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Volume 11 | Issue 2
Inside This Issue
February Edition 2021
Medical Record Retention By Richard Cahill, JD, Vice President and Associate General Counsel The Doctors Company
T Mediterranean Diet May Decrease Risk of Prostate Cancer Progression for Men See pg. 11
INDEX Legal Matters........................ pg.3 Oncology Research......... pg.5 Mental Health...................... pg.6 Healthy Heart....................... pg.8 The Framework.................. pg.10
Memorial Hermann Appoints Rhonda Abbott as Senior Vice President and CEO of TIRR Memorial Hermann See pg. 12
he unexpected advent of the COVID-19 pandemic and the subsequent dramatic shift to delivering more medical care via telehealth underscore the importance of complete and accurate charting for maintaining continuity of care and defending claims of professional liability. Accurate charting can also help protect physicians against licensing board complaints and hospital peer review queries, or respond to investigations by governmental compliance agencies. The potential for billing audits by the Centers for Medicare and Medicaid Services (CMS) or commercial third-party payers provides further motivation to create— and store—complete documentation. A number of variables affect the length of time a physician should keep a medical record. Factors include state and federal laws, medical board and association policies, and the type of record (for example, that of an adult patient versus that of a pediatric patient). The following information can guide you in developing a medical record retention policy. Basis for Keeping Medical Records The most important reason for keeping a medical record is to provide information on a patient’s care to other healthcare professionals. Accurately charting an individual’s presenting complaints, signs, and symptoms derived from a careful physical examination, differential diagnoses, and treatment plan help to optimize patient well-being and promote more effective continuity
of care. Patient health records serve a number of other vital functions. For example, billing audits require clear documentation demonstrating medical necessity and the nature and scope of the services provided. Another major rationale is that a well-documented medical record provides support for the physician’s defense in the event of a medical malpractice action. Entries made in the medical record at or near the time of the event are regarded as highly reliable evidence in subsequent judicial procedures. The chart and progress notes—key evidence in a professional liability action—are critical to help refresh the provider’s recollections of events (which might have occurred years earlier) and to establish facts at a time when no conflict or other motivation shaded or otherwise embellished the circumstances at issue. Without the medical record, the physician might not be able to show that the care he or she provided was appropriate and that it met the standard of care. Relying on the practitioner’s testimony of general habit and practice to show that the standard of care was met—without supporting documentation to establish the treatment that was rendered— often fails to convince a jury that the treatment the patient received was
consistent with community standards. Medical records are also important in establishing the quality of care rendered in the event of a medical board or peer review inquiry. Patient complaints are often based on an individual’s mistaken recollection of events, or on a failure to understand the course of treatment or adverse consequences involved in the dispute. With complete charting, frivolous allegations are readily resolved, frequently well before a formal administrative process is even initiated. Federal Law, State Law and Case Law Federal and state laws impose mandatory medical record retention requirements on medical facilities and physician practices. The Medicare Conditions of Participation, for example, require hospitals to retain records for five years (six years for critical access hospitals),1 whereas OSHA requires an employer to retain medical records for 30 years for employees who have been exposed to toxic substances and harmful agents.2 Federal legislation such as HIPAA and HITECH have also added new requirements. HIPAA privacy regulations, for example, require that documents created in compliance with the Privacy Rule, such as policies, procedures, and accountings of see Medical Record ..page 14
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Houston Medical Times
Legal Matters 340B, Drug Pricing and Reimbursement Five Things to Watch In 2021
Kyle Vasquez, J.D. Shuchi Parikh, J.D. Polsinelli, PC
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he final months of 2020 saw a lot of new activity in the 340B and pharmacy space, with stakeholders, HHS, and courts alike taking action that could have lasting impacts on the industry. Drug pricing remains a top priority, although recent successes with a COVID-19 vaccine could thwart meaningful attempts to regulate manufacturers. Below are five recent legal and policy developments that will continue to impact industry participants well into 2021. 1. Manufacturer Activity Impacting 340B Contract Pharmacies – A growing list of manufacturers have
launched attacks on the 340B contract pharmacy program. Eli Lilly was the first manufacturer to restrict access to 340B pricing for all products in the contract pharmacy setting, with a number of manufacturers quickly following suit. Covered entity groups have challenged the actions in federal court as unlawful under a plain reading of the 340B statute. Other manufacturers, such as Sanofi and Novartis, have initiated other 340B restrictions. If left unchecked, these manufacturer actions could establish a dangerous precedent under the 340B program. In a positive development for 340B entities, the US Department of Health and Human Services issued an advisory opinion which concludes that manufacturers are obligated to provide access to 340B pricing to contract pharmacies. Despite the advisory opinion, manufacturers have continued to enforce their contract pharmacy restrictions and several have filed suit challenging the legality of the HHS advisory opinion.
