Oregon Bulletin
Rule
Caption: Prior authorization; usual and
customary definitions and billing guidelines
Adm.
Order No.: DMAP 23-2011
Filed with Sec. of
State: 8-24-2011
Certified to be
Effective: 9-1-11
Notice Publication
Date: 8-1-2011
Rules Amended: 410-121-0000, 410-121-0150
Subject: 410-121-0000: Redefine usual and customary charges
410-121-0150:
Update billing guidelines for usual and customary costs
Rules Coordinator: Darlene Nelson—(503) 945-6927
410-121-0000
Foreword and Definition of Terms
(1) The Division of Medical Assistance Program’s
(Division) Oregon Administrative Rules (OAR) are designed to assist providers
in preparing claims for services provided to the Division’s fee-for-service
clients. Providers must use Pharmaceutical OARs in conjunction with the General
Rules OARs (chapter 410, division 120) for Oregon Medical Assistance Programs.
(2) Pharmaceutical services delivered through managed
care plans contracted with the Division, under the Oregon Health Plan (OHP),
are subject to the policies and procedures established in the OHP
administrative rules (chapter 410, division 141) and by the specific managed
health care plans.
(3) Definition of Terms:
(a) Actual Acquisition Cost (AAC): The cost or basis
for reimbursement of supplies. The AAC will be established by the Division or
its contractor by rolling surveys of enrolled pharmacies to verify the actual
invoice amount paid by the pharmacy or corporate entity to wholesalers,
manufacturers, or distribution centers for the product and as such will serve
as the basis for reimbursement;
(b) Average Actual Acquisition Cost (AAAC): The AAAC
will be the average of AAC invoice amounts for individual drug products based
on the Generic Sequence Number (GSN);
(c) Average Manufacturer’s Price (AMP): The average
price that manufacturers sell medication to wholesalers and retail pharmacies,
as further clarified in 42 CFR 447;
(d) Average Net Price: The average of net price
(definition below) of all drugs in an identified Preferred Drug List (PDL)
(definition below) class or group;
(e) Bulk Dispensing: Multiple doses of medication
packaged in one container labeled as required by pertinent Federal and State
laws and rules;
(f) Centers for Medicare and Medicaid Services (CMS)
Basic Rebate: The quarterly payment by the manufacturer of a drug pursuant to
the Manufacturer’s CMS Medicaid Drug Rebate Agreement made in accordance with
Section 1927(c)(3) of the Social Security act 42 U.S.C. 1396r-8(c)(1) and 42
U.S.C. 1396r-8 (c)(3). See 410-121-0157;
(g) CMS Consumer Price Index (CPI) Rebate: The quarterly
payment by the manufacturer pursuant to the Manufacturer’s CMS Medicaid Drug
Rebate Agreement made in accordance with Section 1927(c)(2) of the Social
Security act (42 U.S.C. 1396r-8(c)(2);
(h) Community Based Care Living Facility: For the
purposes of the Division’s Pharmacy Program, a home, facility, or supervised
living environment licensed or certified by the state of Oregon that provides
24 hour care, supervision, and assistance with medication administration. These
include, but are not limited to:
(A) Supportive Living Facilities;
(B) 24-Hour Residential Services;
(C) Adult Foster Care;
(D) Semi-Independent Living Programs;
(E) Assisted Living and Residential Care Facilities;
(F) Group Homes and other residential services for
people with developmental disabilities or needing mental health treatment; and
(G) Inpatient hospice;
(i) Compounded Prescription:
(A) A prescription that is prepared at the time of
dispensing and involves the weighting of at least one solid ingredient that
must be a reimbursable item or a legend drug in a therapeutic amount;
(B) Compounded prescription is further defined to
include the Oregon Board of Pharmacy definition of compounding (see OAR
855-006-0005);
(j) Dispensing: Issuance of a prescribed quantity of an
individual drug entity by a licensed pharmacist;
