TechHealth Perspectives

STRATEGY, ANALYSIS, AND COMMENTARY ON CURRENT AND NEW HEALTH TECHNOLOGIES

ATA Gets Clarification Regarding New Medicare Reimbursement Rules for Telehealth

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Earlier this week, the American Telemedicine Association reported an important clarification regarding the Centers for Medicare & Medicaid Services’ (“CMS’s”) plans for expanding reimbursement for telehealth services provided to Medicare beneficiaries.  The October 31, 2014 final rule with comment period regarding payments to physicians generated much excitement in the telehealth community, particularly because it opens a door, albeit only slightly, to possible Medicare coverage for remote patient monitoring services.

However, the ATA has clarified with CMS just how far this door is ajar at the present time.  While CMS has added a new CPT code (99490) for “chronic care management” (described by CMS in the final rule as a service “designed to pay separately for non-face-to-face care coordination services furnished to Medicare beneficiaries with multiple chronic conditions”), and this new code does not require the patient to be present during the care encounter, CMS still will not allow any additional payments for CPT code 99091 (collection and interpretation of physiologic data) if it is bundled with the new code 99490.  According to the article, “[CMS] will allow providers to count the time they spend reviewing data towards the monthly minimum time for billing the chronic care management code.  CMS expects that this accommodation will enhance the utilization of the 99490 service.”  As the ATA article points out, while CMS has acknowledged that data collection is a valuable service and should be incorporated into chronic care management, the CY 2015 PFS apparently will not allow additional payment for these data collection efforts.

Telehealth providers still should feel encouraged by the positive strides that the final rule makes to reimburse providers for a widening range of telehealth services provided to Medicare beneficiaries.  Interested providers should follow related Congressional efforts to pursue payment under Medicare for remote patient monitoring.  While the recent final rule may have yielded less momentum on the Medicare reimbursement front than originally thought, it is momentum nonetheless.

CMS Expands Telehealth Reimbursement in New Rule

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Who knew?!  Buried among more than 1,000 pages of a new final rule with comment period on payments to physicians, released on October 31, 2014, the Centers for Medicare & Medicaid Services (“CMS”) finally has given telehealth providers a glimpse of its plans to expand reimbursement for telehealth services provided to Medicare beneficiaries. 

The final rule includes a provision that would cover remote chronic care management using a new current procedural terminology (“CPT”) code, 99490 (with a monthly unadjusted, non-facility fee of $42.60).  This new CPT code can be bundled with the existing CPT code 99091 for collecting and reviewing patient data, which does not require the beneficiary to be present and pays an average monthly fee of $56.92 to the physician.  The final rule also includes a provision that would cover remote-patient monitoring of chronic conditions using existing CPT code 99091 (with a monthly unadjusted, non-facility fee of $56.92).  This provision will significantly broaden Medicare payments for remote patient monitoring of chronic conditions—while CPT code 99091 has been available for coverage of patient monitoring for many years, CMS traditionally has required (and will continue to require), that 99091 be billed in conjunction with evaluation and management (“E&M”) services (CPT codes 99201-99499), the most common of which are office visits.  Yet, since the new CPT code 99490 is an E&M code and is intended for coverage of monitoring chronic conditions, the two services can now be combined as chronic care management and remote patient monitoring with a combined monthly fee of approximately $100.  Notably, the 99490 and 99091 codes are available nationwide, as they are not considered by CMS as rural-only “telehealth” services.  CMS also added seven new procedure codes for telehealth services, including annual wellness visits, psychotherapy services, and prolonged services in the office.  Coverage under these new codes would begin in 2015.

Historically, Medicare has provided limited coverage for telehealth services, which has included coverage for interactive audio and video telecommunications that provide real-time communications between a practitioner and a Medicare beneficiary while the beneficiary is present at the encounter (Social Security Act § 1834(m); 42 C.F.R. § 410.78; Centers for Medicare & Medicaid Services, Medicare Benefit Policy Manual, ch. 15, § 270).  Medicare only has covered the provision of telehealth services if the beneficiary is seen: (a) at an approved “originating site” (e.g., physician offices, hospitals, skilled nursing facilities); (b) by an approved provider (e.g., physicians, nurse practitioners, clinical psychologists); and (c) for a small defined set of services, including consultations, office visits, pharmacological management, and individual and group diabetes self-management training services.

