduct, which was detailed in the DEA Administrator’s order, and acted within its discretion to uphold Petitioner’s inclusion on its Preclusion List.  CMS Ex. 1. 

Petitioner further asserts that CMS failed to consider evidence relating to remediation, monitoring, and absence of ongoing risk.  Petitioner argues that reasonable inferences

Page 11

should be drawn in his favor, and thus “a reasonable factfinder could conclude that CMS’s preclusion-list analysis overstated present risk and failed to account for evidence undermining a finding that [Petitioner’s] continued relationship to the Medicare program would negatively affect program integrity.”  P. Br. at 9.  Again, I accept Petitioner’s disputes as true, but, even so, these disputes do not change the outcome. 

Petitioner presented these points in his request for reconsideration, thereby making them available to CMS during its determination.  Nonetheless, CMS upheld Petitioner’s inclusion on the Preclusion List.  The regulatory framework does not obligate CMS to weigh these factors; therefore, CMS’s decision not to do so falls within its discretion.  As already stated, where regulations afford CMS discretion to determine whether a provider or supplier’s conduct is detrimental to the Medicare program, it is not my role to reweigh regulatory factors or supplant CMS’s judgment with my own. 

Even if I were permitted to substitute my discretion for that of CMS, considering only the undisputed allegations and conduct, I would not reach a different outcome.  Petitioner acknowledges engaging in improper prescribing practices over multiple years and with multiple patients.  P. Ex. 3 at 4 (stating Dr. Smith was aware of prescribing infractions included in the DEA Administrator’s suspension order, but instead disputing their significance).  This fact alone supports Petitioner’s inclusion on CMS’s Preclusion List.  As noted by the Hearing Officer, the Preclusion List was established to comply with Congressional mandates for preventing prescription drug abuse among Medicare beneficiaries.  CMS Ex. 5 at 6 (citing the Comprehensive Addiction and Recovery Act of 2016 requiring, among other things, the Secretary to implement a drug management program to limit access to controlled substances for at-risk Medicare beneficiaries.).  Petitioner’s conduct aligns with the type of activity Congress intended to deter and, accordingly, plainly detrimental to the Medicare program and its beneficiaries. 

Moreover, I recognize the passage of time since the underlying conduct, and acknowledge Petitioner’s claims of enhanced monitoring, oversight, and other remedial measures, including transferring patient care to other providers and refraining from engaging in certain pain management practices.  I do not doubt Petitioner has taken these steps, but find these steps do not, by themselves, establish that Petitioner is a reliable partner to the Medicare program.  The Medicare program depends on its suppliers to consistently uphold accepted standards of practice and care, and it must be able to rely on them to provide appropriate services to beneficiaries without requiring continued supervision or additional restrictions. 

For all the reasons discussed, I affirm CMS’s conclusion that the underlying basis for Petitioner’s revocation of enrollment is detrimental to the best interests of the Medicare program and CMS’s placement of Petitioner’s name on the CMS Preclusion List is appropriate. 

Page 12

VI.  Conclusion

For the foregoing reasons, I affirm the revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(13) and inclusion on CMS’s Preclusion List. 

/s/

Debbie K. Nobleman Administrative Law Judge

  • 1

      The matter was first reassigned to ALJ Benjamin Zeitlin on December 29, 2025, upon ALJ Alves’s resignation, and then to the undersigned on May 6, 2026, upon ALJ Zeitlin’s resignation. 

Back to top
Secretary Robert F. Kennedy Jr.

Follow @SecKennedy

HHS icon

Follow @HHSGov

HHS Email updates

Receive email updates from HHS.

Subscribe

HHS Logo

HHS Headquarters

200 Independence Avenue, S.W.
Washington, D.C. 20201
Toll Free Call Center: 1-877-696-6775​

  • Contact HHS
  • Careers
  • HHS FAQs
  • Nondiscrimination Notice
  • Press Room
  • HHS Archive
  • Accessibility Statement
  • Privacy Policy
  • Budget/Performance
  • Inspector General
  • Web Site Disclaimers
  • EEO/No Fear Act
  • FOIA
  • The White House
  • USA.gov
  • Vulnerability Disclosure Policy