Cal. Code Regs. tit. 22 § 97441

Current through Register 2024 Notice Reg. No. 43, October 25, 2024
Section 97441 - Review of Material Change Transaction Notice; Decision to Conduct Cost and Market Impact Review
(a) Office Determination Whether to Conduct a Cost and Market Impact Review (CMIR).
(1) The Office shall base its decision whether to conduct a CMIR on any of the following factors:
(A) The transaction may result in a negative impact on the availability or accessibility of health care services, including the health care entity's ability to offer culturally competent care.
(B) The transaction may result in a negative impact on costs for payers, purchasers, or consumers, including the ability to meet any health care cost targets established by the Health Care Affordability Board pursuant to section 127502(n) of the Code, and as set forth at 22 CCR 97447.
(C) The transaction may lessen competition or create a monopoly in any geographic service areas impacted by the transaction.
(D) The transaction may lessen competition for health care entities to hire workers or may negatively impact the labor market by, for instance, lowering wages or slowing wage growth, worsening benefits or working conditions, or resulting in other degradations of workplace quality.
(E) The transaction negatively impacts a general acute care or specialty hospital by, for instance, restricting or reducing the health care services offered.
(F) The transaction may negatively impact the quality of health care services available to patients from the parties to the transaction.
(G) The transaction is part of a series of similar transactions by the health care entity or entities that furthers a trend toward consolidation.
(H) The transaction may entrench or extend a dominant market position of any health care entity in the transaction, including extending market power into related markets through vertical or cross-market mergers.
(I) The transaction between a health care entity located in this state and an out-of-state entity may negatively impact affordability, quality, or limit access to health care services in California, or undermine the financial stability or competitive effectiveness of a health care entity located in this state.
(b) Request for Review of Determination to Conduct a Cost and Market Impact Review.
(1) Within 10 business days after the date of a determination that a CMIR is required, the submitters of the notices for that transaction may collectively request review by the Director of the Office's determination. The request shall:
(A) Be in writing;
(B) Be signed by all requesting submitters;
(C) Be submitted through the Office's portal;
(D) Specifically set forth the grounds upon which the submitters consider the determination to be in error; and
(E) State the reasons why a CMIR is not warranted.
(2) The request will be denied if it contains no more than a request for a waiver of a CMIR, unsupported by specific facts.
(3) Within five business days of receipt of a request for review, the Director shall either:
(A) Decline review and uphold the determination that a CMIR is required; or
(B) Grant the request and waive a CMIR.
(4) The Director may extend this period by an additional five business days if the Director needs additional time to complete the review.
(5) The determination of the Director, either upholding the original determination or waiving the determination, is final.

Cal. Code Regs. Tit. 22, § 97441

Note: Authority cited: Sections 127501 and 127501.2, Health and Safety Code. Reference: Sections 127502 and 127507.2, Health and Safety Code.

1. New section filed 12-18-2023 as an emergency; operative 12/18/2023 (Register 2023, No. 51). Pursuant to Health and Safety Code section 127501.2, subdivision (b), this regulation shall be repealed by operation of law on 12-19-2028 unless the adoption, amendment, or repeal of the regulation is promulgated by the Department of Health Care Affordability pursuant to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of title 2, of the Government Code before that date.
2. New section, including amendment of subsections (a)(1)(B) and (b)(1)(c) and amendment of Note, refiled 8-22-2024 as an emergency; operative 8/22/2024 (Register 2024, No. 34). Pursuant to Health and Safety Code section 127501.2, subdivision (b), this regulation shall be repealed by operation of law on 12-19-2028 unless the adoption, amendment, or repeal of the regulation is promulgated by the Office of Health Care Affordability pursuant to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of title 2, of the Government Code before that date.