(k) Drug Order/Prescription:
(A) A medical practitioner’s written or verbal
instructions for a patient’s medications; or
(B) A medical practitioner’s written order on a medical
chart for a client in a nursing facility;
(l) Durable Medical Equipment and supplies (DME):
Equipment and supplies as defined in OAR 410-122-0010, Durable Medical
Equipment, Prosthetics, Orthotics, and Supplies;
(m) Estimated Acquisition Cost (EAC): The estimated
cost that the pharmacy can obtain the product listed in OAR 410-121-0155;
(n) Intermediate Care Facility: A facility providing
regular health-related care and services to individuals at a level above room
and board, but less than hospital or skilled nursing levels as defined in ORS
442.015;
(o) Legend Drug: A drug limited by § 503(b)(1) of the
Federal Food, Drug, and Cosmetic Act to being dispensed by or upon a medical
practitioner’s prescription because the drug is:
(A) Habit-forming;
(B) Toxic or having potential for harm; or
(C) Limited in its use to use under a practitioner’s
supervision by the new drug application for the drug:
(i) The product label of a legend drug is required to
contain the statement: “CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A
PRESCRIPTION”;
(ii) A legend drug includes prescription drugs subject
to the requirement of § 503(b)(1) of the federal Food, Drug, and Cosmetic Act
which shall be exempt from § 502(F)(1) if certain specified conditions are met;
(p) Long Term Care Facility: Includes skilled nursing
facilities and intermediate care facilities with the exclusions found in ORS
443.400 to 443.455;
(q) Maintenance Medication: Drugs that have a common
indication for treatment of a chronic disease and the therapeutic duration is
expected to exceed one year. This is determined by a First DataBank drug code
maintenance indicator of “Y” or “1”;
(r) Mental Health Drug: A type of legend drug defined
by the Oregon Health Authority (Authority) by rule that includes, but is not
limited to those drugs classified by First DataBank in the following Standard
Therapeutic Classes:
(A) Therapeutic Class 7 ataractics-tranquilizers; and
Therapeutic Class 11 psychostimulants-antidepressants;
(B) Depakote, Lamictal and their generic equivalents
and other drugs that the Division specifically carved out from capitation from
Fully Capitated Health Plans (FCHPs) in accordance with OAR 410-141-0070;
(s) Narrow Therapeutic Index (NTI) Drug: A drug that
has a narrow range in blood concentrations between efficacy and toxicity and
requires therapeutic drug concentration or pharmacodynamic monitoring;
(t) Net Price: The amount a drug costs the Division and
is calculated using the following formula: “Estimated Acquisition Cost minus
CMS Basic Rebate minus CMS CPI Rebate minus State Supplemental Rebate”;
(u) Non-Preferred Products: Any medication in a class
that has been evaluated and that is not listed on the Practitioner-Managed
Prescription Drug Plan Preferred Drug List in OAR 410-121-0030 and may be
subject to co-pays;
(v) Nursing Facility: An establishment that is licensed
and certified by the Department’s Seniors and People with Disabilities Division
(SPD) as a Nursing Facility;
(w) Physical Health Drug: All other drugs not included
in section (r) of this rule;
(x) Point-of-Sale (POS): A computerized, claims
submission process for retail pharmacies that provides on-line, real-time
claims adjudication;
(y) Preferred Drug List (PDL): A PDL consists of
prescription drugs in selected classes that the Authority, in consultation with
the Health Resources Commission (HRC), has determined represent the most
effective drug(s) available at the best possible price. (See details for the
Division’s PMPDP PDL in OAR 410-121-0030):
(A) Enforceable Physical Health Preferred Drug List:
The list of drug products used to treat physical health diagnosis that the
Division has identified which shall be exempt from client co-pays and may be
