reglab/statecodes huggingface dataset:
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 4 - Hospital Bill Complaint Program › Section 96051.17 - Complaint Review

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) For
				  the Department to investigate an eligibility determination by a hospital for
				  its discount payment and/or charity care programs, the patient or their
				  authorized representative must have already submitted an application for
				  discount payment and/or charity care to the hospital for the services at issue
				  in the complaint.
(b) Upon receipt
				  of a complaint, the Department will forward the complaint to the hospital for
				  response.
(1) The hospital shall respond to
				  the complaint within 30 calendar days unless extended pursuant to section
				  96051.18.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 4 - Hospital Bill Complaint Program › Section 96051.18 - Request for Extension

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) If
				  the hospital cannot provide the response required by section
				  96051.17(b)(1) and
				  (d)(1) within 30 calendar days, the hospital
				  may request a reasonable extension of time through the online patient complaint
				  portal. The request must be submitted prior to the due date and describe the
				  actions being taken to obtain the information or records and when receipt is
				  expected.
(b) The Department has
				  discretion to agree to a requested extension of time. The Department will
				  consider the following factors in determining whether to grant the extension
				  request:
(1) Complexity of required
				  response.
(2) Hospital's history of
				  cooperativeness.
(3) Necessity for
				  third party assistance in obtaining records.
(4) Any other factors submitted by the
				  hospital showing good cause.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 4 - Hospital Bill Complaint Program › Section 96051.19 - Debt Collection While Complaint Pending

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
After the hospital has been notified that the patient has
					 filed a complaint with the Department, the hospital shall not send the unpaid
					 bill to any collection agency, debt buyer, or other assignee unless that entity
					 has agreed to comply with the Act. This shall apply only to the bill(s) for
					 which the patient has filed a complaint with the Department. Failure to comply
					 with this section is grounds for a penalty under this chapter.
Note: Authority cited: Sections
						127010
						and
						127436,
						Health and Safety Code. Reference: Sections
						127425
						and
						127436,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 5 - Administrative Penalties › Section 96051.20 - Applicability

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  This article applies to the assessment of administrative penalties to hospitals
				  licensed under Health and Safety Code section
				  1250(a), (b), and
				  (f), for violations of the Act and this
				  chapter.
(b) This article applies
				  to incidents occurring on or after January 1, 2024. As to such incidents, the
				  hospital's compliance history with the Act, and related federal statutes and
				  regulations prior to January 1, 2024, shall be considered in assessing
				  administrative penalties as outlined in section
				  96051.26.
Note: Authority cited: Sections
						127010
						and
						127436,
						Health and Safety Code. Reference: Sections
						127400,
						127436
						and
						127401,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 5 - Administrative Penalties › Section 96051.21 - Penalties for Late Filing of Documents and Responses

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  hospital that fails to file a required policy and/or response by the due date
				  established by section
				  96051.6(b)(1), (b)(3), (b)(4), (d)(1), or
				  (d)(4), is liable for a penalty assessment of
				  five hundred dollars ($500) for each calendar day after the due date that the
				  required document is not filed.
(b)
				  A hospital that fails to file a required response to the Department by the due
				  date established by section
				  96051.17(b)(1),
				  (d)(1), or
				  96051.18, is liable for a penalty
				  assessment of five hundred dollars ($500) for each calendar day after the due
				  date that the required response is not filed.
Note: Authority cited: Sections
						127010
						and
						127436,
						Health and Safety Code. Reference: Section
						127436,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 5 - Administrative Penalties › Section 96051.22 - Notification of Penalty Assessment for Late Filing of Documents and Responses

