Archive for April, 2020

Alabama Department of Public Health Advises Health Care Providers in Use of COVID-19 Tests not Approved by the United States Food and Drug Administration

Alabama Department of Public Health Advises Health Care Providers in Use of COVID-19 Tests not Approved by the United States Food and Drug Administration

The Alabama Department of Public Health (ADPH) supports health care workers’ efforts to care for Alabama citizens during this COVID-19 health crisis. As this public health emergency evolves, there is need for increased availability of SARS CoV-2 diagnostic testing. In response to this demand, the United States Food and Drug Administration (FDA) released policies to authorize emergency use of in vitro diagnostics to increase testing capacity and development to promote widespread testing for COVID-19. As a result, the availability of commercial testing devices proliferated, many with false claims by distributors. ADPH therefore advises health care providers to choose COVID-19 testing systems that are FDA approved when making decisions regarding their patients.

Tests not approved by the FDA can produce false results and lead to unintended consequences for the patient and broader community. A false negative result from a non-approved kit may lead someone who has COVID-19 to think they are not infected and cannot spread the illness. Patients need accurate information about their health, and health care providers and officials need accurate information to provide appropriate medical care and make public health decisions.

Currently, the most accurate FDA-approved testing available is polymerase chain reaction (PCR) assays. PCR tests can detect small amounts of the virus collected in samples from the patient’s nose or throat. Public health, commercial, and some clinical laboratories use PCR technology to diagnose COVID-19 infections. Many of these tests have FDA approval through emergency use authorization (EUA).

Serology testing is gaining momentum in the marketplace as collection of blood samples is easy and many platforms are point of care with results in minutes.  Serological tests detect if an individual’s body is developing antibodies against COVID-19. While these tests can be used to track disease, they are not reliable as or recommended for diagnostics and is even stated on most package inserts. At this time, there are only three serological tests that are EUA approved (https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd).

If your facility is considering a serology-based test that is not EUA approved by FDA, understand that:

  • Currently no Centers for Disease Control and Prevention guidance exists as to how to interpret or take public health action in response to a positive or negative COVID-19 serology result.
  • These tests have not had performance reviews by FDA.
  • Negative serology results do not rule out COVID-19 in a patient.
  • Serological testing should not be the sole basis to diagnose or exclude infection, or to inform infection status. 
  • The immune response to SARS-CoV-2 infection is poorly understood at this time.
  • Cross reactivity is likely. Positive results could reflect past or present infection with non-SARS-CoV-2 strains.
  • False negative results could occur when the immune response is too low to be detected.
  • If serology-based test results are submitted to ADPH, they will not be included in the COVID-19 counts at this time due to lack of guidance regarding interpretation.

ADPH fully supports health care providers on the front lines of this pandemic and trust they will use this advisory to make informed decisions regarding their patient’s health. It is important to be aware of distributors’ false claims. Thank you for your commitment and dedication in service for the citizens of Alabama. If you have questions regarding this information, contact Burnestine Taylor, M.D., at burnestine.taylor@adph.state.al.us.

Posted in: Coronavirus, Members

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Chronic Care Management in the Coronavirus Pandemic

Chronic Care Management in the Coronavirus Pandemic

Article contributed by: Tammie Lunceford, CMPE CPC with Warren Averett

Chronic Care Management Expands Care

Several years ago, the Center for Medicare and Medicaid Services released Chronic Care Management to assist in improving patient outcomes, extend care, and improve quality in chronic illness.  The initial chronic care code, 99490 allowed for 20 minutes of non-face to face phone communication with clinical staff per month which reimbursed forty-two dollars per month.  The patient had to agree to be enrolled in the program and agree to an $8 co-pay.  Only one physician can enroll a patient and the patient must have at least two complex chronic conditions lasting more than twelve months.  Most physicians did not adopt chronic care management due to the low reimbursement, the physician had to treat all chronic conditions which excluded most specialists from participating.

Some large practices outsource chronic care management and share the reimbursement.  Whether the practice uses internal staff or outsourced staff, CCM services provide additional care and coordination to the most chronically ill.  The patients receiving this service feel more connected to their provider and a change in their status is identified quickly.  If the practice also has telemedicine, a non-face to face service can quickly become a face to face visit to address concerns. Due to the recent COVID-19 pandemic, these interactions could provide the care needed to protect the chronically ill from being exposed to the deadly virus. 

