April 28, 2014
Department of Health and Human Services
Office of the National Coordinator for Health Information Technology
Attention: 2015 Edition EHR Standards and Certification Criteria Proposed Rule
Hubert H. Humphrey Building
Suite 729D
200 Independence Avenue, S.W.
Washington, D.C. 20201
Submitted electronically via www.regulations.gov
RE: RIN 0991-AB92, Voluntary 2015 Edition Electronic Health Record (EHR)
Certification Criteria; Interoperability Updates and Regulatory Improvements
Dear Sir or Madam:
Prescriptions for a Healthy America (P4HA; www.adhereforhealth.org) is pleased to submit
comments on the 2015 Edition EHR Standards and Certification Criteria Proposed Rule. P4HA
is a multi-stakeholder alliance representing patients, consumers, providers, pharmacies,
pharmaceutical manufacturers, medication compliance packagers, technology companies and
employers. We came together to raise awareness on the growing challenges posed by medication
non-adherence, as well as to advance public policy solutions that will help reduce health care
costs and improve the lives of patients across the nation through medication adherence
interventions.
Medication adherence is when a patient takes their medications as prescribed, which includes
taking it according to the specific dosage, time, and frequency prescribed. A breakdown in any
one of these elements has the potential to result in unanticipated side effects and complications.
Despite this, studies show that:
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Half of all patients do not take their medications as prescribed;
Twenty percent of all new prescriptions go unfilled; and
Adherence is lowest among patients with chronic illnesses.
Poor medication adherence, or non-adherence, affects patient health by reducing the ability to
effectively manage and control chronic diseases. Non-adherent patients are more likely to
experience preventable disease progression, increased hospitalizations, doctor and emergency
room visits and other problems arising from poor health, which can significantly increase costs.
For example:
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At least 125,000 Americans die annually due to poor medication adherence;i
As adherence declines, emergency room visits increase by 17 percent and hospital stays
rise 10 percent among patients with diabetes, asthma, or gastric acid disorder;ii
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Poor medication adherence results in 33 to 69 percent of medication-related hospital
admissions in the United States, at a cost of roughly $100 billion per year;iii and
NEHI estimates that total potential savings from adherence and related disease
management could be $290 billion annually—13 percent of health spending. iv
The Medicare and Medicaid EHR incentive program (Meaningful Use (MU)) holds great
promise as a tool to advance medication adherence strategies. Various functionalities and
measures associated with MU can assist both providers and patients in improving medication
adherence. We urge the Department to focus more intently on the various aspects of Meaningful
Use, including changes in the 2015 Edition Proposed Rule, which might be applied to reducing
medication non-adherence. Doing so will help address the significant defects produced by nonadherence, including increased costs and poor health outcomes.
Our comments on the proposed rule are outlined below.
General Comments
The anticipated rapid advancement of new models of care and payment, and the evolution in
health information technology capabilities between now and 2017, when the Stage 3 standards
are due to take effect, calls for new capabilities for EHRs. The sooner these capabilities are
envisioned, created, tested, and deployed, the better. We applaud ONC for moving forward to fix
the known problems associated with the 2014 Edition in the proposed rule, which envisions a
market in which both the 2014 and 2015 editions of products will be available. These products
will not have the same certified functionalities, and we are concerned this may create confusion
among eligible providers. We believe ONC should fix the known problems in the 2014 Edition
and release the 2015 Edition as an iterative update that becomes the new mandatory certified
technology as a better way to mitigate against any confusion in the provider community.
Interoperability
Many elements of current health IT policy are already focused on medication-related tasks, both
directly and indirectly. However, bidirectional exchange and interoperability, especially in care
coordination models, remain under utilized. Stage 2 Meaningful Use standards are mostly
designed to improve the overall safety and therapeutic effectiveness of each patient’s medication
regimen (i.e. drug-drug interaction checks, medication reconciliation). Because successful
medication adherence strategies often require a team based approach and enhanced
communication between providers and patients and their caregivers, systems must be
interoperable to facilitate coordination and to maximally assist successful adherence
interventions.
Decoupling Transport and Data Standards
We are encouraged by the approach in the proposed rule that would decouple or untether the
transport standard from the data content standards in order to promote interoperability. This
change will help ensure flexibility in the transport of data based on a provider’s needs or
workflow, and will help facilitate information exchange. We would urge ONC to go further so
that developers may certify a product to use Direct or the alternative standards in the 2014
criteria (Direct+XDR/XDM and SOAP). Patients and their caregivers are given options in how
their health information will be sent to a third party in the View, Download, and Transmit (VDT)
criterion. We believe providers should be allowed similar flexibility in exchanging Transitions of
Care (ToC) documents with other providers.
Consuming Consolidated CDAs
We also support ONC’s proposal to add a performance score that would require EHR technology
to successfully electronically process validly formatted Consolidated CDAs no less than 95
percent of the time. ONC proposes to reference this performance standard as a capability that
must be demonstrated to meet the certification criteria of the 2015 Edition. This means that most
EHRs would be able to parse and consume data within a summary of care record. Practically, it
means most providers using certified EHR technology would have access to usable information
across a patient’s care team members related to medications and allergies, problems and care
plan. We believe such information is important to promote effective adherence interventions,
which is why we support the addition of the performance score.
Directory Services
For adults aged 65 or older, more than half see two or more prescribing physicians. Directory
services will thus be central in identifying and sending information to the various providers seen
by patients. The 2014 Edition includes a view-download-transmit (VDT) criterion that allows
patients and their caregivers to self-direct their health information to a subsequent provider. We
support ONC’s effort in the 2015 Edition NPRM to clarify that certified EHR technology must,
at a minimum, support the entry of a “Direct Address.” To make this functionality meaningful,
we urge ONC to require all MU providers to have a Direct address as a way to facilitate the
sharing of information related to medications, problems and care plans.
