On January 31, 2020, the Secretary of the U.S. Department of Health and Human Services (HHS) declared a public health emergency in response to the COVID-19 pandemic. A number of federal government agencies have since taken action to temporarily relax certain regulatory requirements that will allow healthcare providers and payors to address the COVID-19 emergency expeditiously and efficiently through the use of telehealth. Similar actions are also being taken at the state level. Below is a summary of the more significant measures that have been taken to promote the use of telehealth in combatting COVID-19 in the United States. These measures will be in effect for the duration of the public health emergency.

Waived Practitioner Licensure Requirements

On March 13, CMS announced a waiver of the requirement that healthcare practitioners providing telehealth services must be licensed in the state where the patient is located in order to obtain Medicare and Medicaid reimbursement. As a result, a practitioner licensed in one state may now be paid by Medicare and Medicaid for a telehealth visit with a patient located in a different state.

CMS’s waiver is limited to reimbursement and does not waive long-standing state laws requiring those practicing medicine to be licensed in that state. However, states, including California and Florida, are beginning to waive in-state licensing requirements for healthcare practitioners licensed in other states who are assisting with COVID-19 response efforts.

Continue Reading Telehealth Being Deployed to Combat COVID-19: Federal and State Governments Relax Numerous Requirements

A Pennsylvania resident (“Plaintiff”) has filed a class action complaint (the “Complaint”) in the United States District Court for the Central District of California against Sunshine Behavioral Health Group LLC (“Sunshine Behavioral”), which operates drug and alcohol addiction rehabilitation centers. The Complaint alleges, among other things, violations of the California Consumer Protection Act (Cal. Civ. Code § 1798.100, et seq.) (“CCPA”) in connection with a September 2019 data breach. The complaint alleges that Sunshine Behavioral violated the CCPA by exposing class members’ personal and health information because of a failure to “implement and maintain reasonable security procedures and practices appropriate to the nature and protection of that information.” Plaintiff seeks injunctive relief enjoining further violation of the CCPA, as well as potential “actual, punitive, and statutory damages[.]” The Complaint further alleges that, although Sunshine Behavioral was made aware of the data breach in September 2019, it failed to provide affected individuals and the California Attorney General notice of the breach until January 21, 2020.

The CCPA offers a limited private right of action to consumers “whose nonencrypted or nonredacted personal information . . . is subject to an unauthorized access and exfiltration, theft, or disclosure” resulting from a failure to implement reasonable security measures. Except for specific pecuniary damages, however, plaintiffs may only seek damages after notifying defendant of the purported violation and allowing 30 days to cure the violation.

Continue Reading Former Patient Brings Class Action Against Rehab Center Under CCPA’s Private Right of Action

It has been a busy last few weeks at the U.S. Department of Health and Human Services Office for Civil Rights (OCR).  OCR has announced four new enforcement actions, the most recent of which is rooted in a healthcare provider’s failure to properly identify and report a breach of protected health information (PHI), and the others in healthcare providers’ failure to conduct thorough, enterprise-wide HIPAA security risk analyses.

Interestingly, the actions involve a varied group of healthcare providers, from a state health services agency to a multi-hospital system—only two of which decided to enter into settlement agreements with OCR.  Despite the differences in the healthcare providers and their approaches to reaching a resolution, the enforcement actions provide several key takeaways for other covered entities and business associates.  Continue Reading Spate of New OCR HIPAA Enforcement Actions Confirms the Importance of (No Surprise!) Conducting a Thorough Risk Assessment and Prompt Breach Reporting

The laws, rules, and regulations regarding privacy and data security are changing throughout the world. In the United States, California recently passed the California Consumer Privacy Act (CCPA), which is due to take effect in 2020. In May 2018, Europe enacted the General Data Protection Regulation (GDPR), which introduced sweeping changes to EU privacy law and contains specific requirements regarding data security and safeguarding information. Brazil and India have respectively passed and proposed privacy laws that borrow heavily from the GDPR. Other countries and states are also in the process of implementing or updating their privacy and security laws. These laws will require organizations to ensure that privacy and data security—beyond just HIPAA—are key considerations in the early stages of new product and service development and throughout the life cycle of these products and services. Venable has compiled a helpful summary of the high-level privacy and security considerations to keep in mind while designing products and services and during the entire life cycle of those products and services. The considerations outlined below are drawn from certain common principles in these laws and should be used to help plan and manage new or materially changed products and services.

