On December 10, 2020, the Office for Civil Rights (“OCR”) at the United States Department of Health and Human Services (“HHS”) announced proposed changes to the regulations implementing the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). The proposed changes, which are set out in the Notice of Proposed Rulemaking (“NPRM”), are a part of the broader initiative to promote value-based care, enable better coordination among healthcare providers, and facilitate patient autonomy and engagement.
One key theme found in the NPRM that will likely enable better coordination among healthcare providers and potentially increase patient safety is expanded permission to disclose protected health information (“PHI”) to third parties in emergency situations. For example, under the proposed changes, covered entities would be allowed more flexibility to disclose PHI in emergencies like a mental illness and substance abuse crisis. The current standard for disclosure of PHI in an emergency or health crisis is based on the covered entity’s “professional judgment.” This standard has often left covered entities unsure as to when a disclosure is permitted. The proposed modification relaxes this standard slightly in that it would allow a covered entity to disclose PHI in an emergency situation or health crisis when the covered entity has a good faith belief that the disclosure is in the best interest of the individual. A good faith belief could be based either on direct knowledge of relevant facts or representations by a person who can reasonably be expected to know relevant facts. For example, OCR has provided the following scenarios:
Good faith would permit a licensed health care professional to draw on experience to make a determination that it is in the best interests of a young adult patient, who has overdosed on opioids, to disclose relevant information to a parent who is involved in the patient’s treatment and who the young adult would expect, based on their relationship, to participate in or be involved with the patient’s recovery from the overdose. Likewise, front desk staff at a physician’s office who have regularly seen a family member or other caregiver accompany an adult patient to appointments could disclose relevant information to the family member or caregiver as a way of checking on the welfare of the patient, when a patient misses an appointment, based on the staff’s knowledge of the person’s involvement and a good faith belief about the patient’s best interest.
But not only would covered entities be allowed more flexibility to disclose PHI when individuals are experiencing emergencies or health crises, they would also be allowed more leniency to disclose PHI to avert a threat to safety. While covered entities are currently allowed to disclose PHI to prevent threats to health and safety, the current standard is considerably more stringent in that it allows the disclosure of PHI to avert a threat to health or safety only when the threat is “serious and imminent.” Under the changes proposed in the NPRM, covered entities could make a disclosure when the threat is “serious and reasonably foreseeable.” OCR has stated that “[a]dopting a ‘serious and reasonably foreseeable’ standard can enable a health care provider to timely notify a family member that an individual is at risk of suicide, even if the provider cannot predict that a suicide attempt is ‘imminent.'” In addition, “[a]n emergency room doctor who sees an elderly patient with COVID-19 could contact the patient’s nursing home to alert them of the potential exposure of other residents and staff based on the serious and reasonably foreseeable threat of infection with COVID-19 without delay caused by the need to assess whether the threat is sufficiently ‘imminent’ to permit the disclosure.”
These proposed modifications provide additional clarity regarding PHI disclosures that would assist in the Department’s initiatives to increase coordination among healthcare providers and ultimately improve patient safety. Both of these proposed changes would hopefully empower covered entities to disclose PHI in situations where there is a genuine belief that harm is likely without being fearful of HIPAA penalties because the harm was not imminent.
Lindsey Phillips is an associate at Burr & Forman LLP practicing exclusively in the firm’s Healthcare Industry Group.
After the 2020 Session was cut short by the COVID-19 pandemic, it was widely expected that health care would be a hot topic for the 2021 Session. Those forecasts proved to be true, with roughly 20 percent of bills and resolutions filed during the 2021 Session relating to health care!
Had the Medical Association not been “on call” during the 2021 Session, problematic bills for physicians and bills dangerous to patients could have become law.
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While preventing dangerous and problematic proposals from
becoming law consumes much of the Association’s advocacy efforts, at the same
time the Association is trying to move medicine forward each session. The 2021
Session saw continued success for the Association in two top-priority funding
requests (MMRC and BMSA) as well as the enactment of legislation to further
access to physician-led, team-based care for patients in Alabama.
