Public Policy
Read on to see what Surescripts policy experts have to say about a number of key topics. Click on a topic below.
Meaningful Use
1. Letter to the Centers for Medicare and Medicaid (CMS) regarding Meaningful Use comments.
Surescripts recently provided comments on the Notice of Proposed Rule Making (NPRM) titled, "Medicare and Medicaid Programs; Electronic Health Record (EHR) Incentive Program," published by the Centers for Medicare & Medicaid Services (CMS) in the Federal Register on January 13, 2010 [CMS-003-P]. Click here to read the letter to CMS.
2. Letter to the Office of the National Coordinator for
Health Information Technology (ONC) regarding standards,
implementation specifications, and certification requirements for
Electronic Health Record technology (RIN 0991-AB58).
Surescripts recently provided comments on the rules published by
the ONC that outline the initial set of standards, implementation
specifications, and certification criteria that ONC is establishing
for electronic health record (EHR) technologies that will support
the achievement of meaningful use Stage 1 by eligible professionals
and hospitals under the Medicare and Medicaid EHR Incentive
Programs established in the HITECH Act of 2009. Click here to
read the lettter to the ONC.
Interoperability
1. Surescripts comment on the PCAST Report Entitled "Realizing
the Full Potential of Health Information Technology to Improve
Healthcare for Americans: The Path Forward"
In general, Surescripts applauds the PCAST's effort to examine how
HIT could improve the quality of healthcare and reduce its cost, as
well as analyzing whether existing Federal efforts in HIT are
optimized for these goals. As a key national HIT participant,
Surescripts also agrees with the PCAST's conclusions about the
benefits of HIT, including improved access to patient data,
streamlined monitoring of public health patterns and trends, and
enhanced ability to conduct clinical trials. Much of what our
organization does on a daily basis supports these very
activities.
Click here to read the entire letter
New HITECH Privacy Provisions
1. Surescripts comments on proposed HITECH Privacy and Security Rule Modifications.
This letter is in response to the notice of proposed rulemaking (NPRM) that the Department of Health and Human Services (HHS) published in the Federal Register, Volume 75, Number 134, beginning on page 40868 on July 14, 2010. Surescripts appreciates the opportunity to comment on the proposal rules to implement certain provisions of the Health Information Technology for Economic and Clinical Health Act (HITECH) and applauds HHS and the Office of Civil Rights believing that many of the changes proposed represent significant and necessary steps towards ensuring accountability of actors in this evolving environment of health information technology.
2. 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.
Controlled Substances
E-Prescribing of Controlled Substances Regulatory Status by State
Click on the link below to review the regulatory status of e-prescribing for controlled substances in your state.
E-Prescribing Regulatory Status by State
Surescripts provides comments to the DEA regarding its Interim Final Rule on E-Prescribing for Controlled Substances
Surescripts applauds the publication of this groundbreaking Internal Final Rule (IFR), which we believe is a substantial step forward from the NPRM that the DEA published in the Federal Register in 2008. The requirements of this IFR are much more responsive to the needs and concerns of the health information technology (HIT) industry, and we strongly support said requirements. There is no question that the implementation of these requirements will enhance patient safety, strengthen fraud prevention, promote systemic efficiencies, and lower healthcare costs in the United States. It is our intent to leverage the expertise in e-prescribing that we have accumulated over the last eight years to assist prescribers, pharmacies, and their application vendors in fully complying with the IFR's requirements.
Click here to read the entire letter.
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
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
Surescripts comments on CMS' rule adopting 10.6 as a standard under the Medicare Modernization Act
Surescripts' role as the largest e-prescribing network in the U.S. places us in a unique position to provide CMS with real-world guidance with regard to the adoption of NCPDP SCRIPT Version 10.6 as a backward compatible update of the adopted NCPDP SCRIPT Version 8.1 for Medicare e-prescribing transactions as described in the Medicare Modernization Act of 2003 (MMA). In fact, Surescripts representatives testified before the National Committee on Vital and Health Statistics (NCVHS) on February 26, 2009 recommending that the Secretary adopt NCPDP SCRIPT 10.6 for MMA purposes as soon as practicable.
Having now reviewed this interim final rule with comment (IFC), we are pleased to share that we are in complete agreement with the changes adopted therein...
Click to read the entire letter.
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.
- 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.
- The SCRIPT standard is currently on Version 10 and has been implemented by all major physician and pharmacy software vendors.
- 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
- 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
- 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.
