Thursday, March 26, 2020

COVID: Office for Civil Rights Issues Guidance on How Covered Entities May Disclose PHI About an Individual Infected/Exposed to COVID-19

Written by Bob Coffield, Flahety Sensabaugh Bonasso PLLC

On March 24, 2020, the Office for Civil Rights (OCR), U.S Department of Health and Human Services issued the following guidance document related to the ongoing COVID crisis, COVID-19 and HIPAA: Disclosures to law enforcement, paramedics,other first responders and public health authorities.

The OCR guidance indicates that covered entities (hospitals, physicians, long term care facilities, home health agencies, and other providers) may disclose protected health information (PHI) about an individual who has been infected with or exposed to COVID-19 to law enforcement, paramedics, other first responders, and public health authorities in compliance with the Health Insurance Portability and Accountability Act of 1996 under the Privacy Rule  (HIPAA). The PHI can be disclosed by the covered entity without first obtaining the individual's HIPAA authorization. 

The guidance explains the circumstances under which a covered entity may disclose PHI such as the name or other identifying information about individuals, without their HIPAA authorization, and provides examples including:
  • When needed to provide treatment;
  • When required by law;
  • When first responders may be at risk for an infection; and
  • When disclosure is necessary to prevent or lessen a serious and imminent threat.
This guidance clarifies the regulatory permissions that covered entities may use to disclose PHI to first responders and others so they can take extra precautions or use personal protective equipment. The guidance also includes a reminder that generally, covered entities must make reasonable efforts to limit the PHI used or disclosed to that which is the "minimum necessary" to accomplish the purpose for the disclosure. 

Examples outlined in the guidance include the following: 
  • HIPAA permits a covered skilled nursing facility to disclose PHI about an individual who has COVID-19 to emergency medical transport personnel who will provide treatment while transporting the individual to a hospital’s emergency department. 45 CFR 164.502(a)(1)(ii); 45 CFR 164.506(c)(2).
  • HIPAA permits a covered entity, such as a hospital, to disclose PHI about an individual who tests positive for COVID-19 in accordance with a state law requiring the reporting of confirmed or suspected cases of infectious disease to public health officials. 45 CFR 164.512(a). 
  • HIPAA permits a covered entity to disclose PHI to a public health authority (such as the Centers for Disease Control and Prevention (CDC), or state, tribal, local, and territorial public health departments) that is authorized by law to collect or receive PHI for the purpose of preventing or controlling disease, injury, or disability, including for public health surveillance, public health investigations, and public health interventions. 45 CFR 164.512(b)(1)(i); see also 45 CFR 164.501 (providing the definition of “public health authority”).
  • HIPAA permits a covered county health department, in accordance with a state law, to disclose PHI to a police officer or other person who may come into contact with a person who tested positive for COVID-19, for purposes of preventing or controlling the spread of COVID-19. 45 CFR 164.512(b)(1)(iv).
  • HIPAA permits a covered entity, consistent with applicable law and standards of ethical conduct, to disclose PHI about individuals who have tested positive for COVID-19 to fire department personnel, child welfare workers, mental health crisis services personnel, or others charged with protecting the health or safety of the public if the covered entity believes in good faith that the disclosure of the information is necessary to prevent or minimize the threat of imminent exposure to such personnel in the discharge of their duties. 45 CFR 164.512(j)(1).
  • HIPAA permits a covered entity, such as a physician, located at a prison medical facility to share an inmate’s positive COVID-19 test results with correctional guards at the facility for the health and safety of all people at the facility. 45 CFR 164.512(k)(5).
  • A covered entity, such as a hospital, may provide a list of the names and addresses of all individuals it knows to have tested positive, or received treatment, for COVID-19 to an EMS dispatch for use on a per-call basis. The EMS dispatch (even if it is a covered entity) would be allowed to use information on the list to inform EMS personnel who are responding to any particular emergency call so that they can take extra precautions or use personal protective equipment (PPE). Under this example, a 911 call center that is a covered entity should only disclose the minimum amount of information that the officer needs to take appropriate precautions to minimize the risk of exposure. Depending on the circumstances, the minimum necessary PHI may include, for example, an individual’s name and the result of the screening.
For more information on HIPAA and COVID-19, see OCR's February 2020 Bulletin, Office for Civil Rights, U.S. Department of Health and Human Services BULLETIN: HIPAA Privacy and Novel Coronavirus.

UPDATE (3/30/2020): 

Following is additional HIPAA privacy related flexibility and guidance issued by the Office for Civil Rights (OCR):

Wednesday, March 25, 2020

COVID-19: Small Business Administration Implementing Automatic Deferment on Payments Through the End of 2020

Additional relief was announced on Monday, March 23, 2020, by the U.S. Small Business Administration (“SBA”) for borrowers of home and business disaster loans currently in repayment. To assist borrowers who are repaying SBA loans from past disasters, the SBA is implementing a deferment on payments through the end of 2020.  The deferment is automatic, so borrowers of business and home disaster loans do not have to contact the SBA to request the deferment.

Written by Bryan Price of Flaherty Sensabaugh Bonasso, PLLC

Tuesday, March 24, 2020

Municipal Law: Navigating the West Virginia Open Governmental Meetings Act in Response to COVID-19

Municipal Law: Navigating the West Virginia Open Governmental Meetings Act in Response to COVID-19

By James V. Cann and Michael Secret, Flaherty Sensabaugh Bonasso PLLC

On March 23, 2020, Governor Jim Justice issued an executive “Stay-at-Home” home order, officially known as Executive Order 9-20, in an attempt to further combat the spread of COVID-19 within West Virginia. However, municipal governments may be left asking themselves what impact this will have on their ability to hold meetings and make decisions to best benefit their citizens. Below is a quick guide to the requirements for a meeting under the West Virginia Open Governmental Meetings Act (“the Act”) and how these requirements can be met in consideration of COVID-19.