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  When a document required by section
				  96051.6 is filed after the due
				  date specified in section
				  96051.6(b)(1), (b)(3), (b)(4), (d)(1), or
				  (d)(4), the Department will notify the
				  hospital of the accrued penalty. The notice shall be provided to the primary
				  contact identified by the hospital under section
				  96051.5.
(b) When a response required by section
				  96051.17(b) or
				  (d) is filed after the due date specified in
				  section 96051.17(b)(1),
				  (d)(1), or
				  96051.18, the Department will
				  notify the hospital of the accrued penalty. The notice shall be provided to the
				  primary contact identified by the hospital under section
				  96051.12(a).
(c) The Department will calculate the accrued
				  penalty pursuant to section
				  96051.21.
Note: Authority cited: Sections
						127010
						and
						127436,
						Health and Safety Code. Reference: 127435, Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 5 - Administrative Penalties › Section 96051.23 - Penalty Assessment for Violations of Hospital Policy, Posting, and Website Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  Administrative penalties assessed for the following violations shall be
				  calculated under this section:
(1) Policies
				  submitted pursuant to Health and Safety Code section
				  127435
				  that fail to comply with the Act and this chapter.
(2) Hospital posting requirements pursuant to
				  Health and Safety Code section
				  127410(c)(1),
				  (c)(2), (c)(3), and (c)(4) that fail to
				  comply with the Act and section
				  96051.10.
(3) Website requirements pursuant to Health
				  and Safety Code section
				  127410(c)(5)
				  that fail to comply with the Act and section
				  96051.11.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 5 - Administrative Penalties › Section 96051.24 - Definition of Multiple Violations Identified During the Same Investigation, for the Purpose of Penalty Assessments

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) For
				  the purposes of this chapter, all violations arising out of an investigation
				  resulting from a complaint filed by a patient pursuant to Health and Safety
				  Code section
				  127436(b),
				  are subject to one penalty assessment.
(b) For purposes of this chapter,
				  "investigation" is defined as information arising out of a single complaint,
				  filed by a single patient, or the patient's authorized representative,
				  regarding a single bill.
(c)
				  Violations discovered during the investigation regarding other patients, or
				  other bills, are excluded from this definition.
Note: Authority cited: Sections
						127010
						and
						127436,
						Health and Safety Code. Reference: Section
						127436,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 5 - Administrative Penalties › Section 96051.25 - Determining the Base Penalty for Each Investigation Resulting in One or More Violation(s)

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The
				  base penalty shall be determined for each investigation resulting in one or
				  more violations, as follows:
(1) If
				  violation(s) are identified and the patient experienced financial harm, the
				  violation will be assessed a base penalty of twenty-five thousand dollars
				  ($25,000).
(2) If the violation(s)
				  caused no financial harm, the violation will be assessed a base penalty of
				  twelve thousand and five hundred dollars ($12,500).
(3) There is no penalty for alleged
				  violation(s) that do not affect patient access to, or eligibility for, the
				  hospital's discount payment or charity care programs, provided the hospital
				  takes corrective action as directed by the Department.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 5 - Administrative Penalties › Section 96051.27 - Final Penalty

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The final penalty for an investigation of a patient's
					 complaint resulting in one or more violations is the cumulative adjusted base
					 penalty as determined under sections
					 96051.22(b),
					 96051.25, and
					 96051.26, or the maximum penalty
					 specified in Health and Safety Code section
					 127436(b)(4),
					 whichever is lower.
Note: Authority cited: Sections
						127010
						and
						127436,
						Health and Safety Code. Reference: Section
						127436,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 5 - Administrative Penalties › Section 96051.28 - Failure to Reimburse Patient and Pay Assessed Penalty

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  Upon determination by the hospital that a patient paid an amount in excess of
				  the amount required under the Act or this chapter, the hospital shall reimburse
				  the patient within 30 calendar days of the hospital's determination, in
				  accordance with Health and Safety Code 127440.
(b) Upon determination by the Department that
				  the hospital owes reimbursement to the patient pursuant to Health and Safety
				  Code section
				  127440,
				  payment shall be made to the patient within 30 calendar days if no appeal is
				  filed, or if an appeal is filed, 30 calendar days after all appeal rights have
				  been exhausted.
(c) A hospital that
				  fails to reimburse the patient by the due date established by subsection (b) is
				  liable for a penalty assessment, paid to the Department, of one thousand
				  dollars ($1,000) for each calendar day after the due date that the required
				  payment is not made, not to exceed three times the amount of the reimbursement
				  owed to the patient, including interest.
(d) When the payment is made after the due
				  date indicated in subsection (b), the Department will calculate the accrued
				  penalty pursuant to subsection (c) and will notify the hospital of the assessed
				  penalty. The notice shall be provided to the designated contact identified by
				  the hospital under section
				  96051.12.
Note: Authority cited: Sections
						127010
						and
						127436,
						Health and Safety Code. Reference: Section
						127440,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 5 - Administrative Penalties › Section 96051.29 - Small and Rural Hospitals