If no one was on call . . . physicians, their staff, and their practices
would have no protection from COVID-19 frivolous lawsuits. The Association worked with both Sen. Arthur
Orr (R-Decatur) and a coalition of other organizations on legislation providing
liability protection to businesses but also to physicians for care whose
provision to patients was affected or impacted by COVID-19 and/or the state’s
response to the pandemic. This bill was one of the first to become law in 2021.
If no one was on call . . . the Maternal Mortality Review Committee (MMRC) could not have
received vital funding for the second year in a row. In 2019, the Association spearheaded a
coalition of stakeholders – which included March of Dimes, the American
College of Obstetricians and Gynecologists, the American Academy of Pediatrics,
and Johnson & Johnson – to bring awareness to the issue of increasing
maternal mortality rates in Alabama and spotlight the impact this committee
could have to reverse that trend if properly staffed and resourced. As she did
in 2020, Gov. Ivey again supported funding for the MMRC in her initial 2022
budget request and legislators maintained that funding in the final budget.
If no one was on call . . . the MMRC’s inaugural report outlining its findings and initial recommendations would not have been recognized. To raise awareness of this important work, the Association worked with Sen. Linda Coleman-Madison on a legislative resolution (SJR106) and joined several legislators at a press conference event in April.
If no one was on call . . . the Board of Medical Scholarship Awards could not have maintained
its significant funding increase in the coming fiscal
year.
As she did in 2020, Gov. Ivey recommended maintaining the additional $500,000
increase for the BMSA. The legislature agreed, and the total amount for physician-student-loans
for 2022 remains at $1.9 million, allowing roughly 10 medical school tuition
loans to be granted annually to physicians willing to set up practice in
medically underserved areas of Alabama. This program remains one of the best
mechanisms for expanding access to quality care.
If no one was on call . . .necessary physician-supported updates toAlabama’s athletic trainer statute as it relates to supervision and
care continuity wouldnot have
become law. The Association
worked closely with the Athletic Trainers Association and several medical
specialty societies in drafting legislation to better define the practice of
athletic training, ensure appropriate physician supervision, and allow
joint-promulgation of athletic trainer rules between the professions’
respective licensure boards.
If no one was on call … the creation of a new
physician-led program to utilize paramedics to reach at-risk patients in
communities across the state would not have become law. The Association worked closely
with the Alabama Chapter of the American College of Emergency Physicians on the
legislation.
If no one was on call … the medical community’s voice and needs of physicians as it
relates to expanding broadband in Alabama would not have been heard. The legislation that passed creates a digital expansion authority
to expand access to the internet in all 67 counties and will undoubtedly help
patients connect with their physicians via telehealth.
If no one was on call … awareness of the need to expand
Medicaid would not
have grown as much as it did. The Association, as part of Cover Alabama – a
coalition of more than 100 organizations supporting Medicaid expansion –
continues to advocate for those caught in the coverage gap.
Fighting “Scope Creep”
(the Replacing of Education with Legislation)
Many people would like to be a physician, but few are willing to endure medical school, residency, and all the other various education and training requirements to become an M.D. or D.O. Instead of pursuing higher education, some non-physician organizations pursue legislative changes as an end-around-means to practice medicine, endangering quality care for patients.
If no one was on call . . .the physician referral requirement for physical therapy could have been
abolished. As introduced, the legislation (sponsored by Sen. Jim
McClendon) would have abolished the need for a medical diagnosis before a
physical therapist could begin providing therapy to a patient.
If no one was on call . . .podiatrists could have been granted the ability to perform surgery on
the ankle and lower leg. The legislation (co-sponsored by Sen. Jim
McClendon) would have allowed podiatrists who have completed as few as 2-years
of podiatry residency (significantly less than either a general orthopaedist or
an orthopaedic surgeon specializing in the ankle) to perform ankle surgery.
