Policy Corner
Welcome to Policy Corner, your one stop shop for keeping
abreast of important developments with issues and polices in
and around e-prescribing. Read on to see what Surescripts
policy experts have to say about a number of key topics.
Click on a topic below and read on!
Meaningful Use
New HITECH Privacy Provisions
Controlled Substances
E-Prescribing and Healthcare Costs
Standards
Meaningful Use
Letter to the Office of the National Coordinator for Health Information Technology Regarding Meaningful Use.
by Paul Uhrig
Surescripts recently provided comments on the draft definition of meaningful use as submitted by the Meaningful Use Workgroup of the HIT Policy Committee.
Click here to read Surescripts' letter to the Office of the National Coordinator for Health Information Technology regarding meaningful use.
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New HITECH Privacy Provisions
Click here to read Surescripts' comments to the Department of Health and Human Services regarding its guidance for technologies and methodologies that render Protected Health Information unusable, unreadable, or indecipherable to unauthorized individuals under the Health Information Technology for Economic and Clinical Health (HITECH) Act, and the breach notification provisions of the HITECH Act.
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Controlled Substances
The DEA Proposal on E-Prescribing
by Paul Uhrig
We believe, and have heard countless times from physicians,
that the DEA prohibition against prescribing controlled
substances electronically is a significant barrier to
physician adoption of e-prescribing technology ... so we,
along with many others, have eagerly awaited movement by the
DEA on this issue.
The DEA’s proposed rule regarding e-prescribing – formally
known as the Notice of Proposed Rule Making by the Drug
Enforcement Agency with respect to the e-prescribing of
controlled substances - sets forth requirements for the use
of electronic systems to:
1. create,
2. sign,
3. dispense, and
4. archive controlled substance prescriptions.
So how will this NPRM impact practitioners?
First, there is in-person identity proofing. Each
practitioner must have her identity
verified through an in-person identity proofing process
before a service provider may
permit that prescriber to use the electronic system to
prescribe controlled substances.
Entities that may conduct in-person identity proofing of a
prescriber include:
1. The credentialing office of a DEA-registered hospital;
2. The State professional licensing Board or State
controlled substance authority
that authorized the practitioner to prescribe controlled
substances; or
3. A State or local law enforcement office.
So each prescriber will have to present themselves to one of
these three entities, prove through documentation that they
are who they claim to be, and then provide to the service
provider documentation that proves that they successfully
underwent this identity proofing process in compliance with
the reg, and who did the identity proofing.
Even after receiving this documentation, the service
provider is required to contact the practitioner, using a
phone number obtained from a public source, to confirm the
practitioner's intent to send prescriptions for controlled
substances using the vendor's system.
Second, there is two factor authentication. In order for a
prescriber to access the system and write electronic
prescriptions, the practitioner must authenticate herself
using a two factor authentication process that meets what is
referred to as the NIST Level 4 standards.
The practitioner will have to authenticate herself using a
strong password or biometric device, such as a fingerprint
scan, as well as use a hard token such as a smart card,
thumb drive, or other similar device. This process will have
to be used each time the practitioner wants to sign a
controlled substance prescription.
The practitioner must retain sole possession of the hard
token used for this authentication purpose, and she must
notify the service provider within 12 hours of discovering
that the token has been lost or otherwise compromised. If
the prescriber does not make this notification within 12
hours, then she will be held responsible for all
prescriptions sent using that token after it was lost or
compromised.
There are other requirements that the NPRM imposes on
practitioners, service providers that sell physician
e-prescribing systems as well as pharmacies.
As I mentioned, this is a brief and very high level review
of some of the requirements
imposed by the NPRM on participants in the e-prescribing
system. As you know, the
NPRM is now in the public comment period - comments to the
Proposed Rule are due no later than September 25. As I
indicated, industry has long awaited the DEA's position on
this matter. We have sought rules that are:
a. workable,
b. scalable, and
c. balance the legitimate and important interests of law
enforcement with the
objectives of private industry, the federal government, and
state governments
to promote the adoption and use of health IT.