The 2020 Final Medicare Physician Fee Schedule added some provisions to Chronic Care Management services.  The addition of Principle Chronic Management allows a patient with a single high-risk chronic condition lasting more than 12 months to qualify for the program. PCM should increase the use of chronic care management with specialists, such as cardiologist and pulmonologists.  Also approved for 2020, is G2058 which is an add-on code to allow an additional 20 minutes of time spent in continuous communication with the patient.  The add-on code reimburses $37.89 and can be billed concurrently to 99490, two times monthly, per beneficiary.  The total possible reimbursement for 60 minutes of non-complex CCM is $118.01. 

The new opportunities to provide chronic care management and principle care management will allow specialists managing hundreds of patients with chronic conditions, such as, COPD or diabetes to improve the overall health of the patient, improve patient engagement, improve quality and receive reimbursement worthy of the effort.

Practices are currently working to provide many modes of communication to serve patients without seeing them in the office.  Patient portals have failed in the past because many portals were not user friendly or practices failed to make them valuable by offering valid information through the portal.  In times of crisis, such as COVID-19, it is quite possible for the phone lines to be full but utilizing the patient portal and offering CCM and PCM allows a practice to fulfill many patient’s needs without a physician or mid-level providing the interaction.

We are in crisis as COVID-19 cases increase across the nation, but we have seen monumental change through the emergency expansion of telemedicine.  As administrators and physician leaders review the options to expand communication through technology and ongoing medical management, we will be better prepared for crisis situations in the future.

Posted in: Coronavirus, Management, Members

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Summary of Liability Protection from Starnes, Davis Florie, LLP

Summary of Liability Protection from Starnes, Davis Florie, LLP

Starnes, Davis, Florie, LLP has drafted a summary with some guidance on documentation for physicians concerning some protection in response to potential liability issues facing physicians during the COVID-19 declared emergency.  Governor Ivey’s March 13, 2020 Proclamation declared a state public health emergency.  The Proclamation grants certain immunity from lawsuits if a provider in a covered “health care facility” is practicing pursuant to an “alternative standard of care” plan.  The “alternative standard of care” must be set forth in the “health care facility’s” emergency operation plan, and the specific language or “standards of care” may differ from facility to facility.  Starnes suggests documenting the circumstances surrounding each patient and the reasons for clinical decisions.  [LINK to previous article].  Personnel and a facility are entitled to limited immunity when practicing consistent with those methods outlined in the alternative standard of care.  Physicians should look to the hospital for the specific protective language.

The PREP Act provides limited immunity for the administration or use of covered countermeasures to treat, diagnose, cure, prevent, or mitigate COVID-19.  The PREP Act covers providers for the administration or use of any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine used in the treatment of a COVID-19 patient.  

See Summary Here.

This information is not intended to provide legal advice, and no legal or business decision should be based on its content. No representation is made that the quality of legal services to be performed is greater than the quality of legal services performed by other lawyers.  Read full disclaimer.

Posted in: Legal Watch, Uncategorized

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Summary of Telehealth Waivers as of April 1, 2020

Summary of Telehealth Waivers as of April 1, 2020

By: Jim Hoover, Burr & Forman, LLP

The changes made to the requirements for telehealth services since the start of the COVID-19 pandemic have been swift and substantial. For the first several weeks, it seems changes were made almost daily.  As time has passed, the changes to telehealth have stabilized enough that a summary of the current telehealth issues is possible. However, changes may still be forthcoming so the following is a summary of the significant topics related to providing telehealth services as of the date of this article. Physicians should continue to monitor announcements related to telehealth requirements as changes will surely continue to evolve. 

Medicare – On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) announced additional temporary expansion of telehealth services to Medicare beneficiaries. CMS’s announcement of this new reimbursement flexibility builds on its prior expansion of telehealth services to address the COVID-19 pandemic. Prior to the March 30, 2020 announcement, CMS announced the following: (1) the patient location requirement was being waived to allow the patient to be in their home or other location; (2) the audio-video link can be something as simple as Skype, FaceTime or Facebook Messenger video calls. However, the audio-video link has to be a real-time audio and a one-to-one video connection, and cannot be public-facing; (3) the patient cost share can be waived at the providers’ discretion; and (4) CMS stated it will not audit to verify that there is an established patient relationship.

