Posts Tagged liability

What’s at Stake for Medical Professionals in “Pill Mill” Investigations

What’s at Stake for Medical Professionals in “Pill Mill” Investigations

In an earlier article, I detailed how the DOJ has focused its attention on the aggressive investigation and prosecution of “pill mill” cases.  In this article, I discuss the consequences physicians and other medical professionals potentially face as a result of a “pill mill” investigation.

CRIMINAL PROSECUTION

A litany of criminal charges can be heaped on medical professionals at the conclusion of a “pill mill” investigation. Exactly what charges the government pursues will obviously depend on the facts and circumstances of each particular case. One charge that will inevitably be included in every “pill mill” indictment is an alleged violation of the Controlled Substances Act (“CSA”). The CSA governs the distribution and dispensing of various listed drugs, including narcotics, that are prescribed by physicians and other licensed medical providers. To issue a controlled substance, a physician must be licensed to practice by a state authority and must have a DEA registration number.

Under the CSA, controlled substances are placed into one of five “schedules” based on whether they have a currently accepted medical use in the United States, their relative abuse potential, and their likelihood of causing dependence when abused. Most opioids are Schedule II drugs because they have acceptable medical uses and but a high potential for abuse.

To be convicted under the CSA, the government must prove that (1) the defendant physician knowingly and intentionally distributed or dispensed a controlled substance, and (2) did so “for no legitimate medical purpose and outside the usual course of professional practice.” Determining whether a physician has illegally prescribed drugs under this standard is never simple and will necessarily involve a “battle of the experts.”

A criminal conviction for violating the CSA may result in a vast array of prison sentences under the federal Sentencing Guidelines, a set of advisory sentencing rules that establish a uniform policy for individuals convicted of felony crimes in federal court. The exact range may vary significantly from case-to-case, depending primarily on the type and quantity of controlled substances involved. And these ranges can be staggeringly severe. In a recent “pill mill” case in Mobile, Ala., the physicians each faced a guidelines range of imprisonment of 30 to 240 years, although the court sentenced them well below that range (20 and 21 years, respectively) – as it had the discretion to do. In addition to applicable guidelines ranges in each case, the CSA provides for statutorily “enhanced” sentences in certain circumstances. For instance, if the government proves that a patient’s death resulted from the distribution of a Schedule II controlled substance, the convicted physician will face a sentence of no less than 20 years and up to life in prison.

SEIZURE AND FORFEITURE

In almost every “pill mill” case, the government will attempt to seize (take possession of) and forfeit (take ownership of) bank accounts, business assets, and personal assets of the targeted medical professional based on a theory that they are “proceeds” of the alleged “pill mill” operation or somehow “facilitated” the purported criminal enterprise. For example, following the physicians’ convictions in the case mentioned above, the government forfeited their bank accounts, investment and retirement accounts, college fund accounts, houses, beach-fount condominiums, and 20-plus luxury automobiles.

CIVIL LIABILITY

On top of criminal prosecution, a “pill mill” investigation could result in a civil lawsuit by the government against the targeted physician or medical professional, to the extent they have billed a federal health care program. For instance, the government might bring a direct suit under the False Claims Act (“FCA”), alleging that the physician made false diagnoses, prescribed drugs for non-covered indications, or prescribed excessive or “medically unnecessary” drugs for Medicare or Medicaid patients. Likewise, the government may join in a “qui tam” suit, which is initiated by a “whistleblower” – such as a current or former employee of the practice – claiming the targeted physician or practice has violated the FCA and other laws.

ADMINISTRATIVE PROCEEDINGS

In addition to facing criminal prosecution, the loss of asserts, and civil liability, physicians investigated or charged in a “pill mill” case can be subject to a number of administrative sanctions. The DEA, in particular, has a range of administrative actions it can take, such as: issuing a letter of admonition to the registrant providing notice of a violation of the applicable law/regulations; requiring the registrant to enter into a memorandum of understanding agreeing to take certain corrective steps to stave off revocation of the registration; or, for the most serious alleged violations, pursuing a show cause order to appear before an administrative law judge, during which the DEA will advocate for revocation of the registration.

Like the DEA, state professional boards (such as medical and pharmacy boards) have disciplinary authority and can sanction practitioners for professional violations, such prohibiting a physician from prescribing specific schedules of drugs, suspending a physician’s medical and/or dispensing license, or revoking the license.

