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HIPAA Final Rule
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The federal government has published its final regulations implementing the "Health Information Technology for Economic and Clinical Health (HITECH) Act,” part of the "American Recovery and Reinvestment Act of 2009” (ARRA), described by the head of the Office for Civil Rights (OCR) in the Department of Health and Human Services (HHS) as "the most sweeping changes to the HIPAA Privacy and Security Rules since they were first implemented.” The new rules expand the obligations of doctors of chiropractic to protect patients’ protected health information (PHI), extend these obligations to business associates who have access to PHI and increase the penalties for violations of any of these obligations. The following outlines the changes physicians will need to consider as they implement the new HIPAA requirements necessary by the September 23, 2013, compliance date.  

The new rules affect the following:

Privacy and Security Policies and Procedures The new rules will require changes to a chiropractic practice’s HIPAA policies and procedures in at least the following areas:

Breach notification requirements – The obligation to notify patients if there is a breach of their PHI is expanded and clarified under the new rules. Breaches are now presumed reportable unless, after completing a risk analysis applying four factors, it is determined that there is a "low probability of PHI compromise.” The physicians must consider all of the following four factors: the nature and extent of the PHI involved – including the sensitivity of the information from a financial or clinical perspective and the likelihood the information can be re-identified; the person who obtained the unauthorized access and whether that person has an independent obligation to protect the confidentiality of the information; whether the PHI was actually acquired or accessed, determined after conducting a forensic analysis; and, the extent to which the risk has been mitigated, such as by obtaining a signed confidentiality agreement from the recipient. This rebuttable presumption of breach and four factor assessment of the "risk of PHI compromise” replaces the previous, more subjective "significant risk of financial, reputational or other harm” analysis for establishing a breach.

The new rules further clarify that an independent entity does not need to conduct the risk assessment and, no risk assessment need be conducted at all if the breach notification is made (although D.C.s will want to undertake an appropriate review and steps to mitigate the harm and reduce the likelihood of future breaches in any case). The new rules further confirm that the breach notification requirement may be delegated to a Business Associate (B.A.), and D.C.s are encouraged to coordinate with their B.A.s so that patients receive only one notification of the breach.

The new rules do not modify the actual reporting and time frame requirements for Breach Notification; that is, covered entities must still adhere to requirements for individual notification, HHS notification, and where applicable, media posting of the breach.

Disclosures to health plans – At the patient’s request, doctors of chiropractic may not disclose information about care the patient has paid for out-of-pocket to health plans, unless for treatment purposes or in the rare event the disclosure is required by law. This change updates the previous HIPAA Privacy Rule governing patient requests for restrictions on the use or disclosure of their PHI. Previously, while D.C.s could refuse to abide by any such request, the new rule requires D.C.s to abide by a patient’s request not to disclose PHI to a health plan for those services for which the patient has paid for and requests the restriction. Of all the changes made by the new rules, this change is likely to have the greatest impact on D.C. practice workflow both in terms of documentation and follow up to ensure the restriction is adhered to.

Marketing communications – The new rules further limit the circumstances when D.C.s may provide marketing communications to their patients in the absence of the patient’s written authorization. Generally speaking, the only time a D.C. may tell a patient about a third-party’s product or service without the patient’s written authorization is when:

1) the D.C. receives no compensation for the communication;

2) the communication is face-to-face;

3) the communication involves a drug or biologic the patient is currently being prescribed and the payment is limited to reasonable reimbursement of the costs of the communication (no profit);

4) the communication involves general health promotion, rather than the promotion of a specific product or service; or

5) the communication involves government or government-sponsored programs. D.C.s are also still permitted to give patients promotional gifts of nominal value (e.g., pamphlet).

Sale of PHI – The new rules clarify that the prohibition on the sale of PHI in the absence of the patient’s written authorization extends to licenses or lease agreements, and to the receipt of financial or in-kind benefits. It also includes disclosures in conjunction with research if the remuneration received includes any profit margin. On the other hand, the prohibition on PHI sales does not extend to permitted disclosures for payment or treatment nor to permitted disclosures to patients or their designees in exchange for a reasonable cost-based fee.

Decedents – The new rules allow D.C.s to make relevant disclosures to the deceased’s family and friends under essentially the same circumstances such disclosures were permitted when the patient was alive; that is, when these individuals were involved in providing care or payment for care and the physician is unaware of any expressed preference to the contrary. The new rule also eliminates any HIPAA protection for PHI 50 years after a patient’s death.