Continue Reading Global Privacy and Security by Design Considerations

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced last week that it entered into a Resolution Agreement with a Florida medical center (“Medical Center”) following allegations that the Medical Center failed to respond to a patient’s request for medical records in a timely fashion and in violation of the patient’s right to access such records under HIPAA. While the $85,000 settlement amount is relatively small in comparison to the seven-figure settlements that OCR has entered into in recent years, this enforcement action is notable for being the first related to OCR’s Right of Access Initiative launched earlier this year. The OCR Right of Access Initiative seeks to enforce patients’ right to receive copies of their medical records promptly and without being overcharged.

The Settlement

OCR initiated an investigation into the Medical Center following its receipt of a complaint from a mother who requested access to her unborn baby’s medical records under the HIPAA right of access. The HIPAA right of access extends to personal representatives of the patient, such as parents of minor children. The mother first requested access to her baby’s medical records in October 2017, at which point the Medical Center informed the mother that the records could not be found. The mother’s attorney subsequently requested the records on her behalf in January 2018 and again in February 2018. The Medical Center did not provide the mother with a complete set of records until August 2018, after she had already submitted her complaint to OCR and OCR’s investigation had commenced.

Continue Reading New HIPAA Settlement Is the First under OCR’s Right of Access Initiative

The Department of Health and Human Services Office for Civil Rights (OCR) has shown once again that it is willing to enforce HIPAA against business associates, as seen in a recent settlement. The settlement highlights the importance of thorough risk analysis conducted by business associates and covered entities, as required by the HIPAA Security Rule, and serves as an indication that OCR remains ready to exercise its authority to enforce HIPAA’s requirements for business associates. Following the settlement, OCR released a fact sheet that provides guidance for HIPAA compliance and direct liability for business associates.

Recent Settlement

On May 23, 2019, OCR announced a settlement with a business associate relating to a 2015 data breach. The business associate provides software to healthcare providers that allows patients to access and manage their electronic health records through a patient portal. The company has agreed to pay OCR $100,000 to settle potential violations of HIPAA.

In July 2015, the company filed a breach report with OCR following discovery that hackers had used a compromised user ID and password to access the electronic protected health information (ePHI) of approximately 3.5 million individuals. The hackers gained access to a server containing names, addresses, usernames, passwords, and health insurance information. An investigation by OCR revealed that the company did not conduct a comprehensive risk analysis prior to the breach. In addition to a $100,000 settlement with OCR, the company will also undergo a two-year corrective action plan that includes a complete, enterprise-wide risk analysis. As part of the corrective action plan, the company has agreed to:

Continue Reading Recent Settlement with OCR and New OCR Fact Sheet Serve as Reminders That Business Associates Have Direct Liability under HIPAA

Despite the announcement made last week by the Department of Health and Human Services Office for Civil Rights (OCR) about certain reduced penalty caps under the Health Insurance Portability and Accountability Act (HIPAA), OCR has shown in this week’s settlement that it still plans to vigorously enforce HIPAA.

New Maximum Annual Penalty Caps

On April 30, 2019, OCR announced in a Notification of Enforcement Discretion new annual penalty caps for identical violations of a requirement or prohibition under HIPAA. Specifically, under HIPAA, the penalty tiers are based on four levels of culpability. Until the announcement, the annual cap for identical violations was $1.5 million for every level of culpability. Now, after the announcement, only the last tier (willful neglect-not corrected) is subject to that higher cap of $1.5 million. The lower three tiers of culpability have lesser annual caps for identical violations—specifically, willful neglect-corrected – $250,000; reasonable cause – $100,000, and no knowledge – $25,000. The settlement announced this week signals that OCR is still willing to pursue enforcement of HIPAA violations and to seek big settlements for those violations.

