Rite Aid settles FTC and OCR privacy charges

The Rite Aid Corporation, the third largest pharmacy chain in the United States, reached a major settlement with both the Federal Trade Commission (FTC) and HHS's Office of Civil Rights (OCR) regarding charges that Rite Aid violated federal privacy and security laws and regulations by failing to keep its customers' and employees' data safe. 

Rite Aid employees were reported to discard prescriptions and pill bottles containing sensitive patient data into the dumpsters behind various Rite Aid pharmacies, which were easily accessible to the public.  Such practices violate the HIPAA Privacy Rule, which requires covered entities to safeguard the privacy of patient information, even when such information is being destroyed.  Rite Aid's actions may also violate the company's own promises to their customers regarding keeping their health information private and secure (this broken promise being the basis for FTC's charges).

 

In addition, OCR and FTC found that Rite Aid:

  • failed to implement adequate policies and procedures to appropriately safeguard patient information during the disposal process;
  • failed to adequately train employees on how to dispose of such information properly;
  • failed to employ a reasonable process for discovering and remedying risks to personal information; and
  • did not maintain a sanctions policy for members of its workforce who failed to properly dispose of patient information.

Pursuant to their settlement with HHS, Rite Aid agreed to pay HHS a cool $1 million and agreed to implement a strong corrective action program (lasting 3 years) which includes:

  • Revising and distributing its policies and procedures regarding disposal of protected health information and sanctioning workers who do not follow them;
  • Training workforce members on these new requirements;
  • Conducting internal monitoring; and
  • Engaging a qualified, independent third-party assessor to conduct compliance reviews and render reports to HHS.

Finally, Rite Aid has also agreed to external independent assessments of its pharmacy stores’ compliance with the FTC consent order, which will be in place for 20 years.

FTC and OCR have previously filed charges against CVS Caremark, another major pharmacy chain which was reported to engage in similar violations to Rite Aid's.  

The current economic conditions require most organizations to do more with less. The unfortunate end result is that long term projects, such as major privacy and security compliance reviews and overhauls get postponed and overlooked.  Rite Aid and CVS cases should remind covered entities and other organizations responsible for keeping patient information safe that neglect or procrastination with regard to privacy policies and practices can lead to major fines, PR embarrassments and excessive compliance and legal costs. 

It is also key to remember that your organization must comply with its own privacy policies and procedures -- otherwise, FTC can charge your organization for "false promises," as was the case with Rite Aid.  In order to comply with such policies, however, your organization must train the staff about the critical importance of privacy.  Without such training, all the policies and procedures will be rendered entirely ineffective.

You can read the full OCR press release by clicking here.

You can read the full FTC press release by clicking here.

CMS issues final rules on Meaningful Use

On July 13, 2010, CMS issued the final rule defining "meaningful use" and establishing the parameters and requirements for eligible professionals, hospitals and other providers to receive incentive payments provided under the HITECH Act for widespread adoption of electronic health records.  According to CMS, the key changes included in the final rule (from the meaningful use NPRM published in the Federal Register on January 13, 2010) include:

  • Greater flexibility with respect to eligible professionals and hospitals in meeting and reporting certain objectives for demonstrating meaningful use. The final rule divides the objectives into a “core” group of required objectives and a “menu set” of procedures from which providers may choose any five to defer in 2011-2012. This gives providers latitude to pick their own path toward full EHR implementation and meaningful use.
  • An objective of providing condition-specific patient education resources for both EPs and eligible hospitals and the objective of recording advance directives for eligible hospitals, in line with recommendations from the Health Information Technology Policy Committee.
  • A definition of a hospital-based EP as one who performs substantially all of his or her services in an inpatient hospital setting or emergency room only, which conforms to the Continuing Extension Act of 2010
  • CAHs within the definition of acute care hospital for the purpose of incentive program eligibility under Medicaid.

You can view the PDF of the final rule on Meaningful Use by clicking here.

You can learn more about it from the HHS press release by clicking here.  Also, the New England Journal of Medicine published an excellent summary by Dr. Blumenthal of the changes included in the final rule; you can find this article by clicking here.

At the same time, ONC issued another final rule, finalizing the "standards and certification criteria for the certification of EHR technology, so eligible professionals and hospitals may be assured that the systems they adopt are capable of performing the required functions."  You can find a copy of this final rule by clicking here.

Stay tuned for much more analysis of the final rules published today, as well as the changes to HIPAA Privacy and Security Rules issued by OCR last week.

