RxHub and SureScripts Merge and the DEA Publishes Proposal for ePrescribing of Controlled Substances

by Tony Schueth, Editor-in-Chief

When it rains, it pours. Two of the biggest developments to hit the ePrescribing industry in many years just came to pass, and several major ePrescribing- and HIT-related publications, developed collaboratively by the industry and major stakeholders, were issued—all within days of each other.

RxHub and SureScripts Merge

The ePrescribing industry was rocked by the July 1 announcement of the merger between SureScripts and RxHub. Until a new name and branding strategy can be developed, the new company will go by SureScripts-RxHub, LLC.  The organizations will initially operate as separate divisions and retain their respective staffs and offices in Arlington, Virginia and St. Paul, Minnesota. The new organization will remain privately owned and continue to operate under a cost-recovery model as a low-cost health information utility.

For the short term, the new organization will be jointly managed by the acting CEO of RxHub, J.P. Little, and the acting CEO of SureScripts, Rick Ratliff. A nationwide search is under way to select a CEO, who should be named shortly. Our sources tell us Mr. Little and Mr. Ratliff are candidates for the position.  And they should be. They’ve both done a fine job of steering their respective ships after the departure of charismatic, successful leaders.

The merger was a cashless transaction and ownership will be a 50/50 split between SureScripts’ owners (NACDS and NCPA) and RxHub’s owners (CVS Caremark, Express Scripts and Medco Health Solutions). The new six-member board includes a single director each from CVS/Caremark, Express Scripts, Medco Health Solutions, NACDS and NCPA.  The sixth member of the board is designated by NACDS and NCPA. John Driscoll, president, Insured & Emerging Markets, Medco Health Solutions, Inc., and Bruce Roberts, executive vice president and CEO, NCPA, will serve as co-chairmen of the board of directors through 2009. The co-chairmanship will then rotate on an annual basis to include one co-chair representing PBMs and the other co-chair representing retail pharmacies.

Will this merger be good for ePrescribing? We believe the answer is yes! Merging these two organizations removes the barrier of dual certifications for EHRs and ePrescribing companies and creates one “go-to” organization for those interested in getting involved in ePrescribing. This is the merger of two powerhouses, each with its own strengths and weaknesses. With the right leadership, the whole should be much greater than the sum of its parts.

That said, our clients include employers, health plans, pharmacy benefit managers, technology companies, pharmaceutical manufacturers, federal and state governments, connectivity companies, content companies and coalitions of ePrescribing stakeholders. For each of them, the answer to what it means is a bit more complex, depending on the respective circumstances.  Their reactions range from delightment to, well, acceptance.

There are pockets of stakeholders who are concerned about price and service, as little competition is left. RxHub was providing access to retail pharmacy through a strategic partnership and SureScripts was venturing into the eligibility/formulary/medication history world. We suspect that SureScripts-RxHub will be as cognizant of these concerns as they were as competing entities, mitigating any formal complaints that could invite scrutiny.

In summary, we believe the benefits of removing a barrier far outweigh any concerns at this juncture. After all, ePrescribing is still in its infancy, really, with just 6% of prescribers writing electronic prescriptions and 2% of scripts flowing electronically. There are still barriers to overcome, but one has just been addressed.

DEA Issues Proposed Regulation to Allow ePrescribing for Controlled Substances

Another barrier is the inability of electronic prescribers to transmit scripts for controlled substances electronically. Progress was made since our last issue, as the second big announcement was the Drug Enforcement Agency’s (DEA) long-awaited Notice of Proposed Rulemaking (NPRM) on ePrescribing for controlled substances, which was published in the June 27 Federal Register (http://edocket.access.gpo.gov/2008/pdf/E8-14405.pdf). POCP has been tracking this issue for quite some time and has been advising clients that the ETA on the regulation was in mid-June. Give us a call or drop us an e-mail if you need help interpreting the DEA’s proposed rule and advice on comments and how the next steps will play out.