2. Final 340B Alternative Dispute Resolution (ADR) Rule – Ten years after the statutorily mandated deadline, HRSA released on December 10, 2020 its long-awaited 340B ADR Final Rule. The rule establishes a binding ADR process to resolve disputes between 340B covered entities and manufacturers, such as disputes related to manufacturer overcharges. Manufacturers may also initiate disputes against covered entities related to allegations of diversion or duplicate discounts after conducting an audit of the covered entity. The rule sets forth a three-year lookback period for claims and damages sought must exceed $25,000. Although the final ADR rule will allow covered entities to dispute the recent manufacturer actions detailed above through a formal dispute process, covered entity groups have appealed to HRSA for stronger action against the manufacturers. 3. Medicare Part B Most Favored Nation Rule –CMS recently published its Most Favored Nation (MFN) Model Interim Final Rule (IFR) that seeks to lower the amount paid for 50 high-cost Medicare Part B drugs to the lowest price that drug manufacturers receive in similar countries. CMS will phase in the MFN model over four years
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by setting the drug’s price based on a blend of the MFN price and the average sales price. Although the rule was schedule to take effect on January 1, 2021, a lawsuit was filed challenging the validity of the IFR and a court has issued a temporary injunction suspending the rule. The incoming Biden administration may also further scrutinize the rule. 4. State Regulation of Pharmacy Benefit Managers (PBMs) – Pharmacies obtained a significant victory in the Supreme Court in December in a case upholding a state law regulating PBM reimbursement rates. The Arkansas law at issue requires plans to reimburse pharmacies at or above their acquisition costs and adjust see Legal Matters...page 14
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Houston Medical Times
St. Luke’s Health TX Division Reaches Agreement with Blue Cross Blue Shield
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from patients, providers, employers and other leaders was tremendous. Termination of the contract last month was a difficult decision, especially in the face of COVID-19, but we knew it was a necessary decision as we could only continue to provide the value-driven care our community relies upon by addressing St. Luke’s financial health. This agreement does that. “As this new agreement goes into effect, our focus remains where it has always been--on patients. We’re eager to continue working with those BCBSTX customers who have remained under our care, and to working with those who find themselves in need of hospital-based care in the future.”
St. Luke’s Health is a trusted and highly regarded resource in the greater Houston medical community, with an integrated health network dedicated to delivering advanced medical care and research, compassionate care and a Christian ministry of healing. In addition to its unique academic and community partnerships with Baylor College of Medicine, Texas A&M University, and the Texas Heart Institute, St. Luke’s Health is nationally recognized as having some of the best physicians and hospitals in the country. US News & World Report ranks Baylor St. Luke’s Medical Center as the number two hospital in Houston and the third best hospital in the state, with their programs in oncology,
cardiology, orthopedics, neurology, gastroenterology and geriatrics rated among the best in the country. The new agreement with BCBSTX will help St. Luke’s Health preserve the type of value-driven, high quality, and innovative care our patients and the community have come to expect. Choice is important and consumers rely on St. Luke’s Health for services ranging from life-saving care at our regional facilities in communities like Lake Jackson, Lufkin, and Bryan-College Station to pioneering treatments such as double lung transplant care for COVID patients at our flagship academic medical center at Baylor St. Luke’s. For more information, visit stlukescaringforyou.com.
RELAX
t. Luke’s Health has reached an agreement with Blue Cross Blue Shield of Texas (BCBSTX) on a new contract that will ensure coverage for 65,000 BCBSTX patients who choose to receive their health care at the hospitals in the St. Luke’s Health network. The new agreement was effective January 8, 2021. The following is a statement about the agreement from T. Douglas Lawson, CEO of St. Luke’s Health: “This new contract is an affirmation of how important the choice to receive the accessible, value-driven medical care that we provide at St. Luke’s Health is to the health of our community. The support St. Luke’s Health received
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In the Heart of the Medical Center
Houston Medical Times
Oncology Research Immunotherapy: Fighting Cancer from Within By Henna M. Malik, M.D., to attack cancer cells to stop or slow Texas Oncology their growth or limit the cancer’s
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odern In the fight against cancer, chemotherapy and radiation have been the primary “go-to” treatment options for decades, and a significant amount of research has focused on making these more effective. Immunotherapy now is making its way to the forefront of cancer care thanks to advancements in medical technology and research – even though breakthrough experiments in this treatment method date back to the 1890s. Cancer researchers are just starting to scratch the surface of what may be one of the biggest revolutions in cancer treatment in our lifetimes: harnessing the immune system to help fight cancer. Immunotherapy uses certain parts of a person’s immune system
ability to spread. When used alone or in combination with other types of treatments, including chemotherapy, radiation, or surgery, immunotherapy has been shown to improve patient outcomes. Unlocking the Power of the Human Immune System In the late 1800s, New York physician Dr. William Coley discovered that some cancer patients benefited when their immune systems were “enhanced” with certain bacteria. Coley’s treatment concept faded as advances in chemotherapy, radiation therapy, and surgery developed. However, in the last several decades, researchers returned to Coley’s intriguing idea to give the body’s immune system the boost it needs to fight cancer. Vaccines, which are patient and cancer specific, have been developed for some forms of cancer. They may boost an immune system response or help prevent a future recurrence.
