TITLE 13 INSURANCE
CHAPTER 10 HEALTH
INSURANCE
PART 30 PHARMACY
BENEFITS MANAGERS
13.10.30.1 ISSUING
AGENCY:
Office of Superintendent of Insurance (“OSI”).
[13.10.30.1
NMAC – Rp, 13.10.30.1 NMAC, 3/1/2022]
13.10.30.2 SCOPE: This rule applies
to every pharmacy benefits manager (“PBM”) that provides a service described in
Subsection F of Section 59-A-61-2 NMSA 1978 to or on behalf of any person who
is legally obligated to provide any pharmacy benefit of service to a New Mexico
resident.
[13.10.30.2
NMAC – Rp, 13.10.30.2 NMAC, 3/1/2022]
13.10.30.3 STATUTORY
AUTHORITY:
Section 59A-2-9 NMSA 1978 and Subsection C of Section 59A-61-3 NMSA 1978.
[13.10.30.3
NMAC – Rp, 13.10.30.3 NMAC, 3/1/2022]
13.10.30.4 DURATION: Permanent.
[13.10.30.4
NMAC – Rp, 13.10.30.4 NMAC, 3/1/2022]
13.10.30.5 EFFECTIVE
DATE:
March 1, 2022, unless a later date is cited at the end of a section.
[13.10.30.5
NMAC – Rp, 13.10.30.5 NMAC, 3/1/2022]
13.10.30.6 OBJECTIVE: This rule establishes operating standards, licensing, reporting and
record retention requirements for PBMs to implement and promote the objectives
and policies of the Pharmacy Benefits Manager Regulation Act, Chapter 59A,
Article 61 NMSA 1978.
[13.10.30.6
NMAC – Rp, 13.10.30.6 NMAC, 3/1/2022]
13.10.30.7 DEFINITIONS: For puRposes of
this rule and the Pharmacy Benefits Manager Regulation Act:
A. “Clean claim”
has the definition found in Paragraph (1) of Subsection A of Section
59A-16-21.1 NMSA 1978.
B. “Client” means any
person with whom a PBM contracts to provide pharmacy benefits management
services arising out of or relating to pharmacy operations in New Mexico.
C. “Formulary” is a list of
prescription drugs that has been developed by a health insurance carrier or its
designee that the carrier or health plan in determining applicable prescription
drug coverage and benefit levels.
D. “Health insurance
carrier” or “carrier” has the
definition found in Paragraph (2) of Subsection C of Section 59A-16-21.2 NMSA
1978.
E. “Health plan”
has the definition found in Paragraph (3) of Subsection A of Section
59A-16-21.1 NMSA 1978.
F. “NCPDP” means
the national council for prescription drug program.
G. “NDC” means
national drug code.
H. “Network pharmacy”
means a pharmacy with whom a payor or PBM has contracted to provide pharmacy
services to persons with an expectation of receiving payment directly or
indirectly from the carrier.
I. “Prescription drug claim
administration”
is administrative services performed in connection with the processing,
adjudicating and auditing of claims relating to pharmacy services.
J. “Similarly
situated” refers to a network pharmacy whose PBM contract is subject to the
same reimbursement for a claim as a pharmacy whose appeal was granted.
[13.10.30.7
NMAC – Rp, 13.10.30.7 NMAC, 3/1/2022]
13.10.30.8 REQUIREMENTS
FOR LICENSURE: A PBM shall not conduct any operation or provide any
service in New Mexico unless it holds a valid PBM license issued by the
superintendent.
A. Application
for initial license. A PBM shall apply for a license by submitting a
complete application package on a form, and pursuant to the directions,
prescribed by the superintendent. The application package shall include:
(1) The
non-refundable filing fee prescribed by Paragraph (1) of Subsection AA of
Section 59A-6-1 NMSA 1978 for filing an application for a license.
(2) The
name of the legal entity, federal employer identification number (“FEIN”),
business address, phone number and state of residency.
(3) The
name, business address, phone number and e-mail address of a contact person
designated by the PBM to respond to grievances.
(4) The
name, business address, phone number and e-mail address of a contact person
designated by the PBM to respond to inquiries by the superintendent.
(5) Proof
of current authority from the controlling New Mexico regulator to conduct
business in New Mexico.
