Summary of SB 15 (new state law regarding parental consent for COVID vaccine)

NOTE: As introduced, SB15 would have added new lawsuit opportunities against pediatricians and pediatric practices into the vaccine passport law. The Medical Association worked successfully with the Alabama Chapter of the American Academy of Pediatrics and others to stop that. However, attempts to resolve the vaccine passport law’s broad language currently applying to all vaccinations – including childhood vaccinations – were unsuccessful. That issue will have to be resolved at some point in the future. Other than the new parental consent requirement detailed below for a minor to receive a COVID-19 vaccine, the vaccine passport law’s effect on pediatric practices remains unchanged.

During the recent Special Legislative Session, the State Legislature passed and the Governor signed into law Senate Bill 15 (“SB15”), which effectively requires written consent from a parent or legal guardian before administration of a COVID-19 vaccine to a minor. Prior to enactment of SB 15, Alabama’s general consent law for minors provided that:

“Any minor who is 14 years of age or older, or has graduated from high school, or is married, or having been married is divorced or is pregnant may give effective consent to any legally authorized medical, dental, health or mental health services for himself or herself, and the consent of no other person shall be necessary.” Ala. Code §22-8-4 (1975).

However, during the Special Session, the Legislature created an exception to §22-8-4 in the text of SB15 by using the phrase “Notwithstanding section 22-8-4, Code of Alabama 1975…” prior to the new requirement for written parental consent. Thus, any minor who meets the conditions of §22-8-4 and is allowed to seek medical treatment on his or her own may still do so, EXCEPT when seeking a COVID-19 vaccine, which will now require parental consent.

Physicians who are unfamiliar with §22-8-4 should note that while this statute allows a minor who meets one of the above-stated conditions to consent for medical treatment without the additional consent of a parent, it does not prohibit a parent or legal guardian of a minor who meets one of these conditions from being able to consent on behalf of the minor. Therefore, SB15 does not create a situation where physicians must obtain consent from one party for a COVID-19 vaccine and another party for all other treatment.

However, the Legislature did not address within the text of SB15 another less-used consent statute for minors:

“Any minor who is married, or having been married is divorced or has borne a child may give effective consent to any legally authorized medical, dental, health or mental health services for himself or his child or for herself or her child.” Ala. Code §22-8-5 (1975).

Section 22-8-5 duplicates some of the conditions from §22-8-4, but also provides a distinctly separate condition, allowing any minor who has “borne a child” to not only give effective consent to medical treatment for herself, but also for her child. While the number of minors who have a child old enough to safely receive a COVID-19 vaccine is likely low at this time, this could change if vaccines are approved for use in children under the age of 5. Nevertheless, written consent from a minor for a COVID-19 vaccine for her own child would be in compliance with SB15 as it is written. The situation left unresolved by SB15 is whether a minor who has borne a child can seek a COVID-19 vaccination without the written consent of her parent. Physicians should consider on a case by case basis the circumstances of a minor who meets this condition and is seeking a COVID-19 vaccine.

SB15 provides a penalty for non-compliance within the act, allowing the Attorney General to seek an injunction to stop “a threatened or continuing violation of this section.” Physicians should consider a standard written consent form for COVID-19 vaccinations for minors and should fully document the circumstances of any judgment calls presented by §22-8-5, to avoid an injunction from the State.

Read SB15 here.

By Brandy Boone, General Counsel
Medical Association of the State of Alabama

2022 Medicare Physician Fee Schedule Rule – Conversion Factor and More

By: Anthony Romano, Burr & Forman, LLP

On November 2, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule (the “PFS Rule”) which includes updates for Medicare payments under the Physician Fee Schedule, and other Medicare Part B issues, on or after January 1, 2022.  The PFS Rule is described as part of a broader Administration-wide strategy to create a health care system that results in better accessibility, quality, affordability, empowerment, and innovation. Multiple policy changes were included in the PFS Rule, a few of which are highlighted below: 

Conversion Factor –

The PFS Rule set the fixed-dollar conversion factor (the amount CMS pays per RVU) for 2022 at $33.59.  This is a decrease of $1.30 from the 2021 conversion factor.  CMS noted that they took the 2021 calendar year conversion factor (without the 3.75% increase provided by the CAA) and multiplied it by the budget neutrality adjustment required to offset the spending impact of any changes exceeding $20 Million from what the 2022 expenditures would have been absent any changes.  