Celebrating
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S o m e immunotherapy is not specific to a cancer type. Interleukins and interferons help the immune system resist cancer and viral infections, which has proven effective for some forms of cancer. Other types of immunotherapy are more specific. Your body already makes antibodies to fight infections like the flu. Scientists are now designing antibodies to target specific antigens in cancer cells while not affecting healthy cells. The Role of Clinical Trials New breakthroughs, like immunotherapy, are successful only if there are patients who are willing to participate in the research. While immunotherapy is not currently available for all forms of cancer, the treatments that have been fully approved or are in clinical trials are radically changing cancer treatment – for the better. Clinical trials that included Texas patients and physicians were
instrumental in the development of a form of immunotherapy called CAR-T, or Chimeric Antigen Receptor T cell therapy. This personalized therapy involves engineering a patient’s own immune system’s blood cells – arming the cells, so to speak – to attack cancer cells. During the complex procedure, doctors remove some of the patient’s T cells, a type of white blood cell, which are then genetically reprogrammed to identify and attack cancer. Weeks later, doctors then infuse the re-engineered cells back into the patient’s body. Looking Toward the Horizon The Food and Drug Administration first approved the new see Oncology Research...page 10
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Mental Health Unlocking PTSD: New Study Reveals Why Trauma-Focused Psychotherapy Treatment Works By Adria Johnson
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rauma-focused psychotherapy is widely considered the best available treatment for posttraumatic stress disorder (PTSD). However, the ways in which this method affects the brain to promote recovery from PTSD are not well understood. In a new study published in Biological Psychiatry, researchers used neuroimaging to examine how the brain areas responsible for generating emotional responses to threats are changed by psychotherapy. “We know that psychotherapy works. But we don’t have a lot of good data to explain how it works, how the brain is changed by going through this process,” said Greg Fonzo, Ph.D., lead author of the study and an assistant professor in the Department of Psychiatry and Behavioral Sciences at Dell Medical School at The University of Texas at Austin. “That’s what we sought to find out.”
February 2021
Posttraumatic stress disorder may occur in people who have experienced or witnessed a traumatic event such as war or combat, sexual assault, a natural disaster or terrorist act. Symptoms can include flashbacks, nightmares and severe anxiety, as well as uncontrollable thoughts about the event. Trauma-focused psychotherapy is a treatment that helps people recover from a traumatic event, using techniques such as “in vivo exposure,” which involves directly facing a feared object, situation or activity in real life, and “imaginal exposure,” which involves facing the trauma memory. A person who is afraid of crowds, for example, may be repeatedly exposed to large gatherings. “At first, that patient will obviously experience fear or whatever negative emotion is triggered by being in a crowd,” said Fonzo, who also holds a courtesy appointment in the
Department of Psychology at UT Austin. “But it’s like looking at a fire from behind a window. It appears to be a dangerous situation, but the person is actually quite safe. After a while, the fire will burn out, and the person recognizes there was no actual danger. And so that process eventually promotes new learning in the brain.” Fonzo and his colleagues used functional magnetic resonance imaging (fMRI) scans to identify how brain networks communicate with one another before and after treatment. Specifically, they measured the degree of communication or “traffic,” known as functional connectivity, between areas of the brain responsible for emotion and regions of the cortex in charge of logic and thinking. “What we discovered was a reduction in traffic between these brain regions among patients who had undergone trauma-focused
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psychotherapy,” said Fonzo. “In fact, greater connectivity changes were associated with bigger symptom reductions. This restructuring of brain communication may be a unique signature of PTSD recovery.” Fonzo said these findings could change the way doctors treat people who suffer from PTSD. “Now that we have a better understanding of the brain mechanisms underlying psychotherapy, we may be able to use this information to develop new and better treatments for people with PTSD,” said Fonzo.