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  small and rural hospital that has been assessed an administrative penalty
				  pursuant to the Act and this chapter may request:
(1) Payment of the penalty extended over a
				  period of time if immediate, full payment would cause financial hardship,
				  or
(2) Reduction of the penalty, if
				  extending the penalty payment over a period of time would cause financial
				  hardship, or
(3) Both a penalty
				  payment plan and reduction of the penalty.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 5 - Administrative Penalties › Section 96051.30 - Penalty Adjustment to Reflect Percentage Change in Medical Care Index

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Adjustments to the maximum penalty pursuant to Health and
					 Safety Code section
					 127436(b)(4)
					 shall be made only to the base penalty.
Note: Authority cited: Sections
						127010
						and
						127436,
						Health and Safety Code. Reference: Section
						127436,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 5 - Administrative Penalties › Section 96051.31 - Corrective Action

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
In addition to the penalties addressed in this chapter, the
					 Department may also require corrective action as deemed necessary to achieve
					 and demonstrate the hospital's policies and procedures for discount payment,
					 charity care, and debt collection are in compliance with the Act and this
					 chapter.
Note: Authority cited: Section
						127010,
						Health and Safety Code. Reference: Sections
						127405,
						127410,
						127420,
						127425,
						127426,
						127430,
						127435,
						127436
						and
						127440,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 6 - Appeals › Section 96051.32 - Appeals

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  Filing an Appeal. A hospital that has received notice of an accrued penalty
				  under the Act and this chapter may appeal the penalty assessment by filing a
				  written request for hearing within 30 calendar days after the date of the
				  notice. The request shall be filed with the Department's hearing officer either
				  by mail or by email as follows:
(1) Mail
				  shall be sent to the hearing officer at the Legal Office of the Department of
				  Health Care Access and Information, located at 2020 West El Camino Avenue,
				  Suite 1217, Sacramento, CA 95833.
(2) Email shall be sent to the following
				  email address: HearingOfficer@hcai.ca.gov.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 6 - Appeals › Section 96051.33 - Communications After Appeal Has Been Filed

