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
  • RealFood.gov
  • 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. Holy Cross Hospital, DAB CR6830 (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

Holy Cross Hospital, DAB CR6830 (2026)


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

Centers for Medicare & Medicaid Services,

v.

Holy Cross Hospital,
Respondent.

Docket No. C-24-12
Decision No. CR6830
February 5, 2026

DECISION

Respondent, Holy Cross Hospital, challenges the Centers for Medicare & Medicaid Services’ (CMS’s) determination of noncompliance with hospital price transparency requirements.  Respondent also challenges the imposition of a civil monetary penalty (CMP) of $4,230 per day for 77 days from June 21, 2023 through September 5, 2023, totaling $325,710. 

As explained below, CMS had a legal basis to impose a CMP against Respondent due to violations of the Hospital Price Transparency Act.  However, the amount of the CMP imposed is not reasonable.

I.       Background and Procedural History

On October 5, 2023, Respondent requested a hearing to contest the CMP imposed by CMS. 

The Acknowledgement and Prehearing Order, along with the Civil Remedies Division (CRD) Procedures, was issued on October 12, 2023.

Page 2

On December 11, 2023, Respondent filed a brief (R. Br.) and 13 exhibits (R. Exs. 1-13).  CMS timely filed a prehearing exchange (CMS Br.), along with six exhibits (CMS Exs. 1-6) on February 9, 2024.  

On March 8, 2024, Respondent filed a reply brief with an additional exhibit, R. Ex. 14.  Various motions to strike and requests for discovery followed.  Respondent filed an additional exhibit on April 3, 2024, R. Ex. 15.  On April 30, 2024, Administrative Law Judge (ALJ) Tannisha Bell held a prehearing conference.  In her order following the conference, Judge Bell instructed the parties to conduct discovery and denied the motion to strike.  Judge Bell also asked the parties to confirm whether or not a hearing was still necessary.  On July 19, 2024, Respondent filed a supplement to its prehearing brief (R. Supp.).  Discovery was eventually completed, and Respondent filed two additional exhibits (R. Exs. 15-16).1  Respondent also indicated in its filings that it no longer believed an oral hearing was necessary, and CMS did not make an affirmative request to cross-examine any witnesses pursuant to the October 12, 2023 Acknowledgement Order.  Departmental Appeals Board Electronic Filing System (DAB E-File) doc. # 33 at 1.  As a result, I find that this matter can be decided on the written record.2

II.    Admission of Exhibits and Decision on the Written Record

Absent objections, R. Exs. 1-16 and CMS Exs. 1-6 are admitted into evidence. 

III.    Issues

  1. Whether a basis exists for CMS to assess a CMP against the Respondent pursuant to 45 C.F.R. § 180.90(a); and
  2. Whether the CMP imposed by CMS is reasonable pursuant to 45 C.F.R. §§ 180.90(c), 150.317.  

IV.      Jurisdiction

I have jurisdiction to hear and decide this case.  42 U.S.C. § 300gg-18(b)(3)3; 45 C.F.R. §§ 150.405, 150.417, 180.100.

Page 3

V.      Legal Authorities

In 2010, as part of the Affordable Care Act, Congress enacted section 2718 of the Public Health Services Act (“PHS Act”), entitled “Bringing down the cost of health care coverage”.  42 U.S.C. § 300gg-18(e).  Section 2718(e) of the PHS Act, codified in 45 C.F.R. Part 180, requires each hospital operating in the United States to establish (and update) and make public a list of the hospital’s standard charges for items and services provided by the hospital, including for diagnosis-related groups established under section 1886(d)(4) of the Social Security Act.  45 C.F.R. § 180.10.  The PHS Act provided the

Page 4

U.S. Department of Health and Human Services (HHS) with the authority to codify the “standard charges” that hospitals are required publish.  45 C.F.R. Part 180. 

A standard charge is the regular rate established by the hospital for an item or service provided to a specific group of paying patients, including:  

1)  Gross charge
2)  Payer-specific negotiated charge
3)  De-identified minimum negotiated charge
4)  De-identified maximum negotiated charge
5)  Discounted cash price.

45 C.F.R. § 180.20. 

To comply with transparency requirements, a hospital must make public “a machine-readable file containing a list of all standard charges for all items and services as provided in [45 C.F.R.] § 180.50.”  45 C.F.R. § 180.40(a).  Hospitals must also make public a “consumer-friendly list of standard charges for a limited set of shoppable services as provided in [45 C.F.R.] § 180.60.”  45 C.F.R. § 180.40(b). 