To be sure, we are nowhere near as excited about this event as the SureScripts-RxHub merger. Despite numerous attempts by the industry over the better part of five years to educate the DEA on ePrescribing and inform the development of the NPRM, its outcome remained pretty much a foregone conclusion. DEA stuck to its guns to make ePrescribing for controlled substances far more difficult, costly and time consuming than what is required today for ePrescribing of noncontrolled substances in our inefficient and insecure paper world. The DEA claims that its laundry list of proposed requirements are needed to protect against internal risks—prescribers, employees and other internal sources―who are viewed as bigger threats than hackers to use ePrescribing to divert controlled substances for illegal uses.

The NPRM proposes separate requirements for ePrescribers in federal facilities, such as VA hospitals, and all other prescribers. For the latter group, the DEA would require, among other things:

• An independent, in-person verification of the individual prescriber’s identity at designated hospitals, state licensing boards or state or local law enforcement agency. The prescriber would then provide proof of the identity authentication to the technology vendor before being allowed access to the ePrescribing system.
• Two-factor authentication would be needed for the prescriber to create the prescription, with one factor stored on a hard token, such as a thumb drive or smart card, or using a one-time password that would be used for each prescription written. A separate “key” would be needed for each DEA number associated with the prescriber, all of which potentially could be stored in one place, such as on a thumb drive.
• Practitioners must sign in if they are inactive on the system for more than two minutes.
• If a practitioner is licensed in more than one state, that practitioner must have a separate authentication protocol for each state in which he or she prescribes.
• Prescriptions must be digitally signed.
• Prescriptions cannot be printed and/or faxed; they must be sent electronically.
• A monthly log must be generated by the prescribing technology, which prescribers would be required to check for “obvious anomalies.” Prescribers must indicated they have received and reviewed the log.

The NPRM also proposes requirements on pharmacies, including:

• Verification of the prescriber’s DEA number before the prescription can be filled.
• Ability to accept digitally signed ePrescriptions.
• Creation of an internal audit trail.
•  A third-party security and processing integrity audit before the pharmacy starts receiving ePrescriptions for controlled substances and annually thereafter.

Other proposed requirements include:

• Five-year records retention for prescribers and pharmacies.

• Potential changes in the NCPDP SCRIPT standard to tighten the inability to tamper with the prescription after signing and to capture and report the e-signature.

Whether you agree or disagree with the DEA’s proposal, the important thing now is to submit your written comments before the September 25 deadline. We cannot stress enough that it is imperative to make sure your comments are very detailed and track directly to specific portions of the NPRM. The DEA has told the Department of Health and Human Services (HHS) that there are no data to back up assertions that the ePrescribing industry already has sufficiently strong authentication and nonrepudiation technologies, processes and practices in place. Now is the time to provide the specific information that addresses each point at the appropriately referenced section of the NPRM, as well as your reaction to workflow changes, costs and other potential issues that would arise if the DEA’s proposal is adopted. The level of specificity and detail will be key in making sure that the final rule—based on the comments received―is workable and scalable in our current environment and for years to come.

Reaction to the proposed rule has not yet filtered out; as of publication, most of us are still digesting the rule. We expect many industry segments, particularly prescribers, will have a lot to say. We also expect the industry will be working together to coordinate comments. Stay tuned.

New Publications Hit the Streets

June also was bustin’ out all over with important publications. They represent a new era in ePrescribing and health information technology (HIT), marked by collaborative efforts by a wide range of stakeholders. This plus the merger of RxHub and SureScripts signal what we believe to be the beginning of market consolidation and shakeout in the industry.

The eHealth Initiative and the Center for Improving Medication Management released an update on the state of ePrescribing on June 11. Their roadmap includes a detailed assessment of progress to date, barriers that remain and recommendations for ways to accelerate ePrescribing adoption. Two guides for ePrescribing also were issued, one aimed at payers and the other for consumers. The collaborative also announced it is developing a detailed, “practical” guide for prescribers, with input from  some of America’s leading medical societies, including the American Academy of Family Physicians (AAFP), the American College of Physicians(ACP), the American Medical Association (AMA), and the Medical Group Management Association (MGMA). Details are on the eHI web site, www.ehealthinitiative.org.

