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Archive for HHS

May
18

OCR begins HIPAA compliance audits

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Mac McMillan, CISSM, has an insider’s look at what it’s like to undergo a HIPAA compliance audit.

A hospital randomly selected by OCR for its initial audit phase consulted with McMillan to assist with the audit process. The hospital underwent an audit by KPMG, LLP, the company that OCR hired to conduct the audits. OCR selected the hospital as one of its initial 20 audits.

McMillan, CEO of CynergisTek in Austin, Texas, shared what he learned during “2012 OCR Audits and Enforcement: A View from the Front Lines,” a recent webcast sponsored by ZixCorp. Upon completion of pilot testing, OCR will evaluate the process, and KPMG audit teams will conduct up to 130 additional random audits of healthcare organizations before the end of 2012. The audits are scheduled to begin in May.

The HITECH Act mandated the audits, which will measure healthcare organizations’ compliance with the HIPAA Privacy and Security Rules and breach notification rules.

This article is adapted from an article which originally appeared in the April Briefings on HIPAA published by HCPro, Inc.

 

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HIPAA compliance 101—policies, training, monitoring, and risk assessments—may have saved Blue Cross Blue Shield of Tennessee (BCBST) millions, experts say.

Instead, the health insurer agreed to a $1.5 million settlement with the Office for Civil Rights (OCR) over potential HIPAA security violations and spent another $17 million in breach response costs.

On March 13, BCBST and the OCR, the government’s HIPAA privacy and security enforcer, reached the second largest financial settlement of its kind, behind CVS Caremark’s $2.25 million price tag a little more than three years ago.

The agreement also requires BCBST to update its HIPAA compliance policies and procedures, obtain OCR approval on all policy changes, and conduct unannounced random audits of its own employees.

This is OCR’s first enforcement action related to a breach that was reported per the Health Information Technology for Economic and Clinical Health (HITECH) Act requirements, according to a Department of Health & Human Services (HHS) press release.

‘Not following the basics’

In the fall of 2009, BCBST reported to OCR that 57 unencrypted computer hard drives were stolen from a leased facility in Tennessee. The hard drives contained protected health information (PHI) for more than one million individuals, including member names, Social Security numbers, diagnosis codes, birthdates, and health plan identification numbers.

“This breach seems to be another instance of not following the basics—policies, training, monitoring,” says Phyllis A. Patrick, MBA, FACHE, CHC, of Phyllis A. Patrick & Associates LLC in Purchase, NY. “When organizations include privacy and security as key components of their culture and begin applying similar methods to those used in safety and quality programs, the awareness of these issues increases. A well-trained workforce is a tremendous asset in preventing many breaches, especially breaches of this type.”

In a statement released to HCPro, Inc., BCBST said the stolen hard drives were located in a data storage closet at a former Blue Cross call center located in Chattanooga. They contained audio and video recordings related to customer service telephone calls from providers and members. Patrick says this type of breach can happen in many environments and probably happens more often than is currently reported.

The Evaluation Standard in the HIPAA Security Rule [§164.308(a)(8)]) calls for HIPAA covered entities (CE) to “perform a periodic technical and nontechnical evaluation, based initially upon the standards implemented under this rule and subsequently, in response to environmental or operational changes affecting the security of electronic protected health information.”

CEs seem to overlook this requirement, Patrick says, and must ensure they meet appropriate safeguards when they:

  • Move data files and tapes to another facility
  • Implement a new information system
  • Change access controls
  • Change off-site storage companies or procedures

“BCBST failed to implement appropriate administrative safeguards to adequately protect information remaining at the leased facility by not performing the required security evaluation in response to operational changes,” according to the HHS press release. “In addition, the investigation showed a failure to implement appropriate physical safeguards by not having adequate facility access controls; both of these safeguards are required by the HIPAA Security Rule.”

Dena Boggan, CPC, CMC, CCP, HIPAA privacy/security officer for St. Dominic Jackson Memorial Hospital in Jackson, MS, says CEs must not only review HIPAA security standards but also those by the National Institute of Standards and Technology.

“What can entities do to prevent this from happening? Security risk analysis should be the first order of business, if covered entities haven’t done this in the past year,” Boggan says. “Review past risk analyses and make sure all problem areas have been addressed. The one thing you might think is unimportant could turn out to be the most important issue you have to address.”

To date, there is no indication of any misuse of personal data from the stolen hard drives, according to BCBST. The company’s response included the encryption of all its at-rest data as well as investigation, notification, and protection efforts—to the tune of $17 million, according to its statement. That amounts to about $17 per breached record.

