Helpful Hints

ADPH Says Vaccine Administration is Limited at this Time

The Alabama Department of Public Health issued a press release on January 11, 2021, urging Alabamians to have patience in receiving the COVID-19 vaccine. According to the release, the vaccine is available to healthcare workers, people age 75 and older, law enforcement officers, and firefighters. As of January 18, 2021, the state is now in Phase 1B of the allocation plan developed by the State.

The Department also announced the creation of an online registration portal in addition to the hotline developed for Alabama residents to sign-up to receive the vaccine. Both the portal and hotline allow eligible individuals to register for the vaccine at their local county health departments. Again, the Department urges those that are not currently eligible to wait to call until the state has moved into the phase making the individual eligible for the vaccine.

More information regarding the phases of vaccine allocation can be found here.

OCR Settles Fourteenth Investigation in HIPAA Right of Access Initiative

As reported in the last e-note, the Office for Civil Rights ("OCR") began its Right of Access Initiative in 2019 and has settled numerous complaints against providers as part of this initiative. OCR announced three additional settlements since November 2019. These settlements serve as a reminder of the importance of responding to requests for records.

Twelfth Settlement
The University of Cincinnati Medical Center, LLC ("UCMC"), which is an academic medical center, agreed to pay $65,000 to settle a potential violation of the HIPAA Privacy Rule's right of access standard. According to OCR, UCMC failed to respond to a patient's February 22, 2019, records request. The patient had requested an electronic copy of her medical records be sent to her lawyers. OCR initiated an investigation and determined that UCMC failed to timely provide a copy of the requested medical records in potential violation of the HIPAA Rules, which include the right of patients to have electronic copies of records transmitted directly to a third party. The patient received all of the requested medical records in August 2019.

Thirteenth Settlement
Peter Wrobel, M.D., P.C., doing business as Elite Primary Care ("Elite"), agreed to take corrective actions and pay $36,000 to settle a potential violation of the HIPAA Privacy Rule's right of access standard. OCR received the initial complaint alleging that Elite failed to respond to a patient's request for access to his medical records in April 2019, and in response, OCR provided assistance to Elite on the HIPAA right of access requirements. In October 2019, OCR received a second complaint alleging that Elite still had not provided the patient with access to his medical records. OCR initiated an investigation into this ongoing complaint and determined that the right to access had been violated. The patient received a copy of his medical record in May 2020. OCR initiated an investigation into this ongoing complaint and agreed to settle with Elite based on the potential violation of the patient's right to access.

Fourteenth Settlement
Banner Health ("Banner"), a non-profit hospital system in Arizona, has agreed to take corrective actions and pay $200,000 to settle potential violations of the HIPAA Privacy Rule's right of access standard. OCR received two complaints against Banner alleging violations of the HIPAA Right of Access standard. The first complaint alleged that the individual requested access to her medical records in December 2017, and did not receive the records until May 2018. The second complaint alleged that the individual requested access to an electronic copy of his records in September 2019, and the records were not sent until February 2020. According to OCR, Banner's failure to provide timely access to the requested medical records was a potential violation of the HIPAA right of access standard.

CMS Develops a Web-Based Platform for 1135 Waivers

Under Section 1135 of the Social Security Act, the Secretary of the United States Department of Health and Human Services can waive or modify Medicare and Medicaid requirements during a public health emergency. During the current pandemic, the 1135 waivers or modifications included waivers of certain conditions of participation or other certification requirements, including flexibilities surrounding licensure of physicians and other health care professionals and waiver of Emergency Medical Treatment and Labor Act ("EMTALA") requirements. These waivers have been key to easing the burden on health care providers during the current pandemic.

Due to the volume of 1135 waiver requests associated with the COVID-19 public health emergency, CMS developed a new web-based tool that went live on January 11, 2021, and will be located at CMS PHE Emergency Web Portal. The new tool is a web-based platform designed to reduce the burden and streamline the submissions of 1135 waiver requests/inquiries in a simple-to-use format. The portal assists in expediting the review of submissions, triaging requests or inquiries, and tracking and reporting waivers on a national level.

The memo announcing the platform can be found here.

Proposed Rule to Require all DEA Registration Applications to be Submitted Online

The U.S. Drug Enforcement Administration ("DEA") has proposed a rule that would amend DEA regulations regarding all initial and renewal applications for DEA registration. Under the proposed regulatory amendment, paper submissions would be replaced by online-only submissions. The DEA cites four reasons for the change:

• Drastic drop-off in paper submissions. Based on a cost-benefit analysis, the DEA determined that the use of paper forms has decreased between 2016 and 2020. According to the DEA, 99.3% percent of all DEA registration forms were submitted electronically via DEA's secure website.
• Elimination of errors and omissions. The proposed rule is intended to simplify the registration process and reduce the number of errors made on the paper application. For the paper application, the DEA oftentimes had to seek clarification or corrections from the submitting party. The validation features in the system will flag common errors prior to transmission.
• Submission and production cost savings. Because the submissions will be electronic, there will be no charges associated with printing the forms and mailing them. The DEA estimates there will be a cost savings of $0.63 ($0.55 for postage plus $0.08 for an envelope) per each paper form not submitted for an overall annual cost savings of $52,715 ($2,805 to applicants and $49,910 to the DEA).
• Burden reduction. According to the DEA, the instant validation of online registration applications will result in a reduction of errors in submissions which in turn reduces the burdens on both the DEA and registrants.

A copy of the proposed rule can be found here.

Focus

Recent Stark Law Changes May Impact Physician Compensation Models

On December 2, 2020, the Centers for Medicare and Medicaid Services ("CMS") finalized sweeping changes to the federal Physician Self-Referral Law, commonly known as the Stark Law. Many of the changes reflect CMS' intent to allow greater flexibility to address certain value-based compensation arrangements. However, at least one change may materially impact how physician group practices allocate profits from Stark Law designated health services ("DHS").

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Resources

The COVID-19 Vaccine: An Update for Employers

As of January 19, 2021, two vaccines have been authorized for emergency use by the FDA, with two additional vaccines nearing the end of clinical trials. With vaccines now available, employers are questioning whether they can require employees to be vaccinated and what legal considerations may exist.

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2020 Alabama Health Care Year in Review

Prior to COVID-19, most health care providers were benefiting from a strong economy, low unemployment and increased patient insurance coverage thanks to the Affordable Care Act (but unfortunately not Alabama, which continues to refuse to expand Medicaid). Then, everything changed.

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Reprinted with permission from the Birmingham Medical News.

COVID-19, Mobile Health & the Importance of Maintaining Legal Compliance in an Era of Explosive Growth

It is increasingly important for mobile app developers to ensure their products comply with all governing state and federal laws, and it is critical to understand which business changes might place your product under a different legal framework.

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Reprinted with permission from the Nashville Medical News.

Business Interruption Coverage in the Year of COVID-19

COVID-19 has certainly been a devastating and disrupting force for businesses in 2020. Since the pandemic began, a major point of contention between corporate policyholders and insurers is whether these disruptions rise to "business interruptions" as defined under insurance policies offering business interruption ("BI") coverage. Companies often purchase BI coverage as part of traditional "all-risk" commercial property policies., and the coverage is generally designed to cover lost income (often in the form of reduced gross earnings) arising from disruptions to an insured's business operations. This update serves as a brief summary of how coronavirus-related BI coverage litigation has panned out thus far.

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Headlines

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