Houston Medical Times
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Healthy Heart February Marks 57th Consecutive American Heart Month By American Heart Association
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t’s no secret February is all about hearts — but not just the candy kind. It’s also American Heart Month, a time the nation turns its attention to keeping families and communities free from heart disease. The federally designated event reinforces the importance of heart health and the need for more research, with a reminder to get families, friends and communities involved. It’s a tradition that’s over half a century strong. The first proclamation was issued by President Lyndon B. Johnson in February 1964, nine years after he had a heart attack. Since then, the president has annually declared February American Heart Month. With organizations such as the American Heart Association and others working together, millions of people are enjoying longer, healthier lives. Cardiovascular disease (heart disease and stroke combined) kills about 2,300 a day. Obesity in both youth and adults is at an all-time high,
February 2021
youth are being diagnosed with heart disease earlier than ever and people just ZIP codes apart can live 25 years less than their neighbors because of disparities in health. American Heart Month is vital for awareness, but the American Heart Association urges people to take care of their hearts year-round. Consider the facts: • Heart disease kills more people than all forms of cancer combined. • Heart attacks affect more people every year than the population of Dallas, Texas. • 83% believe that heart attacks can be prevented but aren’t motivated to do anything. • 72% of Americans don’t consider themselves at risk for heart disease. • And 58% put no effort into improving their heart health. While science is advancing medicine in exciting new ways, unhealthy lifestyle choices combined with rising obesity rates in both kids and adults have hindered progress fighting heart disease. The good news is that heart disease is preventable in most cases with
healthy choices, which include not smoking, maintaining a healthy weight, controlling blood sugar and cholesterol, treating high blood pressure, getting at least 150 minutes of m o d e r a t e-i nt e n s it y physical activity a week, and getting regular checkups. Laura Bhatia, the 2021 Houston Go Red for Women Chair, said, “It’s important to monitor your heart health regularly, especially during Heart Month. I practice Yoga six days a week. I find that it keeps me physically challenged and mentally centered. The Go Red for Women campaign is such an important movement to increase awareness and empower women everywhere.” The first Friday of the month, Feb. 5, is National Wear Red Day. Coast to coast and across Greater Houston, landmarks, news anchors and neighborhoods will go red to raise awareness and support for heart disease. Go Red for Women® is an American Heart Association movement to increase heart health awareness and improve the lives of women globally. For 17 years, it has harnessed the energy, passion, and
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power of women to band together and wipe out cardiovascular disease — their leading cause of death that claims the lives of one in three. It challenges every woman to know her personal risk for heart disease and stroke and take action to reduce it. This February, volunteers, survivors, and supporters amplify Go Red for Women’s lifesaving message to raise awareness and encourage action. This includes knowing your numbers and family history, recognizing the signs and symptoms of heart attack and stroke, participating in research, learning CPR, and making healthy behavior and lifestyle changes. For more information, visit goredforwomen.org/en/get-involved/ give/wear-red-and-give.
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The Framework Kelsey-Seybold Announces New Clinic in Memorial City New Clinic Will Expand Access to Coordinated, Evidence-Based Care for Residents Living In Memorial, The Villages, And Spring Branch Areas
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el sey-S eyb old Cli nic announced plans to open a 12,500 sq. ft. clinic in Houston’s Memorial area. Kelsey-Seybold Clinic – Memorial City will be located at 929 Gessner Road, Suite 1450, Houston, inside the Kelsey-Seybold Clinic – Memorial City celebrated its opening day on Jan. 4 with balloons, signage, giveaways, and welcoming staff, Memorial Hermann Tower with including the clinic’s Managing Physician Jessica Stull, M.D., convenient skywalk access from pictured above. Garage 5. The new Memorial back for care with our providers because City Clinic represents the first step by of our commitment to quality and Kelsey-Seybold Clinic in establishing a value, and we are so looking forward to more significant presence in the area, welcoming current and new patients to with enough room for up to six providers this new clinic in Memorial City.” offering comprehensive care for adults. The Memorial City clinic Kelsey-Seybold Clinic – Memorial location will expand access to City will officially open for primary care coordinated, evidence-based care in visits on Jan. 4. Patients will also have an area that is central to several large immediate access to an on-site laboratory. residential suburbs and important Plans to add specialties including industries. Kelsey-Seybold patients will Cardiology (general/interventional), also have access to an extensive referral and Pulmonary Medicine will follow network for various specialists with beginning in the second quarter of 2021; offices at neighboring clinics, including along with X-ray and diagnostics. Downtown at The Shops, Tanglewood, “This Memorial City location Meyerland, and Berthelsen Main helps us close a service-area gap for Campus. current and potential patients living “As a destination location on the in nearby, well-established Houston west side of Houston, this new clinic in area communities. Having a clinic Memorial City gives Kelsey-Seybold a conveniently located in Memorial City presence in a high-traffic area, with easy will make accessing a Kelsey-Seybold access via Interstate 10, along the Energy provider more convenient for those Corridor and near major residential at home and work,” said Tony Lin, areas such as Memorial, Spring Branch, M.D., Chairman, Board of Managers and the Villages,” said Kenneth Janis, and C.E.O., at Kelsey-Seybold Clinic. M.H.A., M.B.A., chief operating officer “Patients who have convenient access of Kelsey-Seybold Clinic. to Kelsey-Seybold doctors keep coming
Oncology Research
Continued from page 5 CAR-T therapy in 2017 for specific types of lymphoma and leukemia after its promising results during clinical trials. Using the body’s own tools to fight cancer is opening up a new and exciting horizon in oncology. For example, immunotherapy led to the first new treatments for melanoma to be approved by the FDA in more than a decade. In some cases,
February 2021
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immunotherapies can mean fewer unpleasant side effects for patients. Research continues to examine the effectiveness of the new therapy for other forms of cancer. Through research and patient participation in trials, oncologists are rapidly discovering dramatically better ways to treat, diagnose, and prevent even the most aggressive forms of cancer.
