May 2018 - Page 2 of 2 - Medical Association of the State of Alabama

Archive for May, 2018

The HIPAA Horizon: What Changes Can We Look Forward to in the Near Future?

Posted by admin on May 17, 2018

The Department of Health and Human Services (HHS) Office of Civil Rights (OCR) oversees compliance with the Health Insurance Portability and Accountability Act (HIPAA). Specifically, this entity is charged with ensuring that HIPAA-covered entities adhere to the HIPAA Privacy, Security and Breach Notification Rules.

On Jan. 30, 2017, Pres. Trump issued an order referred to as the “Executive Order for Reducing Regulation and Controlling Regulatory Costs.” This became known as the “2-for-1 Executive Order.” This order required all federal agencies to cut two existing regulations for every proposed new regulation.

Many health care compliance professionals have been interested to learn how HHS OCR would respond to this challenge. There was significant curiosity about how this mandate would change the way HHS OCR was able to protect patient rights and whether they would be able to continue to develop regulations to protect the confidentiality, integrity and availability of patient records during a period of when ransomware scares and identity theft challenges are more and more prevalent.

It appears the industry has received their answer. At the HIPAA Summit, OCR Director Roger Severino announced, “The HHS Office for Civil Rights is planning to make some changes to the HIPAA Privacy Rule and enforcement regulations but will ask first for input from the health care sector and the public before making possible modifications.”

The proposed rule or Notice of Proposed Rule Making (NPRM) is the official document that announces and explains the agency’s plan to address a problem or accomplish a goal. All proposed rules must be published in the Federal Register to notify the public and to give them an opportunity to submit comments. The proposed rule and the public comments received on it form the basis for the final rule.[1]

HHS OCR has not officially posted the notice of proposed rulemaking for 2018, however, compliance professionals have been given a heads up on what to expect this year. HHS OCR is planning to submit notice of proposed rulemaking (NPRM) in at least the following three areas:

Good Faith of Health Care Providers. This would allow health care providers to share information with an incapacitated patient’s family members without patient authorization so long as the health care provider believes in “good faith” that making the disclosure is in the best interest of the patient.

Request for Information on Distribution of a Percentage of Civil Monetary Penalties or Monetary Settlements to Harmed Individuals. Historically, money collected from HIPAA fines and settlements have not been shared with the individual whose information was compromised. HHS OCR will be seeking comments on what the public thinks will be the best way to allow “victims” of HIPAA violations to be able to share in the money the agency receives as a result of enforcement actions.

Changing Requirements to Obtain Acknowledgment of Receipt of Notice of Privacy Practices. HIPAA-covered entities are currently required to have patients sign an acknowledgment form, which confirms they have been provided with a copy of the entity’s Notice of Privacy Practices. Entities are required to keep copies of those acknowledgment forms for a period of six years. However, patients also have the right to refuse to sign the acknowledgment form, and providers cannot refuse service based on a patient’s refusal to sign the acknowledgment. Potentially, this requirement may be stricken from the regulations or altered to alleviate the administrative burden associated with the current requirement.

In addition to proposed rulemaking, HHS OCR intends to provide long-awaited guidance to the health care industry specifically on encryption, social media and texting.

[1] “A Guide to the Rulemaking Process,” Office of the Federal Register.

Article contributed by Samarria Dunson, J.D., CHC, CHPC, attorney/principal of Dunson Group, LLC, a health care compliance consulting and law firm in Montgomery, Alabama. Find more of Ms. Dunson’s contributions on her partnership page.

Tags: HHS, HIPAA, OCR, penalty, privacy

Posted in: HIPAA

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Medical Association Receives Board of Midwifery Rule Withdrawal

Posted by admin on May 10, 2018

The Medical Association joined with the Alabama Hospital Association, the Alabama Board of Nursing, the Alabama Department of Public Health and the Alabama Chapter-American Academy of Pediatrics recently offered comment to the Alabama Board of Midwifery’s proposed rules concerning the passage of Act No. 2017-282 in May 2017 (regarding licensed midwives). The Medical Association requested the Board withdraw the proposals at this time. Subsequently, the Medical Association attended a meeting of the Board on May 4, 2018, in which the Board took that advice and withdrew the rules to start the process anew.