CMS may monitor and assess hospital compliance through the evaluation of complaints made by individuals or entities to CMS; reviewing individuals’ or entities’ analysis of noncompliance; audit and comprehensive review; requiring submission of certification by an authorized hospital official as to the accuracy and completeness of the standard charge information in the machine-readable filing; and requiring submission of additional documentation as may be necessary to make a determination of hospital compliance.  45 C.F.R. § 180.70(a)(2).  

If CMS concludes that a hospital is noncompliant with transparency requirements it may take the following actions:  provide a written warning notice to the hospital with the specific violations, of which the hospital must submit an acknowledgment of receipt; request a corrective action plan (CAP) from the hospital if its noncompliance constitutes a material violation of one or more requirements; and impose a CMP on the hospital and publicize the penalty on a CMS website if the hospital fails to respond to CMS’s request to submit a CAP or comply with the requirements of a CAP.  45 C.F.R. § 180.70(b).  

VI. Findings of Fact

  1. Respondent is a 423-bed hospital4 located in Maryland.  R. Ex. 5; R. Ex. 14 at 7.

Page 5

  1. On May 11, 2023, CMS conducted a review of Respondent’s public website5 and was unable to find a machine-readable file containing a complete list of standard charges for all items and services provided by the hospital.  CMS Ex. 1.  The reviewer noted that the downloaded machine-readable file of standard charges only listed the codes, description of item / service, and unit charge amount.  CMS Ex. 1 at 6.  The file did not contain the payer-specific negotiated charge, de-identified minimum negotiated charge, de-identified maximum negotiated charge, and discounted cash price.  Id.  The reviewer was unable to find any other machine-readable files on Respondent’s website.  Id. at 7.
  2. By notice6 dated June 22, 2023, CMS notified Respondent of its failure to make public a machine-readable file containing a list of all standard charges and a consumer-friendly list containing a list of all standard charges.  R. Ex. 4.  The notice also informed Respondent that it could submit a corrective action plan within 45 days.  Id. at 3.  CMS requested Respondent acknowledge receipt of the notice within five business days.  Id. at 4.
  3. CMS had not received any acknowledgement of the notice letter from Respondent by July 10, 2023.  As a result, CMS attempted to contact Respondent via telephone by calling the number on the website.  CMS Ex. 2.  CMS was unable to leave a voice mail or speak with the CEO.  Id.
  4. Respondent did not submit a corrective action plan.  As result, CMS conducted another review of Respondent’s website on August 10, 2023.  CMS Ex. 3.  CMS again determined that Respondent failed to make public a machine-readable file containing a list of all standard charges.  Id.  During the review, CMS attempted to confirm the Respondent’s CEO’s email address by calling the hospital but was unsuccessful.  Id.

Page 6

  1. On September 5, 2023, CMS issued a Hospital Price Transparency Notice of Imposition of a Civil Monetary Penalty imposing a $325,710 CMP for Respondent’s alleged noncompliance from June 21, 2023 to September 5, 2023.  R. Ex. 5.  The letter was sent via FedEx with confirmed delivery received on September 6, 2023.  CMS Ex. 4.  The letter was signed for by the same person who signed for the initial June 22, 2023 notice letter.  Id.; R. Ex. 12.
  2. Respondent emailed the Hospital Price Transparency inbox on September 7, 2023 and acknowledged receipt of the CMP letter.  R. Ex. 13.  Respondent indicated in its email that it had not received the June 22, 2023 notice letter and requested a copy.  Id.  CMS responded by providing a copy of the notice letter and a copy of the delivery confirmation.  CMS Ex. 5.
  3. On September 12, 2023, Respondent submitted a corrective action plan to CMS.  CMS Ex. 6.  On September 13, 2023, CMS sent a letter to Respondent stating that the deficiencies had been corrected.  R. Ex. 6.  

 VII.  Analysis and Conclusions of Law

  1. CMS was authorized to impose a civil monetary penalty.

CMS may impose a CMP on a hospital that is noncompliant and fails to respond to CMS’s request to submit a CAP or comply with the requirements of a CAP.  45 C.F.R. § 180.90(a).  Noncompliance includes a hospital’s failure to respond to CMS’s request to submit a CAP in a timely manner as outlined in the notice of violation issued by CMS, and failure to correct violations within specific timeframes.  45 C.F.R. § 180.80(d).  