HHS issues NPRM on HIPAA Privacy, Security and Enforcement Rules

On July 7, 2010, HHS issued a notice of proposed rule making (NPRM) regarding the changes to the HIPAA Privacy, Security and Enforcement Rules, as provided in the HITECH Act, in order "to strengthen the privacy and security protections for health information and to improve the workability and effectiveness of the HIPAA Rules."  Via HHS Press Release:

The proposed modifications to the HIPAA Rules include provisions extending the applicability of certain of the Privacy and Security Rules’ requirements to the business associates of covered entities, establishing new limitations on the use and disclosure of protected health information for marketing and fundraising purposes, prohibiting the sale of protected health information, and expanding individuals’ rights to access their information and to obtain restrictions on certain disclosures of protected health information to health plans. In addition, the proposed rule adopts provisions designed to strengthen and expand HIPAA’s enforcement provisions.

You can view the NPRM by clicking here.

"Notice of Proposed Rulemaking to Implement HITECH Act Modifications," HHS Press Release (July 7, 2010).

In the news: patient privacy edition

  • HHS's Office of Civil Rights (OCR) filed a notice in the Federal Register lifting a requirement preventing OCR from posting names of sole practitioners who suffer breaches of patient data without first obtaining consent from such practitioners.  Pursuant to the HITECH Act, any covered entity reporting a breach affecting over 500 individuals must report such breach to HHS, and HHS will post a notice of such breach on its web site.  At the same time, HHS did not post names of individual physician practices (e.g., sole practitioners) without such physicians' consent because they deemed the name of the physician to be protected under the Privacy Act of 1974. Instead, HHS listed such breaches under "private practice."  However, OCR announced on April 16, 2010, that "it will begin posting on its breach notification web site the names of entities they consider "individuals" regardless of whether or not those entities give consent." According to HealthLeaders Media, the rule will become effective after the comment period closes (about May 23, 2010).
  • Government Health IT reports that OCR will issue more privacy and security rules mandated by the HITECH Act in May 2010, including rules regarding business associate liability; new limitations on the sale of protected health information, marketing, and fundraising communications; and stronger individual rights to access electronic medical records and restrict the disclosure of certain information.  According to HHS, "OCR continues work on a Notice of Proposed Rulemaking (NPRM) regarding these provisions. Although the effective date (February 17, 2010) for many of these HITECH Act provisions has passed, the NPRM and the final rule that follows will provide specific information regarding the expected date of compliance and enforcement of these new requirements."
  • On April 23, 2010 HIT Policy Committee's privacy and security workgroup revealed a draft  technical framework for patient consent requirements, titled Basic Patient Privacy Consent (BPPC).  According to Federal Computer Week, the draft framework includes "at least 12 types of patient consents, including implicit and explicit opt-out and opt-in, authorizations for specific research projects and authorizations for use of the document but not for republishing."
     

 

In the news: Senators request easing of meaningful use requirements; HHS releases over $267M for RECs; and more

  • A group of 37 U.S. Senators sent a letter to HHS Secretary Kathleen Sebelius expressing concern regarding the current definition of meaningful use.  The senators urged the Secretary to "allow providers to 'temporarily defer a limited set of IT goals' without otherwise changing the ultimate timeline or requirements of the program."  The senators also sought to change the eligibility determination based on Medicare provider numbers, considering many healthcare providers have multiple medical campuses under one such Medicare number.  According to Sen. Max Baucus (D-MT), such changes would "improve the guidelines HHS has set in way that will encourage widespread use of basic, functional IT tools and improve patient care.”
  • HHS released over $267 million from the stimulus funds to help 28 non-profit Regional Extension Centers (RECs).  This latest award brought the total of stimulus-funded RECs to 60, and is expected to support 100,000 primary care and hospitals within 2 years.  According to Secretary Sebelius, these 28 awards "represent [HHS's] ongoing commitment to make sure that health providers have the necessary support within their communities to maximize the use of health IT to improve the care they provide to their patients."  
  • Thomson Reuters released its annual study identifying the 100 top U.S. hospitals based on their overall organizational performance. The 10 areas measured are: mortality, medical complications, patient safety, average length of stay, expenses, profitability, patient satisfaction, adherence to clinical standards of care, and post-discharge mortality and readmission rates for acute myocardial infarction, heart failure, and pneumonia. The study has been conducted annually since 1993. Is your hospital one of the 100 Top Performing Hospitals? Find out here.
  • According to the Baltimore Business Journal, a proposed Maryland law could change how primary care providers do business, by creating a patient-centric primary care delivery system whereby insurance companies would financially reward primary care providers for better outcomes.  However, the new law would also ease patient privacy rules by allowing greater sharing of patient information among medical practices and insurance companies. The law will likely pass with little or no opposition.
     