Houston Medical Times
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Mediterranean Diet May Decrease Risk of Prostate Cancer Progression for Men on Active Surveillance
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n a s t u dy to ex a m i ne a Mediterranean diet in relation to prostate cancer progression in men on active surveillance, researchers from The University of Texas MD Anderson Cancer Center found that men with localized prostate cancer who reported a baseline dietary pattern that more closely follows the key principles of a Mediterranean-style diet fared better over the course of their disease. “Men with prostate cancer are motivated to find a way to impact the advancement of their disease and improve their quality of life,” said Justin Gregg, M.D., assistant professor of Urology and lead author of the study, published today in Cancer. “A Mediterranean diet is non-invasive, good for overall health and, as shown by this study, has the potential to effect the progression of their cancer.” After adjusting for factors known to increase risk of cancer getting worse over time, such as age, prostate-specific antigen (PSA) and tumor volume, men with a diet that contained more fruits, vegetables, legumes, cereals and fish had a reduced risk of their prostate cancer growing or advancing to a point where many would consider active treatment. The
researchers also examined the effect of diabetes and statin use and found a similar risk reduction in these patient groups. The study, whose largest number of participants were white, also found that the effect of a Mediterranean diet was more pronounced in African American participants and others who self-identified as non-white. These findings are significant as the rate of prostate cancer diagnosis is more than 50% higher in African American men, who also have a higher risk of prostate cancer death and disease progression. “The Mediterranean diet consistently has been linked to lower risk of cancer, cardiovascular disease and mortality. This study in men with early stage prostate cancer gets us another step closer to providing evidence-based dietary recommendations to optimize outcomes in cancer patients, who along with their families, have many questions in this area,” said Carrie Daniel-MacDougall, Ph.D., associate professor of Epidemiology and senior author of the study. After skin cancer, prostate cancer is the most common cancer in men in the United States. Since most
cases are low-risk disease, localized to the prostate and have favorable outcomes, many men do not need immediate treatment and opt for active surveillance by their doctor. Treatments for prostate cancer can cause changes in quality of life and declines in urinary and sexual function, therefore there is interest in finding modifiable factors for men managed by active surveillance. The study followed 410 men on an active surveillance protocol with Gleason grade group 1 or 2 localized prostate cancer. All study participants underwent a confirmatory biopsy at the beginning of the study and were evaluated every six months through clinical exam and laboratory studies of serum antigen PSA and testosterone. Trial participants were 82.9% Caucasian, 8.1% Black and 9% other or unknown. The median age was 64, 15% of the men were diabetic and 44% used statins. The men completed a 170-item baseline food frequency questionnaire, and Mediterranean diet score was calculated for each participant across 9 energy-adjusted food groups. The participants were then divided into
three groups of high, medium and low adherence to the diet. After adjustments for age and clinical characteristics, researchers saw a significant association between high baseline diet score and lower risk of cancer grade progression. For every one-point increase in the Mediterranean diet score, researchers observed a >10% lower risk of progression. After a median follow-up of 36 months, 76 men saw their cancer progress. The study was limited by the low number of events in these men with mostly low risk disease monitored at MD Anderson. Future research is needed to see if the same effects are seen for larger and more diverse patient groups and men with higher-risk prostate cancer. “Our findings suggest that consistently following a diet rich in plant foods, fish and a healthy balance of monounsaturated fats may be beneficial for men diagnosed with early-stage prostate cancer,” Gregg said. “We are hopeful that these results, paired with additional research and future validation, will encourage patients to adapt a healthy lifestyle.”