In a November 1, 2014 news release, American Telemedicine Association CEO Jonathan Linkous stated that the new final rule “has been a long time coming, but this rulemaking signals a clear and bold step in the right direction for Medicare” and, importantly, “allows providers to use telemedicine technology to improve the cost and quality of healthcare delivery.”

The 5 Issues That Trouble Regulators When Evaluating Direct-to-Consumer Telehealth

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There can be no question that telehealth has gone mainstream.  The numbers speak volumes. Telehealth companies have been able to raise almost $500 million since 2007 according to a noted venture capital analyst.  A recent study indicated that U.S. employers could save up to $6 billion a year through telehealth.  Per the American Telemedicine Association, more than half of all U.S. hospitals now offer some form of telehealth service.  Some leading analysts estimate that global revenue for telehealth will reach $4.5 billion by 2018, and the number of patients using telehealth services will rise to 7 million by the same year.   I can cite countless examples showing the bullish trajectory of telehealth.  But problems remain.

One of the issues I constantly deal with is the patchwork of state statutes and regulations governing various aspects of telehealth. Some of these issues are being addressed by stakeholders such as the Federation of State Medical Boards—which has released a draft model physician licensure compact that could go a long way in streamlining multistate licensure for physicians.  The Federation has also developed a  model telemedicine policy it hopes states will adopts.  Other leading organizations such as the American Medical Association, the American Academy of Pediatrics, the American Academy of Dermatology, and the American Telemedicine Association are addressing various issues in their own way.

These initiatives, however, cannot hide the fact that many state regulators are troubled by a number of issues when evaluating whether various direct-to-consumer telehealth models comply with state law. This is especially true in situations in which the telehealth provider does not have a pre-existing relationship with the patient.  Even beyond the legal issues, the state regulators I have spoken to express unease with various aspects of direct-to-consumer telehealth.  Essentially, their concerns can be boiled down to the following five:

  • Overprescribing.  E-visits drive over-prescription.  That is a view voiced by many state regulators.  Often cited is a study examining urinary tract infections among other things which showed significantly higher antibiotic prescriptions as a result of e-visits for UTIs when compared to in-person provider office visits.  Patients were also more likely to be prescribed an antibiotic for sinusitis if they were treated via an e-visit as opposed to an in-person visit—although that disparity was nowhere near as significant.  The CDC notes that the drivers of inappropriate antibiotic prescribing are more pronounced with telephone and e-visits.
  • Lack of Access to a Patient’s Medical Record.  State regulators also point out that providers in many direct-to-consumer telehealth models usually do not have access to a patient’s full medical record.  In the vast majority of cases, telehealth providers are making diagnoses and treatment recommendations relying on questionnaires the patients are required to complete immediately prior to obtaining services.  Critics believe providing health care without the full context of a patient’s complete medical record is simply not good medicine.
  • No Ability to Document E-Visit Into a Patient’s Medical Record.   Related to the last point, some state representatives voice concern that providers in direct-to-consumer models are unable to document the e-visit into a patient’s medical record—meaning that subsequent health care providers are unable to see the diagnosis, treatment recommendations, or medications prescribed to the patient from the e-visit.
  • No Follow-Up Care.  The nature of how direct-to-consumer telehealth is currently structured does not lend itself easily to follow up care as a normal course of practice.  And many medical board representatives I have spoken to believe that follow-up care is critical to sound medicine.
  • Quality of Care.  Perhaps the most troubling issue for many of the regulators I talk to is the belief that many of the models they see cannot deliver the same quality of care as patients walking into their doctor’s offices.  They point out that quality is compromised without: 1) direct in-person physical examination of the patient by the distant providers; 2) the lack of access to a patient’s full medical record; and 3) the general lack of follow up care.  Moreover, many regulators simply refuse to believe that conditions such as strep throat or ear infections, for example, can be treated via an e-visit—especially when no pre-existing provider/patient relationship exists.  These concerns, they emphasize, are exacerbated by the lack of highly developed protocols and guidelines governing telehealth.  While many recognize that organizations have been developing such guidelines, they warn a lot more work needs to be done.

No one can doubt that regulators raise very valid concerns.  In talking to various clinicians and providers, however, they indicate that many of the issues have been or are being addressed.  One of the problems is that the lines of communication between regulators and industry have not always been open.  In my next blog post, I will discuss what telehealth stakeholders have been doing to address the regulators’ concerns.