 

OCR delays enforcement of certain HITECH provisions

In a much-anticipated move, the Office of Civil Rights (OCR) within the Department of Health and Human Services has issued an update regarding delays of certain HITECH provisions, while confirming enforcement of others.  Via OCR press release:

OCR will implement important privacy and security provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act through notice and comment rulemaking, as required by the Administrative Procedure Act. These provisions include: business associate liability; new limitations on the sale of protected health information, marketing, and fundraising communications; and stronger individual rights to access electronic medical records and restrict the disclosure of certain information. OCR continues work on a Notice of Proposed Rulemaking (NPRM) regarding these provisions. Although the effective date (February 17, 2010) for many of these HITECH Act provisions has passed, the NPRM and the final rule that follows will provide specific information regarding the expected date of compliance and enforcement of these new requirements.

However, interim final rules implementing HITECH Act provisions in two areas have already been issued and are currently in effect: enforcement and breach notification. New civil money penalty amounts apply to HIPAA Privacy and Security Rule violations occurring after February 17, 2009. Covered entities and business associates must comply now with breach notification obligations for breaches that are discovered on or after September 23, 2009. OCR announced previously that it would use its enforcement discretion not to impose fiscal sanctions with regard to breaches discovered before February 22, 2010. Since that date has passed, OCR will enforce the Breach Notification Interim Final Rule, including with the possible imposition of sanctions, as it does with the HIPAA Privacy and Security Rule requirements.

You can find about more here.

"HITECH Act Rulemaking and Implementation Update," OCR Press Release (March 18, 2010).

OCR may delay enforcement of business associate provisions in the HITECH Act

Pursuant to the HITECH Act, on February 17, 2010, business associates of covered entities became subject to the HIPAA Privacy and Security Rules, including provisions regarding implementation of various safeguards to secure protected health information.  As Steve Fox pointed out in a recent report on the subject by the Pittsburgh Business Journal, it is highly unlikely that most companies are ready to comply with these dramatic changes.

However, according to Hunton & Williams's privacy blog, Adam Greene of the HHS Office of Civil Rights (OCR) stated at an ABA conference on February 18, 2010, that OCR will delay enforcement of this provision of the HITECH Act until the relevant regulations are finalized.  OCR itself did not publish a press release on the subject, and we were unable to reach Mr. Greene for comment.

Regardless of OCR's intent to enforce compliance, the business associate provisions in the HITECH Act went into effect last week.  We would strongly encourage all covered entities and business associates to take all necessary actions to comply with the new law.

"Privacy policies over electronic health records expand reach," Pittsburgh Business Journal (February 19, 2010).

"HHS Delays Enforcement of HITECH Act Business Associate Provisions," Privacy & Information Security Law Blog (February 19, 2010).

 

 

HHS releases interim final regulations on HIPAA enforcement changes

Pursuant to the HITECH Act, the Department of Health and Human Services (HHS) released interim final regulations updating enforcement rules for violations of HIPAA.  As reported in Healthcare IT News:

Prior to the HITECH Act, the penalty could be no more than $100 for each violation or $25,000 for all identical violations of the same provision.

A healthcare provider, health plan or clearinghouse could also bar the secretary's imposition of a civil money penalty by demonstrating that it did not know that it violated the HIPAA rules.

Section 13410(d) of the HITECH Act strengthened the enforcement by establishing tiered ranges of increasing minimum penalty amounts, with a maximum penalty of $1.5 million for all violations of an identical provision. A covered entity can no longer bar the imposition of a civil money penalty for an unknown violation unless it corrects the violation within 30 days of discovery.

The interim final rule with request for comments, published last week, conforms the HIPAA enforcement regulations to the revisions made by the HITECH Act. This rule will become effective on Nov. 30. HHS will consider all comments received by Dec. 29.

You can find the full text of the rule is here.

"HIPAA violators could face fines up to $1.5M," Healthcare IT News (November 2, 2009).