First and foremost, municipal government is included as “essential business” under Section 3, Subsection (d) of Governor Justice’s executive order. Therefore, municipal decision-making bodies are still permitted to meet in light of West Virginia’s attempts to combat COVID-19. However, many municipalities may feel the need to hold their meetings in a way that limits in-person contact between citizens while still allowing citizens to take part in and observe municipal government functions.

A “meeting” covered by the Act is a convening of a quorum of a governing body or subcommittee to make a decision or deliberation towards a decision. If this discussion takes place outside the confines of a public meeting—whether in person, by telephone, email or other telecommunication means — it is an illegal meeting. Therefore, a municipal decision-making body cannot make decisions unless it is in the public eye. This can obviously cause some public safety issues when considering meeting in spite of COVID-19.

However, the Act simply requires municipal governing bodies to meet in open session where citizens may observe the proceedings in a reasonably accessible setting. Meetings by telephone, video, or webcast are still allowed if the public is reasonably able to participate. Any effort to hold a public meeting by remote means should be communicated clearly in the meeting agenda, with the procedure to access the meeting laid out.

Monday, March 23, 2020

West Virginia Governor Issues "Stay at Home Order" Effective Tuesday, March 24 at 8:00 pm

Today the Governor of West Virginia announced a "Stay at Home Order" effective Tuesday, March 24 at 8:00 p.m. The Order does not have a duration listed but instead states that the Order will be in effect until terminated. Here is a summary FAQ issued by WVDHHR on "Staying at Home in West Virginia".

The State of West Virginia Executive Department issued Executive Order No. 9-20, March 23, 2020, provides the detailed requirements of the "Stay at Home Order" and specifically lists those essential businesses and operations that can continue along with those non-essential businesses and operations that must temporarily cease operation. The Order states,

1. Stay at home or your place of residence. To preserve public health and safety, and to ensure the healthcare system in West Virginia is capable of serving all citizens in need, especially those at high risk and vulnerable to COVID-19, all individuals within the State of West Virginia are under a general stay-at-home order and are directed to stay at home or their place of residence unless performing an essential activity. An activity is essential if the purpose of the activity is one of the following:

a. Obtaining food, medicine, and other similar goods necessary for the individual or a family member of the individual.

b. Obtaining non-elective medical care and treatment and other similar vital services for an individual or a family member of the individual.

c. Going to and from an individual's workplace if such workplace and/or work is included in the definition of Essential Businesses and Operations as outlined in Section 3, below.

d. Going to and from the home of a family member.

e. Going to and from the home of another individual who, under the terms of a parenting plan or similar agreement, is entitled to visitation with or the care of a child.

f. Going to and from an individual's place of worship.

g. Engaging in outdoor activity, provided that individuals at all times and as much as reasonably possible maintain social distancing of six feet from one another and abide by a 1 0-person limitation on gathering size.

Further, the Order outlines the following prohibited activities stating,

"All places of public amusement, whether indoors or outdoors, including but not limited to locations with amusement rides, carnivals, zoos, museums, arcades, fairs, pool halls, bingo halls, malls (except where stores in a mall that have a direct outdoor entrance and exit that provide essential services and products under the terms of this Order), children's play centers, playgrounds, bowling alleys, movie and other theaters, concert and music halls, adult entertainment venues, racetracks, social clubs, and other similar businesses shall be closed."

The Order continues by stating that,

"All public and private gatherings of any number of people occurring outside a single household or living unit are prohibited, except for the limited purposes permitted by this Order. Any gathering of more than 1 0 people is prohibited unless exempted by this Order. Nothing in this Order prohibits the gathering of members of a household or residence."




COVID: West Virginia Board of Pharmacy Issues Emergency Rule Limiting Prescriptions for Chloroquine and Hydroxychloroquine

West Virginia Board of Pharmacy Issues Emergency Rule Limiting Prescriptions for Chloroquine and Hydroxychloroquine 

Written by Luke Schmitt, Flaherty Sensabaugh Bonasso PLLC

On March 21, 2020, the West Virginia Board of Pharmacy proposed an emergency rule pursuant to its general rulemaking authority seeking to ensure that chloroquine and hydroxychloroquine – two drugs thought to be potentially helpful in the treatment of COVID-19 – are only dispensed to individuals currently in need of these drugs. The emergency rule, Section 15-1-26.1, provides:

26.1 No prescription for chloroquine or hydroxychloroquine may be dispensed except if all the following apply:
26.1.a. The prescription bears a written diagnosis from the prescriber consistent with the evidence for its use;

26.1.b. The prescription is limited to no more than thirty (30) tablets, unless the patient was previously established on the    medication prior to the effective date of this rule; and

26.1.c. No refills may be permitted unless a new prescription is furnished. This requirement does not apply to the patient previously established on the medication prior to the effective date of this rule.
This rule has been approved by the West Virginia Secretary of State and is now in effect.

Both nationally and in West Virginia, some prescribers have begun writing prescriptions for these drugs for family, friends, and coworkers in anticipation of the further spread of COVID-19. This rule limits the ability for persons to obtain prescriptions for these medications by requiring that all new prescriptions for these medications contain a written diagnosis from the prescribing health care provider that is consistent with the medication’s use, limiting the supply to 30 days, and prohibiting refills on prescriptions for these medications.

Today, March 23, 2020, the West Virginia Board of Medicine indicated in its notification "Emergency Rule Regarding Chloroquine and Hydroxychloriquine" that licensees should conform their prescribing practices to align with this emergency rule.

COVID: Resources for West Virginia Businesses in Response to COVID-19 are Coming

As part of Washington's efforts to minimize the economic disruption of COVID-19 to the nation's 30 million small businesses, the United States Small Business Administration ("SBA") is offering companies low-interest federal disaster loans for working capital through its Economic Injury Disaster Loan Program (EIDL). Small businesses in each of the fifty (50) states are eligible to apply. Applications may be submitted online or via mail.