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  Other communications, including, but not limited to, requests for consolidation
				  of appeals, questions about the hearing schedule or process, and all documents
				  and proposed exhibits, shall be made as follows:
(1) For appeals before the Department's
				  hearing officer, communications shall be made via mail or email as specified in
				  section 96051.32(a).
(2) For appeals before an administrative law
				  judge employed by the California Office of Administrative Hearings pursuant to
				  section 96051.35, communications shall be
				  made directly to the administrative law judge serving as hearing officer as
				  directed by their office once an Office of Administrative Hearings case number
				  has been assigned. Prior to a case number being assigned by the Office of
				  Administrative Hearings, other communications shall be made via mail or email
				  as specified in section
				  96051.32(a).
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 6 - Appeals › Section 96051.34 - Prehearing Provisions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The
				  hearing officer will notify the hospital, the patient who filed the complaint,
				  and the Department of the hearing date and time at least 60 calendar days in
				  advance.
(b) The hospital and the
				  Department shall provide copies of all proposed exhibits and list of witnesses
				  to the hearing officer and to the other party no later than 45 calendar days
				  prior to the hearing date.
(c) The
				  hearing officer shall provide a copy of all proposed exhibits and list of
				  witnesses to the patient who filed the complaint and allow the patient 30
				  calendar days to submit a response, including additional evidence in support of
				  the complaint.
(d) Upon receipt of
				  any response or additional evidence from the patient, the hearing officer shall
				  provide copies of the response and evidence to the hospital and the
				  Department.
(e) Request to Change
				  Hearing Date. Either party may request a change of hearing date, if necessary.
				  Requests for rescheduling shall be submitted to the hearing officer at least 10
				  calendar days before the scheduled hearing. Requests for rescheduling must be
				  based upon good cause, as determined by the hearing officer, and will only be
				  granted if the change would not prejudice the other party.
(f) Request to Change Hearing Method. All
				  hearings will be held in-person as specified by the hearing officer; however,
				  the hearing officer may schedule a hearing to be conducted by telephone or
				  other electronic means. If so, either party may object; upon receipt of such an
				  objection, the hearing officer will schedule an in-person hearing. If the
				  hearing officer does not initially plan to conduct a hearing by telephone or
				  other electronic means, either party may so request; if the hospital and the
				  Department consent, the hearing officer may, but is not required to, conduct
				  the hearing by telephone or other electronic means. The hospital and the
				  Department will be notified of the hearing officer's decision.
(g) Request for Consolidation. The hearing
				  officer may, on their own determination or upon written request of one of the
				  parties, consolidate for hearing or decision any number of appeals when the
				  facts and circumstances are similar, and no substantial right of any party will
				  be prejudiced. The hearing officer shall notify both the hospital and the
				  Department if consolidation is occurring. Either party may request
				  consolidation by filing a request with the hearing officer containing the
				  following information:
(1) Identification of
				  the appeals to be consolidated.
(2)
				  A statement of the basis for consolidation.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 6 - Appeals › Section 96051.35 - Conduct of Hearing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The
				  hearing shall be conducted by one of the following, as determined by the
				  Department:
(1) An employee of the Department
				  appointed by the Director to serve as hearing officer.
(2) An administrative law judge employed by
				  the California Office of Administrative Hearings serving as hearing
				  officer.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 6 - Appeals › Section 96051.36 - Settlement

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
If a settlement is reached between the parties prior to the
					 hearing, the Department shall notify the hearing officer and no hearing shall
					 be held.
Note: Authority cited: Sections
						127010
						and
						127436,
						Health and Safety Code. Reference: Section
						127436,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.2 - Hospital Fair Billing Program › Article 6 - Appeals › Section 96051.37 - Decision

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The
				  hearing officer shall prepare a recommended decision for the Director. The
				  recommended decision shall be in writing and shall include findings of fact and
				  conclusions of law.
(b) The
				  Director may either adopt or reject the recommended decision. If the Director
				  does not adopt the proposed decision as presented, the Director will
				  independently prepare a decision based upon the hearing record; the Director
				  may adopt factual findings of the hearing officer.
(c) The decision of the Director shall be in
				  writing and shall be final.
Note: Authority cited: Sections
						127010
						and
						127436,
						Health and Safety Code. Reference: Section
						127436,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 1 - General › Section 96060 - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
For the purposes of this chapter, the following definitions
					 apply:
(a) "Department" means the
				  Department of Health Care Access and Information.
(b) "Drug product" means the finished dosage
				  form of a prescription drug that contains a drug substance, generally, but not
				  necessarily, in association with other active or inactive ingredients, and that
				  has a unique NDC.
(c) "Introduced
				  to market" means made available for purchase in California.
(d) "Manufacturer" means an entity that
(1) holds the NDC for a prescription drug;
				  and
(2) Is described in Health and
				  Safety Code Section
				  127675.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 1 - General › Section 96061 - Purchaser Registration

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  purchaser or reimburser identified in subdivision (a) of Health and Safety Code
				  Section
				  127675
				  may register with the Department for the purpose of receiving advance notice of
				  cost increases under Health and Safety Code Section
				  127677.
(b) A purchaser or reimburser choosing to
				  register must register on the Department's website using the registration
				  portal at
https://hcai.ca.gov/data-and-reports/cost-transparency/rx/
.
				  A purchaser or reimburser must provide the following information:
(1) The legal name of the
				  organization.
(2) The organization
				  type as described in subdivision (a) of Health and Safety Code Section
				  127675.
(3) The name of a contact person designated
				  to receive notices.
(4) The
				  business title of the designated contact person.
(5) A business address.
(6) A business email address.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 1 - General › Section 96062 - Manufacturer Registration