CMS conducted several searches of Respondent’s public website and was unable to locate a comprehensive machine-readable file.  Respondent argues that it was compliant with Maryland’s demonstration program where all third parties pay the same rate.  R. Br. at 4.  Respondent states that CMS is fully aware of Maryland’s unique structure, and therefore, a hospital’s machine-readable file should have a null set for a lot of the data elements.  Id. at 5.  However, as CMS points out the hospital services under Maryland law and the items and services under CMS’s HPT regulations are not an exact match.  CMS Br. at 14.  As a result, it is fair to conclude that there are items and services for which the Maryland commission did not set a rate and for which should have been included in Respondent’s machine-readable file.  Further, when Respondent filed its response to CMS’s CMP letter, it stated that the chargemaster file on the website was outdated and that it updated the website to reflect the proper machine-readable file.  CMS Ex. 6 at 2.   Therefore, Respondent was noncompliant with price transparency requirements by having an outdated machine-readable file containing a list of all standard charges for services.

Page 7

Respondent next argues that CMS violated its due process rights by not sending the CAP letter and the CMP letter to its authorized agents in the PECOS system.  R. Br. at 9.  However, the PECOS system is a different regulatory process than the HPT process.  As a result, CMS is not required to utilize information from its Medicare enrollment system to send notices under its HPT program.  45 C.F.R. § 180.90(b) states that CMS must provide written notice of a CMP imposition via certified mail or another form of traceable carrier.  In response, Respondent argues that this process is unfair and results in packages lost in mailrooms.  R. Br. at 9-10.  However, CMS sent the CAP notice letter and the CMP notice letter via the same method to the same contact person and the CMP notice letter was received and quickly responded to by Respondent.  As a result,  I find that CMS properly provided written notice under the regulation.  To the extent Respondent is arguing that the regulatory framework is unfair, I have no authority to consider such actions either as a request for equitable relief or as a constitutional due process challenge.  45 C.F.R. § 150.403; see Ilya Kogan, DAB No. 3034 at 6 (2021).  

  1. The $4,230 per day CMP is not reasonable.

Because I have determined that CMS had a basis to impose a CMP, I must now determine if the imposed CMP is reasonable.  45 C.F.R. § 150.417(a).  For a hospital with at least 31 beds and up to and including 550 beds, the maximum daily dollar civil money penalty amount is the number of beds times $10.  45 C.F.R. § 180.90(c)(2)(ii)(B).  The effective date for a CMP is the latest of the following dates:  the first day that the hospital is required to meet the Hospital Price Transparency regulations’ requirements; the date 12 months after the date of the hospital’s last annual update of its charges; or, a date determined by CMS, such as one resulting from monitoring activities or a hospital’s development of a CAP.  45 C.F.R. § 180.90(b)(2)(ii)(A)-(C).  Here, CMS imposed a $325,710 CMP, assessing the maximum per day penalty from June 21, 2023, the date when the violation was first observed, through September 5, 2023, the date of the CMP notice letter.  R. Ex. 5.

An ALJ may sustain, reduce, or increase the CMP imposed by CMS.  45 C.F.R. § 150.417(c).  In deciding the reasonableness of a CMP, an ALJ may consider the hospital’s posting(s) of its standard charges (if available); material the hospital timely previously submitted to CMS (including with respect to corrective actions and corrective action plans); and material CMS used to monitor and assess the hospital’s compliance according to section 180.70(a)(2).  45 C.F.R. §§ 180.100(b)(4), 150.417(b), 150.317, 150.323.  In addition, I am authorized to consider evidence of record relating to any factor that CMS did not apply in making its initial determination so long as that factor is identified in the subpart.  45 C.F.R. § 150.417(b)(2). 

Amount of the CMP

When determining the amount of a penalty CMS should consider the following:

Page 8

(a) The entity's previous record of compliance.  This may include any of the following: 

(1) Any history of prior violations by the responsible entity, including whether, at any time before determination of the current violation or violations, CMS or any State found the responsible entity liable for civil or administrative sanctions in connection with a violation of PHS Act requirements. 
(2) Documentation that the responsible entity has submitted its policy forms to CMS for compliance review.
(3) Evidence that the responsible entity has never had a complaint for noncompliance with PHS Act requirements filed with a State or CMS.   
(4) Such other factors as justice may require. 

