HHS has restored some of the balance between privacy protection and healthcare quality in its patient privacy regulations, but hospital finances and care delivery still will suffer unless authorities go further than they did in a recent release of regulatory "guidance."
That's the American Hospital Association's stance on HHS' initial attempt to clarify common problems providers raised in regards to a 1,500-page privacy rule released late last year.
"It's definitely a step forward in terms of the (Bush) administration trying to make these ridiculously arcane rules applicable to the healthcare providers who need to implement them," said Melinda Hatton, the AHA's Washington counsel.
In the HHS correspondence dated July 6, regulators sought to ensure hospitals that their healthcare professionals have considerable latitude to disclose and share information about patients for purposes of treatment, payment and healthcare operations under a privacy-rule requirement that they obtain written consent from patients before disclosing personal information (July 9, p. 6).
HHS also specified that providers can rely on established policies and professional judgment to determine who's eligible to see certain personal information for a particular purpose instead of ruling case by case on a requirement that only the "minimum necessary" information be disclosed to accomplish treatment or essential tasks.
However, guidance on regulating oral communication among clinicians remains vague enough to have a chilling effect on essential information sharing, Hatton said. "Caregivers need to be talking more to each other and to patients, not less," she said, expressing a concern underscored by the Institute of Medicine in its recommendations for avoiding medical errors. The restriction "runs counter to everything we've heard in the field of quality."
HHS didn't address the cost of a requirement that providers renegotiate contracts with every one of their business partners to gain their agreement not to disclose protected health information. Those contracts could number into the hundreds per provider, which Hatton called "a tremendous waste of time. There's got to be a simpler way."
The privacy regulations, which implement part of the Health Insurance Portability and Accountability Act of 1996, have been roundly criticized within the healthcare industry as too burdensome. AHA President Richard Davidson called them "unworkable for patients and caregivers," and industry groups lobbied to suspend the April 14 effective date of the regulations until concerns about cost and barriers to care could be resolved (April 2, p. 9).
But HHS Secretary Tommy Thompson elected not to intervene, despite the more than 11,000 public comments he received during a 30-day comment period preceding the final effective date. Instead, HHS said it would issue a series of guidance missives to clarify key provisions of the privacy regulations as part of an ongoing process to help providers and health plans comply by a statutory deadline of April 14, 2003.
Among the clarifications:
* Information disclosure for treatment purposes is "explicitly exempted" from the regulations on "minimum necessary" sharing of medical details. Healthcare professionals had worried that the regulations would impede care delivery by preventing or hindering necessary exchanges of patient information among providers involved in treatment.
* The "minimum necessary" can encompass the patient's entire record as needed, as long as policies and procedures explicitly state the instances that call for such disclosure and include justification.
* A patient's written consent need be obtained only once by a provider directly involved in the patient's treatment. That provider can freely consult with other providers without gaining the patient's additional consent.
* Healthcare professionals do not have to gain prior consent to request or disclose patient information in an emergency situation, and providers can rely on their own reasonable judgment of what constitutes an emergency.
HHS also acknowledged that the regulations created several unintended consequences for quality patient care and said it would propose corrections (See chart).
To the dismay of the AHA, the guidance document reaffirmed the intent of HHS to include oral communications among the regulated information disclosures, including discussions among healthcare professionals in offices, nursing stations and treatment areas.