(a) As used in this section:
(1) “Extrapolation” means the practice of inferring a frequency of dollar amount of overpayments, underpayments, nonvalid claims or other errors on any portion of claims submitted, based on the frequency or dollar amount of overpayments, underpayments, nonvalid claims or other errors actually measured in a sample of claims;
(2) “Pharmacy audit” means an audit, conducted on-site or remotely by or on behalf of a pharmacy benefits manager or plan sponsor of any records of a pharmacy for prescription drugs or prescription devices dispensed by such pharmacy to beneficiaries of a health benefit plan. “Pharmacy audit” does not include (A) a concurrent review or desk audit that occurs within three business days of the pharmacy's transmission of a claim to a pharmacy benefits manager or plan sponsor, or (B) a concurrent review or desk audit where no charge-back or recoupment is demanded by the pharmacy benefits manager or plan sponsor;
(3) “Plan sponsor” has the same meaning as described in section 38a-479aaa.
(b) (1) No entity other than a pharmacy benefits manager or a plan sponsor shall conduct a pharmacy audit unless such entity and manager or sponsor, as applicable, have executed a written agreement for the conducting of pharmacy audits. Prior to conducting a pharmacy audit on behalf of such manager or sponsor, such entity shall notify the pharmacy in writing that such entity and manager or sponsor, as applicable, have executed such agreement.
(2) Except as otherwise provided by state or federal law, an entity conducting a pharmacy audit may have access to a pharmacy's previous pharmacy audit report only if such report was prepared by such entity.
(3) Any information collected during a pharmacy audit shall be confidential by law, except that the entity conducting the pharmacy audit may share such information with the pharmacy benefits manager and the plan sponsor, for which such pharmacy audit is being conducted.
(4) No entity conducting a pharmacy audit shall compensate, directly or indirectly, any of its employees or any contractor such entity contracts with to conduct a pharmacy audit, based on the amount claimed or the actual amount recouped from the pharmacy being audited.
(c) (1) Any entity conducting a pharmacy audit shall:
(A) Provide the pharmacy being audited at least ten business days' prior written notice before conducting a pharmacy audit;
(B) Provide the pharmacy being audited with a masked list of prescriptions to assist the pharmacy to prepare for the pharmacy audit. A list is considered masked if the last two numbers of a prescription are marked with an “X”;
(C) Not initiate or schedule a pharmacy audit during the first five business days of any month for any pharmacy that averages in excess of six hundred prescriptions filled per week, without the express consent of the pharmacy;
(D) Make all determinations regarding the validity of a prescription or other record consistent with sections 20-612 to 20-623, inclusive, or as specified in federal risk management programs;
(E) Accept paper or electronic signature logs that document the delivery of prescription drug and device and pharmacist services to a health plan beneficiary or such beneficiary's agent; and
(F) Provide to the representative of the pharmacy, prior to leaving the pharmacy at the conclusion of an on-site portion of a pharmacy audit, a complete list of records reviewed.
(2) Any pharmacy audit that involves clinical judgment shall be conducted by or in consultation with a licensed pharmacist.
(3) No pharmacy audit shall cover (A) a period of more than twenty-four months after the date a claim was submitted by the pharmacy to the pharmacy benefits manager or plan sponsor unless a longer period is required by law, or (B) more than two hundred fifty prescriptions.
(d) (1) (A) Not later than sixty calendar days after an entity concludes a pharmacy audit and before such entity issues a final pharmacy audit report, such entity shall provide an initial pharmacy audit review to the pharmacy. The pharmacy may, within thirty calendar days after it receives such initial review, respond to the findings in such initial review.
(B) To validate the pharmacy record and delivery, a pharmacy may use authentic and verifiable statements or records, including, but not limited to, medication administration records of a nursing home, assisted living facility, hospital or health care provider with prescriptive authority.