If no one was on call . . . optometrists could have begun performing eye surgeries using
scalpels and lasers as well as eye injections. The legislation (pushed by Sen.
Jim McClendon) would have allowed optometrists, who do not undergo any surgical
residencies anywhere in the U.S., to perform surgeries and injections on the
eye and would also have given the Alabama Board of Optometry the sole
power to define and regulate what is considered to be the practice of
optometry, taking all authority away from the Legislature to define it.
If no one was on call . . . a newly-created state board
could have unilaterally set the scope of practice for imaging technologists and
significantly increased costs to medical
practices utilizing medical imaging. Working with the Alabama Academy
of Radiology, the Alabama Academy of Family Physicians and other medical
specialty societies, the Association was able to reach a consensus with the technologists
on their legislation.
If no one was on call . . .the State Board of Nursing could have gained jurisdiction over, along
with the ability to charge licensure fees to, medical assistants working in
physician offices. Working with
a coalition of partners, the problems with the legislation were resolved.
If no one was on call … various “interstate compacts” for
non-physicians could have enabled “scope creep” far beyond
what Alabama law allows.
Beating Back the Lawsuit
Industry
Plaintiff lawyers are constantly seeking new opportunities
to sue physicians. Alabama’s medical liability laws have long been recognized
for ensuring a stable legal climate and fostering fairness in the courtroom. But
those laws come in jeopardy every session and the Association must defend
against allowing more frivolous lawsuits to be filed against physicians.
If no one was on call … new vaccine-related lawsuits
against physician-employers and medical practices could have become law.
If no one was on call … physicians accepting Medicaid
could have been subject to whistleblower lawsuits for honest billing mistakes,
costing $5,500-$11,000 per billing mistake plus triple damages under a Medicaid fraud bill
(sponsored by Sen. Jim McClendon). The
Association, along with a coalition of health care associations, offered a
substitute bill the sponsor rejected.
If no one was on call … physicians treating prisoners who
are pregnant could have been exposed to new liability for others’ actions. The Association worked with the
bill sponsor to remove the problematic language.
If no one was on call … physicians treating survivors of
sexual assaults could have been exposed to new liability and requirements for
new statutory standards of care. The Association worked with the bill sponsor to remove the
problematic language.
If no one was on call . . .physicians could have been held liable for emergency medical treatment
decisions of individuals believed to be a threat to themselves or others. The
Association worked with the bill sponsor to remove the problematic language.
If no one was on call . . .physicians could have been held liable for school system employees’
deviations from DNR orders made portable for minors in schools. The
Association worked with the bill sponsor and bill proponents to remove the
problematic language.
If no one was on call . . .physicians could have been held liable for the actions of school system
employees if the physician helped create a “seizure action plan” for his or her
minor child patient with a seizure disorder. The Association worked
with the bill sponsor to remove the problematic language.
If no one was on call … legislation to criminalize female
genital mutilation could have unintentionally created new liability issues for
physicians. The
Association worked with the bill sponsor and the Alabama Section of the
American College of Obstetricians and Gynecologists to ensure the bill adhered
to ACOG guidelines and that no new physician liability was created.
Other Health-Related Legislation
of Interest
If no one was on call . . .the Board of Medical Examiners and Medical Licensure Commission would
have been abolished. The legislation (sponsored by Sen. Jim McClendon)
would have banned physicians who were members of county, state or national
medical and specialty societies from participating in regulating their
profession. The proposed structure in the legislation would also have ensured
little diversity amongst the physicians serving on the reconstituted BME and
would likely have prevented rural physicians from being represented as
well.
If no one was on call … the State Health Officer and the
State Committee of Public Health would have been abolished. The legislation (sponsored by Sen.