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  Prior to filing a report or notice as required under Sections
				  96070,
				  96075, and
				  96076, a manufacturer must
				  register on the Department's website using the report submission portal at
https://hcai.ca.gov/data-and-reports/cost-transparency/rx/
.
				  Registration must occur at least five business days prior to the date the
				  manufacturer's first submission is due.
(b) In order to register, a manufacturer must
				  provide the following information:
(1)
				  Manufacturer name and the following information for the manufacturer:
(A) Business address.
(B) Business phone number.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 2 - Prescription Drug Cost Increase Notification and Report Requirements › Section 96065 - Wholesale Acquisition Cost Increase Notification

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  This section shall apply to each manufacturer of a drug product with a
				  wholesale acquisition cost of more than forty dollars ($40) for a course of
				  therapy as defined in subdivision (a) Health and Safety Code Section
				  127677.
(b) When a manufacturer proposes a wholesale
				  acquisition cost increase that will result in a total wholesale acquisition
				  cost increase of more than 16% above the wholesale acquisition cost of the drug
				  product on December 31 of the calendar year three years prior to the current
				  calendar year, the manufacturer shall provide each registered purchaser with
				  advance notice as required by subdivisions (b) and (c) of Health and Safety
				  Code Section
				  127677.
(c) Total wholesale acquisition cost increase
				  includes the current proposed wholesale acquisition cost increase and the sum
				  of the wholesale acquisition cost increases that occurred in the current
				  calendar year to date and the two previous calendar years.
Note: Authority cited: Section
						127685, Health and Safety Code.
						Reference: Section
						127677, Health and Safety
						Code.
Note: Authority cited: Section
						127685,
						Health and Safety Code. Reference: Section
						127677,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 2 - Prescription Drug Cost Increase Notification and Report Requirements › Section 96071 - Wholesale Acquisition Cost Increase Report Periods and Due Dates

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The reports
				  described in Section
				  96070 are due as follows:
(1) Each report related to a cost increase
				  with an effective date between January 1 and March 31, inclusive, shall be due
				  by April 30 of the same year.
(2)
				  Each report related to a cost increase with an effective date between April 1
				  and June 30, inclusive, shall be due by July 31 of the same year.
(3) Each report related to a cost increase
				  with an effective date between July 1 and September 30, inclusive, shall be due
				  by on October 31 of the same year.
(4) Each report related to a cost increase
				  with an effective date between October 1 and December 31, inclusive, shall be
				  due by January 31 of the following year.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 3 - New Prescription Drug Notice and Report Requirements › Section 96075 - New Drug Notice

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  When a manufacturer introduces a new prescription drug to market at a wholesale
				  acquisition cost that exceeds the threshold set for a specialty drug under the
				  Medicare Part D program (Medicare Prescription Drug, Improvement, and
				  Modernization Act of 2003 (Public Law 108-173)), the
				  manufacturer shall file a notice with the Department.
(b) The notice shall include the following
				  information;
(1) The NDC. The NDC shall be
				  reported in numeric form.
(2) The
				  date the new prescription drug was, or will be, introduced to market.
(3) The wholesale acquisition cost of the new
				  prescription drug as of the introduction to market date.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 3 - New Prescription Drug Notice and Report Requirements › Section 96076 - New Drug Report