(6) For
each partner, managing member, and director, as applicable, the application
package shall include a background investigation report through a vendor approved
by OSI upon initial application. Changes in leadership shall submit a
background investigation report at the time of renewal of license.
(7) For
the preceding 10 years, a statement of whether the applicant has:
(a) been
refused a registration, license or certification to act as or provide the
services of a PBM or third-party administrator; or
(b) had
any registration, license or certification denied, suspended, revoked or
non-renewed for any reason by any state or federal entity; and
(c) if
either (a) or (b) apply, the PBM shall separately attach the details of each
such action, including the date, nature and disposition of the action.
(8) A
statement of whether the applicant in the most recent 10 years had a business
relationship terminated for any admission, legal finding, or judgement of
fraudulent or illegal activities in connection with the administration of a
pharmacy benefits plan and a description of each termination.
(9) A
list of all New Mexico clients serviced by the PBM.
(10) A list of each regulatory enforcement
action against the PBM in any other state for the previous 10 years.
(11) The application shall be signed and
verified by an officer, director, managing member, or partner, as applicable,
of the PBM.
(12) Any
other information that is deemed necessary by the superintendent in evaluating
the application to evidence compliance with Chapter 59A, Article 61 NMSA 1978
or the requirements of rules promulgated by the superintendent.
(13) Confidentiality
requests by an applicant are governed by the superintendent’s bulletin 2022-001
or any superseding bulletin or rule.
(14) The application package, except for the
application fee, shall be submitted as directed by the superintendent. After
the application has been approved or rejected by the PBM program coordinator,
the applicant shall pay the application fee through NIPR. Failure to pay the
application fee for a rejected application will preclude licensure or renewal.
B. Review and approval process for initial license.
Within 30 days of receipt of an application pursuant to Subsection A of this
section, the superintendent will review the application and:
(1) if
the application is incomplete, notify the applicant in writing that additional
information is needed, and allow the applicant 30 days to cure any deficiency
in the application.
(2) approve the application and issue a
PBM license to the applicant if the superintendent determines that the
applicant meets the requirements for licensure; or
(3) deny the application if the
superintendent determines that the applicant does not meet the requirements for
licensure.
C. Content and scope of
license.
(1) Content. A license issued by the
superintendent under this rule shall identify the PBM by name and business
address; the capacity of the licensee to act as a PBM in New Mexico; and the
effective and expiration dates of the license.
(2) Scope.
A license issued under this regulation entitles the PBM to act for one or more
authorized insurance carriers, health plans, workers’ compensation insurers,
Medicaid MCO, multiple employer welfare arrangement or government plan or
persons that self-insure without being required to obtain a separate license.
D. License renewal. To continue a license
a PBM shall submit a renewal application by March 1, of each year pursuant as
directed by the superintendent After the application has been approved or
rejected by the PBM program coordinator, the applicant shall pay the required
application fee through NIPR and shall pay the annual report fee as directed by
the superintendent. Failure to pay the application fee will preclude renewal. A
renewal application shall include updates to any items required by the initial
application for licensure.
E. Review and approval process for renewal of license.
Within 60 days of receipt of a renewal license application, the superintendent
will review the application and:
(1) if the application is incomplete,
notify the applicant in writing that additional information is needed, and allow
the applicant 30 days to cure any deficiency in the application.
(2) approve the application and issue a
PBM license to the applicant if the superintendent determines that the
applicant meets the requirements for licensure; or
(3) deny the application if the
superintendent determines that the applicant does not meet the requirements for
licensure. For disapprovals or denials of an application for renewal, the
superintendent will notify the applicant of the denial or rejection and state
the basis or reason for the denial.
F. Corrective
action plan. In lieu of a denial for initial licensure or renewal, the
superintendent may require the PBM to submit a plan to cure or correct
deficiencies in its application.
[13.10.30.8
– Rp, 13.10.30.8 NMAC, 3/1/2022]
13.10.30.9 PHARMACY
SERVICES ADMINISTRATIVE ORGANIZATION (“PSAO”) REGISTRATION:
A. Registration required. A PSAO shall not
provide any service in New Mexico unless it is registered with the
superintendent.
