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February Edition 2021

Inside This Issue

Medical Record Retention By Richard Cahill, JD, Vice President and Associate General Counsel The Doctors Company

T Why Some Americans Are Hesitant to Receive The Covid-19 Vaccine See pg. 10

INDEX Legal Matters....................... pg.3 Oncology Research......... pg.4 Mental Health...................... pg.6 Healthy Heart....................... pg.8

VA Administers 1 Million COVID-19 Doses 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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Legal Matters 340B, Drug Pricing and Reimbursement Five Things to Watch In 2021

Kyle Vasquez, J.D. Shuchi Parikh, J.D. Polsinelli, PC


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.

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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

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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Oncology Research Immunotherapy: Fighting Cancer from Within By Jason Melear M.D., Texas Oncology Austin Midtown


n 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

to attack cancer cells to stop or slow their growth or limit the cancer’s 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.

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 13

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February 2021

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Mental Health Unlocking PTSD: New Study Reveals Why Trauma-Focused Psychotherapy Treatment Works By Adria Johnson


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

“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

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February 2021

sought to find out.” 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.


charge of logic and thinking. “What we discovered was a reduction in traffic between these brain regions among patients who had undergone trauma-focused 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.

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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, 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 February 2021


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 moderate-intensity 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 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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Concordia Opens New Interactive Learning Site for Nursing Students Simulation and Clinical Skills Labs Featured in North Austin Facility


t a time when the demand for nurses in central Texas is surging, Concordia University has welcomed 288 new students so far this year to its traditional and accelerated Bachelor of Science in Nursing programs. But they didn’t report to main campus as usual. In August 2020, under many COVID constraints, the university opened the doors to its Austin Nursing Satellite Campus. The new, interactive learning environment spans 17,000 square feet, complete with a cutting-edge simulation lab, a 10-bed clinical skills lab and simulation debriefing rooms. The building also houses a student lounge and administrative and faculty offices. The Austin community and prospective students can get a tour of this state-of-the-art teaching facility at a virtual grand opening on Tuesday, February 9, at 7 p.m. To attend,

visit https://www.concordia.edu/ AustinNursing on Facebook or find it on Concordia University Texas’ YouTube channel at https://youtube. com/user/CTXAdmissions. Rooted in the university’s Christian values, the nursing program features an accredited and rigorous curriculum delivered utilizing an interactive e-learning platform, along with hands-on skills training and clinical rotations at the area’s top hospitals. All of Concordia University Texas’ nurses now prepare for a career in this dynamic field by testing their knowledge and practicing their skills at a premier facility,” said Dr. Donald Christian, the university’s president and chief executive officer. “Additionally, our accelerated nursing (ABSN) students can earn their degree in 16 months by leveraging

In the skills lab at Concordia University Texas’ new satellite nursing site, a student practices giving an intramuscular injection on a manikin that produces a heartbeat, pulse, and breath as well as the ability to speak, cough, scream, and even vomit.

their college credits in non-nursing fields. There is significant need for nurses, and this is a way to send quality, trained individuals into the community quickly,” Christian said. Concordia’s 2020-21 nursing enrollment in both the ABSN and traditional tracks is the largest since its highly-ranked program began in 2011. New ABSN students will add to the total enrollment this year when a May cohort begins.

Texas ranks second only to California among states hardest hit by the nursing shortage, according to the National Center for Health Workforce Analysis. By 2030, the number of unfilled registered nurse positions will swell to nearly 60,000, based on projections by the Texas Center for Nursing Workforce Studies. In central Texas, the demand for see Concordia...page 13


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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


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

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

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.


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Austin Medical Times

VA Administers 1 Million COVID-19 Doses, Publishes Facility Vaccination Numbers


he U.S. Department of Veterans Affairs (VA) reached a milestone in just a month and a half’s time administering 1 million doses of the COVID-19 vaccine to Veterans and VA health care workers. As of Feb. 2, VA has dispensed at least one dose of either the Pfizer-BioNTech or Moderna vaccine to more than 582,000 Veterans and has fully vaccinated over 44,000, totaling more than 626,000 doses. This is in addition to administering more than 401,000 doses to VA employees, and more than 1,200 vaccine doses to federal partners. “In addition to administering 1 million doses of the COVID-19 vaccine, VA has begun publishing the number of Veterans who have received Pfizer BioNTech or Moderna vaccines at each facility across its enterprise,” said Acting VA Secretary Dat Tran. “The number of doses administered to Veterans at each facility will be updated daily on the VA COVID-19 National Summary website.”