Generally, the Medical Association commented that the proposed rules failed to properly follow the requirements under Act No. 2017-282 (the “Act”) and substantially failed to adequately protect the public. The Medical Association was successful when the Act passed the last day of the legislative session in May 2017, in requiring licensed midwives to use informed consent, maintain levels of liability insurance, and provide certain statistics annually. The proposed rules failed to provide a duty for the Board to enforce any of these requirements as well as enforce many other statutory requirements. In fact, the proposed rules failed to even provide a duty that the Board establishes the minimum levels of liability insurance, as specifically required under the Act.

Below are some of the items upon which the Medical Association commented:

Under the proposed rules, a licensed midwife was to make a “reasonable effort” to contact a receiving health care professional or receiving institution in an emergency transfer. The Medical Association commented that a licensed midwife must make “every effort” to contact the institution. The Medical Association strongly objected to a licensed midwife simply calling 911 and washing his or her hands of the matter to effect a transfer.
The Board proposed a rule that it would only look at conduct for licensed midwives in the previous 12 months in a complaint. The Medical Association commented that the Board should look to all conduct and that 12 months, considering a pregnancy is nine months, is grossly insufficient.
The Board attempted in the proposed rules to create a formulary for prescription drugs when neither the Act nor any other law, allowed licensed midwives to use prescription drugs.
Under the proposed rules, licensed midwives were attempting to provide certain care for newborns. The Medical Association pointed out that nowhere in Alabama law is licensed midwives authorized to provide newborn care. Instead, the Medical Association suggested licensed midwives stabilize and transfer any newborn needing medical care.
The Board attempted to establish the name of the Act as the Childbirth Freedom Act when no such name was given.
The proposed rules failed to follow the Alabama Administrative Procedures Act.

In other words, the Medical Association believed that substantial changes in the proposed rules were necessary and that they should be redrafted to follow the law and protect clients sufficiently. The Medical Association was successful in convincing the Board that withdrawal of the rules was appropriate at this time.

Tags: midwife, midwifery

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Four Takeaways from Trump’s Plan to Rescind CHIP Funding

Posted by admin on May 10, 2018

President Donald Trump wants to employ a rarely used budget maneuver called “rescission” to eliminate $15 billion in federal spending, including $7 billion from the popular Children’s Health Insurance Program (CHIP).

Administration officials insist the cuts wouldn’t negatively affect any programs — rather, they would merely return money into the Treasury that Congress appropriated but is no longer needed.

In a statement on the White House blog, Russ Vought, the deputy director of the Office of Management and Budget, said the administration strongly supports the CHIP program. “Rescinding these funds will have no impact on the program,” Vought wrote. “At some point Congress will likely ‘rescind’ those funds as a budget gimmick to offset new spending elsewhere, as it did on the recently passed omnibus. Instead Congress should rescind the money now.”

But child health advocates are wary, particularly since the proposal comes a few months after Congress let funding authorization for CHIP lapse, which forced states to request millions in emergency contingency funds to keep children covered.

CHIP, which covers 9 million children from low-income families that earn too much to qualify for Medicaid, is mostly federally funded. But states operate the program within federal guidelines.

As budget hawks and children’s advocates dispute the effect of the plan, here are some takeaways on the Trump proposal.

What Are Rescissions?

Since the 1970s, presidents have had the power to take back money from federal programs previously appropriated by Congress — if Congress approves. That budget tool is not regularly used. The last president to seek and get approval for one was President Bill Clinton.

Once the president recommends a rescission, Congress has 45 days to approve the request. It needs only a majority vote in each chamber to pass.

If it isn’t approved, the rescission does not take effect.

The president can recommend such cuts only with funds that Congress appropriates. Mandatory programs, such as Medicaid and Medicare, are not subject to rescissions.

Will Cutting $7 Billion From CHIP Really Have No Impact On The Program?