B. A PSAO’s
registration application shall be submitted on a form provided by the
superintendent and shall include:
(1) full
business name of PSAO;
(2) name,
business address, phone number and e-mail address for primary contact;
(3) name,
business address, phone number and e-mail address for contact designated to
handle grievances; and
(4) FEIN.
[13.10.30.9
– Rp, 13.10.30.9 NMAC, 3/1/2022]
13.10.30.10 PHARMACY GRIEVANCES:
A. Health plans subject to 13.10.16 NMAC: a pharmacy grievance relating to a PBM who
is performing services for a health plan or carrier subject to rule 13.10.16
NMAC shall be governed by that rule.
B. Health plans not subject to 13.10.16
NMAC: A pharmacy with a grievance relating to a PBM who is performing services
for a health plan or carrier that is not subject to rule 13.10.16 NMAC may file
a grievance against the PBM with the superintendent.
(1) A
grievance by a pharmacy against a PBM shall be in writing on a form provided by
the superintendent.
(2) A
pharmacy shall submit a grievance within six months from the date the pharmacy
knew or should have known of alleged PBM misconduct.
(3) A
grievance may allege multiple violations against a single PBM.
(4) A
pharmacy shall provide supporting documentation.
(5) The
superintendent shall transmit any grievance, including supporting documentation
to the e-mail contact designated by the PBM to receive a grievance.
(6) The
superintendent will specify the documentation necessary to address the
grievance.
(7) A
PBM shall have 14 business days from receipt of the grievance to respond in
writing.
(8) The
superintendent may request additional documentation. The PBM shall provide any
additional documentation in writing within 14 business days from the date of
the superintendent’s request.
(9) The
superintendent may grant a PBM’s request for an extension of time.
(10) The
superintendent will send a copy of all submissions received in connection to a
grievance to the opposing party.
C. Enforcement: If the superintendent finds probable cause
that a PBM violated a law enforceable by the superintendent, the superintendent
may issue a notice to show cause, why the superintendent should not take
specified enforcement action against the PBM and its principal.
[13.10.30.10
NMAC – Rp, 13.10.30.10 NMAC, 3/1/2022]
13.10.30.11 PAYMENT OF CLAIMS: Claims for reimbursement by a pharmacy are
subject to the clean claim laws.
[13.10.30.11
NMAC – Rp, 13.10.30.11 NMAC, 3/1/2022]
13.10.30.12 MAXIMUM ALLOWABLE COST (“MAC”) APPEALS:
A. Submission of appeal. A network
pharmacy that disputes a MAC reimbursement amount may submit a MAC appeal, to
the PBM within 21 business days after a network pharmacy receives notice of the
reimbursement amount. A PSAO may submit a MAC appeal on behalf of a network
pharmacy.
B. Appeals mechanism. A PBM shall provide
a mechanism for submitting MAC appeals, including the dedicated phone number
and electronic mail address or website. The phone number shall be manned at a
minimum during the hours of 8:00 a.m. to 5:00 p.m., mountain time. Information
about MAC appeals mechanisms shall be prominently displayed in any contract or
manual provided by a PBM to a pharmacy.
C. Appeal instructions on website. The
PBM’s website shall prominently display instructions for submitting a MAC
appeal and instructions for seeking assistance in navigating the website. This
link shall also be included in the PBM’s provider manual.
D. Response to denied appeal(s). The PBM’s
response to a denied MAC appeal shall include:
(1) the
source or sources used, including NDC and name of supplier, to determine
pricing for the maximum allowable cost list specific to that provider.
(2) the
date of the last MAC list update for the drug which is the subject of the MAC
appeal;
(3) documentation
evidencing that the drug was available for purchase by a pharmacy in New Mexico
at the MAC price from a national or regional wholesaler at the time of claim
submission; and
(4) any
other information the PBM deems relevant to the MAC appeal.
E. Nonresponse to appeal. The MAC appeal
shall be deemed granted if the PBM does not respond within 14 business days of
a complete appeal submission or its response does not include the items
outlined in Subsection D of 13.10.30.12 NMAC.
F. Notice of granting appeal. If a MAC
appeal is granted or deemed granted, a PBM shall:
(1) within
one day, notify by email the challenging pharmacy and any similarly situated
network pharmacy and their PSAO(s) that a MAC appeal was granted, the NDC of
the drug, the MAC price challenged and the updated MAC price; and
(2) permit
the appealing pharmacy and any similarly situated pharmacy to resubmit the
claim at the updated price.