The SBA's EIDL Program offers up to $2 million in assistance per applicant that can provide vital support to small businesses in these trying times. The interest rate for qualifying non-profit businesses is 2.75%, and 3.75% for other small businesses.

EIDL Program loans offer long-term repayment structures, up to 30 years, to keep payments affordable. The repayment terms are determined on a case-by-case basis and by taking into account each borrower's ability to repay.

These are unprecedented times. Flaherty Sensabaugh Bonasso PLLC stands ready to assist you in your interactions with the United States Small Business Administration and to partner with you as you navigate these previously uncharted waters.

Written by Bryan Price and Meghan Capps

COVID: Legislative Responses and Legal Challenges to Viral Exclusions for Business Interruption Loss Coverages

Part I: Legislative Responses and Legal Challenges to Viral Exclusions for Business Interruption Loss Coverages

Written by Luke Schmitt, Flaherty Sensabaugh Bonasso PLLC (Part I)
Written by Erica Baumgras, Flaherty Sensabaugh Bonasso PLLC (Part II)

All eyes are on New Jersey Legislature, which is currently discussing and reviewing a bill that could force coverage under business interruption insurance for coronavirus related losses even in the presence of a “virus” related exclusion.

After the SARS outbreak in 2003, which saw devastating effects, insurance companies made serious changes to their insurance policies relating to coverage for interruptions stemming from the disease. Specifically, many businesses who purchased business interruption coverage had “virus and bacteria” exclusions added to their policies.

Business interruption policies generally cover direct property damage, which leads to periods of in-operation of the company. Arguably, pandemics, like COVID-19, could lead to property damage if there is contamination of the property or HVAC system, which caused property damage, but such claims may be difficult to demonstrate.

Many insurers have added “Exclusion for Loss Due to Virus or Bacteria” provisions or similarly named exclusion provisions. As seen in reports out of New Jersey, these exclusions may bar first-party recovery for companies who suffer “loss or damage caused by or resulting from any virus . . . that induces or is capable of inducing physical distress, illness or disease.” Many business interruption policies contain slightly different language; however, the effect is still the same: no coverage for viral related damage during pandemics.

Fast forward to 2019, when the world sees its second coronavirus related pandemic in the 21st Century, COVID-19 (a virus in the coronavirus family similar to that of SARS).

To battle business losses stemming from the required social-distancing and other related damage, the New Jersey legislature appears to be the first to attempt to negate or void these existing insurance exclusion provisions. On March 16, 2020, New Jersey’s legislature proposed the following:

“Notwithstanding the provisions of any other law, rule or regulation to the contrary, every policy of insurance insuring against loss or damage to property, which includes the loss of use and occupancy and business interruption in force in this state on the effective date of this act, shall be construed to include among the covered perils under that policy, coverage for business interruption due to global virus transmission or pandemic . . . concerning the coronavirus disease 2019 pandemic.”

The purpose behind this proposed legislation is to ease the burden on local, state, and federal governments, which would most likely need to provide nationwide bailouts, and of course, to aid the businesses who paid premiums for business interruption loss coverage. The New Jersey proposed legislation only intends to provide two changes: 1) to eliminate the virus exclusion, and 2) to eliminate the need to prove direct physical property damage under the business interruption policy. Aside from the myriad financial effects that this bill will have on the public and the insurance industry, this type of prospective legislation raises constitutional issues and will likely be reviewed by the courts in New Jersey and anywhere else similar legislation is adopted.

This is not the first time that a legislature has retroactively acted to influence liability determinations. Following the Minnesota I-35W Bridge Collapse in 2007, which resulted in thirteen deaths and many injuries, the Minnesota legislature voluntarily established a $37 million fund for the compensation of affected families. To offset these payments, the state sought recovery from the engineering companies that had designed the bridge between 1962 and 1965. Typically, such a claim would be barred by the applicable statute of repose due to the passage of significant time since construction. Since the design professionals’ liability had been extinguished by way of that statute of repose, the Minnesota legislature revised its statutes to permit claims for indemnity and reimbursement against the designers. Specifically, the laws were amended to retroactively revive these time-barred claims arising out of one specific incident. The design professionals argued that the legislature’s action was unconstitutional; however, the Minnesota Supreme Court disagreed and allowed the state’s claims for indemnity against the engineer to stand.

Not wishing to wait for their respective legislatures to act, some businesses are resorting to the courts to seek relief from these types of coverage exclusions. March 16, 2020, marked the date for the first of many anticipated declaratory actions brought in light of COVID-19 related business losses. Oceana Grill, a restaurant in New Orleans, filed suit seeking a declaration of coverage under their “all risks” property policy, which provided an extension of coverage for business closure by order of Civil Authority. The business is seeking a declaration that “the policy provides coverage to plaintiffs for future civil authority shutdowns of restaurants in the New Orleans area due to physical loss from Coronavirus contamination and that the policy provides business income coverage in the event that the coronavirus has contaminated the insured premises.” In advancing these arguments, businesses are relying upon the nature of the virus, specifically its propensity to stay on surfaces or materials, “fomites” for up to 28 days, and its ability to infect individuals physically. The outcome of these declaratory actions will likely not be seen for months, or even years.

Moreover, legislatures that pursue similar measures to the one advanced in New Jersey will likely see their actions challenged on constitutional and other grounds. Which path West Virginia will follow will be determined in the coming weeks, months, and even years.

Until then, Flaherty is here for your needs, whether they are part of your routine business or new in the face of unprecedented actions taken to combat COVID-19. In these fluid times, you can count on us to have current information that will help your business take advantage of opportunities as they become available. Please reach out if you have any questions or concerns about how these new requirements may impact your business or employees.

Part II: Insurance Law Update on COVID-19: Part II

Flaherty will continue to follow developments at both the national and state level, whether in the legislative, administrative, or judicial arena.  Please reach out to Erica Baumgras or Luke Schmitt if you have any questions about how these developments may impact you, your business, or your employees.