That’s hard to say.

There is $7 billion at stake. The administration says $5 billion can no longer be spent because the period for it to be sent to states has expired. The other $2 billion is being taken from a federal contingency fund for CHIP. That money is to be used only if they face a budget shortfall. The economy is improving, and the administration is betting demand for CHIP will wane, leaving little need for the contingency fund.

“Anytime you cut spending, there is going to be some effect, said Marc Goldwein, senior vice president of the nonpartisan Committee for a Responsible Federal Budget. “But in terms of CHIP, it’s likely close to be zero — these are tiny cuts.”

Still, child health advocates, who endured months of uncertainty about whether Congress would restore federal funding to CHIP in 2017, are worried.

“I think the cut to the contingency fund is particularly troubling,” said Bruce Lesley, president of First Focus, an advocacy group.

Why Is President Trump Using This Budgetary Maneuver?

After signing a $1.3 billion spending bill in March, the president came under pressure from conservatives in Congress to cut the federal deficit. It is projected to hit nearly $1 trillion next year.

One strategy, according to these conservatives, is to rescind money that has not been spent to keep lawmakers from tapping those funds to pay for other programs.

Should Parents Of Kids On CHIP Be Worried?

Yes, if Congress goes along with the cuts, said David Super, a law professor at Georgetown University. But political analysts suggest that’s not likely to happen since some Republican senators have already spoken out against the move. With Republicans holding a 51- 49 majority in the Senate — and Sen. John McCain (R-Ariz.) battling brain cancer back home — the president likely would need all Republicans in the Senate to pass a rescission.

“This is pure political theater, ugly theater,” Super said.

He notes the administration is telling conservatives the cuts will reduce the deficit. But in media calls, senior administration officials said the cuts won’t have any programmatic effects.

“If the money would not have been spent, there are no savings,” Super said. “Any rescission of money that would not be spent, by definition, cannot reduce the deficit.”

Other programs targeted for cuts include relief funds for Hurricane Sandy, which struck in October 2012, and money allocated to respond to a possible outbreak of the deadly Ebola virus.

Super noted health advocates should be most worried about the $800 million in rescissions identified by the administration to the Center for Medicare and Medicaid Innovation. This program was created by the 2010 Affordable Care Act to find ways to make health programs work more efficiently — and save money.

Article reprinted by permission from KHN. KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.

Tags: CHIP

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Four Dangerous Words Physicians Regularly Say

Posted by admin on May 10, 2018

One trend evident in all medical practices is the shift in payment responsibility from insurance payers to the insured patients. As employers modify coverage to contain their premium costs, health care providers are treating patients who have $2,500, $5,000 and even $10,000 deductibles. Physicians who have practiced for many years have instructed their collections staff with the phrase “take what insurance pays.” This brief instruction was understandable when the patient portion of the treatment was only a co-pay of $25. The additional charge to the patient’s insurance made it acceptable to extend professional courtesy to many patients. In the era of paper charts, physicians even developed a shorthand note of “TWIP” for this common habit. In the modern era of high deductibles, this habit, if not broken, will cause serious damage to the cash flow of a practice in three ways.

Decline in Cash Flow

The most immediate impact is a decline in cash flow, and since these patient payment dollars can be seen as the last dollars of revenue, the impact on physician income will be dramatic. A practice which formerly collected $1,000,000 but loses 10 percent from failure to collect patient payments will suffer a 20-percent or more decline in physician income. If practice overhead costs 55 percent of collections, there would have been $450,000 left for salaries, fringe benefits and bonuses to the doctors. If collections decline by $100,000, for continued write off of patient payments, the doctor income drops to $350,000 — a 22-percent reduction. This is an example of how daily habits can produce bad cumulative outcomes.

Staff Discouragement

In addition to this drop in profits, the extension of professional kindness can diminish the collection enthusiasm among collections staff. Physicians are quick to instruct staff to extend special dispensation to patients who are friends or socially connected to the doctor. Collections staff members tell us that the doctor refused to let them collect from people who attend the same church as the physician, share a membership in a country club or social organization with the physician or have children who share activities with the physician’s family. When this group, which most likely has the greatest capability to pay for medical care, is excused from responsibility, the collections team is no longer as enthusiastic about collecting from the patients who have no social connection to the doctor. This additional loss of revenue is never known but can be significant.