The Center for Health Transformation issued a white paper on ePrescribing on June 10 ( http://www.healthtransformation.net/cs/CHTwhitepapers). Also an assessment of the state of ePrescribing, it includes a foreword by Newt Gingrich and Sen. John Kerry, examples of best practices and recommendations to overcome barriers to adoption. The report was written collaboratively by CHT members, including AllScripts, AHA, AMA, AMGA, Availity, Blue Cross/Blue Shield Association, Covisint, Chrysler, HCA, MicroSoft, PCMA,  RxHub, SureScripts, UnitedHealthcare, WellPointand Zix.

Finally, Connecting for Health released its "Common Framework for Networked Personal Health Information" on June 25 (www.connectingforhealth.org/phti). It includes four overviews and 14 specific technology and policy approaches for consumers to access health services, to obtain and control copies of health information about them, to authorize the sharing of their information with others, and sound privacy and security practices. The report was endorsed by a wide range of industry and consumer groups, reflecting a national interest in a common PHR standard, as well as ways to provide enhanced privacy, security and consumer control of information.  Groups okaying the report include AARP, Aetna, AAFP, AHIP, BlueCross/BlueShield Association, Consumers Union, Dossia, Google, Intuit, Microsoft, National Breast Cancer Coalition, National Partnership for Women and Families, Partners Healthcare System, RxHub, SureScripts, the VA and WebMD.

Odds and Ends … We’re still tracking a bill in Congress that would “mandate” ePrescribing. It’s actually a bill that would authorize incentive payments for physicians who prescribe electronically to offset physician fee cuts.  The House version passed on June 24. Word is this should be addressed after the July 4 recess. … During an American Health Insurance Plans Institute roundtable on June 20, former Secretary of Health and Human Services Tommy Thompson suggested that insurers pay more for electronic prescriptions than paper. To accomplish that, payers would have to know in the claim whether the prescription was received electronically or not. In the June 4 issue of HIT Perspectives, we noted that efforts are under way to make sure that happens. … At the same conference, Charles Kennedy, MD, vice president of HIT at WellPoint, pointed out that ePrescribing could be the starting point for health information exchanges. We agree. In fact, in May 2005, I wrote an article for Healthcare IT News making a similar point: http://www.pocp.com/HIT.aspx. ... On June 18, the American Medical Association (AMA) House of Delegates voted for a resolution to support ending barriers to ePrescribing, and that it not be mandatory. … On May 23, a group of ePrescribing stakeholders sent a letter to Congress arguing that the current state of ePrescribing standards is not a barrier to ePrescribing, as the AMA had argued a few weeks earlier. We wholeheartedly agree, and had tried to make this point to AMA executives in Washington in April. … Highmark is back on track to distributing the $29 million for ePrescribing grants. In 2005, this was big news but the program got stalled, reportedly because of the Internal Revenue Service. According to a June 6 article in the Pittsburgh Business Times, this program is back on track and will distribute the money directly from Highmark to physicians or institutions. … On May 29, GE Healthcare announced it will market eScript Messenger by Kryptiq with its Centricity ambulatory electronic medical record product. … In May, Arizona Governor Janet Napolitano issued an executive order directing state agencies to work with the Arizona Health e-Connection Initiative, health plans and providers to increase the use of electronic prescribing and other medication safety tools.

Disease Registries: Leveraging Technology to Manage Chronic Conditions and Meet P4P Needs

by Michael Solomon, Executive Editor

As the dimensions of the chronic disease epidemic continue to be documented, interest grows in how health information technology (HIT) can help manage the range of chronic healthcare conditions and their related costs. Late last month, the Centers for Disease Control and Prevention (CDC) announced that nearly 24 million Americans had diabetes in 2007, up by more than 3 million since 2005. This means that nearly 8% of the US population has the disease. The majority have type 2 diabetes, which is linked to obesity and sedentary living. The CDC also reported that roughly two-thirds of American adults are obese, costing US employers $45 billion annually, according to research also published late last month by the Conference Board and RTI International.  This is significant because of the link between obesity and chronic diseases. Furthermore, almost 10% of Americans live every day with asthma. Research shows that asthma and diabetes health outcomes improve when patients have regular medical checkups and adopt diet, exercise and medication regimens.
 