Fitbit Help Support Veteran Health and Wellness During COVID-19 Pandemic
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he U.S. Department of Veterans Affairs (VA) announced a new initiative with Fitbit that will provide eligible Veterans, caregivers and VA staff with access to Fitbit programs and services to help manage stress, improve sleep and increase physical activity during the COVID-19 pandemic. The initiative will be focused on participants who currently use Fitbit devices. VA has contracted with Fitbit to initially provide 10,000 eligible Veterans, caregivers and VA staff a one-year free membership to Fitbit
Premium. This includes access to guided programs, hundreds of workouts, mindfulness content, a wellness report and a health metrics dashboard. Participants will also have access to Fitbit Health Coaching, one-on-one coaching and guidance from a certified health coach or licensed health professional. Eligibility will be based on various factors such as whether an individual is a Veteran, already a Fitbit user and their location. Additionally, some Veterans who currently receive VA health care may be eligible to
receive a Fitbit Sense, Fitbit’s most advanced health smartwatch. “This initiative is an example of the way VA is successfully adapting to the COVID-19 pandemic,” said VA Secretary Robert Wilkie. “It also ensures the department continues to provide efficient, quality and timely care.” VA is also working with Veteran service organizations and community-based organizations to
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explore how wearables and other digital health technologies can help Veterans and VA health care teams meet their health care needs. As VA and Fitbit assess the feedback from the program and the outreach efforts, they will consider new ways to help support the health and wellbeing of Veterans. To learn more about the initiative and eligibility, visit Fitbit Health Solutions..
February 2021
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Houston Medical Times
Memorial Hermann Appoints Rhonda Abbott as Senior Vice President and Chief Executive Officer of TIRR Memorial Hermann
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emorial Hermann Health System has named Rhonda Abbott the new senior vice president and chief executive officer of TIRR Memorial Hermann. In this role, Abbott will oversee TIRR Memorial Hermann’s continued excellence in rehabilitative care, research and education across the system, effective immediately. “Rhonda has been pivotal in strategically growing and expanding TIRR Memorial Hermann, leading therapy teams across the network to enhance the lives of countless patients,” said Greg Haralson, SVP, CEO, Memorial Hermann-Texas Medical Center Campus. “Known for her unwavering dedication, operational strength and results-oriented focus, Rhonda will
February 2021
continue to ground our organization as a leader in medical rehabilitation and research and as a provider of exceptional patient experiences.” For 19 years, Abbott has held many pivotal positions within TIRR Memorial Hermann. She started her career as a staff therapist in the spinal cord injury and specialty rehabilitation program and earned successive promotions to director of therapy services and director of clinical programs and vice president of operations, and now CEO. Under her leadership, TIRR across the Memorial Hermann Rehabilitation Network by driving clinical care redesign initiatives, translational research efforts, expansion of therapy education programs and length of stay improvements. She also
managed efforts for TIRR to earn the Commission on Accreditation of Rehabilitation Facilities (CARF) accreditations across multiple Memorial Hermann Rehabilitation Network locations. “I am humbled by this appointment and proud to lead TIRR Memorial Hermann by providing exemplary clinical care, expanding and translating evidence-based practices, and advancing education and advocacy,” said Abbott. “I look forward to the future of TIRR Memorial Hermann and Memorial Hermann’s Rehabilitation Network as we continue to redefine rehabilitation through innovation and empower patients to achieve a higher quality of life.” Abbott is on the board of directors for the American Medical Rehabilitation Providers Association, a member of the American Physical Therapy Association and American College of Healthcare Executives, a Texas Physical Therapy Association Tom Waugh Leadership Development Fellow, a champion of Women Leaders of Memorial Hermann, a graduate of the Center for Houston’s
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Rhonda Abbott
Future Business/Civic Leadership Forum and an advocate for the ReelAbilities Film Committee. Abbott holds a master’s degree in business administration from West Texas A&M University, a master’s in science in physical therapy from Texas Woman’s University and a bachelor’s degree from Texas A&M University. Prior to this appointment, Abbott has served as interim SVP and CEO of TIRR Memorial Hermann, succeeding Jerry Ashworth who was named SVP and CEO of Memorial Hermann Cypress Hospital and Memorial Hermann Katy Hospital in September 2020.
