The fast-tracked NHIN Direct project aims to enable clinicians to perform one-to-one exchanges of patient information. Exchanging information with electronic health-record systems to improve patient care is a statutory requirement clinicians must achieve to qualify for federal EHR subsidy payments under the meaningful-use provisions of the stimulus law.
Malec said the ONC foresees an inevitable transition by clinicians in which such simple modes of transaction “will end up getting replaced by more robust forms of transactions.” NHIN Direct will address those early, simpler transactions such as electronically sending a referral or a care summary from one physician to another.
Malec said work is well under way on NHIN Direct, with dozens of organizations participating in its development, including a few health IT system vendors, 11 state and local health information exchange organizations, two electronic prescribing exchanges, the Veterans Affairs Department, the Social Security Administration and the National Institutes of Health.
But the ONC had not done a good job of coordinating its NHIN Direct efforts with the HIT Standards Committee, according to one of its members, Dixie Baker, who also serves as chairwoman of that committee's workgroup on privacy and security.
“I've never heard of any of this,” Baker said. In fact, Baker said, the privacy and security workgroup spent a good part of its meeting last week on a discussion of point-to-point exchange and the NHIN, and recommended that the workgroup's effort “needs to be better tied to this project” with NHIN Direct.
“The timelines are out of whack,” Baker said. “This is way farther along, or sounds like it, than the discussions we've been having in our workgroup.”
“I would agree to that and apologize for the oversight,” said Malec, adding by way of explanation that his group has been focused on getting the NHIN Direct project developed under tight deadlines. The hope is to have it tested and ready for EHR vendors and users by October. That's the start of the first “payment year” for what is expected to be the main EHR incentive plan operating under the Medicare portion of the stimulus law subsidy program.
According to a top ONC official, the ONC did a better job coordinating with the Drug Enforcement Administration, which on March 31 released its interim final rule governing electronic prescribing and controlled substances. The effective date of the DEA rule is June 1 this year, the same day that the public comment period on the rule closes.
Timing by the DEA was “perfect,” said Jodi Daniel, director of the office of policy and planning at the ONC. “The DEA regulations have come out at the same time that we're working through our regulations and we came out with our final rules for our standards and certification criteria.”
HHS worked closely with the DEA in developing the rule, Daniel said. “It led to a rule that we feel we could support and is a very good rule for this space.”
“We knew some people could not adopt because they were high-prescribers of controlled substances,” she said. Others who prescribed far fewer controlled drugs wouldn't switch to e-prescribing because they didn't want the hassle of maintaining both paper and electronic prescription records, Daniel said.
Michelle Ferritto, chief of the regulatory drafting unit of the Office of Diversion Control at the DEA, told the committee the new e-prescribing rule covers Schedule II, III, IV and V medications, all of the controlled drugs “that have legitimate use in practices.”
The rule provides DEA-approved practitioners with the option of signing and transmitting electronically prescriptions for all of these drugs, but does not require them to use e-prescribing for these prescriptions.
E-prescribing software application providers must evaluate their applications and reprogram them where necessary to accommodate the new rule, Ferritto said. That includes submitting the applications to third-party audit or certification to determine whether the systems meet DEA requirements, she said.
Pharmacy and provider e-prescribing systems must be able to maintain audit trails on all prescriptions of controlled substances and be able to produce daily audit reports in a human readable format as well as lists of all schedule drugs prescribed, Ferritto said.
One wrinkle about the new rule, Ferritto explained, is that it disallows computer-generated and authenticated prescriptions to be converted to a fax.
The prescription has to remain in its electronic form from end to end, Ferritto said. Converting it to a fax “would make it illegal.”
It remains legal to manually sign and fax a prescription for schedule drugs, Ferritto said. But creating a prescription on a computer with a digital signature and then faxing it via computer without a manual signature, Ferritto said, would “turn that into an unsigned prescription; it would invalidate the prescription.”
That wrinkle could pose a problem, said Kevin Hutchinson, an HIT Standards Committee member and the president and CEO of Prematics, McLean, Va., a provider of electronic prescribing services primarily for office-based physicians.
Hutchinson is the former CEO of Surescripts, an electronic prescription exchange service owned by two pharmacy trade groups and the three major pharmacy benefits management companies.
At Surescripts, Hutchinson led a pharmacy industry campaign to bring the DEA around to allowing e-prescribing for scheduled drugs, telling Ferritto at the meeting he had been waiting for years for this day to arrive.
Still, Hutchinson questioned the DEA position to disallow computer-generated fax transmissions for prescriptions of scheduled drugs.
“I think that's going to be a little bit disruptive in the process,” Hutchinson said. “I think it's going to create issues with the physicians.”
Prescriptions created by the provider's software could be printed out and signed by a physician and then faxed to the pharmacy, but “they will be sending it to the very same fax machine,” Hutchinson said.