Further, the Centers for Medicare & Medicaid Services (“CMS”) may limit, suspend, or revoke a provider’s Medicare billing privileges for, among other things, noncompliance with Medicare enrolment requirements, a felony conviction related to controlled substances, or a pattern of improper prescribing practices. Likewise, state Medicaid agencies can impose various administrative sanctions against providers, including outright exclusion from the program.

CONCLUSION

The consequences physicians and other medical professionals face as a result of a “pill mill” investigation are varied and potentially severe. Given that, pain management practitioners should be acutely aware of any signs that they are under investigation, including, among other things, receiving a government subpoena or civil investigative demand or learning that the practice’s employees or patients have been interviewed by investigating agents. Upon receiving the slightest hint of an investigation, practitioners should act quickly in obtaining legal counsel to conduct an internal investigation, determine the practice’s potential exposure, and intervene on the practice’s behalf in the hopes of warding off further government scrutiny.

Adam W. Overstreet is counsel in Burr & Forman’s Birmingham office, practicing in the firm’s health care section, and is a former Assistant United States Attorney. Burr & Forman is an official partner with the Medical Association.

Posted in: Opioid

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Trends In False Claims Lawsuits

Trends In False Claims Lawsuits

 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. 

Posted in: Legal Watch

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What If No One Was On Call [at the Legislature]?

What If No One Was On Call [at the Legislature]?

2018 Recap of the Regular Session of the Alabama Legislature

In times of illness, injury and emergency, patients depend on their physicians. But what if no one was on call? Public health would be in jeopardy.  However, the same holds true for the Legislature. During the 2018 session alone, if the Medical Association had not been on call advocating for you and your patients, unnecessary and costly standards of care would have been written into law, lawsuit opportunities against physicians would have increased and poorly thought out “solutions” to the drug abuse epidemic ─ that could’ve made the problem worse ─ would have become law. Keep reading to find out more.

Moving Medicine Forward

The 2018 Legislative Session is over, but continued success in the legislative arena takes constant vigilance. Click here to download our 2018 Agenda.

If no one was on call…increased state funding for upgrading the Prescription Drug Monitoring Program (PDMP) would not have occurred. Working with the Governor’s Opioid Task Force, the Medical Association proposed increased funding for the PDMP, to allow it to be an effective tool for physicians. As a result, the Task Force made the request its number one recommendation to the Governor and the 2019 budget for the Alabama Department of Public Health (the PDMP administrator) has a $1 million increase for making a long-overdue upgrade to the user-friendliness of the drug database.

If no one was on call…legislation helping veterans at-risk for drug abuse get the care they need and also leverage technology to combat the drug abuse epidemic would not have occurred. Through enactment of SB 200, the prescription information of VA patients will be shared between the VA and non-VA physicians and pharmacists who are outside the VA system, the same kind of information sharing of prescription data that exists for almost all other patients. Passage of SB 200 also establishes a mechanism for vetting requests for release of completely de-identified PDMP information that can be used to spot drug abuse trends and help state officials better allocate resources in combatting this epidemic. The proposals that resulted in the drafting of SB 200 originated with a recommendation from the Governor’s Opioid Task Force, one the Medical Association supported.

If no one was on call…the concerns of physicians regarding the current state of affairs surrounding the Maintenance of Certification program would not have been heard. A formal recommendation from the Medical Association’s MOC Study Committee resulted in the enactment of SJR 62 by Senators Tim Melson, M.D., Larry Stutts, M.D., and the entire Alabama Senate. The resolution was signed by Gov. Kay Ivey. SJR 62 vocalizes Alabama physicians’ frustrations with MOC and urges the American Board of Medical Specialties to honor its commitment to help reduce the burden and cost of MOC. Pursuit of a legislative resolution was just one of several recommendations from the Association’s MOC Study Committee this year.

If no one was on call…the Board of Medical Scholarship Awards could have seen its funding reduced but instead, the program retained its funding level of $1.4 million for 2019. The BMSA grants medical school loans to medical students and accepts as payment for the loan that student’s locating to a rural area to practice medicine. The BMSA is a critical tool for recruiting medical students to commit to practice in rural areas. As well, the economic footprint of every physician is at least $1 million, which improves both community health and local economies.

If no one was on call…Medicaid cuts could have been severe, possibly reducing access for patients within an already fragile system in which less than 20 percent of Alabama physicians participate. The 2019 budget has sufficient funds available for Medicaid without scheduled cuts to physicians. However, increasing Medicaid reimbursements to Medicare levels could further increase access to care for Medicaid patients and remains a Medical Association priority.