Training Patients

Finally, affording patients the discretion to pay or not fosters an environment in which the patients are more inclined to take the medical practice for granted. In working with our medical practice clients at Warren Averett, we typically see that the patients who do not pay for their portion of care are also the ones inclined to not show up for appointments, not follow clinical directions and to treat medical staff rudely. These are the patients we recommend be terminated, when possible, in their treatment. To indiscriminately extend professional courtesy regarding patient financial responsibility is cultivating a problem which could have been staunched by simply collecting what the insurance contract stipulated to begin with.

The four words “take what insurance pays” seem benign at first but can be lethal if used unchecked.

Article contributed by Sae Evans, Maddox Casey and Jim Stroud, Members, Warren Averett Healthcare Consulting Group. Warren Averett is an official Gold Partner with the Medical Association.

Tags: cash, coverage, deductible, flow, Insurance, insure, payment, premium

Posted in: Insurance

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ADPH Issues Synthetic Cannabinoids Alert

Posted by admin on May 8, 2018

ADPH Issues Synthetic Cannabinoids Alert; Severe Bleeding a Dangerous Side Effect

The Alabama Department of Public Health (ADPH) cautions the public about the hazards of synthetic cannabinoids after the Illinois Department of Public Health (IDPH) linked serious complications including death to their use. As of April 24, 2018, IDPH has received reports of 153 cases, including four deaths, linked to the outbreak, since March 7, 2018. Ill persons report using synthetic cannabinoid products before experiencing severe bleeding.

Similar findings have been identified in other states including Florida, Indiana, Kentucky, Maryland, Missouri, Pennsylvania, Virginia and Wisconsin. ADPH has conducted a review of possible cases, but has not confirmed any cases in Alabama to date.

Synthetic cannabinoids are toxic psychoactive chemical compounds that mimic marijuana and have a high potential for abuse. These chemicals are called cannabinoids because they reportedly stimulate the same brain areas affected by marijuana. The manufactured products have brand names such as K2, Spice, AK-47, Black Mamba, Bombay, Blue Genie, Kronic, Kush, Mr. Happy, Scooby Snax, Zohai and others.

Synthetic cannabinoids are not safe, and individuals consuming them may experience severe bleeding, Medical Officer for Disease Control and Prevention Dr. Burnestine Taylor said. These products may contain brodifacoum which is found in rat poisoning. Individuals who have been sickened by the synthetic cannabinoids have reported coughing up blood, blood in the urine, severe bloody nose, bleeding gums, heavy menstrual bleeding and internal bleeding.

“Their effects can be unpredictable, harmful and deadly,” Dr. Taylor advised. “Anyone experiencing severe, unexplained bleeding or bruising after using these products needs to seek medical attention immediately.”

Other signs and symptoms include:

Agitation and irritability
Confusion and concentration problems
Hallucinations, delusions, psychosis, suicidal thoughts and violent behavior
Seizures
Sleepiness and dizziness

Synthetic cannabinoids are unsafe, and it is hard to know what the products contain or what reactions to them will be. There are no standards for making, packaging or sales. Synthetic cannabinoid products may also be contaminated with other drugs or toxic chemicals. These products are illegal in Alabama. There are other symptoms experienced by users of synthetic cannabinoids that include rapid heart rate, nausea and vomiting, headache, kidney and respiratory problems, sweating and trouble sleeping. Health problems the user experiences depend on many factors, including the specific synthetic cannabinoid, how much is used, and for what length of time.

ADPH urges the public not to use synthetic cannabinoids and to warn others about their dangers. For more information, contact Burnestine Taylor, M.D., at (334) 206-5325.