Coordination Across the Continuum of Prescribers
Enabling prescribers to check a patient’s formulary at the point of care is an important step
toward improving adherence as it provides an opportunity for additional dialogue between
prescriber, pharmacist and patient on the right drug for the right patient.
For this to work well, however, ONC should ensure EHRs include functionalities to enable these
capabilities, including those providers ineligible for MU incentives. Specifically:
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Medication history is necessary for obtaining an accurate picture of all of the prescription
medications a patient is taking;
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Formulary check is necessary to determine coverage levels for certain medications;
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Fill history can be used in combination with medication history to determine if a patient
initiates or continues to obtain their prescribed medications; and
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Electronic prior authorization to facilitate coverage.
Standards exist for all of these issues. ONC thus has an opportunity through the 2015 Edition to
foster solutions that enhancing electronic prescribing functionality to allow providers to have a
more holistic view of their patients’ medication use. We believe requiring available standards for
each of the above goals will increase patient awareness and will remove barriers to medication
adherence.
Medication History
Medication history is necessary for obtaining an accurate picture of all of the prescription
medications a patient is taking. ONC should certify EHRs for use of the NCPDP Medication
History standard (NCPDP SCRIPT Standard 10.6 ). CMS and the Health IT Standards
Committee have worked with NCPDP to update any of the standards associated with electronic
prescribing, and NCPDP has consistently convened stakeholders to comply. We suggest ONC
continue to use this process in enhancing the standards associated with medication history.
Fill History
Solutions to medication non-adherence do not stop at the point of prescribing. Information about
whether a patient has filled a prescription strengthens existing tools, such as medication history,
to ensure adherence and to tailor care-plans to fit individual needs. Pharmacists serve as a front
line resource in adherence strategies by ensuring that patients are receiving their prescribed
medications. While pharmacists remain outside of the Meaningful Use incentive structure, they
have been early adopters of health information technology to manage prescriptions, medication
history, and claims processing. For the information generated and gathered when a prescription
is filled to be valuable, data flow must be bi-directional. We recommend that ONC use the
opportunity in releasing the 2015 Edition to include the capacity to send a notification to the
prescriber when a prescription is filled at the pharmacy. If a prescription is unfilled, we suggest
EHRs should have the functionality to send patient reminders about the unfilled script to the
patient.
Formulary Check
ONC proposes to retain the 2014 Edition criteria for drug formulary checks, but is seeking
comment on options to certify real time checking. Physicians that have real-time access to
information related to a patient’s insurance coverage–including drug formularies–can
meaningfully engage the patient about medication options. As they prescribe a medication for
their patient, physicians and other prescribers may not know whether a particular drug is covered
by the patient’s insurance. If it is covered, they may be unaware of the tier and cost-sharing
requirements. NCPDP has developed a standard for formulary and billing (NCPDP Formulary
and Benefit Standard 3.0), which should be adopted as the new required standard for
certification. This standard was already adopted by CMS on December 13, 2013 as part of the
Physician Fee Schedule Final Rule. This standard is mature, has been balloted and accepted by
organizations across the prescribing continuum. We encourage ONC to continue to rely on and
work with NCPDP to upgrade the Formulary and Benefit Standard, as the best way to ensure
information on patient and drug specific variations in benefits is available at the point of
prescribing.
Additionally, as ONC continues to evaluate enabling real-time formulary and benefit checks, we
believe the Agency should also consider implementing certain protections to limit how personal
health information can be used to market products directly to providers and, in turn, to patients at
the point of care. We believe treatment suggestions should be based on clinical effectiveness and
peer-reviewed data, and not by price alone. We suggest ONC consider including requirements
that any alternatives offered to a provider upon querying a drug formulary be sourced so that a
clinician can objectively weigh the information being presented through his or her CEHRT.
Electronic Prior Authorization
Electronic Prior Authorization is yet another area that could positively affect primary adherence
rates. Considering the large number of American who may be changing health plans or gaining
health coverage for the first time as a result of the Affordable Care Act, out-of-pocket obligations
and co-payments for new or current prescriptions may change dramatically. Electronic prior
authorization allows prescribers to instantaneously request approval of coverage. This will
streamline operations and allow patients to access appropriate medications more rapidly.
Liquid Medication Dosing
We agree with ONC that switching to the metric standard for prescribing oral liquid medications
is necessary and should therefore be adopted via a certification standard.
Conclusion
Thank you for requesting comments on 2015 Certification Proposed Rule. We appreciate the
opportunity to comment and look forward to working with you to improve EHR functionality
that will advance medication adherence interventions. If you have any questions or would like to
discuss further, please do not hesitate to reach out to Joel White, Executive Director, the Council
for Affordable Health Coverage, at [email protected] or (202) 559-0192.
Sincerely,
Joel C. White
McCarthy, R., “The price you pay for the drug not taken.” Bus Health. 1998;16:27-28,30,32-33.
Goldman, D., "Pharmacy Benefits and the Use of Drugs by the Chronically Ill.”, Journal of the American Medical
Association, 19 May 2004.
iii Osterberg L., Blaschke T., “Adherence to medication.” N Engl J Med, 2005;353(5):487-497.
iv NEHI Research Brief, “Thinking Outside the Pillbox: A System-wide approach to Improving Patient Medication
Adherence for Chronic Disease.” NEHI, 2009.
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ii