VA employees across the country are working diligently to vaccinate the department’s health care personnel and the most vulnerable Veterans as quickly as possible. Making the data about vaccine doses administered to Veterans available publicly, VA is taking another step toward being as transparent as possible during the pandemic. VA is currently providing vaccines at more than 215 sites nationally with plans to expand to additional sites as vaccine supplies increase. As with states distributing vaccines, VA is currently in the limited supply phase, anticipating an increase in weekly vaccine doses in March. Until VA receives an increase in vaccines, many facilities may temporarily run out of vaccines for short periods of time. VA will continue to follow current Centers for Disease Control and Prevention (CDC) guidance and the VA COVID-19 Vaccination Distribution Plan until new CDC guidance is available. The distribution plan lays out VA’s overarching intent

but implementation of vaccination on a large scale requires agility and flexibility in order to meet the daily threats posed by the COVID-19 pandemic. The federal government will continue to work with states and the private sector to effectively execute an aggressive vaccination strategy, focusing on the immediate actions necessary to

convert vaccines into vaccinations. VA is reaching out to Veterans who are eligible for vaccination. Veterans who would like additional information can visit the VA COVID-19 vaccines webpage, visit their local facility’s website or contact their care team.

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Age Well, Live Well

developed the Texas Talks campaign to help ease into these important topics. Texas Talks covers a range of conversation topics that impact older adults, such as housing, transportation, medical issues, recreation, behavioral health and caregiving. ASC recommends these conversations happen year-round and releases new topics during the fall to coincide with holiday gatherings. “Identifying the issues to cover can be one of the hardest elements as there are so many important aging topics we should be talking to our loved ones about,” said Holly Riley, ASC manager. “In the beginning, we went with topics that were not as challenging. You don’t

want to encourage a never-been-heldbefore discussion to start with end-of-life issues. However, that is one of the most critically important topics to talk about, and with COVID-19, this year we felt it was a good time to begin with that.” This year’s topics are: • Advanced care planning • Maintaining traditions • Mental health • Preventing fraud Each worksite or organization that wants to participate in Texas Talks will receive a toolkit consisting of a communications strategy for engaging conversations through emails, articles and general guidance. To improve the program and gather feedback, a survey is sent to the participants in January. This year, to further enhance engagement among family members, the program is providing worksheets encouraging activities to help navigate these

conversations. “Feedback has been very positive since we started Texas Talks,” Riley said. “Worksite participation grew in the first two years with key reasons being the timeliness and relevance of the campaign as well as the ease of implementation. We work with aging experts, stakeholders and providers so we are able to hear what issues they are working on. We do a lot of research and most importantly, we listen to what communities are telling us — that really guides our focus and ensures we are addressing topics that are relevant.” To learn more and read about previous topics, visit the Texas Talks webpage. For questions, call 800-889-8595 or email texastalks@hhsc.state.tx.us.

senior director of the university’s new College of Health Sciences. Another consideration is the global pandemic, which has prompted a greater need than ever for nurses despite Gov. Greg Abbott’s waiver allowing retired nurses, those with inactive licenses and certain students

in their final year of nursing school to practice medicine. “The pandemic proved what many of us already know: that nurses are the heroes of America’s healthcare system,” Shammas said. “Concordia’s purpose-driven programs allow students to train for what promises to

be a rewarding and noble profession.” For more information about the ABSN program starting in May or the next traditional program start in August 2021, visit https://concordia. edu/nursing. 

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.

Texas Talks Addresses Important Topics with Older Adults By Chelsea Couch, CHES Texas Health and Human Services


he COVID-19 pandemic has shown how something unexpected can have a far-reaching impact on people’s health and well-being. For older adults and their loved ones, this highlights the importance of having a plan for emergencies as well as typical situations that come along with aging. The HHS Aging Services Coordination Office recognizes it can be difficult for family members and friends to talk with the older adults in their lives about the future and sensitive decisions to be made. In 2018 the ASC office

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Continued from page 9 nurses is particularly high: the area will need an estimated 2,568 registered nurses by 2022 to serve a growing and aging population, and replace retiring baby boomers. “And, that number is expected to grow to 7,459 full-time equivalent positions in the next 10 years,” said Dr. Amber Shammas,

Oncology Research Continued from page 4

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, immunotherapies can mean fewer


February 2021

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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

Austin 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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Austin Medical Times


Page 15

February 2021

Austin 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:


• 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.



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”


23% higher than women’s.

Women who have cardiac arrests are more likely to:


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


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


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Austin Medical Times