There is substantial interest by all affected communities in
the NPRM, including
physicians, hospitals, long term care facilities,
pharmacies, payers, vendors, networks, and others. As I
mentioned, the DEA looks at this issue primarily through the
lens of law enforcement, as is appropriate for them - others
will look at these rules also through the lens of, among
other things,
a. patient safety,
b. efficiency,
c. cost of providing care,
d. prescriber and pharmacy workflows,
e. as well as the cost and effort to implement these
proposed requirements.
To read more about the NPRM and to view the full copy of
Surescripts response,
click here.
Update: Eleven Senators Urge Progress on Electronic Prescribing for Controlled Substances. Click here to read their letter to Attorney General Holder and Secretary Sebelius.
A Primer on Controlled Substances
by Ken Whittemore
To set the stage, a passage from the DEA’s web site:
“Many of the narcotics, depressants and stimulants
manufactured for legitimate medical use are subject to
abuse, and have therefore been brought under legal control.
The goal of controls is to ensure that these "controlled
substances" are readily available for medical use, while
preventing their distribution for illicit sale and abuse.”
Two federal agencies, the DEA and the FDA, determine which
medications/substances are added or removed from the various
schedules, though the Controlled Substances Act of 1970
(CSA) created the initial listing. Decisions as to which
medications/substances appear in the schedules are made
based on the criteria of (1) potential for abuse, (2)
accepted medical use in the United States, and (3) potential
for dependence. (Notable exceptions: alcohol, tobacco, and
caffeine, which were exempted from the CSA.)
As noted below, these criteria are somewhat subjective and
might seem like judgment calls, but there is a detailed
regulatory process that is employed by the agencies leading
to the scheduling of medications/substances. There also is
an emergency process for scheduling medications/substances
that present an imminent public hazard. Inconsistencies
exist, such as marijuana being in Schedule I, but its active
ingredient in the form of marinol being in Schedule III, but
they are few. The DEA schedules are as follows:
Schedule I:
(A) The medication/substance has high potential for abuse.
(B) The medication/substance has no currently accepted
medical use in treatment in the U.S.
(C) There is a lack of accepted safety for use of the
medication/substance under medical supervision.
Examples: Heroin, LSD, psilocybin, methaqualone (aka
Quaalude).
Prescription issues: Because the FDA and the DEA have found
that there is no currently accepted medical use for these
substances and a very high potential for their abuse,
possession and use of Schedule I substances is illegal in
the U.S. (exceptions can be made for scientific research,
however).
Schedule II:
(A) The medication/substance has a high potential for abuse.
(B) The medication/substance has a currently accepted
medical use in treatment in the United States or a currently
accepted medical use with severe restrictions.
(C) Abuse of the medication/substance may lead to severe
psychological or physical dependence.
Examples: Cocaine, methadone, amphetamine, oxycodone (aka
OxyContin) and other strong opioids used during anesthesia.
Prescribing issues: Prescriptions for C-II medications must
be written (a few minor exceptions exist) and cannot be
refilled.
Schedule III:
(A) The medication/substance has a potential for abuse less
than the medications/substances in schedules I and II.
(B) The medication/substance has a currently accepted
medical use in treatment in the United States.
(C) Abuse of the medication/substance may lead to moderate
or low physical dependence or high psychological dependence.
Examples: Anabolic steroids, hydrocodone and codeine
combinations (e.g. Vicodin, Tylenol with Codeine #3).
Prescribing issues: Prescriptions for C-III medications can
be written or oral and can be refilled up to five times
within six months if specified by the prescriber.
Schedule IV:
(A) The medication/substance has a low potential for abuse
relative to the medications/substances in schedule III.
(B) The medication/substance has a currently accepted
medical use in treatment in the United States.
(C) Abuse of the medication/substance may lead to limited
physical dependence or psychological dependence relative to
the medications/substances in schedule III.
Examples: Antianxiety/hypnotic agents (e.g. Valium, Xanax,
Restoril, Ambien), phenobarbital.