(b) The gravity of the violation.  This may include any of the following: 

(1) The frequency of the violation, taking into consideration whether any violation is an isolated occurrence, represents a pattern, or is widespread.  
(2) The level of financial and other impacts on affected individuals.  
(3) Other factors as justice may require.

45 C.F.R. § 150.317.  

In determining the reasonableness of the CMP, I am not bound to defer to CMS’s factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS’s discretion.  See, e.g., Barn Hill Care Ctr., DAB No. 1848 at 21 (2002).  The Board has ruled that “[t]he determination of whether a CMP amount is reasonable is a conclusion of law, not a finding of fact.”  Cedar Lake Nursing Home, DAB No. 2344 at 12 (2010), aff’d, Cedar Lake Nursing Home v. U.S. Dept. of Health & Hum. Servs., 619 F.3d 453, 457 (5th Cir. 2010).

CMS has not indicated that it considered any of the above factors in determining that the maximum $4,230 CMP per day is appropriate.  Respondent does not make any arguments regarding the financial impacts of the CMP.  Per the regulations, CMS should also consider the entity’s previous record of compliance and the gravity of the violation when imposing a CMP.  CMS has not addressed either of these factors, nor has it indicated that

Page 9

these factors were considered in its determination to impose the highest possible CMP.  45 C.F.R. § 150.443 (providing that CMS has the burden of coming forward with evidence sufficient to establish a prima facie case and the burden of persuasion regarding facts material to the assessment); but see Coquina Ctr., DAB No. 1860 (2002); Cmty. Nursing Home, DAB No. 1807 (2002) (explaining in the skilled nursing facility (SNF) enforcement context that placing the burden on SNFs to show that a CMP is unreasonable is based on a “careful review of the statute, regulations and the preamble to the regulations at 42 C.F.R. Part 488”).  Based on Respondent’s previous record of compliance, the fact that Respondent had some of the required information posted on its website, Respondent’s quick correction of its error when it received the CMP notice letter, and CMS’s silence regarding the consideration given to these factors, I find that the imposed CMP is unreasonable and a reduction is appropriate.  Based on the facts and evidence provided, I find that a CMP of $5 per bed per day 7 is appropriate in this case.  

Respondent argues that the hospital took affirmative steps to understand the requirements and correct deficiencies while continuing to argue that notice was improper and that it complied with Maryland law.  However, this does not excuse Respondent’s failure to have the proper documents on its website.  CMS has provided proof that both the CAP notice letter and the CMP notice were received by Respondent’s staff.  The record supports CMS’s contention that it attempted to contact Respondent multiple times outside of the notice letters and that nothing additional was required on CMS’s part regarding service.  If Respondent’s staff had responded to the CAP notice letter or the multiple phone calls from CMS, the issue may have been resolved before a CMP was ever imposed. 

Because the CMP has been upheld in part, CMS should “issue a modified notice of imposition of [the CMP] to conform to the adjudicated finding.”  45 C.F.R. § 180.90(b)(3), (e)(2)(iii). 

Lastly, in a supplement to its pre-hearing brief, the Respondent points to two Supreme Court cases – SEC v. Jarkesy, 603 U.S. 109 (2024) and Loper Bright Enters. v. Raimondo, 603 U.S. 369 (2024).  Respondent asserts that, based on Jarkesy, I have no authority to hear this appeal; the Seventh Amendment to the Constitution mandates that the respondent hospital is entitled to a trial by jury.  Respondent also claims that, based on Loper Bright, CMS’s regulations exceeded the agency’s statutory authority to require that hospitals publish lists of standard charges for items and services provided.  R. Supp. 

An administrative law judge is bound by the statute and regulations and has no authority to invalidate those provisions based on constitutional challenges.  45 C.F.R. § 150.403; see Ilya Kogan, DAB No. 3034 at 6 (2021); Funmilola Mary Taiwo, DAB No. 2995 at 9-

Page 10

10 (2020); Donna Rogers, DAB No. 2381 at 5 (2011); Susan Malady, R.N., DAB No. 1816 at 4 (2002). 

