Draft Immunization Rules (posted 5/13/08)
The Indiana Board of Pharmacy will be holding a hearing on July 25 to
consider administrative rules to finalize the implementation of
pharmacist’s authority to provide immunizations to patients. These
rules will flesh out the requirements for pharmacists to provide flu
shots via protocols. Each of the parts of the rule deals with a
different part of the protocol procedure.
Download a copy of the DRAFT Rules here
Please note: This is a
draft copy. Please refer to the final Proposed Rule once
it is available. IPA will update it's members through the listserv
and newsletter once the proposed rule is available.
Digitek
(digoxin tablets) Recalled (Posted 4/28/08)
Actavis Totowa LLC notified healthcare professionals of a Class I
nationwide recall of all strengths of Digitek, a drug used to treat
heart failure and abnormal heart rhythms. The products are distributed
by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL
Laboratories, Inc. under a “UDL” label. The product is being recalled
due to the possibility that tablets with double the appropriate
thickness may contain twice the approved level of active ingredient.
The existence of double strength tablets poses a risk of digitalis
toxicity in patents with renal failure. Digitalis toxicity can cause
nausea, vomiting, dizziness, low blood pressure, cardiac instability and
bradycardia. Several reports of illnesses and injuries have been
reported. Patients should contact their healthcare professional with
questions. Source:
FDA WedWatch, accessed online 4/28/08.
NPI Requirement for Prescriber ID Field (Posted 4/28/08)
Question: After May 23,
2008, is an NPI required for the prescriber ID field on the NCPDP
pharmacy transaction? If the prescriber’s NPI is not available, or the
prescriber doesn’t have an NPI, but the payer requires the prescriber
ID, what alternatives, if any, are available for pharmacies to use to
avoid having the transaction and the claim rejected?
CMS
Response:
The
prescriber identifier field on an NCPDP transaction is a provider
identifier field and, as such, should carry an NPI in almost all cases
when populated. It is expected that most prescribers will be covered
entities and will therefore have an NPI assigned for use on all HIPAA
transactions, where required. However, if the prescriber is not a
covered entity, s/he may not be required to have an NPI, and may not opt
to obtain one voluntarily. Thus, this provider would not have an NPI to
include on the pharmacy transaction. If a health plan or other payer
rejects a (pharmacy) claim because it does not have prescriber ID, and
one is not available to the pharmacy, this presents a potential service
disruption problem in point of service billing, which must be avoided
when possible.
In the rare cases when either a prescriber does not have an NPI or the
pharmacy cannot obtain an NPI, and where the prescriber ID is required
by the payer, non-NPI individual identifiers may be substituted if
allowed by the payer. In keeping with past practice, if no identifier is
available a default identifier may be substituted; providers and
pharmacies are encouraged to work with their payers for such default
alternatives.
This guidance is expected to be used to cover exceptions. It is not
intended to allow routine use of non-NPI identifiers or default
identifiers in place of individual prescriber NPIs. Pharmacies are
expected to make all reasonable efforts to obtain and utilize the
appropriate individual NPIs for prescribers. Payers that elect to
utilize the flexibility allowed under this Q&A should monitor pharmacy
use of non-NPI and default identifiers to ensure that pharmacies comply
with the requirement to use NPI whenever available.
Source: Todd Stankewicz, CDR U.S. Public Health Service,
Pharmacy Officer - CMS Region
Tamper Resistant Prescription Pad Update (Posted 3/27/08)
On April
1, prescriptions for Medicaid patients enrolled in traditional
fee-for-service Medicaid must be written on tamper-resistant
prescription forms. The following is a brief summary of the
requirements, excerpted from the American Pharmacists Association’s
(APHA) issue brief on the matter.
Click here to access the entire brief.
CMS Guidance to State
Medicaid Agencies
-
Beginning April 1,
2008, the tamper-resistant prescription pad requirement applies to
hand-written outpatient Medicaid prescriptions, including over-the
counter medications in States that pay for them.
-
The tamper-resistant
requirement also applies to prescriptions printed in the prescribers
office.
-
Applies regardless of
whether Medicaid is the primary or secondary payer of the prescription
being filled.
-
Section 1927(k)(3) of
the Social Security Act provides exceptions for drugs that are not
separately reimbursed and are provided in specified institutional
settings. Such drugs in these settings (to the extent that they are
not separately reimbursed) are exceptions to Section 1927(k)(2), and
therefore, are not subject to the tamper-resistant prescription pad
requirement.
-
Section 1927(k)(3) of
the Social Security Act includes the following, which are excluded
from the tamper-resistant pad requirement:
-
Inpatient hospital
services
-
Hospice services
-
Dental services
(except when a State plan authorizes direct reimbursement to the
dispensing dentist)
-
Physician services
-
Outpatient hospital
services
-
Nursing facility
services and intermediate care facility services for the mentally
retarded
-
Other laboratory and
x-ray services
-
Renal dialysis
-
In an institutional
setting where the doctor or medical assistant writes the order into
the medical record and then the order is given by medical staff
directly to the pharmacy is considered “tamper-resistant,” so long as
the patient never has the opportunity to handle that written order.
-
Does not apply:
-
To refills of written prescriptions
presented at a pharmacy before April 1, 2008
-
To electronic prescriptions
-
To prescriptions faxed to the
pharmacy
-
To prescriptions called in by the
prescriber
-
When a Medicaid managed care entity
pays for the prescription
-
Does not effect Drug
Enforcement Administration (DEA) regulations regarding controlled
substance medications that may require a written prescription.
-
Does not restrict
providing an emergency fill of any amount (up to the full prescription
amount) of non-controlled or controlled dangerous substances for which
a prescriber provides the pharmacy with a verbal, faxed, electronic,
or compliant written prescription within 72 hours after the date on
which the prescription was filled.
-
CMS deems that the
tamper-resistant prescription pad characteristics required by States’
laws and regulations meet or exceed the baseline standard (Indiana’s
current regulations for controlled substance tamper resistant
prescription forms is deemed acceptable.)
Indiana Prescription Pad Information
The
Indiana Pharmacists Alliance (IPA) and Community Pharmacies of Indiana
(CPI) have previously notified its members of this requirement. As a
reminder, Indiana’s Rule 34 (856 IAC 1-34) details the requirements of
Controlled Substance Prescription Security pads for use by practitioners
and patients in the State of Indiana.
Practitioners seeking a
list of those printers authorized by the Indiana Board of Pharmacy to
produce these pads may review the companies listed on the Board of
Pharmacy’s website at
http://www.in.gov/pla/3207.htm
To
read Rule 34, Security Features for Prescriptions,
visit
www.in.gov/pla/files/856_IAC_1-34.pdf