“Since the theft, we have worked diligently to restore the trust of our members by demonstrating our full commitment to limiting their risks from this misdeed and making significant investments to ensure their information is safe at all times,” Tena Roberson, deputy general counsel and chief privacy officer for BlueCross, said in the statement to HCPro, Inc.

Message in the CAP

In addition to the settlement, BCBST must adhere to its corrective action plan (CAP), which states that the health insurer must:

  • Review, revise, and maintain its privacy and security policies and procedures
  • Conduct regular and robust trainings for all BCBST employees covering employee responsibilities under HIPAA
  • Perform and monitor reviews to ensure BCBST compliance with the CAP

BCBST must also conduct unannounced audits of BCBST facilities housing portable devices and audit 25 BCBST workforce members who use portable devices.

“That’s really something I have not seen before,” says Ali Pabrai, MSEE, CISSP, chief executive of ecfirst, home of The HIPAA Academy. “They are making them randomly audit their facilities that house portable devices. The fact they are saying it should be done randomly and unannounced shows they are serious about this.”

The interim final rule on breach notification went into effect in August of 2009, only months before the BCBST breach. Pabrai says entities should take note that OCR is willing to go back years to investigate breaches.

“Go back and get as much detail as you can on your security incidents,” Pabrai says. “You’ve got to be ready for this. Ensure your policies and procedures for breach and incident management are updated and aligned. Communicate policies effectively to your workforce.”

The CAP agreement emphasizes the need to ensure policies and procedures are updated, and that workforce members are trained on the same, Pabrai says.

“Emphasize the sanctions policy with scenarios to reinforce key policies,” Pabrai says, adding that CEs should also perform regular risk analysis activities and have an active risk management program.

“The bottom line as a result of this OCR action is that organizations are responsible for establishing and driving a carefully designed, delivered, and monitored HIPAA compliance program,” he says.

HITECH breach notification role

The new HITECH requirement to report large patient information breaches to OCR helped bring the BCBST breach to light, an OCR spokesperson wrote in a March 13 e-mail to HCPro, Inc. OCR investigates all reported breaches of 500 or more; it forwards the smaller ones off to its regional offices throughout the United States, the spokesperson said.

As of March 14, the website lists 400 entities reporting breaches of unsecured PHI affecting 500 or more individuals. BCBST has the sixth largest breach.

“Pre-HITECH, a patient may have learned about an impermissible disclosure through a request for accounting of disclosures or if state law required notification,” the spokesperson wrote. “The individual could have then filed a complaint with OCR. This case underscores the important utility of the breach reporting notification to bring these incidents to light.”

Kate Borten, CISSP, CISM, president of The Marblehead Group, says she’s “disappointed” a breach that occurred in the fall of 2009 is just now being settled.

“I would think that self-reported breaches of PHI would be a high priority for HHS to investigate and act on,” Borten says. “Otherwise, how much value is there in the reporting requirement? Further, even though a breach occurred, this is still identified as a ‘settlement of a potential violation,’ not a finding of fault, although the penalty is in line with the HITECH Act civil penalties. How much clearer could this be?”

Asked why it took this long to settle the BCBST case, the OCR spokesperson said, “As one can see from OCR’s list of breaches over 500, many of these cases have been resolved quickly through corrective action. More complex cases take time to move from investigation to resolution.”

LARGEST SETTLEMENTS TO DATE

The OCR’s largest settlements for HIPAA violations include:

  1. CVS Caremark Co.: $2.25 million, February 2009
  2. Blue Cross Blue Shield of Tennessee: $1.5 million, March 13, 2012
  3. Rite Aid: $1 million, July 2010
  4. Massachusetts General Hospital: $1 million, February 2011
  5. University of California at Los Angeles Health System: $865,500, July 2011

Note that in February of 2011, OCR fined Cignet Health a $4.3 million civil money penalty, the largest fine for such violations. It was not a settlement.

Editor’s note: Follow these links for more material on the BCBST settlement with OCR:

 

The following is a Q&A between HCPro, Inc. and an Office for Civil Rights (OCR) spokesperson. HCPro, Inc. Senior Managing Editor Dom Nicastro sent the questions to OCR when news broke Tuesday, March 13, about the $1.5 million settlement between Blue Cross Blue Shield of Tennessee and OCR for HIPAA violations.