Prescribing issues: Prescriptions for C-IV medications can
be written or oral and can be refilled up to five times
within six months if specified by the prescriber.
Schedule V:
(A) The medication/substance has a low potential for abuse
relative to the medications/substances in schedule IV.
(B) The medication/substance has a currently accepted
medical use in treatment in the United States.
(C) Abuse of the medication/substance may lead to limited
physical dependence or psychological dependence relative to
the medications/substances in schedule IV.
Examples: Cough syrups containing codeine (e.g. Robitussin
with Codeine), opioid antidiarrheal agents (e.g. Lomotil).
Prescribing issues: Many of the Schedule V medications do
not require a prescription, although some do. If they
require a prescription, they may be refilled up to five
times within six months if specified by the prescriber.
Other Considerations: Some states have created a Schedule VI
due to local abuse issues, but that does not affect the
DEA’s scheduling system. In addition, some states have added
medications/substances not in the DEA’s schedules to their
schedules and/or have elevated some medications/substances
to higher schedules within their states. This is acceptable,
because states can have rules that are more strict than
federal rules, but not less strict.
Click here to read our bulletin on transmission methods approved by the Drug Enforcement Administration (DEA) for controlled substance prescriptions
E-Prescribing and Healthcare Costs
Medication Affordability and Noncompliance
by Ken Majkowski
Numerous research studies have documented that many elderly
and chronically ill do not get recommended care, fill
prescriptions, adhere to their medication regimens or see a
doctor when sick because of costs. Non-compliance with
prescription medication causes an estimated 125,000 deaths
annually and costs at least $75.6 billion each year. Other
impacts include such adverse outcomes as avoidable
hospitalization, development of complications, disease
progression, and premature disability. These findings
underscore the importance for patients in exploring lower
cost options, including generics, mail-service pharmacies,
and electronic prescribing.
Policymakers should explore cost-savings options, including
accelerating adoption of waste-cutting health information
technologies such as e-prescribing that alert patients and
doctors alike when affordable choices are available.
Standards
E-Prescribing: Proof That Standards Work
by Ken Whittemore
Surescripts recently passed a major milestone: over 150
million e-prescriptions have been transmitted in the U.S.
over the Surescripts network since its inception. And while
there is still plenty of room for growth (see our National
Progress Report on E-Prescribing), these and similarly
impressive statistics underscore that the uniform technical
standards – developed by the industry and endorsed by
government - work.
For those of you who might be new to e-prescribing, here is
a bulleted summary of where e-prescribing standards are
today and what’s in store for 2009.
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The SCRIPT
standard, developed by the National Council for
Prescription Drug Programs (NCPDP), has been the
agreed upon standard used to facilitate
e-prescribing since April 1997. |
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The SCRIPT standard
is currently on Version 10 and has been
implemented by all major physician and pharmacy
software vendors. |
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The Centers for
Medicare and Medicaid Services (CMS) adopted the
SCRIPT standard as a Foundation Standard to be
used by participants in the Medicare Part D
program for electronic prescribing. The
Foundation Standards adopted by CMS include: Transactions between prescribers (who write prescriptions) and dispensers (who fill prescriptions) for new prescriptions Refill requests and responses Prescription change requests and responses Prescription cancellation, request and response Eligibility and benefits queries and responses between prescribers and Part D sponsors |
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The Medicare
Modernization Act (MMA) required CMS to
implement pilot projects to test standards that
facilitate additional function and information
exchange. These additional standards were pilot
tested in 2006 and subsequently adopted by CMS. They are:
Formulary and benefit information
Medication history
Fill status notifications |
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Additional standards for prior authorization, patient instructions (Structured and codified SIG) and clinical drug terminology (RxNorm) remain in development. When ready, these additional standards will allow more advanced functions and features to be added to existing e-prescribing systems. However, they are by no means preventing any physician, pharmacist or patient from realizing the substantial and measurable benefits associated with e-prescribing today. |
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