On March 22, 2020, a bipartisan group from the United States House of Representatives sent a letter to four (4) insurance industry trade organizations, asking insurers to provide business interruption coverage under existing commercial property policies for losses due to closures tied to COVID-19. The lawmakers asserted that the coronavirus pandemic fulfills the policies’ requirement that an interruption in business be attributable to a “direct physical loss” or damage to a property. They also asserted that state and local “shelter-in-place” and curfew orders should trigger coverage for losses under the “civil authority” prong that is often found in commercial property policies.

In response, executives of the four groups, the American Property Casualty Insurance Association, National Association of Mutual Insurance Companies, Independent Insurance Agents, and Brokers of America, and Council of Insurance Agents and Brokers, sent a joint letter to Rep. Nydia Velazquez, D-N.Y., saying that business interruption policies “do not, and were not designed to, provide coverage against communicable diseases such as COVID-19.” The groups said that the “U.S. insurance industry remains committed to our consumers and will ensure that prompt payments are made in instances where coverage exists.” The trade groups added that their member companies have assisted in local charitable relief efforts and have begun to work with customers “on issues such as flexibility in premium payments.” The groups also said the “U.S. is in the midst of a national crisis that will require federal assistance that provides funding directly to those American individuals and businesses most in need,” and that their “organizations stand ready to work with Congress on solutions that provide the necessary relief as soon as possible.”

Also, at the national level, a subcommittee of the House Committee on Oversight and Reform on Wednesday asked three (3) travel insurance carriers to produce documents and participate in interviews to address the scope of coverage provided by their policies for trip cancellations related to the coronavirus. The chairman of the Economic and Consumer Policy subcommittee sent letters to Allianz Global Assistance USA, Generali Global Assistance Inc., and Travel Guard Group Inc., asking them to provide certain information by March 25. Among other things, the subcommittee is seeking data on the number of claims the carriers have received from policyholders for reimbursement of trip cancellations or medical expenses, as well how many of those claims have been paid or denied. Rep. Raja Krishnamoorthi, D-Ill., also asked executives of the three insurers to schedule interviews, noting that the subcommittee “can make arrangements for a remote interview.” The executives previously declined invitations to testify at a subcommittee hearing on travel insurance issues scheduled for March 11. The inquiries are part of an ongoing investigation into consumer complaints that their travel insurance claims have been improperly denied.

The three insurers have all issued public statements indicating they now consider the coronavirus outbreak to be a “foreseeable event” and that cancellations for fear of travel generally will not be covered under most of their policies. The carriers have said their “cancel for any reason” policies might provide partial or full coverage for cancellations on these grounds, depending on the policies’ terms. In addition, the insurers have all indicated that some of their policies might cover claims for trip cancellation or interruption if a policyholder’s plans are disrupted by a confirmed diagnosis of COVID-19.

At the state level, in the New Jersey General Assembly, lawmakers are in discussions with insurance carriers regarding potential changes to a bill, A3844, that would retroactively expand business interruption insurance to include losses attributed to the coronavirus pandemic. The bill was reported out of the General Assembly’s Homeland Security and State Preparedness Committee last Monday. It was set for a vote by the full chamber the same day before the sponsors pulled it at the last second. Assemblyman Freiman’s chief of staff reported that the bill was pulled so lawmakers could engage in further discussions with insurers. After several conversations with various insurance companies, they concluded that they are going to allow companies to come forward with their plans to address the issue proactively, and they want to give them a few days to do so. As of March 20, talks were still ongoing.

As currently written, A3844 would apply to business interruption policies held by New Jersey businesses with fewer than 100 full-time employees, provided that the policies were issued by March 9, when Gov. Phil Murphy declared a state of emergency. The bill would effectively rewrite such policies to explicitly include coverage for “business interruption due to global virus transmission or pandemic.” Insurers that pay out business interruption claims under these policies would potentially be eligible for reimbursement from the New Jersey Department of Banking and Insurance, according to as-yet-undetermined standards that would have to be established by the department.

A3844 was met with swift criticism by a host of both New Jersey and national insurance industry trade groups, which cautioned against legislation that would retroactively create coverage for otherwise uncovered losses. Those concerns were echoed by attorneys who represent insurers, who pointed out that many policies with business interruption coverage contain a “virus” exclusion that was developed by the Insurance Services Office and approved by state regulators years ago. If passed in its current form, the bill could be met with numerous constitutional challenges by insurers.

Citing the coronavirus outbreak, the California Insurance Commissioner issued a notice March 19 requesting that all insurance carriers doing business in the state grant their policyholders a “grace period” of at least 60 days before canceling their policies due to a failure to pay premiums. During that period, policyholders would be able to catch up on payments. Commissioner Lara said he issued the notice, which applies to insurers offering life, health, auto, property, casualty, and other types of coverage, to ensure policies are not canceled for nonpayment of premium due to the novel coronavirus (COVID-19) public health emergency. Lara further requested that all insurance agents, brokers and others who accept premium payments on behalf of insurers take steps to ensure that customers have the means to make payments if and where possible, including alternate methods of payment, such as online payments, to eliminate the need for in-person payment methods in order to protect the health and safety of both workers and customers.

COVID: West Virginia Board of Medicine and West Virginia Board of Osteopathic Medicine Responding to Address COVID-19 Crisis

West Virginia Board of Medicine and West Virginia Board of Osteopathic Medicine Responding to Address COVID-19 Crisis

Written by Luke Schmitt, Flaherty Sensabaugh Bonasso PLLC

In response to the COVID-19 pandemic and in anticipation of the challenges to come, the West Virginia Board of Medicine (the “Board”) this week has taken specific measures to prepare and to assist healthcare providers during this unprecedented time. The Board issued a COVID-19 Information Update on March 20, 2020.

First, the Board has announced that it recognizes the need to facilitate the influx of available health care practitioners into West Virginia and is taking efforts to try to expedite the process. The Board has announced that it is working to streamline the licensure approval process for COVID-19 providers and to maximize practice authorizations for physician assistants. However, the Board has not yet released specific details regarding its anticipated changes.