Tags: AK-47, Black Mamba, Blue Genie, Bombay, cannabinoid, death, K2, Kronic, Kush, Mr. Happy, Scooby Snax, spice, synthetic, Zohai

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NIH’s All of Us Research Program Kicks Off in Birmingham on May 6

Posted by admin on May 3, 2018

On May 6, the National Institutes of Health will open national enrollment for the All of Us Research Program, a momentous effort to advance individualized prevention, treatment and care for people of all backgrounds. People ages 18 and older, regardless of health status, will be able to enroll. The official launch date will be marked by community events in seven cities across the country, including Birmingham, as well as an online event. Volunteers will join more than 25,000 participants already enrolled in All of Us as part of a year-long beta test to prepare for the program’s national launch. The overall aim is to enroll 1 million or more volunteers and oversample communities that have been underrepresented in research to make the program the largest, most diverse resource of its kind.

“All of Us is an ambitious project that has the potential to revolutionize how we study disease and medicine,” Health and Human Services Secretary Alex Azar said. “NIH’s unprecedented effort will lay the scientific foundation for a new era of personalized, highly effective health care. We look forward to working with people of all backgrounds to take this major step forward for our nation’s health.”

Precision medicine is an emerging approach to disease treatment and prevention that considers differences in people’s lifestyles, environments and biological makeup, including genes. With eyeglasses and hearing aids, we have long had customized solutions to individual needs. More recently, treating certain types of cancer is now possible with therapies targeted to patients’ DNA. Still, there are many unanswered questions leaving individuals, their families, their communities and the health care community without good options.

“The All of Us Research Program is an opportunity for individuals from all walks of life to be represented in research and pioneer the next era of medicine,” said NIH Director Francis S. Collins, M.D., Ph.D. “The time is now to transform how we conduct research — with participants as partners — to shed new light on how to stay healthy and manage disease in more personalized ways. This is what we can accomplish through All of Us.”

By partnering with 1 million diverse people who share information about themselves over many years, the All of Us Research Program will enable research to more precisely prevent and treat a variety of health conditions.

“All of us are unique, but today we live mostly in an era of ‘one-size-fits-all’ medicine,” said Eric Dishman, director of the All of Us Research Program. “I’m alive today because of precision medicine, and I think everyone deserves that same opportunity no matter the color of your skin, your economic status, your age or your sex or gender. In other words, it will truly take all of us.”

All of Us seeks to transform the relationship between researchers and participants, bringing them together as partners to inform the program’s directions, goals and responsible return of research information. These efforts include building trust among populations historically underrepresented in research. Participants will be able to access their own health information, summary data about the entire participant community and information about studies and findings that come from All of Us.

“Building a diverse participant community will be vital to the success of All of Us, so we can address the many pressing health conditions that disproportionately affect underrepresented communities,” said Dara Richardson-Heron, M.D., chief engagement officer of the All of Us Research Program. “The All of Us Research Program has the potential to help researchers better understand and begin chipping away at health disparities so that everyone can benefit from better health, better health care and exciting new breakthroughs.”

Participants are asked to share different types of health and lifestyle information, including online surveys and data from electronic health records, which will continue to be collected over the course of the program.

The surveys will cover a range of topics to learn more about participants’ overall health and habits and where they live and work. The EHR data will offer useful information related to medical histories, side effects and treatment effectiveness. At different times over the coming months and years, some participants will be asked to visit a local partner site to provide blood and urine samples and to have basic physical measurements taken, such as height and weight. To ensure that the program gathers information from all types of people, especially those who have been underrepresented in research, not everyone will be asked to give physical measures and samples. In the future, participants may be invited to share data through wearable devices and to join follow-up research studies, including clinical trials.

NIH has funded more than 100 organizations from community groups to health centers, academic medical centers and private companies to carry out the program. These organizations have collaborated to develop the program’s protocol and technology systems, to engage diverse communities, to enroll participants and to securely gather and store participants’ information and biological samples for use in research.

In future phases of the program, children will be able to enroll and the program will add more data types, such as genetic data. In addition, data from the program will be broadly accessible for research purposes. Ultimately, the All of Us Research Program will be a rich and open data resource for traditional academic researchers as well as citizen scientists — and everyone in between.