HCPRO: Were it not for the HITECH requirement to report 500-plus breaches to OCR/media, is there a chance OCR may not have known about this breach?

OCR: Pre-HITECH, a patient may have learned about an impermissible disclosure through a request for accounting of disclosures or if state law required notification. The individual could have then filed a complaint with OCR.  This case underscores the important utility of the breach reporting notification to bring these incidents to light.

HCPRO: As for the breach itself, what kind of steps can entities take to ensure this doesn’t happen?

OCR: The Health Insurance Portability and Accountability Act (HIPAA) Security Rule requires covered entities to evaluate risks and vulnerabilities in their environments and to implement policies and procedures to address those risks and vulnerabilities.  Both risk analysis and risk management are standard information security processes and are critical to a covered entity’s Security Rule compliance efforts. OCR has posted guidance on the risk analysis requirements under the Security Rule to our website. A meaningful HIPAA compliance program includes: up-to-date policies and procedures, a well-documented training program, regular internal audits, and ongoing monitoring.

HCPRO: Are there any more investigations pending on entities on that 500-plus list?

OCR: Absolutely. Every 500-plus breach case is investigated. When OCR completes an investigation of a breach affecting over 500 individuals, a summary of this case is posted on OCR’s website under the list of Breaches Affecting More than 500 Individuals. The remaining cases you see on the list are all open and active investigations.

HCPRO: Does OCR have a timetable on release of the breach notification final rule? Or any other HITECH/HIPAA rules?

OCR: OCR is making every effort to publish the final rules on all of the remaining HITECH Act provisions so these important protections and expansions of individual rights under the Privacy and Security Rules can be made available uniformly to consumers across the country. OCR is proceeding with all deliberate speed to ensure the major impacts of these regulations are fully understood and addressed.

HCPRO: If the BCBS breach occurred in 2009 and was just now settled in 2012, is the three-year investigation period normal? Or is OCR backed up? Or is it a matter of prioritizing breach investigations?

OCR: As one can see from OCR’s list of breaches over 500, many of these cases have been resolved quickly through corrective action. More complex cases take time to move from investigation to resolution.

HCPRO: Are all 500-plus breaches investigated? If not, how does OCR filter which are not?

OCR: Yes, each and every one of the 500-plus breaches are investigated to ensure first that appropriate breach procedures were followed, and that the root cause of the impermissible disclosure was remedied to prevent a similar breach from occurring in the future.

HCPRO: Does OCR investigate every breach report it receives – even the ones under 500?

OCR: All breach reports are forwarded to regional HHS offices, and these offices have discretion as to whether to open an investigation of small breaches.

CMS' Office of E-Health Standards and Services (OESS) has announced a 90-day period of "enforcement discretion" for compliance with the 5010 HIPAA transaction standards, but leading professional organizations say that is not enough, according to a February 6 HealthLeaders Media article.

Expressing serious concerns about the ability of physician practices and payers to make the conversion to the 5010 electronic transaction standards and ICD-10 (a new code set for medical diagnoses) in time, both MGMA and the AMA are calling for change. The two agencies say that the government needs to form a comprehensive contingency plan permitting health plans to adjudicate claims that may not have all the required data content; or the government needs to call an outright halt to the transition.

CMS has extended the 5010 compliance deadline to March 31, 2012. OESS announced that it is delaying compliance enforcement in order to allow more physician practices the opportunity to implement the new billing coding standard without incurring penalties. The 90-day delay did not affect the implementation date for the coding systems, which took effect January 1, 2012 (January 1, 2013, for small health plans).

Read more on the HealthLeaders Media website.

Categories : HHS
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An HHS task force recommends that if the government encourages and helps develop health text messaging and mobile health programs, it better look into privacy and security concerns.

The task force Jan. 26 recommends that HHS conduct “further research” into the privacy and security risks associated with text messaging of health information and establish guidelines for managing such privacy/security issues.

“The exchange of health information via text messages raises privacy and security issues specific to this medium,” the task force wrote in an HHS release. “Text messaging programs may be subject to numerous privacy and security laws, including [HIPAA's] privacy and security rules.”

HHS says in recent years, mobile health technologies have seen the expansion of:

  • Health text messaging
  • Mobile phone apps
  • Remote monitoring
  • Portable sensors

These “have changed the way healthcare is being delivered in the U.S. and globally,” according to the HHS release.

According to HHS, the task force was charged with helping identify ongoing initiatives and proposals for the delivery of health information via mobile phones.

 

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