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) For
				  each new prescription drug for which a notice was filed with the Department
				  under Section
				  96075, a manufacturer shall file a
				  report with the Department.
(b) The
				  report shall include the following information:
(1) A narrative description of the marketing
				  and pricing plans used in the launch of the new prescription drug in the United
				  States and internationally.
(2) The
				  estimated annual number of patients in the United States with a condition for
				  which the new prescription drug may be prescribed. This estimated number shall
				  account for the total number of patients with a condition for which the new
				  prescription drug may be prescribed and shall not be limited to or based on the
				  quantity of the particular new prescription drug introduced to market,
				  anticipated to be introduced to market, or anticipated to be
				  prescribed.
(3) Indicate whether
				  the drug was granted breakthrough therapy designation or priority review by the
				  federal Food and Drug Administration prior to approval.
(4) If the drug was not developed by the
				  manufacturer:
(A) The date the manufacturer
				  acquired the drug; and
(B) The
				  price of acquisition.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 3 - New Prescription Drug Notice and Report Requirements › Section 96077 - New Drug Report Due Date

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  Each report required under Section
				  96076 shall be filed within 30
				  days after the notice required under Section
				  96075 was filed with the
				  Department.
(b) A report shall be
				  filed by 11:59 P.M. Pacific Time of the due date.
Note: Authority cited: Section
						127685, Health and Safety Code.
						Reference: Section
						127681, Health and Safety
						Code.
Note: Authority cited: Section
						127685,
						Health and Safety Code. Reference: Section
						127681,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 4 - Submission of Notice and Reports › Section 96078 - Method of Submission

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  report required under Section
				  96070, a notice required under
				  Section 96075, or a report required under
				  Section 96076 shall be submitted to the
				  Department through the Department's website using the report submission portal
				  at
https://hcai.ca.gov/data-and-reports/cost-transparency/rx/
.
(b) Reports and notices must be submitted
				  using one of the following methods:
(1)
				  Uploading comma separated value (.csv) files including all of the required
				  information for one or more notices and/or reports. Such files shall comply
				  with the Department's Format and File Specifications for Submission of
				  Prescription Drug Reports Version 2.0, dated May 19, 2022, and hereby
				  incorporated by reference; or
(2)
				  Entering the required information for individual notices or reports
				  online.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 5 - Penalties and Appeals › Section 96080 - Penalties for Late Filing of Reports

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
A manufacturer that fails to file a required report by the
					 due date established by either Section
					 96071 or
					 96077 is liable for a civil
					 penalty of one thousand dollars ($1,000) for each day after the due date that
					 the required report is not filed.
1. New
					 article 5 (sections
					 96080-96087) and section filed
					 11-29-2018; operative 1-1-2019 (Register 2018, No.
					 48).
Note: Authority cited: Section
						127685,
						Health and Safety Code. Reference: Sections
						127679
						and
						127681,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 5 - Penalties and Appeals › Section 96081 - Penalty Assessment

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  When either a report required by Section
				  96070 is filed after the due date
				  specified in Section
				  96071, or a report required by
				  Section 96076 is filed after the due date
				  specified in Section
				  96077, the Department will notify
				  the manufacturer of the accrued penalty. The notice shall be provided by email
				  to the authorized individual identified by the manufacturer under subdivision
				  (b)(2) of Section
				  96062.
(b) The Department will calculate the accrued
				  penalty pursuant to Section
				  96080.
Note: Authority cited: Section
						127685, Health and Safety Code.
						Reference: Sections
						127679 and
						127681, Health and Safety
						Code.
Note: Authority cited: Section
						127685,
						Health and Safety Code. Reference: Sections
						127679
						and
						127681,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 5 - Penalties and Appeals › Section 96082 - Filing an Appeal

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  manufacturer that has received notice of an accrued penalty under Section
				  96081 may appeal the penalty
				  assessment by filing, as explained in Section
				  96083, a written request for
				  hearing no later than 30 days from the date of the notice. The request shall be
				  filed with the Department's hearing officer.
(b) The request for hearing shall include the
				  following:
(1) The name of the
				  manufacturer.
(2) The name of the
				  authorized representative of the manufacturer and contact information for that
				  representative.
(3) The date of the
				  penalty assessment notice.
(4) A
				  statement of the basis for the appeal.
(5) A copy of the penalty notice.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 5 - Penalties and Appeals › Section 96082.5 - Good Cause