Community-based launch events

On the program’s May 6 launch date, the All of Us Research Program will host special events in diverse communities around the country, including:

Birmingham, Alabama
Chicago
Detroit
Kansas City, Missouri
Nashville, Tennessee
New York City
Pasco, Washington

People also may take part in social media activities (#JoinAllofUs) or tune in at https://Launch.JoinAllofUs.org to watch speakers across the country talk about precision medicine and the power of volunteering for research.

To learn more about the program and how to join, please visit www.JoinAllofUs.org.

“All of Us” is a registered service mark of the U.S. Department of Health & Human Services (HHS).

About the All of Us Research Program: The mission of the All of Us Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us. The program will partner with one million or more people across the United States to build the most diverse biomedical data resource of its kind, to help researchers gain better insights into the biological, environmental, and behavioral factors that influence health. For more information, visit www.JoinAllofUs.org and www.allofus.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Tags: clinical, data, diverse, health, lifestyle, medicine, NIH, precise, precision, research, trial

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Trends In False Claims Lawsuits

Posted by admin on May 3, 2018

Trends in False Claims Lawsuits Since the Ruling in Universal Health Services v. U.S. ex rel. Escobar on June 16, 2016

Generally, the False Claims Act (“FCA”) imposes liability on any person who “knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval to the United States; [or] knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim 31 U.S.C. § 3729. The Supreme Court decided Universal Health Services v. U.S. ex rel. Escobar on June 16, 2016, which changes the way FCA lawsuits are litigated. The Supreme Court ruled in Escobar that the implied false certification theory can form the basis for False Claims Act (“FCA”) liability. In an implied false certification theory case, the defendant is alleged to have falsely certified that it complied with a statute or regulation, the compliance of which is a condition of Government payment.

However, in Escobar, the Supreme Court put limits on the application of the implied false certification theory. Importantly, it first emphasized the False Claims Act is not a means of imposing treble damages and other penalties for insignificant regulatory or contractual violations.

Although the Supreme Court held that the implied certification theory can be a basis for liability, it requires that two conditions are satisfied. First, the claim must make specific representations about the goods or services provided. Second, the health care provider’s failure to disclose noncompliance with material statutory, regulatory, or contractual requirements makes those representations misleading half-truths. Compliance with the statutory, regulatory or contractual requirements does not have to be an expressly stated condition of payment for liability under the FCA to attach. Rather, liability depends on whether the health care provider knowingly violated and/or misrepresented compliance with a legal requirement that the health care provider knew was material to the Government’s decision to pay the claim.

While the Supreme Court recognized the theory of implied certification, the theory does not turn upon whether the payment requirements are expressly designated as conditions of payment. “Statutory, regulatory and/or contractual requirements are not automatically material, even if they are labeled conditions of payment” and “[a] defendant can have ‘actual knowledge’ that a condition is material without the Government expressly calling it a condition of payment.” The Court further stated that requiring the Government to expressly designate conditions of payment for every regulation would be too burdensome, and the “rigorous” materiality and scienter threshold requirements in the FCA should suffice to ease health care provider’s concerns.

FCA analysis turns on whether the defendant knowingly violated a requirement that the health care provider knew was material to the Government’s payment decision. A misrepresentation about compliance with a statutory, regulatory, or contractual requirement must be material to the Government’s payment decision in order to be actionable under the False Claims Act. The Court provided clarification on how the “materiality requirements” should be enforced. The Court noted that the term “material” is defined in the FCA as “having a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property.” The Court called the materiality standard “demanding” and largely dependent on the particular facts of the case rather than an objective bright-line standard. “[W]hen evaluating materiality under the False Claims Act, the Government’s decision to expressly identify a provision as a condition of payment is relevant, but not automatically dispositive…Conversely, if the Government pays a particular claim in full despite its actual knowledge that certain requirements were violated, that is very strong evidence that those requirements are not material. Or, if the Government regularly pays a particular type of claim in full, despite actual knowledge that certain requirements were violated, and has signaled no change in position, that is strong evidence that the requirements are not material.”