In addition, the Board in its March 20, 2020, update encouraged the use of telemedicine technologies, to provide flexibility for licensed health care professionals to respond to this emergency and expected patient volume surges. Specifically, the Board has stated that physicians who are evaluating and/or triaging COVID-19 patients are providing emergency care that falls within a statutory exception to the requirement for a face-to-face (in person or video) initial encounter to establish a physician/patient relationship. These providers may, consistent with the standard of care, conduct such evaluations through an audio-only encounter. The Board cautioned, however, that all non-COVID-19 telemedicine practice must continue to comply with the requirements prohibiting the establishment of a physician/patient relationship via audio-only communication.

Finally, the Board has stated that physician assistants with authorized Practice Agreements and/or active Practice Notifications may practice via telemedicine in collaboration with physicians even if the Practice Agreement and/or Practice Notification does not specifically identify telemedicine as an authorized practice modality. The Board further stated that physician assistants who are likewise evaluating and/or triaging COVID-19 patients may similarly conduct initial patient encounters through audio-only measures even though the establishment of a physician/patient ordinarily must occur via a face-to-face (in person or by video) initial encounter. Again, regular practice requirements continue to govern in situations not involving the treatment of COVID-19 patients.

Following is the complete language posted by the Board regarding its recommendations on telemedicine services in West Virginia: 

Telemedicine:  (New 3-18-2020)
 In an effort to ensure maximum flexibility for our licensees and to surge the response to this emergency,  the Board encourages the use of telemedicine technologies, consistent with the standard of care, where appropriate.  
Physician Telemedicine Practice for COVID-19 Emergency 
For physicians who are evaluating and/or triaging COVID-19 patients, this emergency care falls within a statutory exception to the requirement for a face-to-face (in person or via video) initial encounter to establish a physician/patient relationship and may, consistent with the standard of care, occur through an audio-only encounter.  All non-COVID-19 telemedicine practice must continue to comport with the requirement that a physician-patient relationship may not be established via audio-only.    
Physician Assistant Telemedicine Practice for COVID-19 Emergency and Non-COVID-19 Practice 
Physician assistants with authorized Practice Agreements and/or active Practice Notifications may practice via telemedicine, where appropriate and in collaboration with physicians, even if the PA’s Practice Agreement and/or Practice Notification does not specifically identify telemedicine as an authorized practice modality.   For physician assistants who are evaluating and/or triaging COVID-19 patients, this emergency care falls within a statutory exception to the requirement for a face-to-face (in person or via video) initial encounter to establish a practitioner/patient relationship and may, consistent with the standard of care, occur through an audio-only encounter.  All non-COVID-19 telemedicine practice must continue to comport with the requirement that a practitioner/patient relationship may not be established via audio-only.

Likewise, the West Virginia Board of Osteopathic Medicine has indicated that it is in the process of reviewing its licensing and renewal requirements and its authority to make changes to those requirements in emergencies. While specific measures have not been announced, the Board has stated it will initiate every possible action to ensure that qualified individuals can efficiently obtain a license so that they can assist in responding to this unfolding health care challenge.


COVID: Loosening of HIPAA Requirements

Loosening of HIPAA Requirements

Permit providers subject to HIPAA to communicate with patients and provide telehealth services through certain remote communications technologies
Written by Caleb Knight, Flaherty Sensabaugh Bonasso PLLC

The Office for Civil Rights (“OCR”) at the Department of Health and Human Services (“HHS”) has taken steps to permit covered health care providers subject to the HIPAA Rules to seek to communicate with patients and provide telehealth services through remote communications technologies.  Some technologies and the manner in which they are used may not comply with the requirements of HIPAA; however, OCR announced that it will exercise its enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under HIPAA rules against covered health care providers in connection with the good faith provision of telehealth during the COVID-19 nationwide public health emergency.

For example, a covered health care provider, in the exercise of their professional judgment, may request to examine a patient exhibiting COVID- 19 symptoms using a video chat application to assess a greater number of patients while limiting the risk of infection. Likewise, a covered health care provider may provide similar telehealth services, in the exercise of their professional judgment, to assess or treat other medical conditions unrelated to COVID-19, such as a sprained ankle, dental consultation, or psychological evaluation, or other conditions.

Under OCR’s Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency issued March 17, 2020, covered health care providers may use popular applications that allow for video chats, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype, to provide telehealth without the risk that OCR might seek to impose a penalty for noncompliance with the HIPAA Rules related to the good faith provision of telehealth during the COVID-19 nationwide public health emergency. Providers are encouraged to notify patients that these third-party applications potentially introduce privacy risks, and providers should enable all available encryption and privacy modes when using such applications.

Under this Notice, however, Facebook Live, Twitch, TikTok, and similar video communication applications are public facing. They should not be used in the provision of telehealth by covered health care providers.

Covered health care providers that seek additional privacy protections for telehealth while using video communication products should provide such services through technology vendors that are HIPAA compliant and will enter into HIPAA business associate agreements (BAAs) in connection with the provision of their video communication products. The list below includes some vendors that represent that they provide HIPAA-compliant video communication products and that they will enter into a HIPAA BAA.
  • Skype for Business
  • Updox
  • Zoom for Healthcare
  • Google G Suite Hangouts Meet


The Notification of Enforcement Discretion on telehealth remote communications may be found at: https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html.
For more information on HIPAA and COVID-19, see OCR's February 2020 Bulletin: https://www.hhs.gov/sites/default/files/february-2020-hipaa-and-novel-coronavirus.pdf - PDF


Sunday, March 22, 2020

COVID: Expanded Medicare Telehealth Coverage

Expanded Medicare Telehealth Coverage

Enables beneficiaries to receive a broader range of telemedicine healthcare
Written by Caleb Knight, Flaherty Sensabaugh Bonasso PLLC

To promote continuity of care and to help minimize exposure and spread, on Monday, March 16, 2020, the Trump Administration announced expanded Medicare telehealth coverage that will enable beneficiaries to receive a broader range of healthcare services from their doctors without having to travel to a healthcare facility. Beginning on March 6, 2020, Medicare will temporarily pay clinicians to provide telehealth services for beneficiaries residing across the entire country.