Billing for Physician Assistant (“PA”) Services –

Beginning January 1, 2022, Medicare can make direct payment to PAs for professional services that PAs furnish under Part B.  As you likely know, Medicare payment for PA services currently can only be paid to a PA’s employer and cannot be billed directly by the PA (unlike nurse practitioners and clinical nurse specialists who can bill Medicare and be paid directly). Effective January 1, 2022, PAs may bill Medicare directly for their professional services, may reassign their rights to payment for their professional services, and may incorporate as a group comprised solely of PAs and bill Medicare for PA services.  The PFS Rule did not change the requirement that PA services be performed under physician supervision.  

Rural Health Clinics (“RHCs”) and Federally Qualified Health Centers (“FQHCs”) – 

Absent changes in the definition of “mental health visits,” RHCs and FQHCS would no longer be paid by Medicare for mental health care services delivered via telecommunications technology after the COVID-19 public health emergency. In order to avoid potentially problematic interruptions to mental health care in rural and vulnerable populations, for 2022, CMS revised the definition for RHC or FQHC “mental health visits” to include visits furnished using interactive, real-time telecommunications technology. This change will allow RHCs and FQHCs to report and receive payment for mental health visits furnished via real-time telecommunication technology in the same way they currently do when visits take place in-person, including audio-only visits when the beneficiary is not capable of, or does not consent to, the use of video technology. The PFS Rule does require an in-person, non-telehealth visit at least every 12 months for these services; subject to certain exceptions which are documented in the patient’s medical record. 

Opioid Treatment Program (“OTP”) Payment For Audio-Only Interaction – 

The PFS Rule provides Medicare coverage and payment for OTP’s furnishing counseling, individual therapy, and group therapy services via audio-only interaction (such as telephone calls) after the conclusion of the COVID-19 public health emergency in cases where audio/video communication is not available to the beneficiary, including circumstances in which the beneficiary is not capable of or does not consent to the use of devices that permit a two-way audio/video interaction, provided all other applicable requirements are met.  When services are furnished using audio-only technology, practitioners must certify that they had the capacity to furnish the services using two-way audio/video communication technology, but instead, used audio-only technology because audio/video communication technology was not available to the beneficiary.

Please do not hesitate to contact us should you have any questions about the PFS Rule or how the PFS rule may impact you or your practice.

Anthony Romano practices with Burr & Forman LLP in the firm’s Health Care Industry Group. Anthony may be reached at aromano@burr.com or (205) 458-5210.

President Biden’s Executive Order to Expand Vaccination Requirements for Healthcare Facilities and Federal Contractors

by:  Jim Hoover

As most people know by now, on September 9, 2021 President Biden announced his Path Out of the Pandemic: COVID-19 Action Plan.  As part of the plan, the President signed Executive Order 14042, Ensuring Adequate COVID Safer Protocols for Federal Contractors.  The Executive Order is a six-prong, comprehensive plan outlining the President’s plan to combat COVID-19 and its variants. One prong of that plan includes expanding vaccination requirements for federal contractors including Medicare and Medicaid-certified facilities. This requirement is expected to apply to approximately 50,000 healthcare providers and cover a majority of healthcare workers across the country.

To combat the spread of COVID-19, the Centers for Medicare & Medicaid Services (CMS) is using its authority to expand the emergency regulations that require vaccinations for nursing home workers to encompass additional healthcare providers and suppliers who participate in Medicare and Medicaid. As a condition for participating in the Medicare and Medicaid programs, CMS will require that staff of all Medicare and Medicaid-certified facilities be vaccinated.