Beating Back the Lawsuit Industry

While Alabama’s medical liability laws have fostered fairness in the courtroom and improved the legal climate, each year personal injury attorneys seek to undo parts of the very law that helps keep “jackpot justice” and frivolous suits in check.

If no one was on call…bill language that could have pulled physicians into new lawsuits targeting opioid drug makers and opioid wholesale drug distributors could have been included in the final version of the legislation, whose subject matter was originally limited to placing new criminal penalties on unlawful possession, distribution and trafficking of Fentanyl. After the liability language was added on the House floor, a committee of the House and Senate removed the new cause of action language that could have affected physicians. Additionally, an unsuccessful attempt was made to amend this same bill to give law enforcement the authority to determine what is the unlawful “prescribing” or “dispensing” of prescription drugs. The final bill that passed contained neither of these elements that would have been problematic for physicians.

If no one was on call…physicians and medical practices could have been forced to provide warranty and replacement coverage for “assistive medical devices.” As originally drafted in the bill, the term “assistive medical devices” was broadly defined to include any device that improves a person’s quality of life including those implanted, sold or furnished by physicians and medical practices like joint or cochlear implants, pacemakers, hearing aids, etc. However, the Medical Association successfully sought an amendment to remove physicians, their staff and medical practices from having any new warranty or assistive device replacement responsibility under the act, and the final version doesn’t expand liability on doctors.

If no one was on call…legislation granting nurse practitioners and nurse midwives new signature authority outside of a collaborative practice and for some items prohibited under federal law – thereby significantly expanding liability for collaborating physicians – could have become law. The Medical Association successfully sought to ensure that all new signature authority granted to CRNPs and CNMs was subject to an active collaborative agreement and all additional forms or authorizations granted were consistent with federal law, protecting collaborating physicians from new liability exposure. The final bill was favorably amended with this language.

If no one was on call…physicians could have been held legally responsible for others’ mistakes including individuals following or failing to follow DNR orders on minors. The language of the final bill does not expand liability for physicians.

Protecting Public Health and Access to Quality Care

Every session, various pieces of legislation aimed at improving the health of Alabamians are proposed. At the same time however, many bills are also introduced that endanger public health and safety, like those where the Legislature attempts to set standards for medical care, which force physicians and their staffs to adhere to non-medically established criteria, wasting health care dollars, wasting patients’ and physicians’ time and exposing physicians to new liability concerns.

If no one was on callcollaborative practice in Alabama between nurse practitioners, nurse midwives and physicians could have been abolished. The legislation did not pass. Read the joint statement on the bill from the Medical Association and allied medical specialties here. The bill may return next session.

If no one was on call…legislation to give law enforcement the authority to determine what is the unlawful “prescribing” or “dispensing” of controlled substances (and making violations a Class B Felony) could have become law. The Medical Association sought changes to the bill to require prosecutors to have to prove beyond a reasonable doubt that a physician knowingly or intentionally prescribed controlled substances for other than a legitimate medical purpose and outside the usual course of his or her professional practice, and also to ensure sufficient qualifications for expert witnesses. The sponsor however – arguing that expert witness testimony for prosecuting a physician should not be required – asked the bill not be passed and instead “indefinitely postponed it,” killing the bill for the 2018 session. The bill will return next session.

If no one was on callmarriage and family therapists could have been allowed unprecedented authority to diagnose and treat mental illnesses without restriction. The legislation would also have deleted numerous prohibitions in current law including prescribing drugs, using electroconvulsive therapy, admitting to a hospital and treating inpatients without medical supervision, among other things. The Medical Association offered a substitute bill that (1) ensures all diagnoses and treatment plans made by MFTs are within the MFT treatment context; (2) ensures MFTs cannot practice outside the boundaries of MFT services; (3) prohibits MFTs from practicing medicine; and, (4) ensures all the current prohibitions in state law regarding prescribing of drugs, electroconvulsive therapy and inpatient treatment remain intact. The final bill that is now law contains all of these elements.

If no one was on call…legislation creating a new state board with unprecedented authority over medical imaging could have passed. The legislation would have required x-ray operators, magnetic resonance technologists, nuclear medicine technologists, radiation therapists, radiographers and radiologist assistants to acquire a new license from a new state board, a board granted total control over the scope of practice for each licensee. Quality and access to care concerns abounded with this legislation that many saw as unnecessary. The legislation did not pass, but is likely to return next session.