Escobar makes clear that the district court’s principal method for evaluating implied certification claims has changed. Since the ruling in Escobar, several federal circuit and district courts have taken the Supreme Court’s demanding materiality standard to heart and examines false claims cases using the criteria set out in Escobar. For example, the Eleventh Circuit recognized the district court should be given the opportunity to reconsider the allegations in false claims cases in light of the changed legal landscape. Marsteller for use & benefit of United States v. Tilton, 880 F.3d 1302, 1313 (11th Cir. 2018). The Eleventh Circuit states the Supreme Court explicitly rejected a standard for implied certification claims that focuses exclusively on whether the Government expressly designates a contractual, statutory, or regulatory obligation as a condition of payment. Whether a condition is so designated is “relevant to but not dispositive of the materiality inquiry,” but not a precondition to the theory of liability itself. Id. at 2001.

Escobar now provides the district court with a more refined framework to address false claims cases. The definition of “material” contained within the statute itself considers whether the misrepresentation had a natural tendency to influence or be capable of influencing, the payment or receipt of money or property. Escobar now instructs courts to consider whether noncompliance is “minor or insubstantial” and amounts to “garden-variety breaches of contract or regulatory violations,” or, conversely, whether the Government would have attached importance to the violation in determining whether to pay the claim. Id. at 2002–03.

As time goes on, the federal courts will continue refining what conduct warrants prosecution in FCA cases that can result in substantial civil monetary penalties. The meaning of “materiality” will continue to form a central consideration in litigation of any FCA case for years to come.

Jim Hoover is a partner in the Health Care Practice Group at Burr & Forman LLP and exclusively represents health care providers in false claims litigation and regulatory compliance. Burr & Forman LLP is a preferred partner with the Medical Association.

Tags: burr, escobar, government, hoover, liability

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Eat Your Veggies with Dr. and Mrs. Bryan Strickland

Posted by admin on May 2, 2018

MONTGOMERY – We’ve all heard the saying, “Eat your veggies,” but have you ever stopped to think exactly why we say it? It’s not just because our parents told us to. There’s scientific fact behind the benefits of loading up on those garden goodies. Montgomery physician Bryan Strickland and his wife, Carolyn, were not only impressed by the results of switching to a plant-forward lifestyle – they are passing their knowledge along to others hoping to reap the benefits of plant power.

For the Stricklands, it all began with The China Study, a study which examines the relationship between the consumption of animal products, including dairy, and chronic illnesses such as coronary heart disease, diabetes, breast cancer, prostate cancer and bowel cancer. The authors of the study concluded that people who eat a predominantly whole-food, plant-based diet, avoiding animal products as a main source of nutrition, including beef, pork, poultry, fish, eggs, cheese and milk, and reducing their intake of processed foods and refined carbohydrates, will escape, reduce or reverse the development of numerous diseases.

“About 10 years ago I read The China Study, which is the largest study on nutrition and health. It was an amazingly well-done study that looked at how nutrition impacted human health and health problems, most specifically cancer, over a 27-year period. When I read the study I was fascinated by it so I told my husband about it. Then we watched the movie Forks over Knives, which also looked at the impact of food on our health. That’s when Bryan and I really decided we needed to change our eating habits,” Carolyn said.

For Dr. Strickland, he felt this was a case of “physician health thyself.” The time had come for him to take the advice he was offering to his patients and put it into practice for himself.

“For me, it tipped the balance in that this was scientifically solid enough that we should act on what we saw and make changes in our lives first. There was enough evidence in this one study to prove to me that I didn’t need to look for nutritional supplements to keep me healthy. I could stop damaging my health by changing what I was eating and drinking every day,” Dr. Strickland said. “It was just that simple.”

Carolyn, who is also president of the River Region Medical Alliance, wanted to get more involved, so she became a certified Food for Life Instructor through the Physicians Committee for Responsible Medicine. The Physicians Committee for Responsible Medicine is a nonprofit organization steered by medical professionals advocating education and research in an effort to change the way chronic diseases such as diabetes, heart disease, obesity and cancer are treated with a focus on plant-forward nutrition.