(C) To validate claims in connection with prescriptions or changes in prescriptions, or refills of prescription drugs, a pharmacy may use any valid prescription, including, but not limited to, medication administration records, facsimiles, electronic prescriptions, electronically stored images of prescriptions, electronically created annotations or documented telephone calls from the prescribing health care provider or such provider's agent. Documentation of an oral prescription order that has been verified by the prescribing health care provider shall meet the provisions of this subparagraph for the initial audit review.
(D) No entity conducting a pharmacy audit may use extrapolation to calculate penalties or amounts to be charged back or recouped unless otherwise required by federal requirements or federal plans. No such entity shall include dispensing fees in the calculation of overpayments unless a prescription is considered a misfill. As used in this subparagraph, “misfill” means a prescription that was not dispensed, a prescription error, a prescription whereby the prescriber denied the authorization request or where an extra dispensing fee was charged.
(2) (A) Not later than sixty calendar days after any responses from the pharmacy under subdivision (1) of this subsection are received by the entity conducting the pharmacy audit or, if no such responses are received, after the entity concludes a pharmacy audit, such entity shall issue a final pharmacy audit report that takes into consideration any responses provided to such entity by the pharmacy.
(B) A pharmacy may appeal a final pharmacy audit report in accordance with the procedures established by the entity conducting the pharmacy audit.
(e) (1) No pharmacy shall be subject to charge-back or recoupment for a clerical or recordkeeping error in a required document or record, including a typographical error, scrivener's error or computer error, unless such error resulted in actual financial harm to the pharmacy benefits manager, plan sponsor or a plan beneficiary.
(2) No entity conducting a pharmacy audit or person acting on behalf of such entity shall charge-back or recoup, attempt to charge-back or recoup, or assess or collect penalties from a pharmacy until the time period to file an appeal of a final pharmacy audit report has passed or the appeals process has been exhausted, whichever is later. If an identified discrepancy in a pharmacy audit exceeds twenty-five thousand dollars, future payments to the pharmacy in excess of such amount may be withheld pending adjudication of an appeal. No interest shall accrue for any party during the audit period, beginning with the notice of the pharmacy audit and ending with the conclusion of the appeals process.
(f) The provisions of this section shall not apply to an audit of pharmacy records conducted when (1) fraud or other intentional or wilful misrepresentation is indicated by physical review or review of claims data or statements, or (2) other investigative methods indicate a pharmacy is or has been engaged in criminal wrongdoing, fraud or other intentional or wilful misrepresentation.
(P.A. 14-193, S. 1.)
Structure Connecticut General Statutes
Chapter 700c - Health Insurance
Section 38a-469. - Definitions.
Section 38a-472a. - Medical provider indemnification agreements prohibited.
Section 38a-472g. - Restrictions applicable to prior authorization or precertification.
Section 38a-472j. - Restrictions applicable to cost-sharing for covered benefits. Regulations.
Section 38a-472k. - Disability income policies. Discretionary clauses prohibited. Regulations.
Section 38a-476. - Preexisting condition coverage.
Section 38a-476b. - Standards re psychotropic drug availability in health plans.
Section 38a-477. - Standardized claim forms. Information necessary for filing a claim. Regulations.
Section 38a-477a. - Notification by Insurance Commissioner of required benefits and policy forms.
Section 38a-477bb. - Cost-sharing re facility fees.
Section 38a-477f. - Contract provision prohibiting certain disclosures prohibited.
Section 38a-477ff. - Third-party discounts and payments for covered benefits. Credit required.
Section 38a-477g. - Contracts between health carriers and participating providers.
Section 38a-477h. - Participating provider directories.
Section 38a-477ll. - Coverage for health enhancement programs.
Section 38a-478. - Definitions.
Section 38a-478a. - Commissioner's report to the Governor and the General Assembly.
Section 38a-478f. - Provider profile development requirements.
Section 38a-478g. - Managed care contract requirements. Plan description requirements.
Section 38a-478i. - Limitation on enrollee rights prohibited.
Section 38a-478j. - Coinsurance and deductible payments based on negotiated discounts.
Section 38a-478k. - Gag clauses prohibited.
Section 38a-478l. - Consumer report card required. Content. Data analysis by commissioner.