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  penalty for which a written request for hearing has been filed under Section
				  96082 may be reduced or waived if
				  the hearing officer finds that good cause exists for the late filing of the
				  report required by Section
				  96070 or Section
				  96076 for which the penalty was
				  issued.
(b) For purposes of this
				  section, good cause for the late filing of a required report shall be lateness
				  due to circumstances beyond the control of the manufacturer. Circumstances
				  beyond the control of the manufacturer does not include neglect or
				  administrative inadequacy on the part of the manufacturer or any of its
				  offices, officers, employees, or agents.
Note: Authority cited: Section
						127685, Health and Safety Code.
						Reference: Sections
						127679 and
						127681, Health and Safety
						Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 5 - Penalties and Appeals › Section 96083 - Hearing Officer Contact Information

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  Hearing requests shall be addressed to the Department's hearing officer either
				  by mail or by email as follows:
(1) Mail
				  shall be sent to the hearing officer at the Legal Office of the Department of
				  Health Care Access and Information in Sacramento.
(2) Email shall be sent to the following
				  email address: HearingOfficer@hcai.ca.gov.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 5 - Penalties and Appeals › Section 96084 - Prehearing Provisions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The
				  manufacturer and the Department will be notified of the hearing date and time
				  at least 30 days in advance.
(b)
				  The manufacturer and the Department shall provide copies of all proposed
				  exhibits to the hearing officer and to the other party no later than 10
				  business days prior to the hearing date.
(c) Request to Change Hearing Date. Either
				  party may request a change of hearing date, if necessary. Requests for
				  rescheduling must be submitted to the hearing officer at least 10 business days
				  before the scheduled hearing. Requests for rescheduling must be based upon good
				  cause, as determined by the hearing officer, and will only be granted if the
				  change would not prejudice the other party.
(d) Request to Change Hearing Method. All
				  hearings will be held in person as specified by the hearing officer; however,
				  the hearing officer may schedule a hearing to be conducted by telephone or
				  other electronic means. If so, either party may object; upon receipt of such an
				  objection, the hearing officer will schedule an in-person hearing. If the
				  hearing officer does not initially plan to conduct a hearing by telephone or
				  other electronic means, either party may so request; if the manufacturer and
				  the Department consent, the hearing officer may, but is not required to,
				  conduct the hearing by telephone or other electronic means. The manufacturer
				  and the Department will be notified of the hearing officer's
				  decision.
(e) Request for
				  Consolidation. The hearing officer may, on her or his own determination or upon
				  written request of one of the parties, consolidate for hearing or decision any
				  number of appeals when the facts and circumstances are similar and no
				  substantial right of any party will be prejudiced. The hearing officer shall
				  notify both the manufacturer and the Department if consolidation is occurring.
				  Either party may request consolidation by filing a request with the hearing
				  officer containing the following information:
(1) Identification of the appeals to be
				  consolidated.
(2) A statement of
				  the basis for consolidation.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 5 - Penalties and Appeals › Section 96085 - Conduct of Hearing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The
				  hearing shall be conducted by one of the following, as determined by the
				  Department:
(1) An employee of the Department
				  appointed by the Director of the Department to serve as hearing
				  officer.
(2) An administrative law
				  judge employed by the California Office of Administrative Hearings serving as
				  hearing officer.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 5 - Penalties and Appeals › Section 96086 - Settlement

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
If a settlement is reached between the parties prior to the
					 hearing, the Department shall notify the hearing officer and no hearing shall
					 be held.
Note: Authority cited: Section
						127685, Health and Safety Code.
						Reference: Sections
						127679 and
						127681, Health and Safety
						Code.
Note: Authority cited: Section
						127685,
						Health and Safety Code. Reference: Sections
						127679
						and
						127681,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 5 - Penalties and Appeals › Section 96087 - Decision