CMS indicated the Medicare and Medicaid-certified facilities will include hospitals (acute care, critical access hospitals, and inpatient rehabilitation facilities), outpatient facilities (ambulatory surgical centers, comprehensive outpatient rehabilitation facilities, federally qualified health centers, and rural health clinics), long-term care facilities & skilled nursing facilities, durable medical equipment suppliers, home health agencies, hospices, clinical labs, and ambulances.  At this time, it is uncertain whether physician practices would fall under the new vaccination mandate.

Based on indications from the White House, we anticipate staff who must be vaccinated will include, but will not be limited to, clinical staff, individuals providing services under arrangements, volunteers, and staff who are not involved in direct patient, resident, or client care.

CMS is developing an Interim Final Rule with a comment period and plans to issue the rule in October 2021. CMS is encouraging all certified Medicare and Medicaid facilities to begin complying with these expected regulations by urging workers who are not currently vaccinated to get vaccinated immediately. Healthcare facilities are encouraged to use all available resources, including employee education and clinics, to meet the new federal requirements.

In support of another prong of the President’s plan, the Safer Federal Workforce Task Force released guidance on September 24, 2021 detailing COVID-19 vaccination and other pandemic-related workplace safety requirements for federal contractors. The guidance attempts to answer many of the questions raised by federal contractors about the requirements, however additional information should be forthcoming by the Task Force in the coming weeks. 

Covered federal contractors are responsible for ensuring that all covered full-time or part-time contractor employees are fully vaccinated for COVID-19, unless the employee is legally entitled to an accommodation. The guidance also requires masking and physical distance in compliance with Centers for Disease Control guidelines at covered contractor workplaces. A covered contractor workplace is a location the contractor controls at which an employee of a covered contractor is likely to be present at any point during the period of performance.

Covered federal contractors are those with contract language mandating adherence with the guidance. Agencies will be required to incorporate contractual language into renewals, extensions, or exercised options of existing contracts, as well as new solicitations and contracts issued, that are above the simplified acquisition threshold (currently $250,000) by October 15, 2021. Though not required, it is likely that the government will encourage modifications of long-term contracts to include the new clause. 

Prime contractors must ensure that compliance clauses are incorporated into its contracts with subcontractors except those solely providing products.  All covered federal contractors and subcontractors must comply regardless of business size.

For covered federal contractors with active contracts, employees must be fully vaccinated by December 8, 2021. For covered federal contractors awarded new contracts (or options, renewals, or extensions), employees must be fully vaccinated by the first day of performance under the new contract, option, renewal, or extension. 

Employees who work from home must be fully vaccinated, but do not have to comply with the masking or physical distancing requirements discussed below.  Employees who work outside must also be vaccinated. However, the mandate does not apply to any employees who work outside of the United States or its outlying areas.

Covered federal contractors must review employees’ documentation to prove vaccination status. Covered federal contractors must require employees provide one of the following documents: a copy of the record of immunization from a healthcare provider or pharmacy; a copy of the employee’s COVID-19 Vaccination Record Card; a copy of immunization records from a public health or State immunization information system; or a copy of any other official documentation verifying vaccination that includes all of the following information: (a) vaccine name, (b) date(s) of administration; (c) name of the health care professional or clinic site who administered the vaccine. Employers can accept digital copies of these records. For example, photographs, scanned documents, or PDFs are acceptable forms of proof. 

If an employee has lost or does not have a copy of the required documentation employees should be directed to obtain new copies or verification of their vaccination status. Employees should be able to obtain new copies of their vaccination card from their vaccination provider. If the vaccination provider is no longer operating, employees may contact their State or local health department’s immunization information system (IIS) for assistance. 

Covered federal contractors still need to accommodate employees with closely held religious beliefs or ADA-qualifying disabilities that inhibit their ability to receive a COVID-19 vaccine. Accommodations must also be offered to employees who are unable to wear masks due to an ADA-qualifying disability or closely held religious belief.