For more information regarding the actions of the Centers for Medicare & Medicaid Services (“CMS”) in this regard, please visit: www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet.

On Tuesday, March 17, 2020, CMS issued further guidance, which can be accessed at: www.medicaid.gov/medicaid/benefits/downloads/medicaid-telehealth-services.pdf. The homepage for general Medicaid Telehealth Guidance can be found at: www.medicaid.gov/medicaid/benefits/telemedicine/index.html.

COVID: Interstate Medical License Compact

Interstate Medical License Compact

Not a new effort, but offers a pathway for establishing a multi-state practice
Written by Luke Schmitt, Flaherty Sensabaugh Bonasso PLLC

Even before the COVID-19 pandemic, efforts were made within the United States to facilitate the borderless practice of medicine in our country.  However, now more than ever, these measures are necessary even if temporarily.  To effectively combat this public health crisis, we need to be able to mobilize resources efficiently and effectively.

The Interstate Medical License Compact (the “Compact”) offers a voluntary, expedited pathway to licensure for qualified physicians who wish to practice in multiple states.  The mission of the Compact is to increase access to health care for patients in underserved or rural areas and to allow them to connect with medical experts through telemedicine technologies more efficiently.  In addition to making it easier for physicians to obtain licenses to practice in multiple states, the Compact also seeks to strengthen public policy by enhancing the ability of states to share investigative and disciplinary information.

The Compact is not a federal program or administered by a federal agency.  Nor was it a product of Congressional action or the result of executive or administrative order.  Rather, it is an agreement among states with the Commission functioning as an independent organization.  The Commission is based in Littleton, Colorado, and is governed by the terms of the Compact, which empowers the Commission to create bylaws, rules, and policies.

In West Virginia, in 2015, the Legislature passed House Bill 2496, adopting the Interstate Medical Licensure Compact.  West Virginia Code 30-1C-1 codifies the Interstate Medical Licensure Compact Act. West Virginia Code 30-1C-3 outlines eligibility requirements, West Virginia Code 30-1C-5 governs applications and the issuance of expedited licenses, and West Virginia Code 30-1C-6 sets forth the application fees.

The efficacy of the Compact may not move the needle much in our current situation, but its goals and purposes are something to keep in mind for the future.

More information about who may qualify to participate in the Compact and how to apply is available at the Interstate Medical Licensure Compact website at: https://imlcc.org/.

In addition, to directly combat COVID-19, on Wednesday, March 18, 2020, the Trump Administration announced that the Department of Health and Human Services (“HHS”) would allow all physicians and other medical personnel to practice in states other than those in which they are currently licensed to practice. The HHS regulation is designed to mobilize doctors across state lines to meet the needs of hospitals as they arise during this public health crisis.

However, it is crucial to recognize that the federal medical licensure waivers by HHS are limited in scope to conditions of participation and payment for federal health care programs such as Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP).  HHS and CMS accomplished these waivers according to Section 1135 of the Social Security Act, which authorizes the Secretary of HHS to waive certain Medicare, Medicaid, and CHIP program requirements and conditions of participation once the President declares a public health emergency (“PHE”)HHS Secretary Alex M. Azar issued a PHE on January 31,2020, and President Trump declared an emergency on March 13, 2020.

These waivers do not waive the requirement for physicians and other healthcare providers to maintain licensure in states where they are practicing a licensed profession, including via telehealth.  State laws continue to govern whether a provider is authorized to provide professional services in that state without holding an active license from that state’s medical board.  However, some states are working to ease these restrictions.

Congress is currently considering additional Legislation that would apply to covered health services by private payors.  We are continuing to monitor these developments.

COVID: The Health Care Law Blog Restart

These unprecedented and uncertain times have all of us worried, seeking data/information, thinking in new ways as a result of our world being turned upside down in the past month due to the ongoing COVID-19 crisis. The law is largely built around precedent and written law/regulations. However, no time during my legal career have I see so much change and fluid movement in the law as I saw this past week.

As we stay home and shelter with our families and communities, I thought it was time to restart my blogging at the Health Care Law Blog as a way to share health care and legal information and content relevant that may be helpful to my health care clients, other health care providers, hospitals, nursing homes, physicians/physician practices, home health agencies and other providers. My last post on this blog was in 2012 - but it is time to dust off the blogging keyboard again in light of these worldwide events that impact us all from every direction. I started the Health Care Law Blog back in 2004, the infant hears of blogging and social media. At that time, there were only a handful of bloggers who connected nationally/globally. It was such an eye opening experience as a young lawyers sitting in little old wild and wonderful West Virginia - through this platform I was immediately connected with health care industry, health care lawyers and other technology interested lawyers around the world. Many of those individuals I still follow today via my Twitter feed at @BobCoffield and other social media platforms. In fact, much of my "trusted content" on the developing COVID crisis comes from these same health care blogging resources who I have trusted over the years. 

So with these opening comments, this health care regulatory, transactional and technology lawyer who practices out of Charleston, West Virginia at Flaherty Sensabaugh Bonasso PLLC is starting up the posts today. In the coming days, I plan to share my own thoughts and health care/legal related content along with content prepared by other health care lawyers in our firm's health care practice group, including, Caleb Knight, Shereen Compton McDanielAmy McLaughlin, Luke Schmitt, and others at our firm. This past week a few of us were brainstorming how we can help our clients, our communities, our state of West Virginia, our country and our globe during these difficult times. I think we all are struggling with what role we can and should play. Maybe through efforts to write, document, share content and commentary we can find some balance to what are likely difficult days and months to come for us and so many. 

Stay home, stay safe.