Section 38a-478o. - Confidentiality and antidiscrimination procedures required.
Section 38a-478p. - Expedited utilization review. Standardized process required.
Section 38a-478q. - Use of laboratories covered by plan required.
Section 38a-478t. - Commissioner of Public Health to receive data.
Section 38a-478u. - Regulations.
Section 38a-479. - Definitions. Access to fee schedules. Fee information to be confidential.
Section 38a-479gg. - Regulations.
Section 38a-479aaa. - Pharmacy benefits managers. Definitions.
Section 38a-479ddd. - Hearing on denial of certificate. Subsequent application.
Section 38a-479eee. - Claims payment to be made by electronic funds transfer upon written request.
Section 38a-479fff. - Expiration of certificates of registration. Renewal. Fees.
Section 38a-479ggg. - Regulations.
Section 38a-479hhh. - Investigations and hearings. Powers of commissioner. Appeals.
Section 38a-479iii. - Pharmacy audits.
Section 38a-479ooo. - Definitions.
Section 38a-479qqq. - Annual report by health carriers. Regulations.
Section 38a-479rrr. - Annual certification by health carriers.
Section 38a-479qq. - Medical discount plans: Definitions, prohibited sales practices, penalties.
Section 38a-482. (Formerly Sec. 38-166). - Form of policy.
Section 38a-482c. - Annual and lifetime limits.
Section 38a-483. (Formerly Sec. 38-167). - Standard provisions of individual health policy.
Section 38a-483a. - Exclusionary riders for individual health insurance policies. Regulations.
Section 38a-483b. - Time limits for coverage determinations. Notice requirements.
Section 38a-483c. - Coverage and notice re experimental treatments. Appeals.
Section 38a-486. (Formerly Sec. 38-170). - Certain acts not to operate as waiver of rights.
Section 38a-487. (Formerly Sec. 38-171). - Coverage after termination date of policy.
Section 38a-488. (Formerly Sec. 38-172). - Discrimination.
Section 38a-488b. - Coverage for autism spectrum disorder therapies.
Section 38a-488d. - Coverage for substance abuse services provided pursuant to court order.
Section 38a-488e. - Coverage for mental health wellness examinations.
Section 38a-488f. - Coverage for services provided under the Collaborative Care Model.
Section 38a-488g. - Acute inpatient psychiatric coverage. Prior authorization not required.
Section 38a-490a. - Coverage for birth-to-three program.
Section 38a-490b. - Coverage for hearing aids.
Section 38a-490c. - Coverage for craniofacial disorders.
Section 38a-490d. - Mandatory coverage for blood lead screening and risk assessment.
Section 38a-491b. - Assignment of benefits to a dentist or oral surgeon.
Section 38a-492a. - Mandatory coverage for hypodermic needles and syringes.
Section 38a-492b. - Coverage for certain off-label drug prescriptions.
Section 38a-492d. - Mandatory coverage for diabetes screening, testing and treatment.
Section 38a-492e. - Mandatory coverage for diabetes outpatient self-management training.
Section 38a-492f. - Mandatory coverage for certain prescription drugs removed from formulary.
Section 38a-492g. - Mandatory coverage for prostate cancer screening and treatment.
Section 38a-492h. - Mandatory coverage for certain Lyme disease treatments.
Section 38a-492i. - Mandatory coverage for pain management.
Section 38a-492j. - Mandatory coverage for ostomy-related supplies.
Section 38a-492k. - Mandatory coverage for colorectal cancer screening.
Section 38a-492m. - Mandatory coverage for certain renewals of prescription eye drops.
Section 38a-492n. - Mandatory coverage for certain wound-care supplies.
Section 38a-492o. - Mandatory coverage for bone marrow testing.
Section 38a-492p. - Mandatory coverage for medically monitored inpatient detoxification.
Section 38a-492q. - Mandatory coverage for essential health benefits.
Section 38a-492t. - Mandatory coverage for prosthetic devices.
Section 38a-492u. - Coverage for psychotropic drugs. Standards re availability.
