Click below to download the comprehensive publication titled:
See last section for prescribing in Long Term Care setting.
Is it legal for pharmacies to put a physician's name on the medication bottle when the medication was prescribed by an ARNP?
Simply stated, the answer is "no". Federal pharmacy law requires that the name of the prescriber be on the medication bottle. In the past this was a problem for ARNPs because insurance company soft ware required a pharmacist to use DEA # as a provider identifier to submit claims for payment. Now all providers must have a NPI # (National Provider Identifier) and this is the number that should be used on claim forms. The federal law is noted below.
Section 503(b)(2) of the Federal, Drug and Cosmetic Act [21 U.S.C. 353(b)(2)] requires the prescription label have the following:
1-the name and address of the dispenser (pharmacy);
2-the serial number of the prescription;
3-the date of the prescription or refill date;
4-the name of the prescriber;
5-the name of the patient;
6-name of drug; and
7-the directions for use, including precautions.
Are pre signed prescriptions legal?
Pre signed prescriptions for any medications are not legal – no exceptions.
Further, Kentucky statutes, as do the federal rules, require that a prescription for a controlled substance be signed by the prescriber on the day it is written. Therefore,pre signed prescriptions areillegal. It's as simple as that. ARNPs who are not registered with the DEA are not authorized to prescribe scheduled drugs. If an ARNP is not authorized to prescribe controlled substances AND they use pre signed prescriptions, they are violating more than one law and face stiff federal and state penalties. 11/01/09
It is NOT legal for NPs to dispense meds that are not samples. KRS citations: 212.275
ARNPs may dispense sample medications (KRS 314.011(8)(17). Although, the law defines the practice of advanced registered nurse practitioners as including dispensing, additional definitions in the statute define dispensing as, "… to receive and distribute non controlled, legend drug samples from pharmaceutical manufacturers to patients, at no charge to the patient or any other party…” Medications ordered from a pharmaceutical company, through special programs for indigent patients and at no cost to the patient, are considered like samples and may be dispensed by ARNPs.
If specifications are met, ARNPs may dispense medications in health departments (KRS 212.275).
ARNPs may not dispense medications that are purchased and sold to patients.
The specific statutes regarding dispensing are below.
KRS 314.011 Definitions for Chapter - Sections 8 and 17
(8) "Advanced registered nursing practice" means the performance of additional acts by registered nurses who have gained added knowledge and skills through an organized postbasic program of study and clinical experience and who are certified by the American Nurses' Association or other nationally established organizations or agencies recognized by the board to certify registered nurses for advanced nursing practice. The additional acts shall, subject to approval of the board, include but not be limited to prescribing treatment, drugs, devices, and ordering diagnostic tests. Advanced registered nurse practitioners who engage in these additional acts shall be authorized to issue prescriptions for and dispense nonscheduled legend drugs as defined in KRS 217.905 and to issue prescriptions for but not to dispense Schedules II through V controlled substances as classified in KRS 218A.060, 218A.070, 218A.080, 218A.090, 218A.100, 218A.110, 218A.120, and 218A.130, under the conditions set forth in KRS 314.042 and regulations promulgated by the Kentucky Board of Nursing on or before August 15, 2006.
(17) "Dispense" means:
(a) To receive and distribute noncontrolled legend drug samples from pharmaceutical manufacturers to patients at no charge to the patient or any other party; or
(b) To distribute noncontrolled legend drugs from a local, district, and independent health department, subject to the direction of the appropriate governing board of the individual health department;
212.275 Distribution of nonscheduled legend drugs at health department by advanced registered nurse practitioner or registered nurse -- Written policy -- Record of prescription drugs -- Responsibility for inventory -- Pharmacist -- Dispensing medication or device prescribed for purpose of causing abortion.