Sunday, April 29, 2012

WVHCA Issues Policy Statement for Public Witnesses

On April 11, 2012, the West Virginia Health Care Authority announced a new policy regarding the testimony for witnesses from the public before the Authority at certificate of need and rate hearings. The policy statement issued by James L. Pitrolo, Jr. Chairman, is effective from April 11, 2012 and states as follows:
I. PURPOSE
To establish procedures and guidelines governing the testimony for witnesses
from the public.


II. CANCELLATION
This policy cancels and supersedes all prior memoranda regarding testimony for
witnesses from the public.
 

III. POLICY
In order to ensure an orderly public hearing, all witnesses from the public
shall register in person during the first day of the hearing. If a witness fails to
register during the first day of the hearing, the witness will not be allowed to
testify during the hearing. If multiple witnesses are present on behalf of one
party, the group can elect up to three representatives. The representative's
comments will be limited to five minutes each up to a maximum of 15 minutes.
Individual comments will be limited to five minutes each. Further, a witness in the
hearing that has provided testimony shall not testify as a witness from the public
in the same hearing.

Wednesday, March 14, 2012

MSBCBS of TN Settles HIPAA/HITECH Violation for $1.5M

The HHS Office for Civil Rights (OCR) announced a settlement of $1.5M with Blue Cross Blue Shield of Tennessee (BCBST) relating to potential violations under the HIPAA Privacy and Security Rules. According to the OCR press release, the enforcement action by OCR is the first reported as resulting from a breach report required under the new Breach Notification Rule implemented as a result of the HITECH provisions of HIPAA.

The breach involved 57 unencrypted computer hard drives that were stolen from a facility leased by BCBST in Tennessee. The hard drives contained protected health information of approximately 1 million individuals. The breach was reported by BCBST to OCR under the HITECH provisions and regulations that require reporting of potential breaches. The press release indicates that OCR’s investigation found that 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. 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.

For more information check out the HHS press release "HHS settles HIPAA case with BCBST for $1.5 million" which includes a link to the HHS Resolution Agreement entered into between OCR and BCBST.

Saturday, March 10, 2012

OHFLAC Announces New Independent Informal Dispute Resolution Procedure for West Virginia Nursing Homes

The latest West Virginia Health Care Association e-News Update announced that the Office of Health Facility Licensure and Certification (OHFLAC) has put into place a new Independent Informal Dispute Resolution (IIDR) review of disputed deficiencies for all nursing homes in West Virginia. The new IIDR procedure goes into effect immediately and three out of state vendors experienced in IDRs were selected to be the third party reviewers. The current Informal Dispute Resolution (IDR) will remain as an alternative option.

According to the e-News Update, the new procedure will be detailed in a letter to providers when OHFLAC returns the Statement of Deficiencies to the provider after a survey. The letter will contain instructions on how to request an IIDR. OHFLAC is proposing to use the following language in the letters:
INFORMAL DISPUTE RESOLUTION:
In accordance with 42 CFR 488.331, you have an opportunity to question cited deficiencies through an informal dispute resolution process. To request an informal dispute resolution, please submit in writing the specific deficiencies being disputed and an explanation of why you are disputing those deficiencies to:

                                    Informal Dispute Resolution Review Committee
                                    Office of Health Facility Licensure and Certification
                                    408 Leon Sullivan Way
                                    Charleston, WV 25301-1713
You may also send your request via email to DHHR.OHFLAC.@wv.gov
This request must be sent during the same ten (10) calendar days you have for submitting a Plan of Correction (POC) for the cited deficiencies and must be contained on a document separate from the CMS-2567L, which contains the POC. 
You may choose between an informal dispute resolution (IDR) and an independent informal dispute resolution (IIDR).  You must clearly indicate your choice in the attention line of your request and the subject line of your email. An IDR will be completed by OHFLAC staff not associated with the referenced survey event.
Per West Virginia State Code §16-5C-12a, an IIDR will be completed by an independent review organization.  If an independent informal dispute resolution process is selected, the matter will be assigned to one of three independent review organizations accredited by the Utilization Review Accreditation Commission.  The facility may be subject to certain costs such as:
•     The cost of a face-to-face conference if one is requested; and
•     The cost charged by the independent review organization, should the facility not be successful in its dispute.
Please call us at 304-346-4575 if you have any questions.
The new IIDR procedure will allow nursing homes an alternative option to the standard IDR process when questions arise during the survey process and related POC requirement. The new procedure will allow a nursing home provider to challenge the particular survey finding through an alternative/independent process. Whether this new alternative procedure will be valuable to nursing home providers is yet to be seen.

Sunday, February 26, 2012

West Virginia Health Care Association Launches WV Senior Care Website

This past week health care colleague and CEO of the West Virginia Health Care Association, Patrick D. Kelly, advised me that the association has launched a new website to provide a resource for families and seniors who are researching residential and health care options in West Virginia. The website is called West Virginia Senior Care: Helping Seniors Make Informed Decisions About Senior Care and can be found at: http://www.wvseniorcare.com/.

The website is designed to help all of us find information and make better decisions regarding care for our parents and the elderly. The website includes everything from in home care services, such as home health, hospice, and other in home services, to care offered in assisted living facilities, residential care, nursing homes, hospitals, etc. The press release issued by the West Virginia Health Care Association provides additional details.

After looking around the website it looks like a great resource of health care information for West Virginia seniors.



Friday, February 24, 2012

CMS Issues proposed rule for Stage 2 Meaningful Use EHR Incentive Programs under HITECH

Yesterday the Centers for Medicare & Medicaid Services (CMS) announced the proposed rule for Stage 2 Meaningful Use under the the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs which is a part of the Health Information Technology for Economic and Clinical Health Act (HITECH).

The incentive program is part of the national health information technology reform effort under the American Recovery and Reinvestment Act of 2009 which provides incentive payments to eligible health care professionals, eligible hospitals and Critical Access Hospitals who adopt certified EHR technology and use it to demonstrate “meaningful use” of that technology to CMS.