Houston Medical Times
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Why Some Americans Are Hesitant to Receive The Covid-19 Vaccine Study Finds Likelihood of Vaccine Refusal Highest Among African Americans, Women And Conservatives By Callie Rainosek
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ecent polls suggest that a significant percentage of Americans are reluctant to receive the COVID-19 vaccine. The results of these polls have stimulated new questions, such as, “Who is most likely to refuse the COVID-19 vaccine?” and “What are their reasons for refusal?” Understanding the answers to these questions is critical in improving COVID-19 vaccination rates and ending the pandemic. Timothy Callaghan, PhD, assistant professor at the Texas A&M University School of Public Health, led a research study published recently in Social Science and Medicine to better understand COVID-19 vaccination intentions in the American public and the reasons why many individuals intend to refuse a COVID-19 vaccine. Callaghan and colleagues surveyed a demographically
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representative sample of more than 5,000 Americans. The results revealed that 31.1 percent of Americans do not intend to take the COVID-19 vaccine once it becomes available to them. The likelihood of vaccine refusal was highest for African Americans, women and conservatives. Overall, the two most cited reasons for vaccine refusal were concerns about vaccine safety and effectiveness, but reasons for vaccine reluctance varied across sub-populations. For instance, women were likely to be hesitant based on concerns about safety and effectiveness, while African Americans were likely to be hesitant because of these same concerns as well as a lack of financial resources or health insurance to afford the vaccine. When it comes to COVID-19 hesitancy in conservatives, Callaghan explained that previous studies have shown that
conservatives are generally less trusting of vaccines, as well as medical and scientific professionals. The finding that most surprised Callaghan was that African Americans, who are being infected and dying at higher rates than the rest of the population, are one of the groups less likely to vaccinate because of a combination of concerns, including concerns related to safety and affordability. “This points to the need for the medical community and policymakers to find ways to both build trust in the vaccine in the African American community and to ensure that it is delivered affordably,” Callaghan said. Callaghan also noted the importance of combatting messaging from anti-vaccine
• Integrating the Montessori method into the public school curriculum • Currently offering Pre-K thru 4th • Open enrollment until positions fill
advocacy groups, which have sowed doubt among key groups—including African Americans—about the safety of the COVID-19 vaccine. Now that COVID-19 vaccine-hesitant populations have been identified, Callaghan plans to explore what kind of health interventions and health promotion efforts are most effective in promoting the vaccine in these populations. Additionally, he notes that it is important to explore the similarities and differences between populations that are generally vaccine hesitant, and populations that are hesitant specifically toward the COVID-19 vaccine.
• Comprehension Stem Program • Character & Leadership Development • High Tech – 7 computers per classroom
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Medical Record
Continued from page 1 disclosures, be retained for six years from when the document was created,3 which follows the federal statute of limitations for civil penalties.4 The healthcare professions have primarily been regulated by the states rather than by a federal oversight agency. As a result, certain facets of medicine are governed differently in numerous jurisdictions across the country. These variations are especially evident in the way that healthcare record retention has been regulated, so it is important for physicians to check and follow state requirements. Record retention policies should not be based solely on the state statute of limitations. This is because case law in various jurisdictions may extend the allowable time for the patient to bring a malpractice action. An example of this situation is when a patient could not have discovered that the injuries were caused by wrongdoing within the statutory timeframe. Medical Board & Medical Association Policies and Recommendations When state or federal laws are silent on medical record retention, medical boards may be able to provide policies or recommendations on how long a physician should keep records. For example, the Colorado State Board of Medical Examiners Policy 40-07 recommends retaining medical records for a minimum of seven years after the last date of treatment for an adult and for seven years after a minor has reached the age of majority, or age 25. In California, where no statutory requirement exists, the California Medical Association concluded that, while a retention period of at least 10 years may be sufficient, all medical records should be retained indefinitely
Legal Matters
Continued from page 3 their maximum allowable cost (MAC) lists accordingly. Pharmacies can also decline to dispense a prescription if the PBM’s reimbursement will be less than the pharmacy’s acquisition cost. The Pharmaceutical Care Management Association challenged the law on the grounds that it is pre-empted by ERISA, a federal law that pre-empts any state law that “relates to” an employee benefit plan. In an 8-0 opinion, the Court held that cost regulation of this type is not pre-empted by ERISA as it
February 2021
Houston Medical Times