If no one was on call…proposals to move the PDMP away from the Alabama Department of Public Health and instead under the authority of some other state agency or even to a private non-profit organization could have been successful. In working with the Governor’s Opioid Task Force, the Medical Association stressed the Health Department was the proper home for the PDMP and the Task Force did not recommend that the PDMP be moved elsewhere.

If no one was on call…legislation to place new requirements on and increase civil liability exposure on referring physicians under the Women’s Right to Know Act could have become law. The legislation aimed to provide a woman seeking an abortion with notice that she can change her mind at any time and be entitled to a full refund for not going through with the abortion. The Medical Association sought to fix a longstanding problem that places information-provision requirements on referring physicians under the Women’s Right to Know law. While the Association’s language was adopted, the bill failed to pass. The bill is expected to return next session.

If no one was on call…state law could have been changed to require mandatory PDMP checks on every prescription. Attempts to change this are expected in 2019.

If no one was on call…law enforcement could have been granted unfettered access to the prescriptions records of all Alabamians. Attempts to change this are expected in 2019.

Other Bills of Interest

Rural physician tax credits…legislation to increase rural physician tax credits and thereby increase access to care for rural Alabamians did not pass but will be reintroduced next session.

Infectious Disease Elimination…legislation to establish infectious disease elimination pilot programs to mitigate the spread of certain diseases failed to garner enough support to pass this session.

Data breach notification…relating to consumer protection, is known as the “data breach bill.” In the event of a data breach by a HIPAA-covered entity, as long as the entity follows HIPAA guidelines for data breaches and notifies the attorney general if the breach affects more than 1,000 people, the HIPAA-covered entity is exempt from any penalties. Now, only North Dakota lacks a “data breach” notification statute. The bill was signed by the Governor.

School-based vaccine program…a Senate Joint Resolution urging the State Department of Education and the Alabama Department of Public Health to encourage all schools to participate in a school-based vaccine program passed in 2018. The Medical Association, Alabama Academy of Pediatrics and Alabama Academy of Family Physicians issued a joint statement in opposition to the resolution.

While we remain committed to increasing vaccine rates in Alabama for the very reasons outlined in the “Whereases” of the resolution, we are very concerned about the potential disruption that a widespread school-based program could bring to local practices and the likelihood of detrimental effects of adolescents not visiting the doctor-their medical home–during the critical teen years,” the joint statement from the medical societies reads.

While Gov. Ivey did not sign the resolution, it was ratified under state law without her signature.

Workers comp…legislation to penalize an individual from obtaining workers comp benefits by fraudulent means was introduced this session. The Medical Association successfully sought an amendment to require notice to the physician of termination of a worker’s benefits and to ensure continued payment of claims submitted by a physician until that notice is received. The bill failed to see any action this session.

Genital mutilation…legislation criminalizing the genital mutilation of a minor female was introduced this session. The Medical Association successfully sought an amendment to exclude emergency situations and procedures. The bill died in the Senate during the last days of the session. It is expected to return next year.

If the Medical Association was not on call at the Legislature, countless bills expanding doctors’ liability, placing standards of care into state law, lowering the quality of care provided and diminishing the practice of medicine could have passed. At the same time, positive strides in public health – like new funding for a much-needed PDMP upgrade, better data-sharing with VA facilities and the resolution on MOC – would not have occurred. The Medical Association is Alabama physicians’ greatest resource in advocating for the practice of medicine and the patients they serve.

Questions? For more information contact Niko Corley at ncorley@alamedical.org

Posted in: Advocacy

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Medical Association’s 2018 State and Federal Agendas

Medical Association’s 2018 State and Federal Agendas

The Medical Association Board of Censors has met and approved the Association’s 2018 State and Federal Agendas. These agendas were developed with guidance from the House of Delegates and input from individual physicians. As the Alabama Legislature and U.S. Congress begin their work for 2018, additional items affecting physicians, medical practices and patients may be added to this list.