Section 38a-494. (Formerly Sec. 38-174l). - Home health care by recognized nonmedical systems.
Section 38a-495b. - Medicare supplement policies and certificates. Definitions.
Section 38a-495d. - Refund of prepaid premium for Medicare supplement policies.
Section 38a-496. (Formerly Sec. 38-174q). - Coverage for occupational therapy.
Section 38a-498a. - Prior authorization prohibited for certain 9-1-1 emergency calls.
Section 38a-498b. - Mandatory coverage for mobile field hospital.
Section 38a-503a. - Mandatory coverage for breast cancer survivors.
Section 38a-503b. - Carriers to permit direct access to obstetrician-gynecologist.
Section 38a-503e. - Mandatory coverage for contraceptives and sterilization.
Section 38a-503g. - Mandatory coverage for ovarian cancer screening and monitoring.
Section 38a-504a. - Coverage for routine patient care costs associated with certain clinical trials.
Section 38a-504b. - Clinical trial criteria.
Section 38a-504d. - Clinical trials: Routine patient care costs.
Section 38a-504e. - Clinical trials: Billing. Payments.
Section 38a-504g. - Clinical trials: Submission and certification of policy forms.
Section 38a-506. (Formerly Sec. 38-173). - Penalty.
Section 38a-507. - Coverage for services performed by chiropractors.
Section 38a-508. - Coverage for adopted children.
Section 38a-509. - Mandatory coverage for infertility diagnosis and treatment. Limitations.
Section 38a-510. - Prescription drug coverage. Mail order pharmacies. Step therapy use.
Section 38a-510a. - Prescription drug coverage. Synchronized refills.
Section 38a-511. - Copayments re in-network imaging services.
Section 38a-512. - Applicability of statutes to certain major medical expense policies.
Section 38a-512a. - Continuation of coverage.
Section 38a-512c. - Annual and lifetime limits.
Section 38a-513a. - Time limits for coverage determinations. Notice requirements.
Section 38a-513b. - Coverage and notice re experimental treatments. Appeals.
Section 38a-513f. - Claims information to be provided to certain employers. Restrictions. Subpoenas.
Section 38a-513g. - Employer submission of plan cost information to Comptroller.
Section 38a-514a. - Biologically-based mental illness. Coverage required.
Section 38a-514b. - Coverage for autism spectrum disorder.
Section 38a-514d. - Coverage for substance abuse services provided pursuant to court order.
Section 38a-514e. - Coverage for mental health wellness exams.
Section 38a-514f. - Coverage for services provided under the Collaborative Care Model.
Section 38a-514g. - Acute patient psychiatric coverage. Prior authorization not required.
Section 38a-515. - Continuation of coverage of mentally or physically handicapped children.
Section 38a-516. - Coverage for newly born children. Notification to insurer.
Section 38a-516a. - Coverage for birth-to-three program.
Section 38a-516b. - Coverage for hearing aids.
Section 38a-516c. - Coverage for craniofacial disorders.
Section 38a-516d. - Coverage for neuropsychological testing for children diagnosed with cancer.
Section 38a-517. - Coverage for services performed by dentist in certain instances.
Section 38a-517b. - Assignment of benefits to a dentist or oral surgeon.
Section 38a-518a. - Mandatory coverage for hypodermic needles and syringes.
Section 38a-518b. - Coverage for certain off-label drug prescriptions.
Section 38a-518d. - Mandatory coverage for diabetes screening, testing and treatment.
Section 38a-518e. - Mandatory coverage for diabetes outpatient self-management training.
Section 38a-518f. - Mandatory coverage for certain prescription drugs removed from formulary.
Section 38a-518g. - Mandatory coverage for prostate cancer screening and treatment.
Section 38a-518h. - Mandatory coverage for certain Lyme disease treatments.
Section 38a-518i. - Mandatory coverage for pain management.
Section 38a-518j. - Mandatory coverage for ostomy-related supplies.
Section 38a-518k. - Mandatory coverage for colorectal cancer screening.