or, in the alternative, for 25 years.5 The Doctors Company Recommendations Medical record retention laws and regulations differ from state to state. It should be emphasized that once a record is destroyed, it is difficult—if not impossible—to defend the case. We encourage physicians to consult with their own legal counsel regarding how the law in the jurisdictions relevant to their practice has been interpreted by the judicial system. You must follow your state’s specific guidelines or laws. Where no statutory requirement exists, The Doctors Company makes the following recommendations for retaining medical records: • Adult patients, 10 years from the date the patient was last seen. • Minor patients, 28 years from the date of birth. • Deceased patients, five years from the date of death. Check any signed HMO or managed care agreements to ensure compliance with the medical records retention requirements of those agreements. For example, Medicare managed care plans require providers to maintain records for 10 years. Medical records, whether paper or electronic, must be maintained in a HIPAA-compliant format. If using a commercial service, the records should be stored with a reputable document storage company. Many companies offer alternative methods for paper document management, such as electronic scanning and storage, and may offer storage of previous electronic records when software formats change. Storing closed or archived records at a residence or on a home computer puts the records at risk of damage from fire, flood, or other weather-related disasters, vermin, loss due to theft, or unauthorized access. Check state statutes and professional
licensing agencies for state-specific requirements or recommendations. If a physician chooses to destroy clinical records after a set time period, confidentiality must not be compromised. Use a record destruction service that guarantees records will be properly destroyed without releasing any information. Records that are destroyed should be listed on a log with the date of destruction. What Records Should You Retain? Retain all records that reflect the clinical care provided to a patient, including provider notes, nurses’ notes, diagnostic testing, photos, and medication lists. Additionally, records from other providers that are directly related to your care and are maintained as a regular part of your chart should be kept for the same period of time that you retain your own records. This is especially true if you have relied on any of the previous records or information when making clinical decisions. Review patient bills for any reference to care provided. For example, review a bill to determine if it shows a limited examination or an annual physical with diagnostic tests obtained or requested. If the billing document shows that care was provided, it may be in your best interest to keep the bill for as long as you retain the medical record. Otherwise, retain the bill for the same length of time as other business records and in accordance with federal and state income tax requirements. Storing medical records for the recommended time can generate a financial expense for the physician or practice. Given the importance of the medical record in defending a malpractice action, however, it is vital to ensure that the record is available to defend proper care.
does not govern a central matter of plan administration. A growing number of states have issued laws regulating the PBM industry in recent years, and the Court’s decision could spur additional state regulation of drug reimbursement that is favorable to pharmacies. 5. Elimination of Anti-Kickback Statute Safe Harbor Protection for Manufacturer Rebates to PBMs –The HHS Office of the Inspector General (OIG) published a final rule that removes protection under the Anti-Kickback Statute (AKS) discount safe harbor for manufacturer rebates on prescription drugs for PBMs under Medicare Part D and
Medicaid managed care. The changes are effective January 1, 2022. The Pharmaceutical Care Management Association filed a lawsuit challenging the legality of the rule. The above developments could fundamentally alter the way pharmacies, 340B covered entities, and related stakeholders do business, although the fate of some of the Trump administration’s recent drug pricing policies is tenuous. We expect 2021 to continue to bring significant legal activity and policy developments in the 340B and pharmacy space.
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Page 15
GET YOUR HEART BACK TO WHAT MAKES IT REALLY BEAT
HEART ISSUES SHOULDN’T WAIT. SEE YOUR DOCTOR. Staying on top of your heart health has never been more important. If you are at high risk for heart disease or are experiencing new or worsening symptoms, it’s time to see your doctor. At Memorial Hermann, our network of affiliated cardiologists offer proactive assessments and personalized plans to help keep risk factors in check. And with enhanced safety measures in place at all of our facilities, you can get the care you need with peace of mind.
Advancing health. Personalizing care.
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Houston Medical Times
need CPR, too!
More and more people are surviving cardiac events — BUT NOT WOMEN. Numbers tell the story
Only 39% of women received CPR from bystanders in public compared to 45% of men.
In a 2017 study of more than 19,000 people who had cardiac events:
Why?
• Have cardiomyopathy, a disease of the heart muscle • Have non-schockable rhythms that cannot be treated with an AED • Be older and live at home alone Plus, a few common fears and myths may prevent them from getting help.
Fears
=?
Even in training environments, some people are less likely to use CPR or an AED on female avatars
“I will be accused of inappropriate touching” “I will cause physical injury”
AHA’S RESPONSE: RAISING AWARENESS
23% higher than women’s.
Women who have cardiac arrests are more likely to:
THE PROBLEMS: CPR +
Men’s odds of surviving a cardiac event were
about cardiac arrest in women.
“I will get sued if I hurt a woman”
Myths Many believe that women: • Are less likely to have heart problems • Overdramatize incidents
To help overcome the problems and fears AHA is: IMPROVING TRAINING
ADVOCATING
AHA’s CPR training addresses gender-related barriers to improve bystander CPR rates for women. This includes representation of women in our training materials and informational videos.
to improve the response to cardiac arrest for everyone. Good Samaritan laws offer some protection to those who perform CPR.
Overcome your fear and learn CPR. Learn more at goredforwomen.org/WomenandCPR The Red Dress Design is a trademark of U.S. DHHS. Unauthorized use prohibited. 10/20 DS16771
February 2021
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