subject to prior authorization (PA). Drugs prescribed that do not appear on the
PDL (non-preferred products) shall be subject to both co-pays and PA as
determined to be appropriate by the Division;
(B) Voluntary Mental Health Preferred Drug List: The
list of drug products used to treat mental health diagnosis. These drugs are
exempt from client co-pay. Any drug prescribed for the treatment of mental
health diagnosis shall be exempt from PA requirements by the Division;
(z) Preferred Products: Products in classes that have
been evaluated and placed on the PMPDP PDL in OAR 410-121-0030 and are not
subject to co-pays;
(aa) Prescription Splitting: Any one or a combination
of the following actions:
(A) Reducing the quantity of a drug prescribed by a
licensed practitioner for prescriptions not greater than 34 days (see OAR
410-121-0146);
(B) Billing the agency for more than one dispensing fee
when the prescription calls for one dispensing fee for the quantity billed;
(C) Separating the ingredients of a prescribed drug and
billing the agency for separate individual ingredients, with the exception of
compounded medications (see OAR 410-121-0146); or
(D) Using multiple 30-day cards to dispense a
prescription when a lesser number of cards will suffice;
(bb) Prior Authorization Program (PA): The Prior
Authorization Program is a system of determining, through a series of
therapeutic and clinical protocols, which drugs require authorizations prior to
dispensing:
(A) OAR 410-121-0040 lists the drugs or categories of
drugs requiring PA;
(B) The practitioner, or practitioner’s licensed
medical personnel listed in OAR 410-121-0060, may request a PA;
(cc) State Supplemental Rebates: The Division and CMS
approved discounts paid by manufacturers per unit of drug. These rebates are
authorized by the Social Security Act section 42 USC 1396r-8(a)(1) and are in
addition to federal rebates mandated by the Omnibus Budget Rehabilitation Act
(OBRA 90) and the federal rebate program;
(dd) Unit Dose: A sealed, single unit container of
medication, so designed that the contents are administered to the patient as a
single dose, direct from the container, and dispensed following the rules for
unit dose dispensing system established by the Oregon Board of Pharmacy;
(ee) Urgent Medical Condition: A medical condition that
arises suddenly, is not life-threatening, and requires prompt treatment to
avoid the development of more serious medical problems;
(ff) Usual and Customary Price: A pharmacy’s charge to
the general public that reflects all advertised savings, discounts, special
promotions, or other programs including membership based discounts, initiated
to reduce prices for product costs available to the general public, a special
population, or an inclusive category of customers;
(gg) Wholesale Acquisition Cost (WAC): The price paid
by a wholesaler for drugs purchased from the wholesaler’s supplier, typically
the manufacturer of the drug. WAC is the price of a covered product by the
National Drug Code (NDC) as published by First DataBank, MediSpan or Red Book;
(hh) 340B Pharmacy: A federally designated community
health center or other federally qualified covered entity that is listed on the
Health Resources and Services Administration (HRSA) website.
[ED NOTE: Publications referenced are
available from the agency.]
Stat. Auth.: ORS 409.010, 409.025,
409.040, 409.050, 409.110, 414.065 & 414.325
Stats. Implemented: ORS 414.065
Hist.: HR 29-1990, f. 8-31-90,
cert. ef. 9-1-90; OMAP 1-1999, f. & cert. ef. 2-1-99; OMAP 31-2001, f.
9-24-01, cert. ef. 10-1-01; OMAP 1-2003, f. 1-31-03, cert. ef. 2-1-03; OMAP
18-2004, f. 3-15-04 cert. ef. 4-1-04; DMAP 36-2008, f. 12-11-08, cert. ef.
1-1-09; DMAP 14-2009 f. 6-12-09, cert. ef. 7-1-09; DMAP 39-2009, f. 12-15-09,
cert. ef. 1-1-10; DMAP 17-2010, f. 6-15-10, cert. ef. 7-1-10; DMAP 40-2010, f.