CMS announced in its March 30, 2020 announcement that it is now also allowing Medicare beneficiaries to receive care via telehealth by: (1) adding more than 80 services to the list of services payable under the Medicare Physician Fee Schedule when furnished via telehealth, including emergency department visits, initial nursing facility and discharge visits, critical care services, home visits for new and established patients, and physical and operational therapy services; (2) allowing clinicians to provide Virtual Check-In services to new patients in the same manner as they previously could provide only to established patients; (3) allowing licensed clinical social workers, clinical psychologists, physical therapists, occupational therapists, and speech language pathologists to provide e-visits; (4) allowing clinicians to provide certain services by audio phone only to their patients; (5) allowing clinicians to provide Remote Patient Monitoring, for acute or chronic conditions, to both new and established patients; (6) removing certain frequency limitations on Medicare telehealth; (7) expanding the use of telehealth to certain home health and hospice services; and (8) expanding the definition of “homebound” so that when a physician determines that a Medicare beneficiary should not leave the home due to suspected or confirmed COVID-19, the patient can qualify for the Medicare Home Health benefit.

Medicare Miscellaneous Issues – Patient consent may be obtained annually and obtained by ancillary staff.  Direct Supervision of services, such as incident-to services, normally require that the supervising/billing physician be in the office suite and immediately available. However, for the duration of the PHE, direct supervision can be provided by real-time interactive audiovisual technology.

Billing

Medicare – As an initial matter, telephone calls are still not the same as telehealth for Medicare purposes. A full list of the Compliant List of Medicare Telehealth and the Medicare Telehealth Code List for 2019-2020 is located on CMS’ website at the following address https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.

CMS is allowing payment for certain codes related to telehealth services because as an example, CMS recognizes that some problems can be handled over the phone without a face-to-face, but may require more than the 5-10 minutes. The codes for established patients for physician or other qualified professionals (nurse practitioners or physician assistants) include 99441 (requires 5-10 minutes of medical discussion), 99442 requires 11-20 minutes of medical discussion), 99443 (requires 21-30 minutes of medical discussion). Practitioners should report the E/M code that best describes the nature of the care they are providing. Previous guidance was to use POS 02 that will cause payment to be made at the lower facility rate. Alternatively, providers can choose to use the POS code that most accurately reflects where the service is performed and append modifier 95. This will cause payment to be made at the higher non-facility rate.

Alabama Medicaid – Medicaid normally requires separate credentialing for providers performing telehealth; however, that restriction has been waived for the time period for dates of service from 3/16/2020 – 4/16/2020. Medical providers may bill established patient evaluation and management codes 99211, 99212 and 99213 for telephone consultations. Psychologists and behavioral health professionals should bill 90832, 90834, 90837, 90846, 90847 and H2011. Verbal consent must be obtained and documented in the medical record. These visits will count against the patient’s office visit limit of 14 visits per year.

Blue Cross and Blue Shield of Alabama – is allowing providers to bill for telephone call treatment of existing patients under the established patient office visit codes for dates of service from 3/16/2020 – 4/16/2020. They are allowing codes up to 99213 with place of service code 02 for telehealth. No modifier is required. The physician should be the one speaking with the patient — not the office staff.

HIPAA – Over the past several weeks, the Office for Civil Rights (“OCR”) has issued several notices regarding HIPAA in light of the current COVID-19 pandemic. The OCR issued a Notification of Enforcement Discretion for Telehealth Remote Communications during the COVID-19 Nationwide Public Health Emergency. OCR stated that it would relax its enforcement actions with regard to compliance with certain aspects of HIPAA (and not enforce penalties) in order to allow providers to better treat their patients via telehealth. A health care provider that wants to use audio or video communication technology to provide telehealth to patients during the public health emergency can use any non-public facing remote audio or video communication product that is available to communicate with patients. Health care providers may use applications that allow for video chats, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype, to provide telehealth without risk that OCR might seek to impose a penalty for noncompliance with the HIPAA Rules. However, communication applications that are public facing should not be used. OCR further stated that it would not impose penalties against health care providers for the lack of a Business Associate Agreement with video communication vendors. The above applies to telehealth provided for any reason, regardless of whether the telehealth service is related to the diagnosis and treatment of health conditions related to COVID-19. The OCR also issued additional guidance in the form of frequently asked questions (FAQs) which are available at https://www.hhs.gov/sites/default/files/telehealth-faqs-508.pdf.  