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The
				  hearing officer shall prepare a recommended decision for the Director of the
				  Department; the recommended decision shall be in writing and shall include
				  findings of fact and conclusions of law.
(b) The Director of the Department may either
				  adopt or reject the proposed decision. If the Director does not adopt the
				  proposed decision as presented, she or he will independently prepare a decision
				  based upon the hearing record; the Director may adopt factual findings of the
				  hearing officer.
(c) The decision
				  of the Director shall be made within 180 calendar days after the conclusion of
				  the hearing. The decision shall be in writing and shall be final.
Note: Authority cited: Section
						127685, Health and Safety Code.
						Reference: Sections
						127679 and
						127681, Health and Safety
						Code.
Note: Authority cited: Section
						127685,
						Health and Safety Code. Reference: Sections
						127679
						and
						127681,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 10 - Health Facility Data › Article 1 - General › Section 97003 - Accounting System Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The hospital accounting system prescribed
				  by this Chapter shall be used by all hospitals licensed pursuant to Chapter 2
				  (commencing with Section
				  1250) of Division 2, Health and
				  Safety Code.
(b) The long-term care
				  facility accounting system prescribed by this Chapter shall be used by all
				  skilled nursing facilities, intermediate care facilities, intermediate care
				  facilities/developmentally disabled, and congregate living health facilities
				  licensed pursuant to Chapter 2 (commencing with Section
				  1250) of Division 2, Health and
				  Safety Code.
1.
					 Renumbering and amendment of former title 4, chapter 10 (sections
					 7003,
					 7005,
					 7007 and
					 7008) to title 22, division 7
					 (sections 97003,
					 97005,
					 97007 and
					 97008) filed 11-5-85; designated
					 effective 1-1-86 (Register 85, No. 45). For prior history, see Register 83, No.
					 16.
2. Amendment of subsection (b) filed 9-7-93; operative 10-6-93
					 (Register 93, No. 37).
3. Change without regulatory effect amending
					 NOTE filed 10-31-2000 pursuant to section
					 100, title 1, California Code of
					 Regulations (Register 2000, No. 44).
Note: Authority cited: Section
						128810,
						Health and Safety Code. Reference: Section
						128760,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 10 - Health Facility Data › Article 1 - General › Section 97005 - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
As used in this Chapter:
(a) "Act" means the Health Data and Advisory
				  Council Consolidation Act set forth in Chapter 1, Part 5 of Division 107
				  (commencing with Section
				  128675) of the Health and Safety
				  Code.
(b) "Unrestricted funds"
				  means funds which bear no external restrictions as to use or purpose: i.e.,
				  funds which can be used for any legitimate purpose designated by the governing
				  board as distinguished from funds restricted externally.
(c) "Restricted funds" means funds restricted
				  by donors or grantors for specific purposes. The term refers to plant
				  replacement and expansion, specific purpose and endowment funds.
(d) "Long-term care facility" and "long-term
				  care facilities" mean all skilled nursing facilities, intermediate care
				  facilities, intermediate care facilities/developmentally disabled, and
				  congregate living heath facilities licensed pursuant to Chapter 2 (commencing
				  with Section
				  1250) of Division 2, Heath and
				  Safety Code.
(e) "Preponderance"
				  means 51 percent or more of gross in-patient revenue. This definition also
				  applies to Section
				  128760
				  of the Health and Safety Code.
(f)
				  "Director" means the Director of the Office of Statewide Health Planning and
				  Development.
(g) "Health facility"
				  or "health facilities" means all health facilities required to be licensed
				  pursuant to Chapter 2 (commencing with Section
				  1250) of Division 2 of the Health
				  and Safety Code.
(h) "Health
				  facility gross operating cost for the provision of health care services"
				  (Section
				  127280(a),
				  Health and Safety Code) means total patient-related operating expenses as
				  reported to the Office for the fiscal years ending on or before June 30 of the
				  previous calendar year on:
(1) Hospital
				  disclosure report CHC 7041 d-1, column 1, line 200, for hospitals,
				  and
(2) Long-term care facility
				  disclosure report CHFC 7041 d-1, column 1, line 200, for long-term care
				  facilities.