12-28-10, cert. ef. 1-1-11; DMAP 23-2011, f. 8-24-11, cert. ef. 9-1-11
410-121-0150
Billing Requirements
(1) When billing the Division of Medical Assistance
Programs (Division) for drug products, the provider must:
(a) Not bill in excess of the usual and customary
charge to the general public:
(A) The sum of charges for both the product cost and
dispensing fee must not exceed a pharmacy’s usual and customary charge for the
same or similar service;
(B) When billing the Division for a prescription, the
pharmacy shall bill the lowest amount accepted from any member of the general
public who participates in the pharmacy provider’s savings or discount program;
(b) Indicate the National Drug Code (NDC), as it
appears on the package from which the prescribed medications are dispensed;
(c) Bill the actual metric decimal quantity dispensed;
(d) When clients have other insurances, bill the other
insurances as primary and the Division as secondary;
(e) When clients have Medicare prescription drug
coverage, bill Medicare as primary and the Division as secondary.
(2) When submitting a paper claim, the provider must
accurately furnish all information required on the 5.1 Universal Claims Form.
(3) The prescribing provider’s National Provider
Identifier (NPI) is mandatory on all fee-for-service client drug prescription
claims. Claims will deny for a missing or invalid prescriber NPI. An exception
to this includes, but is not limited to a Prescribing provider who does not
have an NPI for billing, but who prescribes fee-for-service prescriptions for
clients under prepaid health plans (PHP), long-term care, or other capitated
contracts. This provider is to be identified with the:
(a) Non-billing NPI-assigned for prescription writing
only;
(b) Clinic or facility NPI until an individual NPI is
obtained; or
(c) Supervising physician’s NPI when billing for
prescriptions written by the physician assistant, physician students, physician
interns, or medical professionals who have prescription writing authority;
(4) Billing for Death With Dignity services:
(a) Claims for Death With Dignity services cannot be
billed through the Point-of-Sale system;
(b) Services must be billed directly to the Division,
even if the client is in a PHP;
(c) Prescriptions must be billed on a 5.1 Universal
Claims Form paper claim form using an NDC number. Claims should be submitted to
the address indicated at the Division Supplemental Information for
Pharmaceutical Services.
Stat. Auth.: ORS 409.050, 414.065
Stats. Implemented: ORS 414.065
Hist.: AFS 15-1987, f. 3-31-87,
ef. 4-1-87; AFS 56-1989, f. 9-28-89, cert. ef. 10-1-89, Renumbered from
461-016-0093; HR 29-1990, f. 8-31-90, cert. ef. 9-1-90, Renumbered from
461-016-0240; HR 20-1994, f. 4-29-94, cert. ef. 5-1-94; OMAP 44-1998(Temp), f.
12-1-98, cert. ef. 12-1-98 thru 5-1-99; OMAP 11-1999(Temp), f. & cert. ef.
4-1-99 thru 9-1-99; OMAP 25-1999, f. & cert. ef. 6-4-99; OMAP 5-2000, f.
3-31-00, cert. ef. 4-1-00; OMAP 29-2000, f. 9-29-00, cert. ef. 10-1-00; OMAP
31-2001, f. 9-24-01, cert. ef. 10-1-01; OMAP 7-2002, f. & cert. ef. 4-1-02;
OMAP 40-2003, f. 5-27-03, cert. ef. 6-1-03; OMAP 43-2003(Temp), f. 6-10-03,
cert. ef. 7-1-03 thru 12-15-03; OMAP 49-2003, f. 7-31-03 cert. ef. 8-1-03; OMAP
18-2004, f. 3-15-04 cert. ef. 4-1-04; OMAP 9-2005, f. 3-9-05, cert. ef. 4-1-05;
OMAP 16-2006, f. 6-12-06, cert. ef. 7-1-06; DMAP 4-2007, f. 6-14-07, cert. ef.
7-1-07; DMAP 26-2007, f. 12-11-07, cert. ef. 1-1-08; DMAP 34-2008, f. 11-26-08,
cert. ef. 12-1-08; DMAP 14-2009 f. 6-12-09, cert. ef. 7-1-09; DMAP 23-2011, f.