With Dr. Strickland’s already busy office filled with patients who could use what he and his wife were learning about a plant-forward diet, the next logical step was to find a partner willing to host cooking demonstrations. So, Carolyn contacted Jason Autry, Mission & Purpose Field Specialist with Whole Foods, and the Meatless Monday Supper Club was born.

“If a physician tries to go out into the community alone to do something, you don’t accomplish as much as you can if you enable a team who can work together,” Dr. Strickland said. “The key to getting the word out about Food for Life is definitely with teamwork.

The Stricklands work with Jason and Bari Levin, who is also a Food for Life instructor, to prepare plant-based meals with a purpose for each Meatless Monday dinner event. Most events have an educational theme, such as diabetes, in which Dr. Strickland offers a bit of medical advice and how the benefits of changing a person’s eating habits can bring positive health changes as well.

“The China Study really illustrated a whole food, plant-based diet can tip the odds back into a patient’s favor if that patient is pre-diabetic or has high cholesterol or other chronic health issues. But you can’t ever make promises about what a diet is going to do for any specific person. I have examples of cases where people have lost between 40 and 70 lbs. and got totally off their diabetes medication, but still, those are isolated cases. If you go all the way to a plant-based diet, you’ll earn a couple of milestones in your life. What’s happening is you’re breaking an addiction to fat, salt and meat that all work on those pleasure centers in the brain. What they all have in common is that if you stop what you’re addicted to, you’ll feel bad for a couple of weeks, but that goes away. After a couple of months, the cravings go away. But it’s what you’re giving yourself in the long run that’s so good. It’s those medical milestones that you’re looking for.”

For Carolyn, Jason and Bari, their mission is not only awareness of the health benefits of eating your veggies, but also to break down the misconceptions that eating a plant-based diet can’t be fulfilling or even tasty.

“The change is so much more than weight and what we look like on the outside. Internally, our health is a lot better, and we both have so much more energy,” Carolyn said. “Of course people are skeptical at first when I tell them about how we eat plant-based and never get tired of it, but that’s until they try it. And, that’s why we wanted to team up with Whole Foods. The cooking demonstrations show just how tasty vegetables truly are…and they are never boring!”

The Meatless Monday Supper Club at Whole Foods in Montgomery meets on the last Monday of each month at 6 p.m. and it’s free. Visit Whole Foods for details.

*Before beginning any new diet or exercise regime, please consult your physician.

Still not convinced? Here’s a recipe compliments of the Meatless Monday Supper Club you might want to try:

Rad Thai

Yield: 4 Servings

This dish has all the flavor of traditional Pad Thai and is low in fat.

Ingredients

1/3 cup water
1 tablespoon almond or peanut butter
1/4 cup lime juice
3 tablespoons tamari (or low sodium soy sauce)
3 tablespoons ketchup
3 tablespoons coconut nectar or pure maple syrup
1 tablespoons peeled, roughly chopped ginger
2 cloves garlic, sliced or chopped
1/4 teaspoon sea salt
1/4 teaspoon red pepper flakes
8 ounces dry rice noodles, such as stick or vermicelli noodles
1 cup thinly sliced red pepper
1 cup matchstick-cut carrots
1/2 cup sliced green onion
1 cup mung bean sprouts
1/4 cup chopped cilantro
1 tablespoon chopped peanuts (optional)
4 lime wedges
Baked tofu (optional)

Instructions

In a blender, combine water, nut butter, lime juice tamari (or soy sauce), ketchup, coconut nectar or maple syrup, ginger, garlic, salt and red pepper flakes. Puree until smooth. Set aside.

Cook the noodles according to package directions. Once just tender (do not overcook or they will become mushy), drain. Add sauce to the cooking pot and place over low heat. Add the cooked noodles, red pepper, carrots and green onion. Mix until noodles are coated evenly. Once warmed through, add sprouts and cilantro. Top with peanuts (optional) and serve immediately with lime wedges. Add baked tofu if desired.