FSMB Releases Completed Draft Framework for Interstate Physician Licensure

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On September 5, 2014, the Federation of State Medical Boards, a nonprofit organization representing the 70 state medical and osteopathic boards nationwide, announced the completion of its drafting process for its Interstate Medical Licensure Compact (“Compact”). Finalizing the Compact is a critical step toward removing one of the major barriers preventing a greater proliferation of telehealth technologies and services. Under the Compact, a physician who is licensed in his or her principal state and who meets certain educational, certification, and disciplinary criteria would be eligible to apply for an expedited medical license in another state that has adopted the Compact. Adoption of the Compact by states not only will increase license portability for physicians by alleviating the traditional rigid state licensure requirements that impede the practice of telehealth, but also will help improve access to health care for patients across the nation who will benefit from greater adoption of telehealth.  You can read more here.

HIPAA Update: Insights from NIST and OCR

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On September 23 and 24, 2014, the National Institute of Standards and Technology (“NIST”) and the Department of Health and Human Services Office of Civil Rights (“HHS OCR”) hosted their annual HIPAA conference “Safeguarding Health Information: Building Assurance through HIPAA security.”

OCR officials and key industry leaders engaged in dialogue regarding developments and trends in data breach incidents with respect to health information as well as stakeholder responses and best practices to mitigate risk and respond to potential incidents.

VULNERABILITY AWARENESS: ASSESSING RISK

In her opening remarks, OCR Director Jocelyn Samuels highlighted the observation that information privacy compliance is poorly prioritized within organizations.  Specifically, Samuels identified the lack of widespread risk analysis and vulnerability assessment activities at the enterprise level as a key area meriting internal and agency prioritization.  Samuels reiterated that organizations dealing in protected health information (“PHI”) should, and in fact must, undertake to routinely assess and investigate vulnerability as part of an effective compliance program.

ENTERPRISE APPROACH

The aspiration of enterprise-wide security protocol for PHI, and adoption thereof, continues to be an ongoing work-in-progress.  This is especially true given the often divergent priorities within large provider systems and the endemic evolution of “local” IT systems that integrate with the sanctioned IT environment but often create network porosity and points of vulnerability.  Embracing comprehensive, end-to-end, privacy and security policies and procedures that serve the IT needs of the organization while operating within the security protocol established by the system is imperative to establish and maintain network integrity and compliance with the HIPAA Security Rule (“Security Rule”).

IF YOU LOOK FOR IT, YOU WILL FIND IT

OCR representative Linda Sanches proposed the thesis that “the question is not if you will have a breach, but more so when.”  To this end, the initial step to preparedness is the undertaking of a risk analysis as required by the Security Rule.  Stakeholders expressed frustration with the broadly stated requirements of the Security Rule that are non-specific as to what precise set of activities constitute compliance and how much is in fact enough.   This uncertainty adds to existing organizational tensions between resource allocations to business objectives versus compliance obligations with respect to the establishment and implementation of a reasonable compliance program.  Sanches indicated that a defensible and reasonable approach is what is required to establish compliance.

LESSONS FROM THE FIELD: REPORT FROM OCR

Iliana Peters, Senior Advisor for HIPAA Compliance and Enforcement at HHS OCR, reported on recent enforcement activities as well as OCR’s regulatory agenda.  With respect to reported incident activity, through August 31, 2014, theft and loss accounted for 51% and 9% of breach incidents, respectively followed by unauthorized access/disclosure at 18% among a total of 1176 reported breaches involving more than 500 people and in excess of 122,000 smaller breaches.

With respect to OCR’s regulatory agenda, Peters indicated that OCR is working on providing additional guidance and clarification to the Omnibus Final Rule including a breach safe harbor update, breach risk assessment tool, and clarification of the standards for minimum necessary. Peters also explained how the audit pilot program which is anticipated to go live in the near future will create a new enforcement channel for OCR outside of the breach response protocol.  She commented that although the audits will be mostly desk audits with shorter timelines than investigations, they will require covered entities and business associates to have their documents in order and respond quickly to requests.  Peters continued to state that “audits will be an enforcement tool which will result in compliance reviews and could result in enforcement actions up to and including civil monetary penalties. Peters stated “we may come to you because of an audit or a breach, but if we find gaps in the compliance program while there, we can’t walk away; it is our job to see it through”

RISK ELIMINATION: THE HOLY GRAIL

The global advice from OCR over the course of the conference was preparedness.  To that end, however, the best that healthcare stakeholders can aspire to is effective mitigation of risk.  OCR repeatedly stressed that “it is really important that covered entities and business associates prepare as much as possible” and take affirmative steps to protect their data.  A comprehensive and documented risk analysis is the key to identifying system vulnerabilities and stakeholders should undertake to conduct or update their risk analyses and work in concert with organizational management to prioritize security compliance.