Regional Extension Program: Important Updates and Links from HHS

Via HHS e-mail update:

The Office of the National Coordinator for Health Information Technology (ONC) is pleased to announce the availability of materials that are of immediate interest and use to stakeholders and potential applicants for the Health Information Technology Extension Program: Regional Centers Cooperative Agreement Program, and that are new or updated since the August 27, 2009 technical assistance telephone and web conference.

REVISED – Preliminary Application Template (Attachment I to the Funding Opportunity Announcement):  As discussed on the August 27th technical assistance public conference, the suggested template for applicants’ use in compiling and presenting the information required for the Preliminary Application has been updated to include the complete requirements established in the funding opportunity announcement and is now available from www.grants.gov and the Extension Program section of ONC’s website at http://healthit.hhs.gov/extensionprogram.

NEW – A complete transcript of the August 27th technical assistance conference is available for download from the Extension Program section of ONC’s website.  Please visit http://healthit.hhs.gov/extensionprogram to access detailed information about the conference, including the transcript and the presentation slides used during the call.

NEW/REVISED – Program-specific Frequently Asked Questions (FAQs) are now available on the Extension Program section of ONC’s website.  New FAQs are posted frequently, so potential applicants and other interested parties are encouraged to visit often.  Please visit http://healthit.hhs.gov/extensionprogram then scroll down and click on “Frequently Asked Questions”.

On the HIT Extension Program site, you can find the Funding Opportunity Announcement / Application Instructions document,  as well as a large FAQ section and the "Facts-At-A-Glance" summary. 

You can find the August 27th, 2009 presentation (PPT) here, and the transcript of that same presentation here.

"Health Information Technology Extension Program: Regional Centers Cooperative Agreement Program Update," HHS e-mail update (September 3, 2009).

HHS News: Interim Final Regulations on Breach Notification; Regional Office Privacy Advisors

On August 19, 2009, pursuant to the HITECH Act, the Department of Health and Human Services (HHS) published the interim final regulations regarding breach notification requirements for health care providers and other entities covered by HIPAA. 

According to the HHS press release:

The regulations, developed by the HHS Office for Civil Rights (OCR), require health care providers and other HIPAA covered entities to promptly notify affected individuals of a breach, as well as the HHS Secretary and the media in cases where a breach affects more than 500 individuals. Breaches affecting fewer than 500 individuals will be reported to the HHS Secretary on an annual basis. The regulations also require business associates of covered entities to notify the covered entity of breaches at or by the business associate.

You can find the text of the regulation here.

Stay tuned for more analysis of this important set of regulations on this blog. The interim final regulations are effective 30 days after publication in the Federal Register and include a 60-day public comment period. 

Also, pursuant to Section 13403(a) of the HITECH Act, the HHS Secretary Kathleen Sebelius designated an individual in each regional office of HHS (Regional Office Privacy Advisors) in order "to offer guidance and education to covered entities, business associates, and individuals on their rights and responsibilities related to the HIPAA Privacy and Security Rules."  The names, addresses, and contact information for each of the Regional Managers are listed here, together with a list of the States for which each Regional Manager has responsibility.

"HHS Issues Rule Requiring Individuals Be Notified of Breaches of Their Health Information," HHS Press Release (August 19, 2009).

" Designation of Regional Office Privacy Advisors," HHS Press Release (July 27, 2009).

Government Health IT: CCHIT to serve temporarily as sole EHR certifier

Via Government Health IT:

The federal Health IT Policy Committee today endorsed recommendations that would leave the Certification Commission for Health IT in the short term as the sole organization authorized to certify health IT systems that qualified for funding under the economic stimulus plan. More certifying organizations would be added later.

Certification of electronic health record systems that met federal criteria for “meaningful use” of health IT could start as early as October, members of the Department of Health and Human Services’ Health IT Policy Committee said at the August 14th meeting.

Under the plan, CCHIT would provide a preliminary stamp of approval that health IT systems were HHS-qualified or certified until a final meaningful use regulation is published at the end of the year, said Marc Probst, chief information office of Intermountain Healthcare and co-chairman of the Committee’s certification work group.

Preliminary certification is meant to give providers and vendors enough certainty to proceed with planning, designing and purchasing systems in 2010. The HHS certification-qualification would mean that a provider purchasing the systems would be eligible for Medicare and Medicaid incentive payments under the stimulus law beginning in 2011.

"CCHIT will be sole health IT certifier, for now," Government Health IT (August 14, 2009).