(1) The governing board for each local, district, and independent health department shall have a written policy concerning the distribution of nonscheduled legend drugs at the health department by an advanced registered nurse practitioner or a registered nurse. In a health department, an advanced registered nurse practitioner or a registered nurse may distribute nonscheduled legend drugs from a list that has been prepared by the commissioner of the Department for Public Health. Nothing in this section shall be construed to limit advanced registered nurse practitioners from dispensing nonscheduled drug samples under KRS 314.011. Each prescription drug distributed or dispensed at the health department shall be recorded in the patient record. The director of each health department shall be responsible for keeping track of the inventory of stock medications and accounting for the medications dispensed or distributed.
(2) Only a health department board having within its membership a pharmacist holding a valid license issued pursuant to KRS 315.030 shall be authorized to permit advanced registered nurse practitioners or registered nurses to dispense nonscheduled legend drugs according to the written policy of the board. If a health department is unable to recruit a licensed pharmacist to serve on the board, the board shall document consultation with a pharmacist licensed pursuant to KRS 315.030 in the public health practice of the health department.
(3) No health department shall dispense any medication or device prescribed for the purpose of causing an abortion as defined in KRS 311.720(1).
Send in a new KBN notification form to KBN and fax a copy of your new CAPA-CS to Pam Bixler at the DEA.
If your practice site has changed, fax Pam Bixler the DEA change of address form found on the DEA web site.
There is no additional DEAcharge for changing address or CAPA-CS. Your DEA # will not change.
If you leave a practice, you should also notify the DEA. If you don't notify them, they will send correspondence to your old practice, and mail from the DEA cannot be forwarded to another address.
May ARNPs prescribe diabetic shoes?
Nurse practitioners (NPs) and clinical nurse specialists (CNSs) may prescribe diabetic shoes, but they may not certify that the patient needs the shoes. A physician (MD or DO) must certify that the patient needs the shoes. Both certification of the need and a prescription for the shoes are necessary before a patient may obtain diabetic shoes through Medicare. This rule is the result of a recently issued opinion from CMS. A copy of the CMS opinion is printed below or you may go on line to http://www.cms.hhs.gov/mcd/viewarticle.asp?article_id=47129&article_version=11&show=all
Confusing this issue are rules that have been issued in theMedicare Policy Benefits Manual, Section 140, which covers diabetic shoes. It says that a physician must order and certifythe shoes. However, if you go to Section 200 (page 143), which covers NP services, it says that the services of a NP are covered under Part B if they are the type that are considered physician services. Therefore, itappears thatNPs may certify and prescribe diabetic shoes. A copy of the CMS manual may be obtained at:http://www.cms.hhs.gov/manuals/Downloads/bp102c15.pdf
The new CMS rule was issued in September 2009 and therefore, is the rule that is currently being followed by Medicare.
CMS Article for Therapeutic Shoes for Persons with Diabetes - Policy Article - Effective September 2009 (A47129)
Primary Geographic Jurisdiction
Illinois
Indiana
Kentucky
Michigan
Minnesota
Ohio
Wisconsin
Article Revision Effective Date 09/01/2009
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES
For an item addressed in this policy to be covered by Medicare, a written signed and dated order must be received by the supplier prior to claim submission. If the supplier bills for an item without first receiving the completed order, the item will be denied as noncovered.
The Certifying Physician is defined as a doctor of medicine (M.D.) or a doctor of osteopathy (D.O.) who is responsible for diagnosing and treating the patient's diabetic systemic condition through a comprehensive plan of care. The certifying physician may not be a podiatrist, physician assistant, nurse practitioner, or clinical nurse specialist.
The Prescribing Physician is the person who actually writes the order for the therapeutic shoe, modifications and inserts. This physician must be knowledgeable in the fitting of diabetic shoes and inserts. The prescribing physician may be a podiatrist, M.D., D.O., physician assistant, nurse practitioner, or clinical nurse specialist. The prescribing physician may be the supplier (i.e., the one who furnishes the footwear).