Jim McClendon) would have allowed for a non-physician to head the Health
Department and would have replaced most of the physicians on the committee with
an optometrist and other non-physicians.Instead of making drastic changes to ADPH midstream, the legislature and
the governor agreed to a full-spectrum study of the state’s COVID-19 response
efforts between now and the beginning of the 2022 Session to identify areas for
improvement moving forward.
Legislation was enacted to enable cannabis
for medicinal use ifapproved by
a physician certified by the state to recommend it to patients. The bill
provides for the regulation by the state, from “seed to sale”, of
cannabis for medicinal use and creates a new commission to oversee all aspects
(other than physician regulation) of cannabis.
The new law allows
physicians to become “certifying physicians” and allows patients who are
approved by a certifying physician to access medical cannabis at a state
approved dispensary. In 2019, the Medical Association did an in-depth survey of
its members to gauge Alabama physicians’ opinions on the topic.
While opinions amongst individual physicians on cannabis for
medicinal use differed then and still do, there was broad support amongst
physicians for – IF cannabis for medicinal use were legalized in Alabama – that
the state would regulate and inspect the products. As well, there was also
broad support for keeping all regulation of physicians who choose to recommend
cannabis to patients under the Board of Medical Examiners and not moved under
the purview of the new Cannabis Commission or the Agriculture Department. Those
areas and others of strong support identified via the 2019 survey, as well
as several others, became the basis for the
Association’s advocacy efforts on the legislation. As a result, those areas of
broad agreement were included in the final bill that passed.
Legislation was enacted that would prevent practices of pharmacy benefit managers relating to patient steering to use mail-order pharmacies and would prevent price discrimination. It would also require the PBM to act as a fiduciary to clients and would prevent them from stopping pharmacists from disclosing prices.
A resolution was enacted to establish the chronic weight management and type 2 diabetes task force. The task force will study the health implications of chronic weight management and type 2 diabetes, the costs associated with the diseases, and the various health treatments available to reduce the epidemic in this state caused by those diseases. The task force is also tasked with making recommendations for improving the health of Alabamians. The Association has an appointment to the task force.
Legislation was filed to require all vaccine
providers to check the state vaccine registry (ImmPrint) before
administering a vaccine and also to input vaccine-recipient information into
the database. The legislation was amended to exclude flu shots for those 19 and
older from falling under the legislation. The bill did not pass.
Legislation was filed to ban transgender
therapy. It would have criminalized counseling, prescribing and performing
surgery if the intent of any of the preceding was to assist and/or affirm in
transitioning a patient to a gender different than the one listed on the
patient’s birth certificate. The legislation was amended to remove “counseling”
from the list of banned therapies for treating transgender patients. The bill did not pass.
Legislation was filed to change the way
county health officers issued countywide public health orders. Various bills were filed related to county health
orders. Some would have established an advisory panel to weigh in on countywide
health orders before implementation while others would
have prohibited a county health officer from
issuing an order that relates to pandemic or outbreak unless it was approved by
the State Health Officer. These bills did not pass.
Legislation was filed to change
how statewide public health orders are issuedand also to curtail the emergency declaration powers of the governor.
These bills did not pass.
Multiple pieces of legislation were filed related to abortion. The topics ranged in focus from requiring information be
provided to patients about possible reversal of chemical abortion medications,
to banning chemical abortions altogether, to banning the public funding of
abortions, to requiring that babies born alive after an abortion in a
reproductive health center be provided the same life-sustaining treatment than
if the baby were born elsewhere. Of these, the “born alive” bill passed in the final legislative day.
Multiple pieces of legislation were filed related to banning vaccine passports. The bill that passed on the
final legislative day leaves in place existing immunization requirements for
students (and also allows exceptions for religious or medical reasons) but bans
the issuance of vaccine passports in Alabama by the state or any other
governmental body. It also prevents businesses from being able to require proof
of vaccination for entry into a business or as a condition for provision of a
good or service to a customer.
