Health plans and health insurers, health care providers, healthcare clearinghouses (Covered Entities) and their business associates should verify that their copying charges and other policies and practices for responding to requests of individuals for copies and other access to protected health information (PHI) comply with the Privacy and Security Rules (Privacy Rule) of the Health Insurance Portability & Accountability Act of 1996 (HIPAA) as construed in a new Frequently Asked Question (FAQ published May 24, 2016 as follow up to two other sets of guidance about HIPAA assess rights published by the Department of Health & Human Services Office of Civil Rights (OCR) since January, 2016.
New OCR Guidance Sheds New Light On HIPAA Access Rule Requirements
The OCR FAQ titled New Clarification – Up to $6.50 Flat Rate Option published May 24, 2016 is the third in a series of guidance materials OCR discussing OCR’s interpretation of individuals’ core right under HIPAA to access and obtain a copy of their PHI from Covered Entities since January, 2016 (the “Access Rule”). With OCR Enforcement Data already showing Access Rule violations among the top 5 issues in cases investigated by OCR every year since HIPAA took effect in 2003, Covered Entities can expect OCR to include Access Rule violations among the Privacy Rule violations OCR likely will target as it continues to ramp up its HIPAA audit, investigation and enforcement efforts.
As part of its sweeping requirements concerning the use, access, protection and disclosure of PHI, the Access Rule provisions of the Privacy Rule generally require Covered Entities to provide individuals, upon request, with access to the protected health information (PHI) about them in one or more “designated record sets” maintained by or for the Covered Entity or its business associate. This includes the right to inspect or obtain a copy, or both, of the PHI, as well as to direct the Covered Entity to transmit a copy to a designated person or entity of the individual’s choice as long as the Covered Entity or a business associate on its behalf maintains the PHI, regardless of the date the information was created; whether the information is maintained in paper or electronic systems onsite, remotely, or is archived; or where the PHI originated (e.g., whether the Covered Entity, another provider, the patient, etc.).
With its publication of the New Clarification FAQ on May 24, 2016, OCR now has published three pieces of guidance (the Access Guidance) about its interpretation of the Access Rule since January, 2016 that it hopes will promote greater understanding of and compliance with the Access Rule by Covered Entities:
- In January, OCR published a comprehensive Fact Sheet (Fact Sheet) and the first in a series of topical frequently asked questions (FAQs) addressing patients’ right to access their medical records, which set forth requirements providers must follow in sharing medical records with patients, including that they must do so in a timely manner and in a format that works for the patient;
- On March 1, OCR published a second set of FAQs accessible here addressing when Covered Entities may charge individuals to provide requested copies of their PHI, how Covered Entities must calculate these fees, when Covered Entities must send an individual’s PHI to a third party designated by the individual in its request for copies, and other issues relating to access rights guaranteed by the Privacy Rule; and
- On May 24, 2016 OCR clarified this prior Access Guidance by publishing another FAQ titled New Clarification – Up to $6.50 Flat Rate Option .
Collectively, the Access Guidance addresses a broad range of questions and issues about the responsibilities of Covered Entities under the Access Rule including what PHI Covered Entities must provide as well as detailed guidance about when and how much Covered Entities can charge individuals for requested copies of their PHI or summaries of their PHI. Since the OCR Access Guidance may restrict the charge that health care providers or other Covered Entities can charge for copies or other access more than applicable state law rules, Covered Entities need to verify their practices comply with OCR’s Access Guidance in addition to any applicable state law rules. The Access Guidance makes clear that OCR expects Covered Entities and their business associates to ensure that their charges for copying or providing other access to PHI guaranteed by the Privacy Rule complies with this Access Guidance even if that practice does not violate applicable state law.
Are You Charging Too Much? Charges For Copies of PHI Must Meet OCR Privacy Rule Guidance
Concerning charges for copies of PHI requested by an individual, Privacy Rule § 164.524(c)(4) permits a Covered Entity to impose a reasonable, cost-based fee if the individual requests a copy of the PHI (or agrees to receive a summary or explanation of the information) provided that the Covered Entity properly and timely notifies the individual of the cost and properly determines the cost in accordance with OCR guidance.
Many physicians or other health care providers that use electronic health records (EHRs) certified to allow individuals to access their PHI in the system may be unaware that OCR views the availability of electronic access from the EHR affects the health care provider’s ability to charge for copies of requested PHI. OCR’s position is that the Privacy Rule prohibits a Covered Entity from charging an individual for requested copies of PHI when the request is fulfilled by the individual accessing the requested PHI using the View, Download, and Transmit functionality of the provider’s certified electronic health record.