8-24-11, cert. ef. 9-1-11
Rule
Caption: 10/11 Technical Changes for
1/1/11–12/31/12 Health Services Commission’s Prioritized List of Health
Services.
Adm.
Order No.: DMAP 24-2011(Temp)
Filed with Sec. of
State: 9-15-2011
Certified to be
Effective: 10-1-11 thru 3-26-12
Notice Publication
Date:
Rules Amended: 410-141-0520
Subject: The OHP Program administrative rules govern the
Division of Medical Assistance Programs’ payments for services provided to
clients. The Division temporarily amended 410-141-0520 to reference the Oregon
Health Services Commission’s Prioritized List of Health Services’ January 1,
2011–December 31, 2012, Prioritized List of Health Services effective
October 1, 2011, including interim modifications and technical changes made for
2009 national code set.
The Division
intends to permanently amend this rule on or before March 26, 2012.
Rules Coordinator: Darlene Nelson—(503) 945-6927
410-141-0520
Prioritized List of Health
Services
(1) The Prioritized List of Health Services
(Prioritized List) is the Oregon Health Services Commission’s (HSC) listing of
physical health services with “expanded definitions” of preventive services and
the HSC’s practice guidelines, as presented to the Oregon Legislative Assembly.
The Prioritized List is generated and maintained by HSC. The HSC maintains the
most current list on the HSC website: www.oregon.gov/DHS/
healthplan/priorlist/main, or, for a hardcopy contact the Office for Oregon
Health Policy and Research. This rule incorporates by reference the CMS
approved biennial January 1, 2011–December 31, 2012 Prioritized List,
including interim modifications and technical revisions made for the 2009
national code set effective October 1, 2011 that includes expanded definitions,
practice guidelines and condition treatment pairs funded through line 502.
(2) Certain mental health services are only covered for
payment when provided by a Mental Health Organization (MHO), Community Mental
Health Program (CMHP) or authorized Fully Capitated Health Plan (FCHP) or
Physician Care Organization (PCO). These codes are identified on their own
Mental Health (MH) section of the appropriate lines on the Prioritized List of
Health Services.
(3) Chemical dependency (CD) services are covered for
eligible OHP clients when provided by an FCHP, PCO, or by a provider who has a
letter of approval from the Office of Addictions and Mental Health and approval
to bill Medicaid for CD services.
Stat. Auth.: ORS 192.527, 192.528,
413.042 & 414.065
Stats. Implemented: ORS 192.527,
192.528, 414.065 & 414.727
Hist.: HR 7-1994, f. & cert.
ef. 2-1-94; OMAP 33-1998, f. & cert. ef. 9-1-98; OMAP 40-1998(Temp), f.
& cert. ef. 10-1-98 thru 3-1-99; OMAP 48-1998(Temp), f. & cert. ef.
12-1-98 thru 5-1-99; OMAP 21-1999, f. & cert. ef. 4-1-99; OMAP 39-1999, f.
& cert. ef. 10-1-99; OMAP 9-2000(Temp), f. 4-27-00, cert. ef. 4-27-00 thru
9-26-00; OMAP 13-2000, f. & cert. ef. 9-12-00; OMAP 14-2000(Temp), f.
9-15-00, cert. ef. 10-1-00 thru 3-30-01; OMAP 40-2000, f. 11-17-00, cert. ef.
11-20-00; OMAP 22-2001(Temp), f. 3-30-01, cert. ef. 4-1-01 thru 9-1-01; OMAP
28-2001, f. & cert. ef. 8-10-01; OMAP 53-2001, f. & cert. ef. 10-1-01;
OMAP 18-2002, f. 4-15-02, cert. ef. 5-1-02; OMAP 64-2002, f. & cert. ef. f.