Covered federal contractors must continue to enforce other measures such as masking or social distancing.  There are differing requirements based on the location of the worksite.  The rules state that covered contractors must ensure that all individuals and visitors (regardless of vaccination status) comply with the published CDC guidance for masking at workplaces in areas of high or substantial community transmission. In areas with low or moderate community transmission, fully vaccinated individuals do not need to wear masks. Fully vaccinated individuals do not need to practice social distancing, regardless of the level of community transmission. Individuals who are not fully vaccinated must wear a mask indoors and in crowded outdoor settings or outdoor settings that require sustained close contact with other individuals who are not fully vaccinated regardless of the level of community transmission. 

Masks will not be required if an individual who is not fully vaccinated is alone in an office with floor to ceiling walls and a closed door, in brief times when an individual is eating or drinking so long as physical distance of at least 6 feet is maintained, or if the individual obtains an accommodation pursuant to an ADA-qualifying disability or a sincerely held religious belief.

Covered federal contractors may also allow exceptions for employees who are engaging in activities in which masks may get wet, during high-intensity activities, or when wearing a mask would create a risk to workplace health, safety, or job duty as determined by a workplace risk assessment. These exceptions must be approved in writing by an authorized representative of the covered federal contractor. 

The full text version of the Task Force Guidance can be found here. 

Jim Hoover is a partner at Burr & Forman LLP practicing exclusively in the firm’s Healthcare Industry Group. Jim may be reached at (205) 458-5111 or jhoover@burr.com.

HHS Announces $25.5 Billion in Provider Funding for Covid-19 Relief

More help is on the way for health care providers affected by the Covid-19 pandemic. The U.S. Department of Health and Human Services, through the Health Resources and Services Administration (HRSA), is providing $25.5 billion in new funding. This includes $8.5 billion for the American Rescue Plan (ARP) and $17 billion for Phase 4 of the Provider Relief Fund (PRF). 

ARP Rural is intended to help address the disproportionate impact that COVID-19 has had on rural communities and rural health care providers. The ARP Rural payments will be based on the amount of Medicaid, CHIP, and Medicare services provided to patients living in rural areas. The payments will generally be based on Medicare rates. Providers who serve any patients living in  HHS Federal Office of Rural Health Policy defined rural areas with Medicaid, CHIP, or Medicare coverage, and who otherwise meet the eligibility criteria, will receive a minimum payment.

The Provider Relief Fund provides payments for healthcare-related expenses or lost revenue due to coronavirus. These distributions generally do not need to be repaid. The PRF Phase 4 payments will be based on the provider’s lost revenue and expenditures between July 1, 2020 and March 31, 2021. Smaller providers will be reimbursed at a higher rate than larger providers. PRF Phase 4 payments will include bonus payments for serving Medicaid, CHIP and Medicare patients. These bonus payments will be reimbursed at Medicare rates. 

Providers may apply for both programs with one application. The application portal opens September 29, 2021. To prepare, providers should start gathering supporting documentation, such as most recent tax documents and financial statements for the second half of calendar year 2020 and the first quarter of calendar year 2021. Providers should also search the Rural Health Grants Eligibility Analyzer to see what areas qualify as rural for the ARP rural payments.

For more information about how to apply for the PRF Phase 4 and ARP Rural payments, visit: https://www.hrsa.gov/provider-relief/future-payments.

Providers who believe their Phase 3 PRF payment was not calculated correctly may now request a reconsideration. HHS has released detailed information about the methodology utilized to calculate Phase 3 payments. Additional detail on this reconsideration process will be forthcoming from HHS. 

HHS has also announced a final 60-day grace period to comply with PRF reporting requirements for the September 30, 2021 deadline. The deadline to use the funds and the reporting time period will not change. Additional information may be found regarding the  PRF Reporting requirements.