Expect Increased OCR HIPAA Security Rule Enforcement for Mobile Devices

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The increasing prevalence of mobile technology in the healthcare sector continues to create compliance concerns for physician practices and other health care entities.  While the Office of Civil Rights (OCR) of the Department of Health and Human Services, has traditionally focused on technology breaches within larger health systems, smaller physician practices and health care entities must also ensure that their policies and practices related to mobile technology do not foster non-compliance and create institutional risk. 

Physicians Integrate Mobile Technology Into Daily Practice

The Physicians Practice’s 2014 Technology Survey found that only 31 percent of more than 1,400 survey respondents reported implementing policies and rules to address bring your own device (“BYOD”) practices.  With more than 80 percent of doctors using mobile devices at work and integrating their personal devices into their professional practice, these devices could potentially represent a significant privacy and security risk. 

Traditional Safeguards Undermined By “Anywhere” Access

The HIPAA Security Rule applies when any protected health information (PHI) is accessed and communicated through a mobile device, such as texting a patient’s name and phone number for follow-up calls.  In the annual OCR report to Congress on breaches of unsecured PHI for calendar years 2011 and 2012, OCR reported that information loss or theft from mobile devices was among the top three sources of breached PHI in 117 of the 222 reported breaches in 2012. Additionally, the Physicians Practice’s 2014 Technology Survey indicated that only 61 percent of the respondents surveyed reported securely backing data on a second server or via another method, thereby not complying with the HIPAA Security Rule which requires covered entities to create and maintain retrievable copies of electronic protected health information (ePHI).

OCR Enforcement Areas, Especially Among Small Breaches, Continue to Grow

OCR officials routinely remind covered entities and business associates to understand their obligations with respect to mobile device security – obligations that continue to become more complex to satisfy as the use of mobile technology in the workplace proliferates.  Simultaneously, OCR continues to increase enforcement of data breaches by entities subject to the HIPAA Security Rule. Significantly, this enforcement expansion has included smaller entities and breaches affecting fewer than 500 individuals.  OCR expects HIPAA Security Rule enforcement to continue its trend and increase going forward in 2014

Be Prepared

Physician practices and health care entities should conduct a thorough risk assessment which addresses the use of mobile devices and storage of mobile device data in their environment.  Additionally, policies and procedures should be developed to manage the risk associated with mobile devices to a business tolerable level.  Risk management plans and security evaluations should be updated and conducted periodically.  Additionally, physician practices and health care entities must remember that their business associates must also comply with the HIPAA Security Rule.  Thus, some diligence on the use of mobile devices in their business associates environment is advisable.  In practice, over 20 percent of HIPAA data breaches have been traced to noncompliant business associates. While the risk may be significant, with proper staff training to identify and address questionable HIPAA behaviors, physician practices and health care entities can minimize the risk of OCR enforcement and large settlement costs associated with mobile devices.

Reviewing Trends in PHI Breaches & Enforcement

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On May 20, 2014, the Secretary of the Department of Health and Human Services (HHS) submitted the agency’s Annual Report to Congress on Breaches of Unsecured Protected Health Information for Calendar Years 2011 and 2012 (“Breach Report”). This report provides valuable insight for healthcare entities regarding their data security and enforcement priorities.

Section 13402(i) of the Health Information Technology for Economic and Clinical Health Act (HITECH) requires the Secretary of Health and Human Services to prepare an annual report regarding the number and nature of breaches report to HHS, as well as the actions taken in response to those breaches.

By way of background, HITECH requires that both covered entities and business associates (as defined under HIPAA) provide notifications after a breach of unsecured protected health information (PHI).  These required notifications include the affected individuals, HHS, and also media outlets in cases where the breach includes more than 500 residents of a state or jurisdiction.  However, HHS has issued guidance explaining that encryption and destruction make PHI “unusable, unreadable, or indecipherable to unauthorized persons” and, thus, loss of such secured PHI does not trigger the breach notification requirements.

Report Findings

                Healthcare providers accounted for the majority of breaches affecting 500 or more individuals in both 2011 and 2012 while business associates and health plans accounted for the remainder, as illustrated below.

