Gulf Coast Pain Consultants Notice of Final Determination

U.S. Department of Health and Human Services
Office for Civil Rights
Office of the Secretary
Hubert H. Humphrey Building
200 Independence Ave., S.W.
Washington, D.C. 20201
http://www.hhs.gov/ocr

Via Personal Service, Certified Mail, Return Receipt Requested, and Email

September 27, 2024

Ira Kornbluth, President
Clearway Pain Solutions
201 Defense Highway, Ste. 205
Annapolis, MD 21401

Re:       Gulf Coast Pain Consultants, LLC d/b/a Clearway Pain Solutions Institute (Gulf Coast)
             OCR Transaction Number: 19-339057

Notice of Final Determination

Dear Dr. Kornbluth:

Pursuant to the authority delegated by the Secretary of the United States Department of Health and Human Services (“HHS”) to the Office for Civil Rights (“OCR”), I am writing to inform you that the civil money penalty (“CMP”) of $1,190,000 against Gulf Coast Pain Consultants, LLC d/b/a Clearway Pain Solutions Institute (“Gulf Coast”) is final. This letter also contains instructions to make payment of the CMP amount.

I. Gulf Coast is Waiving the Right to Request a Hearing Before an Administrative Law Judge and Petition for Judicial Review

By its August 14, 2024, Notice of Proposed Determination (attached hereto), OCR informed Gulf Coast that it was proposing to impose a CMP of $1,190,000.00 based on the findings of the facts of noncompliance specified in the letter. The Notice of Proposed Determination notified Gulf Coast of its right to request a hearing on the proposed CMP within ninety (90) days of the date of receipt of the letter and provided instructions on requesting a hearing with the Departmental Appeals Board. The Notice of Proposed Determination further advised that failure to request a hearing within this time period could result in the imposition of the proposed CMP without a hearing under 45 C.F.R. § 160.504 or the right of appeal under 45 C.F.R. § 160.548. Gulf Coast received the Notice of Proposed Determination on August 15, 2024, when it was delivered by a duly registered process server to Marsha Winik, Vice President of Accounting, who confirmed that she was expressly authorized to accept process for Clearway Pain Solutions. Gulf Coast also received the Notice of Proposed Determination on August 16, 2024, when OCR emailed it to Gulf Coast’s attorney, Iliana Peters.

By letter dated September 23, 2024, sent via email to OCR, Gulf Coast's counsel advised that Gulf Coast waives its right to a hearing pursuant to 45 C.F.R. §160.420(b), is not contesting OCR’s proposed determination, and will pay the $1,190,000.00 CMP. Accordingly, by operation of Gulf Coast’s waiver of its procedural rights to challenge the CMP under 45 C.F.R. Part 160 Subparts D and E and 42 U.S.C. § 1320a-7a, the CMP referenced above is now final. Therefore, pursuant to the authority delegated by the Secretary of HHS to the Director of OCR, I am authorized to impose the CMP against Gulf Coast in the full amount of $1,190,000.00, as set forth in the Notice of Proposed Determination.

II. No Right of Appeal

Gulf Coast has no right to appeal the imposition of the CMP under 45 C.F.R. § 160.548 since Gulf Coast chose to waive its right to appeal OCR’s proposed determination and its right to request a hearing.

III. Instructions for Payment of the CMP Amount

Payment of the full and aggregate amount of $1,190,000.00 is due upon Gulf Coast’s receipt of this Notice of Final Determination. Payment can be made in accordance with the instructions enclosed with this Notice.

IV. Consequences of Nonpayment

In the event that payment is not received upon Gulf Coast’s receipt of this Notice of Final Determination, a civil action may be brought in the United States District Court to recover the amount of the penalty.

V. Legal Basis for This Action

This action is being taken under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), § 262(a), Pub.L. 104-191, 110 Stat. 1936, as amended, codified at 42 U.S.C. § 1320d-5, and under the enforcement regulations at 45 C.F.R. Part 160, subpart D. The Secretary of HHS is authorized to impose CMPs (subject to the limitations at 42 U.S.C. § 1320d-5(b)) against any covered entity, as described at 42 U.S.C. § 1320d-l(a), that violates a provision of Part C (Administrative Simplification) of Title XI of the Social Security Act. See 42 U.S.C. § 1320d- 5(a), as amended. This authority extends to violations of the regulations commonly known as the Security Rule promulgated at 45 C.F.R. Part 160 and subparts A and C of Part 164, pursuant to Section 262 of HIPAA. The Secretary has delegated enforcement responsibility for the Security Rule to the Director of OCR. See Office for Civil Rights; Delegation of Authority, 74 Fed. Reg. 38630 (July 27, 2009).

If you have any questions concerning this letter, please contact Taryn Elliott, Health Information Privacy, Data, and Cybersecurity Compliance and Enforcement Specialist, at (202) 690-5542.

Sincerely,

/s/

Melanie Fontes Rainer
Director
Office for Civil Rights
U.S. Department of Health and Human Services

Enclosed:
Payment Instructions
Notice of Proposed Determination (August 14, 2024)

CC:      Iliana Peters, Polsinelli (via email only at IPeters@Polsinelli.com)