& cert. ef. 10-2-02; OMAP 65-2002(Temp), f. & cert. ef. 10-2-02 thru
3-15-0; OMAP 88-2002, f. 12-24-02, cert. ef. 1-1-03; OMAP 14-2003, f. 2-28-03,
cert. ef. 3-1-03; OMAP 30-2003, f. 3-31-03 cert. ef. 4-1-03; OMAP
79-2003(Temp), f. & cert. ef. 10-2-03 thru 3-15-04; OMAP 81-2003(Temp), f.
& cert. ef. 10-23-03 thru 3-15-04; OMAP 94-2003, f. 12-31-03 cert. ef.
1-1-04; OMAP 17-2004(Temp), f. 3-15-04 cert. ef. 4-1-04 thru 9-15-04; OMAP
28-2004, f. 4-22-04 cert. ef. 5-1-04; OMAP 48-2004, f. 7-28-04 cert. ef.
8-1-04; OMAP 51-2004, f. 9-9-04, cert. ef. 10-1-04; OMAP 68-2004(Temp), f.
9-14-04, cert. ef. 10-1-04 thru 3-15-05; OMAP 83-2004, f. 10-29-04 cert. ef.
11-1-04; OMAP 27-2005, f. 4-20-05, cert. ef. 5-1-05; OMAP 54-2005(Temp), f.
& cert. ef. 10-14-05 thru 4-1-06; OMAP 62-2005, f. 11-29-05, cert. ef.
12-1-05; OMAP 71-2005, f. 12-21-05, cert. ef. 1-1-06; OMAP 6-2006, f. 3-22-06,
cert. ef. 4-1-06; OMAP 46-2006, f. 12-15-06, cert. ef. 1-1-07; DMAP
14-2007(Temp), f. & cert. ef. 10-1-07 thru 3-28-08; DMAP 28-2007(Temp), f.
& cert. ef. 12-20-07 thru 3-28-08; DMAP 8-2008, f & cert. ef. 3-27-08;
DMAP 10-2008(Temp), f. & cert. ef. 4-1-08 thru 9-15-08; DMAP 23-2008, f.
6-13-08, cert. ef. 7-1-08; DMAP 31-2008(Temp), f. & cert. ef. 10-1-08 thru
3-29-09; DMAP 40-2008, f. 12-11-08, cert. ef. 1-1-09; DMAP
4-2009(Temp), f. & cert. ef. 1-30-09 thru 6-25-09; DMAP 6-2009(Temp), f.
3-26-09, cert. ef. 4-1-09 thru 9-25-09; DMAP 8-2009(Temp), f. & cert. ef.
4-17-09 thru 9-25-09; DMAP 26-2009, f. 8-3-09, cert. ef. 8-5-09; DMAP
30-2009(Temp), f. 9-15-09, cert. ef. 10-1-09 thru 3-29-10; DMAP 36-2009(Temp),
f. 12-10-09 ef. 1-1-10 thru 3-29-10; DMAP 1-2010(Temp), f. & cert. ef.
1-15-10 thru 3-29-10; DMAP 3-2010, f. 3-5-10, cert. ef. 3-17-10; DMAP
5-2010(Temp), f. 3-26-10, cert. ef. 4-1-10 thru 9-1-10; DMAP 10-2010, f. &
cert. ef. 4-26-10; DMAP 27-2010(Temp), f. 9-24-10, cert. ef. 10-1-10 thru
3-25-11; DMAP 43-2010, f. 12-28-10, cert. ef. 1-1-11; DMAP
4-2011, f. 3-23-11, cert. ef. 4-1-11; DMAP 24-2011(Temp), f. 9-15-11, cert. ef.
10-1-11 thru 3-26-12
Notes
1.) This online version of the OREGON BULLETIN is provided for convenience of reference and enhanced access. The official, record copy of this publication is contained in the original Administrative Orders and Rulemaking Notices filed with the Secretary of State, Archives Division. Discrepancies, if any, are satisfied in favor of the original versions. Use the OAR Revision Cumulative Index found in the Oregon Bulletin to access a numerical list of rulemaking actions after November 15, 2010.
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