Section 38a-518l. - Mandatory coverage for certain renewals of prescription eye drops.
Section 38a-518m. - Mandatory coverage for certain wound-care supplies.
Section 38a-518o. - Mandatory coverage for bone marrow testing.
Section 38a-518p. - Mandating coverage for medically monitored inpatient detoxification.
Section 38a-518q. - Mandatory coverage for essential health benefits.
Section 38a-518t. - Mandatory coverage for prosthetic devices.
Section 38a-518u. - Coverage for psychotropic drugs. Standards re availability.
Section 38a-521. - Home health care by recognized nonmedical systems.
Section 38a-522. - Medicare supplement policies. Coverage of home health aide service.
Section 38a-524. - Coverage for occupational therapy.
Section 38a-525a. - Prior authorization prohibited for certain 9-1-1 emergency calls.
Section 38a-525b. - Mandatory coverage for mobile field hospital.
Section 38a-526. - Coverage for services of physician assistants and certain nurses.
Section 38a-530a. - Mandatory coverage for breast cancer survivors.
Section 38a-530b. - Carriers to permit direct access to obstetrician-gynecologist.
Section 38a-530e. - Mandatory coverage for contraceptives and sterilization.
Section 38a-530g. - Mandatory coverage for ovarian cancer screening and monitoring.
Section 38a-534. - Coverage for services performed by chiropractors.
Section 38a-536. - Mandatory coverage for infertility diagnosis and treatment. Limitations.
Section 38a-542a. - Coverage for routine patient care costs associated with certain clinical trials.
Section 38a-542b. - Clinical trial criteria.
Section 38a-542d. - Clinical trials: Routine patient care costs.
Section 38a-542e. - Clinical trials: Billing. Payments.
Section 38a-542g. - Clinical trials: Submission and certification of policy forms.
Section 38a-543. (Formerly Sec. 38-262j). - Reduction of payments on basis of Medicare eligibility.
Section 38a-544. - Prescription drug coverage. Mail order pharmacies. Step therapy use.
Section 38a-544a. - Prescription drug coverage. Synchronized refills.
Section 38a-549. - Coverage for adopted children.
Section 38a-550. - Copayments re in-network imaging services.
Section 38a-551. (Formerly Sec. 38-371). - Definitions.
Section 38a-552. (Formerly Sec. 38-372). - Provision of service to certain low-income individuals.
Section 38a-556a. - Connecticut Clearinghouse.
Section 38a-558. (Formerly Sec. 38-380). - Office of Health Care Access.
Section 38a-560. - Small employer grouping for health insurance coverage.
Section 38a-564. - Definitions.
Section 38a-565. - Special health care plans.
Section 38a-567. - Provisions of small employer plans and arrangements.
Section 38a-569. - Connecticut Small Employer Health Reinsurance Pool.
Section 38a-573. - Validity of separate provisions.
Section 38a-574. - Standard family health statement.
Section 38a-577. (Formerly Sec. 38-174ii). - Consumer dental health plans. Definitions.
Section 38a-578. (Formerly Sec. 38-174jj). - Certificate of authority. Application requirements.
Section 38a-580. (Formerly Sec. 38-174ll). - General surplus required.
Section 38a-584. (Formerly Sec. 38-174pp). - Complaint system.
Section 38a-588. (Formerly Sec. 38-174tt). - Penalty. Insolvency.
Section 38a-589. (Formerly Sec. 38-174uu). - Confidentiality.
Section 38a-590. (Formerly Sec. 38-174vv). - Commissioner's power to adopt regulations.
Section 38a-591. - Compliance with the Patient Protection and Affordable Care Act. Regulations.
Section 38a-591a. - Definitions.
Section 38a-591b. - Health carrier responsibilities re utilization review.
Section 38a-591c. - Utilization review criteria and procedures.
Section 38a-591g. - External reviews and expedited external reviews.
Section 38a-591h. - Record-keeping requirements. Report to commissioner upon request.
Section 38a-591i. - Regulations.
Section 38a-591k. - Violations. Notice and hearing. Penalties. Appeal.