The proposed rule also revised certain Stage 1 criteria, as well as criteria that apply regardless of the Stage, as finalized in the final rule titled Medicare and Medicaid Programs; Electronic Health Record Incentive Program published on July 28, 2010 in the Federal Register. The provisions included in the Medicaid section of the proposed rule (which relate to calculation of patient volume and hospital eligibility) would take effect shortly after finalization of this rule, not subject to the proposed 1 year delay for Stage 2 of meaningful use of certified EHR technology. Changes to Stage 1 of meaningful use would take effect for 2013, but most would be optional until 2014.

CMS provides the following Fact Sheet summary of the Stage 2 requirements. The complete proposed rule can be found here and should be published in the Federal Register in the next week. If you are interested in submitting comments to the proposed rule the deadline for submission will be 60 days from the date of publication of the proposed rule in the Federal Register.

SCOTUS Overturns Supreme Court of Appeals of West Virginia Decision on Nursing Home Arbitration Agreements


On February 21, 2012, the U.S. Supreme Court vacated a ruling by the Supreme Court of Appeals of West Virginia in the matter of Marmet Health Care Center, Inc. v. Brown et al., 565 U.S.(2012). The Supreme Court of Appeals of West Virginia previously held that all pre-dispute arbitration agreements that applied to personal injury and wrongful death claims against nursing homes were unenforceable. 

In a strongly worded opinion, the U.S. Supreme Court held that the West Virginia court misread and disregarded national precedent and controlling federal law regarding the Federal Arbitration Act.

The litigation involved three negligence suits against nursing homes in West Virginia for the care they provided to three separate residents: Clayton Brown, Jeffrey Taylor, and Sharon Marchio. In each of the cases, a family member entered into a binding arbitration agreement on behalf of the resident with the respective nursing home. In all three cases, after the resident died, lawsuits were filed in state circuit courts alleging personal injury and wrongful death against the nursing homes. The Brown and Taylor cases were dismissed by the circuit courts based on the arbitration agreements. The Marchio case was consolidated with the other two cases when it was brought before the West Virginia Supreme Court on a certified question.

In a decision concerning all three cases, the West Virginia Supreme Court held that "as a matter of public policy under West Virginia law, an arbitration clause in a nursing home admission agreement adopted prior to an occurrence of negligence that results in a personal injury or wrongful death, shall not be enforced to compel arbitration of a dispute concerning the negligence." Brown v. Genesis Healthcare Corp., No. 35494 (W.Va., June 29, 2011).

The West Virginia Supreme Court found unpersuasive the U.S. Supreme Court's prior interpretation of the Federal Arbitration Act, calling it "tendentious" and "created from whole cloth." Brown v. Genesis Healthcare Corp., No. 35494 (W.Va., June 29, 2011).

In vacating the West Virginia court's ruling, the U.S. Supreme Court held that the West Virginia court's interpretation of the Federal Arbitration Act was incorrect and inconsistent with its clear instruction and prior precedents. On remand, the West Virginia court was instructed to consider whether, absent the general public policy issue, the arbitration clauses in the Brown and Taylor cases are unenforceable under state common law principles that are not specific to arbitration and preempted by the Federal Arbitration Act. This leaves the possibility that certain arbitration clauses may be invalidated on such general contract grounds, such as fraud, duress, and lack of capacity, to name a few.


For additional information you can review the documents filed in the matter the U.S. Supreme Court docket for the Marchio portion of the case. Also, the briefs filed in the Brown, Taylor, and Marchio matters filed before the Supreme Court of Appeals of West Virginia can be found here.  

Thanks to Ryan A. Brown, a member of the Flaherty Sensabaugh Bonasso PLLC Health Care Practice Group who represents the defendant nursing home, Clarksburg Nursing & Rehabilitation Center, Inc., in the Marchio matter for the above summary of the decision. Also involved in the case was my partner, Mark Robinson

Friday, January 20, 2012

HIPAA Privacy Action Filed Against University Health Associates

The West Virginia Record reports the filing of a medical record breach action against West Virginia University Medical Corporation dba University Health Associates (UHA) under the Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The action filed in Monongalia Circuit Court was filed by Jennifer M. McGinley on behalf of Randy Friend (11-C-774).

The complaint asserts that Mr. Friend received a letter from UHA indicating that an employee had accessed his medical record without authorization. Mr. Friend claims that his medical record was accessed multiple times by a former UHA employee and that this former employee related the medical information to several other people living in Mr. Friend's community causing him emotional distress and embarrassment.

Also, Jeff Drummond at the HIPAA Blog reports on an interesting lawsuit filed by the Minnesota AG against Accretive Health in Minnesota. The action involves Fairview Health and North Memorial who hired Accretive Health as its debt collection company. Accretive Health lost an unencrypted laptop with medical and other personal information. As Jeff indicates this has some interesting aspects including the question of direct liability of a business associate under the HITECH amendments to HIPAA and also whether the covered entities only disclosed the "minimum necessary" information to its debt collection company. Interesting case to watch develop.

UPDATE: The complaint filed in the United States District Court District of Minnesota, State of Minnesota, by its Attorney General Lori Swanson v.Accretive Health, Inc.

Tuesday, January 03, 2012

WVHCA: 2012 CON Capital Expenditure Minimum

The West Virginia Health Care Authority has announced the 2012 certificate of need capital expenditure minimum threshold of $2,916,104. The new threshold is effective beginning January 1, 2012. The threshold is used as a part of the analysis by health care providers who must determine whether or not a certificate of need is required for a proposed project or health care acquisition. 

Pursuant to W.Va. Code 16-2D-2(h) and (s), the Authority is required to adjust the expenditure minimum annually and publish an update of the amount on or before December 31 of each year. The expenditure minimum adjustment isbased on the DRI inflation index published in the Global Insight DRI/WEFA Health Care Cost Review. The DRI inflation index as of December 31, 2011 is 2.9%.