Assuming the request for access or copies is not fulfilled through download from an HER, the Access Guidance indicates q Covered Entity must use one of three potentially applicable OCR-approved methods to calculate the fee the Covered Entity charges an individual for copies of PHI or an agreed upon summary provided that the method used takes into account only labor costs for copying or producing an agreed upon summary as defined by OCR.:
- The “Actual Cost” Method;
- The “Average Cost” Method; or
- For electronic copies of PHI maintained electronically, the “Flat Fee” Method.
Charging a flat fee not to exceed $6.50 is an option available to those entities that do not want to go through the process of calculating actual or average costs for requests for electronic copies of PHI under either the Actual Cost or Average Cost Methods. However, by its terms, the “Flat Fee” Method is only an allowable for Covered Entities to use to avoid calculating actual or average allowable costs when a Covered Entity is providing electronic copies of PHI maintained electronically (and presumably when the access request is not fulfilled through download from an EHR). When applicable, the Flat Fee Method allows a Covered Entity to charge a flat fee for all requests for electronic copies of PHI maintained electronically, provided the fee does not exceed $6.50, inclusive of all labor, supplies, and any applicable postage. The New Clarification – Up to $6.50 Flat Rate Option clarifies that use of the Flat Rate Method is permitted not required when a Covered Entity provides copies of PHI maintained electronically other through download directly from a certified EHR. Covered Entities that wish to charge more than the $6.50 flat rate allowed under the Flat Rate Option retain the right, if the facts and evidence warrant, to use either the Actual Cost Method or Average Cost Method to calculate the fee for providing electronic records electronically within the boundaries of what is permissible under the Privacy Rule.
Where the Flat Fee Method is inapplicable or the Covered Entity elects not to use it, the Covered Entity must use either the Actual Cost Method or the Average Cost Method to calculate the fee in accordance with OCR’s rules.
Under the “Actual Cost Method,” a Covered Entity may calculate actual labor costs to fulfill the request, as long as the labor included is only for copying (and/or creating a summary or explanation if the individual chooses to receive a summary or explanation) and the labor rates used are reasonable for such activity. The Covered Entity may add to the actual labor costs any applicable supply (e.g., paper, or CD or USB drive) or postage costs. Covered Entities that charge individuals actual costs based on each individual access request still must be prepared to inform individuals in advance of the approximate fee that may be charged for providing the individual with a copy of her PHI. An example of an actual labor cost calculation would be to time how long it takes for the workforce member of the Covered Entity (or business associate) to make and send the copy in the form and format and manner requested or agreed to by the individual and multiply the time by the reasonable hourly rate of the person copying and sending the PHI. What is reasonable for purposes of an hourly rate will vary depending on the level of skill needed to create and transmit the copy in the manner requested or agreed to by the individual (e.g., administrative level labor to make and mail a paper copy versus more technical skill needed to convert and transmit the PHI in a particular electronic format);
Under the “Average Cost” Method, in lieu of calculating labor costs individually for each request, a Covered Entity can develop a schedule of costs for labor based on average labor costs to fulfill standard types of access requests, as long as the types of labor costs included are the ones which the Privacy Rule permits to be included in a fee (e.g., labor costs for copying but not for search and retrieval) and are reasonable. Covered Entities may add to that amount any applicable supply (e.g., paper, or CD or USB drive) or postage costs. This standard rate can be calculated and charged as a per page fee only in cases where the PHI requested is maintained in paper form and the individual requests a paper copy of the PHI or asks that the paper PHI be scanned into an electronic format. However OCR’s guidance states that OCR does not consider per page fees for copies of PHI maintained electronically to be reasonable for purposes of 45 CFR 164.524(c)(4);
Whether using the Actual Cost Method or the Average Cost Method, a Covered Entity must only take into account only “reasonable labor costs associated only with the: (1) labor for copying the PHI requested by the individual, whether in paper or electronic form; and (2) labor to prepare an explanation or summary of the PHI, if the individual in advance both chooses to receive an explanation or summary and agrees to the fee that may be charged.
OCR’s guidance makes clear that the reasonability of the charges for labor must reflect the technology available for providing this access. In this respect, OCR’s guidance states that a Covered Entity cannot charge a fee under HIPAA for individuals to access the PHI from a health care provider’s EHR technology that has been certified as being capable of making the PHI accessible. OCR’s position is that where a Covered Entity fulfills an individual’s HIPAA access request by allowing the individual to access the requested PHI using the View, Download, and Transmit functionality of the provider’s certified electronic health record (CEHRT), an individual requests or agrees to access her PHI available through the View, Download, and Transmit functionality of the CEHRT, there are no labor costs and no costs for supplies to enable such access.