Continue Reading New Settlement with OCR Reminds Healthcare Companies of the Importance of a Timely and Thorough Investigation of Security Incidents

A private practice (Practice) comprising three physicians has agreed to pay the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) $125,000 to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA). While the fine is small compared with OCR’s October announcement of the $16 million settlement with Anthem, it confirms OCR’s ongoing commitment to enforcing HIPAA compliance, regardless of an organization’s size or the number of impacted individuals. Additionally noteworthy is that this enforcement action originated with a civil rights complaint filed by the Connecticut Office of Protection and Advocacy for Persons with Disabilities with the U.S. Attorney’s Office for the District of Connecticut, which initiated a joint investigation into the matter with OCR.

In February 2015, a patient of the Practice contacted a local television station to inform a reporter of a dispute with one of the Practice’s physicians related to the patient’s service animal. When the reporter contacted the physician for comment, the physician responded to the inquiry and, in the process, released the patient’s PHI to the public, even though the Practice’s privacy officer counseled the physician not to respond to the reporter or to respond with “no comment.” OCR determined that the physician’s conversation with the media demonstrated reckless disregard for the patient’s privacy rights, and further found that the Practice failed to take corrective actions or sanction the physician following the impermissible disclosure.

Continue Reading Small Physician Practice Settles with OCR: Yet Another Reminder of the Perils of Responding to Patient Complaints in a Public Forum

After a relatively quiet start to 2018, the Office for Civil Rights within the U.S. Department of Health and Human Services (OCR) has had an incredibly busy week, with the announcement of a blockbuster settlement, an updated security risk assessment tool, and new priorities for the agency.

Anthem Settlement

In a record-breaking settlement, Anthem, one of the nation’s largest health benefits companies, has agreed to pay OCR $16 million and take substantial corrective actions to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) after self-reporting a series of cyberattacks that resulted in the largest health information data breach in U.S. history. Notably, the breach included electronic protected health information (ePHI) that Anthem maintained as a business associate acting on behalf of its affiliated health plans, making this week’s enforcement action by OCR one of the few involving a business associate.

In March of 2015, Anthem filed a breach report with OCR informing the agency of its discovery that cyberattackers had gained access to its information and technology (IT) systems through an undetected continuous and targeted cyberattack for the alleged purpose of extracting data. After filing the report, Anthem later discovered that the cyberattackers had infiltrated its IT systems through a phishing scam sent to one of its subsidiaries that was initiated by at least one employee responding to a malicious e-mail.

Continue Reading A Busy Week at OCR: The Anthem Settlement, an Updated Security Risk Assessment Tool, and New Priorities for OCR

Recently, the attorneys general of eleven states and the District of Columbia filed suit to challenge the Department of Labor’s (DOL) new association health plan (AHP) regulations (the “AG Litigation”). Although it is unclear at this time whether the AG Litigation will be successful in invalidating the regulations, it creates a potential impediment for a key aspect of the Trump administration’s effort to change the health insurance marketplace.

The AHP Regulations

An AHP is a group health plan that is sponsored by an association of employers and is treated as a single employee benefit plan for regulatory purposes. According to the DOL, AHPs offer small employers (and now self-employed individuals) the following key advantages over sponsoring a group health plan at the individual employer level (or procuring individual coverage):

  • Because AHPs can negotiate with insurers or healthcare providers on behalf of the entire group (instead of each employer negotiating individually), the AHP will theoretically obtain lower premium rates; and
  • Because AHPs typically have enough participants to qualify as a “large group” plan, an AHP is not subject to the more stringent Affordable Care Act (ACA) requirements imposed on plans in the “small group” and individual markets.

Although the concept of AHPs predates the DOL’s new regulations, associations had difficulty forming AHPs under prior law. Before the new regulations, an association could form an AHP only if it satisfied stringent “commonality of interest” standards. Those standards require that the association be formed for a purpose unrelated to the provision of benefits, and that it have a common economic or representational interest in a narrow sense. As a practical matter, few employers could satisfy these requirements, and AHPs have not been commonplace.

Continue Reading New Association Health Plan Rules and What the Recent Attorneys General Lawsuit Means for These New Rules