H. Request for MAC
list. A PBM shall provide a MAC list to a network pharmacy or the superintendent
within seven business days upon request.
[13.10.30.12
NMAC – Rp, 13.10.30.12 NMAC, 3/1/2022]
13.10.30.13 SUBMISSION OF A MAC APPEAL:
A. Submission requirements. A MAC appeal
submission include:
(1) fill
date;
(2) BIN
number (six digits);
(3) NCPDP
(seven digits);
(4) Rx
number;
(5) NDC
11 (11 digits);
(6) drug
name;
(7) drug
strength;
(8) invoice
price and net purchase price of drug (whole dollar with two decimal places);
(9) total
reimbursement (whole dollar with two decimal places);
(10) reason
for review;
(11) any
information required by contract; and
(12) notes
(optional).
B. No additional information required. A
PBM shall not require or request additional information to process a MAC appeal
but shall accept and consider any additional information provided in a MAC
appeal submission.
[13.10.30.13
NMAC – Rp, 13.10.30.13 NMAC, 3/1/2022]
13.10.30.14 SEARCHABLE ONLINE DATABASE OF DRUG PRICES:
A. Update timeframe. A PBM shall update
its MAC list at least once every seven days.
B. Searchable online database required. A
PBM shall establish a searchable online database that will allow a network
pharmacy to search MAC list prices for a particular drug for as long as the
pharmacy has the right to file a MAC appeal or grievance concerning a specific
fill. The PBM’s provider manual shall include instructions for accessing the
price list on the PBM’s website. The provider manual shall be transmitted to a
newly joined pharmacy within 10 business days from the date of execution of a
contract with the PBM. A PBM shall provide an updated version of its provider
manual within 30 days of any revisions to all network pharmacies.
C. Search requirements. The database shall
be searchable by NDC or drug name, and specific plan identifier.
D. Drug information. The information
provided for the drug shall contain:
(1) NDC;
(2) NDC
description;
(3) MAC
list price; and
(4) effective
date.
E. Instructions required. The provider
manual shall contain instructions for searching the MAC list and contain
instructions for requesting the name of the sources used to determine MAC
pricing for the MAC list. A network pharmacy may request the name of the
sources through a PBM’s website, e-mail, facsimile or letter, if they are not
already included in the provider manual. The PBM shall respond with the names
of the sources within 10 business days from the date of the request.
F. Website requirements. The PBM’s website
shall contain a prominent link to request the names of the sources used to
establish the MAC price.
G. Accessibility. Upon request a PBM shall
provide the superintendent information contained in the database to determine
compliance with these rules or to resolve a grievance.
[13.10.30.14
NMAC – Rp, 13.10.30.14 NMAC, 3/1/2022]
13.10.30.15 HISTORICAL MAC LIST DATABASE:
A. Searchable list of drugs. A PBM shall
maintain a searchable database containing all MAC list pricing for the preceding
five years, but no earlier than January 14, 2021. The database shall be
searchable by these criteria:
(1) NDC
number;
(2) drug
name;
(3) specific
health plan; and
(4) removal
data.
B. Reason for removal. When a drug is
removed from the MAC database, the database shall indicate the reason for its
removal.
C. Obsolete drugs. The database shall
include obsolete drugs. If a drug is removed because it is obsolete, the
database shall indicate the date it became obsolete.
D. List dated. The database shall
specifically indicate the date a drug price was updated and posted to the PBM’s
website.
E. Accessibility. Upon request a PBM shall provide the superintendent information contained
in the database for any regulatory or legislative purpose.
[13.10.30.15
NMAC – Rp, 13.10.30.15 NMAC, 3/1/2022]
13.10.30.16 ANNUAL REPORT REQUIRED BY PBM: A PBM applying for license renewal shall submit
an annual report to the superintendent’s PBM program coordinator with the
license renewal application. The annual report shall contain the items outlined
in 13.10.30.8 NMAC. Failure to comply with these requirements shall result in
non-renewal of the license. Information submitted in the annual report is
considered PBM data received by the superintendent pursuant to a specific
request pursuant to 13.10.30.17 NMAC.