To the extent that access is not provided through an CEHRT, the fee a Covered Entity charges an individual to provide copies of requested PHI or an agreed upon summary may include only the cost of:
- Copying the PHI; and
- Preparation of an explanation or summary of the PHI, if agreed to by the individual.
As interpreted by OCR, labor for copying includes only labor for creating and delivering the electronic or paper copy in the form and format requested or agreed upon by the individual, once the PHI that is responsive to the request has been identified, retrieved or collected, compiled and/or collated, and is ready to be copied. For example, labor for copying may include labor associated with the following, as necessary to copy and deliver the PHI in the form and format and manner requested or agreed to by the individual:
- Labor for copying the PHI requested by the individual, whether in paper or electronic form;
- Supplies for creating the paper copy or electronic media (e.g., CD or USB drive) if the individual requests that the electronic copy be provided on portable media;
- Postage, when the individual requests that the copy, or the summary or explanation, be mailed; and
- Creating and executing a mailing or e-mail with the responsive PHI.
See 45 CFR 164.524(c)(4).
The Access Guidance states the fee may not include costs associated with verification; documentation; searching for and retrieving the PHI; maintaining systems; recouping capital for data access, storage, or infrastructure; outsourcing the function of responding to individual requests for PHI copies or other costs not listed above even if such costs are authorized by State law. See 45 CFR 164.524(c)(4).
Of course, in any case, OCR’s guidance makes clear that regardless of how a entity chooses to calculate its fee to copy PHI, the Privacy Rule requires that the Covered Entity inform the requesting individual in advance of the approximate fee that may be charged for providing the copy requested and otherwise comply with the Privacy Rule as interpreted by OCR’s latest guidance concerning providing individuals access to PHI and other requirements.
Documented, Timely Action Needed To Mitigate OCR Audit, Investigation & Enforcement Risks
Beyond operationally complying with the Access Guidance, Covered Entities and their business associates generally will want to update their policies, practices and training to position themselves to defend their calculation of any charges made for copies provided in response to a request for access protected by the Privacy Rule and other compliance with the requirements of that rule and the otherwise applicable provisions of HIPAA as well as include monitoring and enforcement of these requirements as part of their ongoing HIPAA compliance efforts.
These and other HIPAA compliance efforts are particularly critical in light of the expanding audit, investigation and enforcement activities of OCR under the Privacy Rule. OCR’s publication of the Access Guidance coincides with a surge in OCR’s HIPAA audit, investigation and enforcement activities.
OCR’s publication of the new Access Guidance comes as OCR is ramping up its interpretation, oversight and enforcement of HIPAA generally. See, Brace For OCR HIPAA Audits & Enforcement; Update Privacy Practices For New OCR HIPAA Enforcement, Security & Records Access Guidance. While continuing to offer guidance like the Access Guidance and other tools to encourage and help Covered Entities and their business to understand and comply with the Privacy Rule, OCR also increasingly now uses the expanded penalties and authority created by the HITECH Act to punish Covered Entities for violating Privacy Rule requirements. HITECH Act amendments, among other things, broadened the duties of OCR to audit, investigate and sanction HIPAA violations as well as tightened various requirements of the Privacy Rules.
The risks to Covered Entities from violating the Privacy Rules are significant and growing. Since the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH) amended HIPAA, Covered Entities and their business associates face heightened risks that violations of HIPAA will trigger liability to pay a Civil Monetary Penalty (CMP) to OCR or other sanctions. The two, multimillion dollar CMPs now imposed by OCR against two different Covered Entities caught violating the Privacy Rules only reflect a small part of OCR’s CMP enforcement. Equally or perhaps more significant are the growing stream of high dollar settlement payments that an ever-growing list of Covered Entities to resolve OCR Privacy Rule violation charges that otherwise also might result in OCR’s assessment of a CMP against them. See, e.g. $2 Million+ HIPAA Settlement, FAQ Warn Providers Protect PHI From Media, Other Recording Or Use; Provider Pays $750K To Settle HIPAA Business Associate Rule Breach Charges; North Memorial Hit With $3.9M HIPAA Fine For HIPAA Violations; 3/30 Webex Shares Latest On Security, Patient Access & Other HIPAA Developments; OCR’s 2nd-Ever HIPAA CMP Nails Lincare For $239,000; Lehey Pays $850K After Unencrypted Laptop Stolen.