But, even if I could consider the issue, I doubt that either of these cases applies to CMPs imposed under the price transparency statute.  Jarkesy applies only if the CMP imposed is punitive, rather than remedial.  Review of the statute and regulations shows that their purpose is to induce hospitals to publish the required price transparency information.  CMS’s actions underscore its commitment to that purpose.  It delayed imposing CMPs at all to give hospitals ample time to comply, emphasizing that hospitals would “have the opportunity to take corrective action prior to the imposition of a penalty.”  84 Fed. Reg. 65,524, 65,588 (Nov. 27, 2019).  CMS explicitly set a CMP amount that was “reasonable and sufficient to ensure hospitals’ compliance with the proposed requirements to make public standard charges.”  See Id. at 65,587 (emphasis added). 

Nor do I agree that Loper Bright invalidates regulations drafted in response to an express delegation from Congress.  That decision recognized that “when a particular statute delegates authority to an agency consistent with constitutional limits, courts must respect the delegation, while ensuring the agency acts within it.”  Loper, 603 U.S. at 413; see Figueroa v. Sec’y of HHS, No. 8:23-cv-2236-SPF, 2025 WL 2337297 at 4-5 (M.D. Fla. 2025) and cases cited therein. 

But these are issues for another tribunal. 

VIII. Conclusion

For the reasons set forth above, I have determined that a basis exists for CMS to impose a CMP against Respondent.  However, the $325,710 CMP is unreasonable based on the facts and circumstances of this case.  Therefore, the amount for the per day CMP has been reduced to $2,115, totaling $162,855.

/s/

Kourtney LeBlanc Administrative Law Judge

  • 1It appears that Respondent filed two exhibits marked as Ex. 15. For clarity, the first R. Ex. 15 will be referenced as Keese Attestation.
  • 2This case was transferred to me on October 7, 2025.
  • 3

    In the final rule for hospital price transparency regulations, CMS stated:

    As we described in the CY 2020 OPPS/ASC proposed rule (84 FR 39593 through 39594), we believe it is important to establish a fair administrative process by which a hospital may appeal CMS’[s] decisions to impose penalties under section 2718(b)(3) regarding the hospital’s noncompliance with the requirements of section 2718(e) of the [Public Health Services (“PHS”)] Act and the requirements of proposed 45 CFR part 180.  Through various Medicare programs, we have gained experience with administrative hearings and other processes to review CMS’[s] determinations.

    We proposed to align the procedures for the appeals process with the procedures established under section 2718(b)(3) of the PHS Act for an issuer to appeal a CMP imposed by HHS for its failure to report information and pay rebates related to MLRs, as required by sections 2718(a) and (b) of the PHS Act, and according to 45 CFR parts 158 and 150.  Therefore, we proposed that a hospital upon which CMS has imposed a penalty under proposed 45 CFR part 180 may appeal that penalty in accordance with 45 CFR part 150, subpart D, except as we have otherwise proposed.

                                                                                                                  * * * *

    We are finalizing as proposed to specify in new 45 CFR 180.100 the procedures for a hospital to appeal the CMP imposed by CMS for its noncompliance with the requirements of 45 CFR part 180 to an [administrative law judge], and for the Administrator of CMS, at his or her discretion, to review in whole or in part the [administrative law judge’s] decision. 

    84 Fed. Reg. 65,524, 65,590-91 (Nov. 27, 2019) (emphasis supplied).

  • 4Hospital means an institution in any state in which state or applicable local law provides for the licensing of hospitals, that is licensed as a hospital pursuant to such law or is approved, by the agency of such state or locality responsible for licensing hospitals, as meeting the standards established for such licensing.  American territories such as the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands are considered states under the regulations.  45 C.F.R. § 180.20.  It is undisputed that Respondent qualifies as a hospital.
  • 5

    Respondent’s public website may be accessed at https://holycrosshealth.org (last accessed January 21, 2026).

  • 6The notice was sent to Norvell V. Coots, CEO, Holy Cross Hospital, 1500 Forest Glen Road, Silver Spring, Maryland 20910.  R. Ex. 4 at 1.  The letter was confirmed delivered to Respondent by FedEx on June 23, 2023.  R. Ex. 12.
  • 7$5 x 423 beds x 77 days = $162,855.
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
  • Budget/Performance
  • Inspector General
  • Web Site Disclaimers
  • EEO/No Fear Act
  • FOIA
  • The White House
  • USA.gov
  • Vulnerability Disclosure Policy