[13.10.30.16
NMAC – Rp, 13.10.30.16 NMAC, 3/1/2022]
13.10.30.17 CONFIDENTIALITY AND CONFLICTS:
A. Confidentiality.
Any PBM data received by the superintendent in response to a specific
request shall be deemed confidential, unless disclosure is required for a
regulatory purpose, enforcement, rulemaking, to respond to a legislative
request, or is otherwise required by law or directed by court order.
Notwithstanding the foregoing, the superintendent may publish aggregated data
that cannot be traced to a specific PBM, provided any published data is at
least 12 months old.
B. Conflicts.
The superintendent shall not share confidential data with a consultant or contractor unless that third-party:
(1) discloses all potential conflicts of interest;
(2) maintains appropriate data safeguards
and firewalls; and
(3) executes an agreement prohibiting
unauthorized disclosure or use of the confidential data.
[13.10.30.17
NMAC – Rp, 13.10.30.17 NMAC, 3/1/2022]
13.10.30.18 COMPLIANCE REPORTING BY PBM: PBMs shall submit the following information to
demonstrate compliance with New Mexico law according to the schedule provided
by the superintendent:
A. Grievance and MAC appeal data. The PBM shall file a log of grievance and MAC appeal data using a form
specified by the superintendent.
B. Pharmacy
and therapeutics (“P&T”) committee data. The PBM
shall submit the following information for any P&T Committee:
(1) names of committee members and conflict
disclosure statements;
(2) dates and meeting minutes of the
P&T committee from the prior plan year; and
(3) statement of the P&T committee’s
duties responsibilities, and goals.
C. Confidentiality
of P&T committee data. P&T committee minutes
provided to the superintendent shall be deemed confidential.
[13.10.30.18
NMAC – Rp, 13.10.30.18 NMAC, 3/1/2022]
13.10.30.19 RETALIATION,
DISCRIMINATION AND UNFAIR PRACTICES: A PBM shall not:
A. Retaliate. Retaliate
against a pharmacy for invoking its rights under these rules or the Pharmacy
Benefits Manager Regulation Act. Selecting a pharmacy that has filed a
grievance for audit at a rate disproportionately higher than for other network
pharmacies may be considered retaliation.
B. Discriminate. Discriminate against any person or
legal entity.
(1) based on any class membership or
characteristic protected under any state or federal anti-discrimination law or
(2) that receives discounts on
prescription drugs as a result of a state or federal program or law.
C. Unfair trade practice. Engage in or commit any act or
practice proscribed by any state or federal unfair practices law.
D. Steer. Induce or attempt to induce, a health plan
member to fill a prescription at a pharmacy benefits manager affiliate or
transfer a prescription to any pharmacy benefits manager affiliated without an
enrollee’s express and informed consent.
[13.10.30.19
NMAC – Rp, 13.10.30.19 NMAC, 3/1/2022]
13.10.30.20 EXAMINATION:
A. Examination. Pursuant to the
examination powers conferred by the Insurance Code, the superintendent may examine a PBM for compliance with any
applicable New Mexico law.
B. Data calls. Pursuant to the oversight and supervision powers conferred by the
Insurance Code, the superintendent may issue a data call to a PBM or PSAO.
[13.10.30.20
NMAC – Rp, 13.10.30.20 NMAC, 3/1/2022]
13.10.30.21 MAINTENANCE
OF INFORMATION: Every
PBM shall maintain at its principal administrative office for the duration of
the written agreement referred to in Section 59A-12A-4 NMSA 1978 and five years
thereafter adequate books and records of all contracts
and transactions. The superintendent shall have access to such books and
records for the purpose of examination, audit and inspection. A PBM may request that
certain records be deemed confidential through the process established by
OSI. The release of any confidential
information shall only be made pursuant to law.
[13.10.30.21 NMAC – Rp,
13.10.30.21 NMAC, 3/1/2022]
13.10.30.22 RULE
NONCOMPLIANCE: Failure to comply with
any provision of these rules is a violation of the Insurance Code.
[13.10.30.22 NMAC – Rp,
13.10.30.22 NMAC, 3/1/2022]
History of 13.10.30 NMAC:
History of Repealed Material.
13.10.30 NMAC, Pharmacy Benefits Managers filed
3/1/2021, was repealed and replaced by 13.10.30 NMAC, Pharmacy Benefits
Managers, effective 3/1/2022.