These already substantial enforcement risks are likely to rise as OCR begins auditing the compliance of selected Covered Entities as part of its recently announced 2016 audit program. As a result of audit requirements enacted as part of the HITECH Act, Covered Entities now need to be prepared to demonstrate the adequacy of their HIPAA compliance in case their organization becomes targeted for audit under OCR’s 2016 audit program. Even if not selected for audit, however, Covered Entities and their business associates still face the risk that a complaint filed with OCR will trigger an OCR investigation of their practices for providing copies or other access or other compliance with the Privacy Rules. In light of the growing aggressiveness of OCR’s enforcement, Covered Entities and their business associates need to be prepared to demonstrate their efforts to comply. Those that cannot show adequate compliance efforts should be prepared for potentially substantial CMP or Resolution Agreement payments and other sanctions. Consequently, Covered Entities and their business associates should move quickly to review and update their practices, communications and training to comply with this new Access Guidance as well as other guidance, enforcement and other developments that might impact the adequacy of their existing practices under the Privacy Rule generally. Because of the risk that any review or investigation of the adequacy of its practices or complaints under the Privacy Rule will involve sensitive information or analysis, Covered Entities and their business associates are cautioned to consider the advisability of arranging for this analysis and review to be conducted within the scope of attorney-client privilege under the guidance of legal counsel experienced with the Privacy Rules and other related legal concerns.
About The Author
Cynthia Marcotte Stamer is a practicing attorney and management consultant, author, public policy advocate and lecturer widely recognized for her extensive work and pragmatic thought leadership, experience, publications and training on HIPAA and other privacy, medical records and data and other health care and health plan concerns.
Recognized as “LEGAL LEADER™ Texas Top Rated Lawyer” in both Health Care Law and Labor and Employment Law, a “Texas Top Lawyer,” an “AV-Preeminent” and “Top Rated Lawyer” by Martindale-Hubble and as among the “Best Lawyers In Dallas” in employee benefits 2015 by D Magazine; Ms. Stamer has more than 28 years of extensive proven, pragmatic knowledge and experience representing and advising health industry clients and others on operational, regulatory and other compliance, risk management, product and process development, public policy and other key concerns.
As a core component of her work as the Managing Shareholder of Cynthia Marcotte Stamer, PC, Ms. Stamer has worked extensively throughout her nearly 30 year career with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, their technology and other vendors and service providers, and others on legal and operational risk management and compliance with HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and concerns; prevention, investigation, response, mitigation and resolution of known or suspected data or privacy breaches or other incidents; defending investigations or other actions by plaintiffs, OCR, FTC, state attorneys’ general and other federal or state agencies; reporting and redressing known or suspected breaches or other violations; business associate and other contracting; insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.
Beyond her extensive involvement advising and defending clients on these matters, Ms. Stamer also has served for several years as the scrivener for the ABA JCEB’s meeting with OCR for many years. She returns as Chair of the Southern California ISSA Health Care Privacy & Security Summit for the third year in 2016, as well as speaks and serves on the steering committee of a multitude of other programs.
A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares shared her thought leadership, experience and advocacy on HIPAA and other concerns by her service in the leadership of a broad range of other professional and civic organization including her involvement as the Vice Chair of the North Texas Healthcare Compliance Association, Executive Director of the Coalition on Responsible Health Policy and its PROJECT COPE; Coalition on Patient Empowerment, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children; former Board Compliance Chair and Board member of the National Kidney Foundation of North Texas, current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, immediate past RPTE Representative to ABA Joint Committee on Employee Benefits Council Representative and current RPTE Representative to the ABA Health Law Coordinating Counsel, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.
Ms. Stamer also is a highly popular lecturer, symposia chair and author, who publishes and speaks extensively on health and managed care industry, human resources, employment and other privacy, data security and other technology, regulatory and operational risk management. Examples of her many highly regarded publications on these matters include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security: Beyond HIPAA,” as well as thousands of other publications, programs and workshops these and other concerns for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other symposia and publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, InsuranceThoughtLeadership.com and many other prominent publications and speaks and conducts training for a broad range of professional organizations and for clients, on the Advisory Boards of InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications. For additional information about Ms. Stamer, see www.CynthiaStamer.com, email Ms. Stamer email@example.com or telephone her at (469) 767-8872.
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