State Licensure – Most states have greatly relaxed or streamlined their licensing requirements and application process to make it easier for physicians to provide telehealth services across state lines. However, the application process and requirements for each state differ so it is extremely important for physicians to check with each state. For example, the state of Tennessee requires the practitioner to complete and submit an application, which can be found at: https://www.tn.gov/content/dam/tn/health/documents/cedep/novel-coronavirus/Boards-Executive-Order-Form.pdf. The determination is made on a case by case basis. It appears most applications are being approved by the Tennessee Department of Health because as of the end of March 2020 the Department had received 61 applications and approved 59 applications, denied one, and one was under review. The State of Florida, for purposes of preparing for, responding to, and mitigating any effect of COVID-19, permits health care professionals not licensed in Florida to provide health care services to a patient located in Florida using telehealth, for a period not to exceed 30 days unless extended by order of the State Surgeon General. The exemption applies only to out of state health care professionals holding a valid, clear, and unrestricted license in another state or territory in the United States who are not currently under investigation or prosecution in any disciplinary proceeding in any of the states in which they hold a license.

While the telehealth waivers and notifications have slowed down in recent days, it is still very important for physicians to keep updated on the various requirements from state licensing authorities and payors.

Jim Hoover practices with Burr & Forman LLP and works exclusively within the firms Health Care Industry Group and primarily handles healthcare litigation and compliance matters.

Posted in: Legal Watch, Medicaid, Medicare, Technology

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The Privacy Vulnerabilities of Zoom Software and Potential Alternatives

The Privacy Vulnerabilities of Zoom Software and Potential Alternatives

Over the past month, as more nationwide “Shelter at Home” orders have been issued and more companies have transitioned to telework, the need for online meetings and webinars has skyrocketed. To accommodate this new way of doing business, many have turned to a platform called Zoom. The problem? No one bothered to read the fine print.

For those in the healthcare field, privacy is paramount. Yet, by using Zoom, users are seceding any and all content displayed or vocalized to the company. In Zoom’s own privacy statement, some of the “Customer Content” it collects includes “information you or others upload, provide, or create while using Zoom.”[i]  Additionally, Zoom also collects personal information like your name, physical address, email address, phone number, job title, employer.[ii]  And, even if you don’t make an account with Zoom, it will collect and keep data on what type of device you are using, and your IP address.[iii]

Now, while Zoom has recently updated its privacy policy and is taking steps to make the platform more secure, there are issues beyond the data mining mentioned above. On Monday, for instance, the Boston office of the Federal Bureau of Investigation issued a warning[iv]  saying that it had received multiple reports from Massachusetts schools about trolls hijacking Zoom meetings with displays of pornography, white supremacist imagery and threatening language — malicious attacks known as “zoombombing.”[v]

So, what’s the solution? Below are a few good alternative platforms to use instead Zoom:

  • Apple FaceTime (only available on iPhone and Macs)
  • Skype (available on all devices) (recommended)
  • Google Hangouts (available on all devices)
  • GoToMeeting (available on all devices)
  • Jitsi (available on all devices)
  • RemoteHQ (available on all devices)

[i] https://zoom.us/privacy

[ii] Id; see also https://protonmail.com/blog/zoom-privacy-issues/

[iii] Id.

[iv] https://www.fbi.gov/contact-us/field-offices/boston/news/press-releases/fbi-warns-of-teleconferencing-and-online-classroom-hijacking-during-covid-19-pandemi; see also https://www.nytimes.com/2020/04/02/technology/zoom-linkedin-data.html?partner=IFTTT

[v] https://www.adl.org/blog/what-is-zoombombing-and-who-is-behind-it; see also https://www.nytimes.com/2020/04/02/technology/zoom-linkedin-data.html?partner=IFTTT

Posted in: Coronavirus, HIPAA, Legal Watch, Management, Scam

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