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April 17, 2005
MMA and ePrescribing - New Compliance Standards for eHealth
Food and Drug
March 2005; Volume 2 Issue 1
In this Issue...
- Appellate Court Rejects FTC Challenge to Patent Settlements
- MMA and ePrescribing - New Compliance Standards for eHealth
- Analysis & Perspective: Lessons Learned - A Practical Guide in Case Management for Mass Tort Practitioners
- FDA to Act on “Titillating” Drug Ads?
MMA and ePrescribing - New Compliance Standards for eHealth
| Shannon Hartsfield Tallahassee |
In the health care industry, eHealth and the role of electronic communication in the provision of health services are once again becoming hot topics. In early 2005, the Department of Health and Human Services (HHS) sought input regarding the development of a national health information network. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule, requiring standards to maintain the integrity and security of electronic protected health information, becomes enforceable in April of 2005. HHS is bringing eHealth to the forefront even more by publishing proposed rules which would adopt standards for electronic prescriptions, or "ePrescribing," under Title I of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA). The ePrescribing rules, once finalized, will impact the pharmaceutical industry as we move toward a national electronic health infrastructure.
HHS published the proposed rules on February 4, and, to be assured consideration, comments had to be submitted by April 5, 2005. HHS is working quickly to finalize the rules, and is actively seeking input from various industry segments.
MMA provides for coverage of drugs under Medicare Part D. The drug benefit is scheduled to begin in 2006. Section 101 of MMA, among other things, requires that electronic prescriptions for covered Part D drugs prescribed for beneficiaries eligible under Part D comply with uniform standards. Providers are not required to write electronic prescriptions, but sponsors that participate in Part D are required to comply with the ePrescribing standards and have the capability to support electronic transmissions of prescriptions.
HHS is required to promulgate two sets of standards: initial standards and final standards. Initial standards to be used in a 2006 pilot project must be adopted by September 1, 2005. Pilot testing is not required, however, for standards for which there is "adequate industry experience." After the pilot project, HHS must promulgate final uniform standards by April 1, 2008, and they will become effective no more than one year later. A report to Congress on the pilot project is due by April 1, 2007. In its proposed regulation, HHS sets forth "foundation standards" that, in its view, do not need to be pilot tested because they meet the criteria for adequate industry experience.
The proposed rules contain definitions of various terms associated with ePrescribing. For example, "ePrescribing" is defined as "the transmission, using electronic media, of prescription or prescription-related information between a prescriber, dispenser, pharmacy benefit manager, or health plan, either directly or through an intermediary, including an ePrescribing network." Part D sponsors, prescribers and dispensers must comply with the applicable standards, once finalized. A "dispenser" is a person or entity licensed, registered or otherwise permitted to provide drug products for human use by prescription in the course of professional practice. A "prescriber" includes a physician, dentist, or other person licensed, registered, or otherwise permitted by the U.S. or the jurisdiction in which he or she practices to issue prescriptions for drugs for human use. The rule proposes standards for electronic prescriptions and eligibility inquiries. The proposed compliance deadline for the foundation standards is January 1, 2006, which is also the day when entities begin participation in the Medicare Prescription Drug Program.
MMA requires the Secretary of HHS to promulgate an anti-kickback statute safe harbor and an exception under the Stark legislation for certain nonmonetary remuneration relating to ePrescribing information technology items and services. The safe harbor and the exception will be proposed separately.
HHS has solicited a number of comments on the proposed rules. For example, HHS has asked for input on how to determine when the standards must be used. HIPAA defines electronic media to include both electronic storage media and transmission media. HHS is asking for comments on how to determine when prescribers and dispensers are transmitting prescription information electronically in a manner that must comply with the standards.
State law preemption is also a particular challenge. The MMA provides that the standards:
shall supercede any State law or regulation that –
(A) Is contrary to the standards or restricts the ability to carry out this part; and
(B) Pertains to the electronic transmission of medication history and of information on eligibility, benefits, and prescriptions with respect to covered part D drugs under this part.
HHS has proposed to interpret this as preempting state laws that conflict with federal ePrescribing requirements that are adopted under Part D. The state law would have to meet the requirements of both paragraph A and B above, and the state provision would have to conflict with a specific federal standard adopted through rulemaking. The preamble to the proposed rules states that some industry representatives believe that HHS' interpretation is too narrow and that Congress intended the ePrescribing provisions to preempt any state law that would restrict ePrescribing for all providers and payors in any way.
HHS has also solicited comments on whether Part D plans should be required to use the ePrescribing standards for transactions within the corporate enterprise. The HIPAA Transactions Rule states that, if a covered entity conducts a covered transaction electronically within the same covered entity, it must use the transaction standards. HHS has asked for comments regarding the advantage, disadvantages and implications associated with excluding internal transactions from the ePrescribing standards.
As eHealth's role becomes more significant, there are myriad legal issues that the health care industry must address. In light of the fact that, according to the Agency for Healthcare Research and Quality, more than three billion prescriptions are written and 65 percent of the population use prescription medications in the United States each year, ePrescribing standards could impact our health care system dramatically. National standards for ePrescribing are an important step in that process, and stakeholders in the ePrescribing process, including pharmacy benefit managers, pharmaceutical manufacturers and vendors, physicians, pharmacies and pharmacists, should monitor the MMA ePrescribing rules and related state legislation and advocate for rules that will promote an efficient and effective eHealth infrastructure.
For more information, e-mail Shannon Hartsfield at shannon.hartsfield@hklaw.com or call toll free, 1-888-688-8500.
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