Breaching Entity 2011 2012 Change
Providers 63% 68% 5%
Business Associates 27% 25% (2%)
Health Plans 10% 7% (3%)
Total 100% 100% -

 

Theft of PHI was the leading cause of a breach in both 2011 and 2012 followed by loss of PHI and unauthorized access/disclosures.  In 2011, theft was the cause for 24% of the total number of individuals affected by a breach and loss accounted for 54% of individuals affected. This high affected rate due to loss was the result of single breach incident involving a business associate and loss of back-up tapes containing information on 4.9 million individuals. In 2012, the causes of breach returned to expected rates with 36% of individuals affected due to theft and 13% due to loss. The below tables outline the frequency of breach causes in 2011 and 2012 as well as the sources of the breached information in each year.

 

Causes of Data Breach 2011 2012
Theft 50% 52%
Loss of PHI 17% 12%
Unauthorized Access 19% 18%
Hacking/IT incident 8% 27%

 

Sources of Breach 2011 2012 Change
Laptop 20% 27% 7%
Paper 27% 23% (4%)
Server 9% 13% 4%
Desktop Computer 14% 12% (2%)
Other Portable Device 13% 9% (4%)
Email 1% 4% 3%
Electronic Medical Records 2% 2% 0
Other 14% 10% (4%)

 

Audit Information

                HITECH authorizes and requires HHS to conduct periodic audits of covered entities and business associates to ensure compliance with HIPAA rules. Unlike compliance reviews (which occur after a major breach) or compliance investigations, these audits are not triggered by an adverse event or incident.  Instead, they are “based on application of a set selection criteria.”

                The Office for Civil Rights (OCR) (the office within HHS that is responsible for administering the Breach Notification Rules) implemented a pilot program of the audit process to assess the privacy and security compliance which was described in the Breach Report. The audit revealed that 31 out of 101 audited entities had at least one negative audit finding related to the Breach Notification Rule.  Specifically, the audit examined the following four areas:  (1) notification to individuals, (2) timeliness of notification, (3) methods of individual notification, and (4) burden of proof.  All four areas had a similar number of deficiencies noted.

Implications and Recommendations for Healthcare Entities

                Breaches involving 500 or more individuals accounted for less than 1% of reports filed with HHS, yet represent almost 98% of the individuals affected by a PHI breach.  It is likely that OCR will continue investing significant resources into large scale PHI breaches due to the extensive impact of these breaches. Additionally, theft remains one of the top causes of PHI breaches and covered entities and business associates must take appropriate measures to ensure that any PHI stored or transported on portable electronic devices is properly safeguarded.  Chronic vulnerabilities include:

Encryption: Even if a device is stolen or misplaced, the Breach Notification Rule will not apply if the data is properly encrypted. Thus, it is imperative that covered entities and business associates encrypt portable electronic devices (such as laptops) and all CDs or USB thumb drives. 

Access Control: Healthcare entities must pay close attention to the physical access to and proper disposal of devices that contain PHI.  Server rooms should be locked with limited access, and the physical access to buildings, floors, and offices should be secured to prevent theft of desktop computers containing PHI. 

Disposal: Electronic devices need to be purged and the data securely erased (also known as “scrubbed”) prior to the device being discarded, recycled, sold, or transferred to a third party, such as a leasing company.  Such devices include computers, external storage media, and photocopiers.

Lastly, as explained in the Breach Report discussion of OCR’s audit pilot program, covered entities most often explain noncompliance with the various aspects of the Breach Notification Rule by pleading unawareness of the requirements of the Rules. Covered entities and business associates should ensure that comprehensive privacy and security policies and procedures are developed and implemented to mitigate the risks of a breach and to effectively respond to a breach should one occur.

Contrary to Misconceptions, a Final Guidance is Not a Final Rule

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Earlier this week, a popular source of regulatory news published an article claiming FDA “finalized a new rule this week that prohibits manufacturers from using so-called “split-predicates”. However, it appears that the article may instead be referencing the Final Guidance for Industry and Food and Drug Administration Staff entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” that FDA published earlier this week.  Unfortunately, as often occurs on the Internet, the post was disseminated by several other popular sources of regulatory news.

This confusion comes a little less than three months after four Senator’s sent a letter to FDA raising concerns about FDA draft guidance “becoming the default FDA policy and position.”

Guidances and final rules carry different legal weight.  Final regulations are legislative rules that have the force of law. Whereas, guidances do not set new legal standards, impose legal requirements or have the force of law. Instead guidances are issued to help interpret or clarify an existing regulation.   

