TechHealth Perspectives

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

Telemedicine Has an Unlikely Ally: The FTC

LinkedIn Tweet Like Email Comment

As a lawyer practicing in the telemedicine space, I am rarely surprised these days.  But every once in a while I will read or hear something that stops me in my tracks. That is exactly what happened when I read a blog post by an FTC Commissioner which, among other things, calls for government policies that help facilitate greater adoption of telemedicine.  The post was part of a broader piece about the FTC’s role in promoting competition and innovation in health care.

By way of quick background, the Federal Trade Commission is the federal agency charged with protecting consumers and promoting competition, which includes challenging anticompetitive business practices.  The agency has been active in the health care sector, challenging several hospital and physician practice mergers. In an effort to highlight some of the FTC’s non-enforcement efforts, one of the agency’s five commissioners, Maureen Ohlhausen, wrote a blog post touting the agency’s advocacy efforts in the health care arena, and specifically highlighted how the FTC’s competition policy could help facilitate greater proliferation of telemedicine.

Among the highlights in the post related to telemedicine:

  • Telemedicine can reduce costs and increase access to care, but such advantages often run afoul of state professional licensing schemes that were developed to regulate local medical practices.
  • The variation in state licensure and other requirements continues despite “the fact that the core entry requirements for physicians are essentially uniform across the U.S”.
  • Legacy statutes and regulations are barriers “to the efficient flow of health care information and expertise and, indeed, specialized labor — barriers that can be costly to public and private payers and, in the end, individual patients,” without necessarily offering better consumer protection benefits.
  • Lawyers and policymakers need to creatively address ways to lower barriers without sacrificing the good in state regulations.
  • It is critical that policymakers “approach new technologies with a dose of regulatory humility” and should educate themselves about technological innovation, and:
    • Understand its effects on consumers and the marketplace;
    • Identify benefits and likely harms, and;
    • If harms do exist, consider whether existing laws and regulations sufficiently address the issues before assuming that new laws would be required.

Ms. Ohlhausen goes on to call for the FTC to use its policy research and development tools to better understand innovative technology, new business models facilitated by the new technology, and the likely risks and benefits for consumers.  More significantly, Ms. Ohlhausen also challenges the agency to educate itself “about undue impediments to innovation and competition” while also using its authority to enforce against harm to consumers from the use of new health information technology vehicles.

I can only applaud Ms. Ohlhausen’s approach.  It is encouraging to see a policymaker acknowledge the role regulations may play in stifling innovation and call for government agencies to find creative ways to lower barriers while balancing consumer protection.  I only hope other regulators follow Ms. Ohlhausen’s lead.


New Jersey Law Requires Encryption of Personal Information

LinkedIn Tweet Like Email Comment

On January 9, 2015, New Jersey Governor Chris Christie signed new legislation that will require health insurance carriers authorized to issue health benefits plans in the state—including insurance companies, health service corporations, hospital service corporations, medical service corporations, and health maintenance organizations—to encrypt personal information. Triggered by a series of data breaches involving the health information of almost a million residents, Senate Bill No. 562 (“SB 562”) was passed unanimously by both houses of the state legislature and will take effect on August 1, 2015.

Under SB 562, health insurance carriers will be prohibited from maintaining computerized records that contain personal information unless the information is “secured by encryption or by any other method or technology rendering the information unreadable, undecipherable, or otherwise unusable by an unauthorized person.” The use of a password protection program that prevents general unauthorized access will not suffice to meet the encryption requirement. “Personal information” is defined as an individual’s first name or first initial and last name linked with at least one of the following: (1) Social Security number, (2) driver’s license number or state identification card number, (3) address, or (4) identifiable health information.

The law applies only to end user computer systems and computerized records transmitted across public networks. “End user computer systems” include desktop computers, laptop computers, tablets and other mobile devices, and removable media.

The requirement to encrypt makes the New Jersey law stricter in this regard than the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), under which encryption of electronic protected health information (“ePHI”) is an addressable specification. Nonetheless, given that encrypted ePHI is exempt from HIPAA’s breach notification requirements, it is considered a best practice to encrypt ePHI.

Violation of New Jersey’s encryption mandate will constitute a violation of the New Jersey Consumer Fraud Act, which imposes penalties of up to $10,000 for the first offense and up to $20,000 for any subsequent offense. The state Attorney General may also issue cease-and-desist orders to violators and award treble damages and costs to affected individuals. Given these potential penalties, health insurance carriers in New Jersey should carefully review their policies and procedures and ensure compliance with the new law.

A Telehealth Tutorial: The Promise of Telehealth

LinkedIn Tweet Like Email Comment

As telehealth grows and becomes more mainstream, all kinds of questions often arise.  They range from administrative to operational to legal issues. In conjunction with the American Hospital Association, my colleague Amy Lerman and I have co-written two white papers for the American Hospital Association Trendwatch series focusing on telehealth issues. Among other things, the white papers discuss telehealth, operational, legal, regulatory, and policy issues.  The first white paper entitled “The Promise of Telehealth for Hospitals, Health Systems and Their Communities,” focuses on the following:

  • How the terms “telehealth” and “telemedicine are defined by various stakeholders;
  • Telehealth market trends and drivers of future growth;
  • Various applications of telehealth by hospitals;
  • The benefits of telehealth for hospitals;
  • Payment for telehealth services provided by hospitals; and
  • Various hospital case studies involving telehealth.

The second part of the white paper series focuses on the legal and regulatory issues implicated by telehealth.  You can read the entire first white paper by clicking here. 

President Obama to Announce New Privacy Initiatives in SOTU

LinkedIn Tweet Like Email Comment

The State of the Union Address, scheduled for January 20, 2015, will contain new initiatives related to privacy, White House officials say. The known initiatives are the introduction of a data breach reporting bill, a bill restricting the sale of student information, and a Consumer Privacy Bill of Rights.

SETTING A NATIONAL DATA BREACH REPORTING STANDARD

President Obama is planning on introducing a data breach bill that would standardize the reporting period nationwide at 30 days. The proposed Personal Data Notification and Protection Act would require direct customer notification. The law would also criminalize selling consumer identities overseas.

Presently, most states have their own consumer data protection laws requiring customer notification in the event of a breach. The new bill may preempt stricter state laws such as California’s 5-day window for reporting.

RESTRICTING THE USE OF STUDENT DATA

The White House will also propose the Student Digital Privacy Act, based on a California law passed last September. The main purpose of the bill is to restrict the sale of student data for use unrelated to education as well as restricting targeted advertising based on school-collected data. The bill seeks to restrict commercial uses while at the same time ensuring that outcome-based studies are allowed to continue.

ENACTING THE CONSUMER PRIVACY BILL OF RIGHTS

In 2012, the White House revealed plans for a Consumer Privacy Bill of Rights. This white paper laid out a set of seven guiding principles for consumer privacy (see Appendix A of the linked PDF). After receiving and incorporating suggestions during the last three years, the President will reportedly ask Congress to enact a revised Consumer Privacy Bill of Rights into law. The bill would ensure more control over personal data for individuals, more closely in line with the rules in place in the European Union.

STAY TUNED FOR UPDATES

As more information is released regarding the President’s privacy and security plans, we will cover it here, so check back in the coming days.

ATA Gets Clarification Regarding New Medicare Reimbursement Rules for Telehealth

LinkedIn Tweet Like Email Comment

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

LinkedIn Tweet Like Email Comment

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

LinkedIn Tweet Like Email Comment

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

LinkedIn Tweet Like Email Comment

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

LinkedIn Tweet Like Email Comment

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

LinkedIn Tweet Like Email Comment

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.