How can HIT help? One possibility is using computerized disease registries to manage individuals with one or more chronic conditions. Upon first hearing the term, you probably think of hospital-based systems containing data about patients with a specific type of disease who is being diagnosed or treated by the facility or large-scale registries that are used to track specific diseases, such as cancer, or those that address population health issues, such as vaccination. 
 
However, electronic disease registries—electronically linked lists of patients, their demographic, clinical information and conditions, the preventive and other services they have received, and their results—can lower costs and improve the quality of chronic care management in solo and small practices, clinics and larger group practices. This is because disease registries can remind physicians about whom patients need what care and can efficiently enable them to proactively help patients get the services they need. Disease registries can also help practices meet pay-for-performance requirements and document performance for quality bonuses.
 
Most importantly, electronic disease registries represent a key structural IT component for the patient-centered medical home, which is gaining momentum as a model for chronic care management [See the June 4, 2008 issue of HIT Perspectives for a discussion of how the patient-centered medical home may be a catalyst for HIT adoption.]
 
Practice-level disease registry functionality is expanding. A few electronic health record (EHR) systems offer it. There are also a number of stand-alone systems. In a 2004 report, the California Healthcare Foundation listed a number of stand-alone disease registry offerings. Although the vendor listing is somewhat dated, the report offers useful insights into issues that might be considered when making an informed purchasing decision.
 
Even cash-strapped practices can implement disease registries. The Medicare Quality Improvement Organizations may offer free or low-cost software. Do-it-yourselfers can create a basic disease registry with spreadsheet software they already have on their computer. David Ortiz, MD, of the American Academy of Family Practice, explained how to set up a disease registry from scratch using Microsoft Excel. Although his registry is aimed at diabetes management, the principles for setting up the spread sheet can apply to just about any condition. [See http://www.aafp.org/fpm/20060400/47usin.html.]
 
Assisting physicians—especially primary care providers—in coordinating the care of their patients with chronic medical conditions is a vital part of any program for improving the quality of our health care system. An IT-based disease registry, either as a prelude to a comprehensive EHR system or to complement one that has already been implemented, can deliver immediate and significant value to both patients and the providers caring for them. Offering a disease registry solution should be a key strategic priority of sponsors of quality improvement and pay-for-performance programs, along with their EHR vendor partners. 
 

Odds and ends: The much anticipated results from the survey on Physician EMR adoption conducted by the Institute of Health Policy for ONCHIT have been published (New England Journal of Medicine, June 2008). While the results affirm what we already know—that 14% to 20% of doctors in the US are using EMRs—this study is an important step forward for at least three reasons. First, the rigor of the study design makes this a definitive snapshot of where we are (and the long slog ahead). Second, it stratifies physician adopters by the extent of capabilities being used. Based on the researchers’ definition of an EMR, only 4% of physicians are using a comprehensive EMR. Lastly, this 4% are experiencing significant benefits by using EMR, including improved quality of clinical decision, reduction in medical errors and improved refill process management….Blue Cross Blue Shield of Massachusetts is the first of what we anticipate will be a stream of health plan payers to support the importing of their members’ claims data into the Google PHR. Microsoft’s HealthVault—designed from the ground up to be a repository, utility type of PHR capturing data from multiple sources—should also see several payer-based health record suppliers announcing support for its PHR. The question still remains, however…if suppliers of personal health information make these data available in a portable PHR, will consumers come? (See the March 2008 issue of HIT Perspectives for more about this.)  …The AHIP Board of Directors has published a set of eight core principles that are integral to advancement of the patient-centered medical home. Principle #3 is all about HIT, stating that adopting patient registries, decision support tools and electronic prescribing by the medical practice is critical to success.