The Supplier is the person or entity that actually furnishes the shoe, modification, and/or insert to the beneficiary and that bills Medicare. The supplier may be a podiatrist, pedorthist, orthotist, prosthetist or other qualified individual. The Prescribing Physician may be the supplier. The Certifying Physician may only be the supplier if the certifying physician is practicing in a defined rural area or a defined health professional shortage area.
Therapeutic shoes, inserts and/or modifications to therapeutic shoes are covered if the following criteria are met:
1. The patient has diabetes mellitus (ICD-9 diagnosis codes 249.00-250.93); and
2. The certifying physician has documented in the patient's medical record one or more of the following conditions:
a. Previous amputation of the other foot, or part of either foot, or
b. History of previous foot ulceration of either foot, or
c. History of pre-ulcerative calluses of either foot, or
d. Peripheral neuropathy with evidence of callus formation of either foot, or
e. Foot deformity of either foot, or
f. Poor circulation in either foot; and
3. The certifying physician has certified that indications (1) and (2) are met and that he/she is treating the patient under a comprehensive plan of care for his/her diabetes and that the patient needs diabetic shoes.
If criteria 1, 2 or 3 are not met, the therapeutic shoes, inserts and/or modifications to therapeutic shoes will be denied as noncovered. When codes are billed without a KX modifier (see Documentation Requirements section in the accompanying Local Coverage Determination), they will be denied as noncovered.
In order to meet criterion 2, the certifying physician must either:
i. Personally document one or more of criteria a – f in the medical record prior to signing the certification statement; or
ii. Obtain, initial, date (prior to signing the certification statement), and indicate agreement with information from the medical records of a podiatrist, other M.D or D.O., physician assistant, nurse practitioner, or clinical nurse specialist that documents one of more of criteria a – f.
Note: The certification statement is not sufficient to meet the requirement for documentation in the medical record.
For patients meeting the coverage criteria, coverage is limited to one of the following within one calendar year (January – December):
- One pair of custom molded shoes (A5501) (which includes inserts provided with these shoes) and 2 additional pairs of inserts (A5512 or A5513); or
- One pair of depth shoes (A5500) and 3 pairs of inserts (A5512 or A5513) (not including the non-customized removable inserts provided with such shoes).
A modification of a custom molded or depth shoe may be covered as a substitute for an insert. Although not intended as a comprehensive list, the following are the most common shoe modifications: rigid rocker bottoms (A5503), roller bottoms (A5503), wedges (A5504), metatarsal bars (A5505), or offset heels (A5506). Other modifications to diabetic shoes (A5507) include, but are not limited to flared heels.
Quantities of shoes, inserts, and/or modifications greater than those listed above will be denied as noncovered.
Items represented by code A5510 reflect compression molding to the patient's foot over time through the heat and pressure generated by wearing a shoe with the insert present. Since these inserts are not considered total contact at the time of dispensing, they do not meet the requirements of the benefit category and will be denied as noncovered.
Inserts used in noncovered shoes are noncovered.
Deluxe features of diabetic shoes (A5508) will be denied as noncovered.
There is no separate payment for the fitting of the shoes, inserts or modifications or for the certification of need or prescription of the footwear. Claims for unrelated evaluation and management services provided by the physician are processed by the local carrier. (KCNPNM 10/24/09)
Prescribing in Long Term Care SettingAlthough the same laws
apply, there are some special considerations for the
long term care settings. I work with Dr. Adrian Pellegrini in several
long term
and personal care settings as a psychiatric NP.
In the past, NP's may have initiated a scheduled drug within the
boundaries
of Ky law, but when the time came for a refill, it was simply refilled
via the
LTC pharmacy via the physician of record (schedule IV rarely, if ever,
requiring
a written prescription). Orders for schedule IV werewritten on the
chart
as anorder, not necessarily via a hard script.
BUT.....read these links very closely for clarification about
recent
changes in upholding LTC regulations. Some LTC pharmacies are enforcing
them to
the letter, some are not...
Print Page
I truly appreciate the benefit that KCNPNM offers in terms of networking!