Copies of e-PHI – D.C.s will now have only 30 days to respond to a patient’s written request for his or her PHI with one 30-day extension, regardless of where the records are kept (eliminating the longer 60-day timeframe for records maintained offsite). They must provide access to EHR and other electronic records in the electronic form and format requested by the individual if the records are "readily reproducible” in that format. Otherwise, they must provide the records in another mutually agreeable electronic format. Hard copies are permitted only when the individual rejects all readily reproducible e-formats.

Emailing PHI – D.C.s must also consider transmission security, and may send PHI in unencrypted emails only if the requesting individual is advised of the risk and still requests that form of transmission.

Charging for copies of e-PHI or PHI – The new rules modify the costs that may be charged to the individual for copies to include labor costs (potentially to include skilled technical labor costs for extracting electronic PHI and supply costs if the patient requests a paper copy, or if electronic, the cost of any portable media (such as a USB memory stick or a CD)), assuming state law does not set a lower reimbursement rate. The rules also clarify that D.C.s may impose a separate charge for creating an affidavit of completeness.

Research authorizations – The new rules permit D.C.s to combine conditioned and unconditioned authorizations for research participation, provided individuals can opt-in to the unconditioned research activity. Moreover, these authorizations may encompass future research.

Notice of Privacy Practices (NPP) – D.C.s must amend their NPPs to reflect the changes set forth above, including those related to breach notification, disclosures to health plans and marketing and sale of PHI. To the extent D.C.s engage in fundraising, they will also have to amend their NPP to inform patients of their right to opt-out of those communications. As the rules presume these are all material changes, D.C.s will have to post the revised NPP, and make copies available at their office, to all new patients and to anyone else on request. D.C.s who maintain a Web site are cautioned to post the updated NPP as required by the existing HIPAA Privacy rule. The new rules also eliminate requirements to include information on communications concerning appointment reminders, treatment alternatives or health-related benefits or services in NPPs, but the rules do not require that that information be removed either.

Business Associates (B.A.s) The new rules expand the universe of individuals and companies that must be treated as business associates to include Patient Safety Organizations and others involved in patient safety activities, health information organizations like health information exchanges that transmit and maintain PHI and personal health record vendors D.C.s sponsor for their patients. Thus, D.C.s must review their relationships and determine if they must enter new B.A. agreements with these entities or others that create, receive, store, maintain or transmit PHI on their behalf. These rules also modify the requirements for B.A. agreements: Physicians no longer must report failures of their B.A.s to the government when termination of the agreement is not feasible, as HHS has concluded that the B.A.’s direct liability for these violations is sufficient.B.A.s are now responsible for their subcontractors. B.A.s must comply with the Security and Breach Notification Rules.D.C.s are liable for the actions of their B.A.s who are agents, but not for the actions of those BAs that are independent contractors.D.C.s have until September 23, 2014, to bring all their B.A. agreements into conformance with the new rules.

B.A. agreements that have not been renewed or modified between March 26, 2013, and September 23, 2013, will be deemed compliant until the date the B.A. agreement is renewed or modified or until September 22, 2014, whichever is earlier.  

Enforcement and Penalties The new rules clarify the four penalty tiers as follows:

Lowest tier – cases in which the D.C. did not and reasonably could not know of the breach.

Intermediate tier – cases in which the D.C. "knew, or by exercising reasonable diligence would have known” of the violation, but the physician did not act with willful neglect.

Highest tiers – cases in which the D.C. "acted with willful neglect” and either corrected the problem within the 30-day cure period, or failed to make a timely correction. HHS must conduct a formal investigation and impose civil monetary penalties in cases involving willful neglect, and is now free to provide PHI to other government agencies for enforcement activities.

The assessment of penalties must be based on five principal factors:

(1) the nature and extent of the violation, including the number of individuals affected;

(2) the nature and extent of the harm resulting from the violation, including reputational harm;

(3) the history and extent of prior compliance;

(4) the financial condition of the covered entity or business associate; and

(5) such other matters as justice may require.

The number of violations may be based on the number of individuals affected or by the number of days of non-compliance. The rule further clarifies that the 30-day cure period begins when the D.C. knew or should have known of the violation.

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3/4/2017 » 10/29/2017
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