FDA certainly understands this difference.  As FDA notes, “FDA regulations are [] federal laws, [even though] they are not part of the [federal Food Drug & Cosmetic Act (FD&C Act)].”  Whereas, “FDA guidance describes the agency’s current thinking on a regulatory issue [but guidance] is not legally binding on the public or FDA.”

FDA also emphasizes this latter point in many of its guidance documents by including the following disclaimer:

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

Unfortunately, not everyone fully appreciates the difference between rules and guidance. The recent confusion suggests that there is a disconnect between FDA’s position on the difference between guidance and final rules and the understanding of at least some in industry.  Therefore, as FDA reviews its current guidance development practice, it is important that FDA look for ways to ensure (draft or final) guidance is just that, guidance.  For example,

  • FDA should make the guidance development process more efficient and so that there is a significant difference between the time it takes to publish a final guidance and the time it takes to implement a final rule;
  • If a manufacturer uses an alternative approach and provides reasonable support for taking such an approach, FDA should be required to provide a reasonably explanation as to why the alternative is insufficient;
  • FDA should include a process for quickly and efficiently incorporating alternative approaches into existing final guidance.

FSMB Releases Revised Draft Framework for Interstate Physician Licensure

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One of the largest hurdles to the growth of telehealth—the lack of a streamlined process for obtaining physician licensure in multiple states—is one step closer to being scaled. The Federation of State Medical Boards (“FSMB”) recently released a revised draft of its Interstate Medical Licensure Compact (“Compact”). This revised draft is a continuation of efforts by FSMB and its member boards to study the feasibility of an interstate license portability. Additionally, the revised draft of the Compact reflects changes based upon comments received from FSMB member boards and other stakeholders since the draft was released by FSMB earlier this year. Adoption of the Compact is critical to the interstate practice of telehealth.  You can read the full alert here.

Promoting Patient Privacy through Effective Notices of Privacy Practices

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By Brandon Ge and Alaap Shah

The Department of Health and Human Services (“HHS”) is taking laudable steps to improve notices of privacy practices (“NPPs”) and make them more clear, understandable, and user-friendly. Under the HIPAA Privacy Rule, individuals are entitled to a receive an NPP informing them of how their health information may be used and shared, as well as how to exercise their health privacy rights. Health plans and health care providers must develop and distribute NPPs that clearly explain these rights and practices. Unfortunately, to date NPPs have been poorly designed, hard to navigate and unclear with regard to patient rights or company obligations regarding use and disclosure of health information.

Privacy is just as much about protecting patients’ rights to data as it is about protecting data. The HIPAA Omnibus Rule, CLIA Rule, and others are designed to improve patient access to their medical records, empowering them to actively manage their health. The digitization of medical records, in the form of electronic health records, personal health records, patient portals, and the like, facilitates patient engagement in healthcare if used properly.  However, ineffective NPPs create barriers for patient understanding their rights.

NPPs that clearly convey patients’ privacy rights are critical in enabling patients to take a more active role in healthcare. Conversely, if patients do not understand NPPs, then they won’t have a good sense of their privacy rights, including their right to access their health information. Some critiques regarding NPPs include that they are frequently lengthy and include legalese that the general public has difficulty understanding.  To remedy these concerns, some suggest simplifying language and “layering” the notice—that is, including a short summary of the individual’s rights as a first layer and including a longer, more detailed explanation as a second layer—would go a long way toward improving the readability of NPPs.

In an effort to address criticisms of NPPs, last month, the Office of the National Coordinator for Health Information Technology (“ONC”) collaborated with the HHS, Office for Civil Rights (“OCR”) to develop model NPPs that clearly convey the required information to patients in an accessible format. Covered entities can customize these model NPPs and then display them and distribute them to patients.

ONC and OCR have also thrown down the gauntlet and established the Digital Privacy Notice Challenge, which will award $15,000 to the creators of the best online NPP (second place wins $7,000 and third place gets $3,000). The challenge calls for designers, developers, and privacy experts to use the model notices as a baseline and create an online NPP that is clear, effectively informs patients of their privacy rights, and is easily integrated online. Once submissions are finalized, the public will have two weeks to vote on the best submission.

The submission period ends on April 7, 2014, and winners will be announced in May or June of 2014.

Does your organization think it has what it takes to win this challenge?

 

Follow Alaap Shah on Twitter: @HealthITLawyers