Download the Medical Association’s 2018 State and Federal Agendas (PDF)

 

2018 STATE AGENDA

 

The Medical Association supports:

  • Ensuring legislation “first do[es] no harm”
  • Extending the Medicaid payment bump for primary care to all specialties of medicine
  • Eliminating the health insurance-coverage gap for the working poor
  • Ensuring fair payment for patient care and reducing administrative burdens on physicians and medical practices
  • Strengthening existing tort reforms and ensuring liability system stability
  • Empowering patients and their doctors in making medical decisions
  • Continued physician compounding, dispensing of drugs
  • The same standards and reimbursements for telehealth and face-to-face visits
  • Training, education and licensing transparency of all individuals involved in patient care
  • Continued self-regulation of medicine over all areas of patient care
  • Increased state funding to upgrade the Prescription Drug Monitoring Program to a useful tool for physician monitoring patients at risk for drug interactions and overdose potential
  • Using data analytics to combat the drug abuse epidemic by strengthening research capabilities of pre-approved, de-identified prescription information
  • Maintaining the Alabama Department of Public Health as the repository for PDMP information to ensure continuity for prescribers and dispensers and security for patients
  • Standard opioid education in medical school so the physicians of tomorrow are prepared to face the realities and responsibilities of opioid prescribing

 

The Medical Association opposes:

  • The radical Patient Compensation System legislation
  • Legislation/initiatives increasing lawsuits against physicians
  • Non-physicians setting standards for medical care delivery
  • Tax increases disproportionately affecting physicians
  • Expanding access to the Prescription Drug Monitoring Program (PDMP) for law enforcement
  • Statutory requirements for mandatory PDMP checks
  • Further expansion of Maintenance of Certification (MOC) requirements
  • Changes to workers’ compensation laws negatively affecting treatment of injured workers and medical practices
  • Any scope of practice expansions that endanger patients or reduces quality of care
  • Biologic substitution legislation that allows lower standards in Alabama than those set by the FDA that doesn’t provide immediate notifications to patients and their physicians when a biologic is substituted, and that increases administrative burdens on physicians and medical practices

 

2018 FEDERAL AGENDA

 

The Medical Association supports:

  • Meaningful tort reforms that maintain existing state protections
  • Reducing administrative and regulatory burdens on physicians and medical practices
  • Repeal of the Affordable Care Act and replacement with a system that:
    • Includes meaningful tort reforms that maintain existing state protections
    • Preserves employer-based health insurance
    • Protects coverage for patients with pre-existing conditions
    • Protects coverage for dependents under age 26
    • With proper oversight, allows the sale of health insurance across state lines
    • Allows for deducting individual health insurance expenses on tax returns
    • Increases allowed contributions to health savings accounts
    • Ensures access for vulnerable populations
    • Ensures universal, catastrophic coverage
    • Does not increase uncompensated care
    • Does not require adherence with insurance requirements until insurance reimbursement begins
    • Reduces administrative and regulatory burdens
  • Overhauling federal fraud and abuse programs
  • Reforming the RAC program
  • Prescription drug abuse education, prevention and treatment initiatives
  • Allowing patient private contracting in Medicare
  • Expanding veterans’ access to non-VA physicians
  • Reducing escalating prescription drug costs
  • A patient-centered MACRA framework, including non-punitive and flexible implementation of new MIPS, PQRS and MU requirements
  • Congressional reauthorization of CHIP (Children’s Health Insurance Program) at the current enhanced funding level
  • Better interstate PDMP connectivity
  • Eliminating “pain” as the fifth vital sign
  • Repealing the “language interpreters” rule
  • Requiring all VA facilities, methadone clinics and suboxone clinics to input prescription data into state PDMPs where they are located

 

The Medical Association opposes:

  • Non-physicians setting standards for medical care delivery
  • Publication of Medicare physician payment data
  • National medical licensure that supersedes state licensure
  • Legislation/initiatives increasing lawsuits against physicians

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U.S. House Passes Legislation to Repair Medical Liability System

U.S. House Passes Legislation to Repair Medical Liability System

The U.S. House of Representatives passed a comprehensive medical liability reform bill, H.R. 1215, the Protecting Access to Care Act of 2017 (PACA), by a vote of 218 to 210, which includes significant reforms to help repair our nation’s broken medical liability system, reduce the growth of health care costs, and preserve patients’ access to medical care. The AMA submitted a letter to Congress strongly supporting H.R. 1215.

PACA provides the right balance of reforms by promoting speedier resolutions to disputes, maintaining access to courts, maximizing patient recovery of damage awards with unlimited compensation for economic damages while limiting non-economic damages to $250,000. Importantly, H.R. 1215 includes language to protect medical liability reforms enacted at the state level. The CBO determined that H.R. 1215 would reduce federal health care spending by $44 billion over 10 years and reduce the deficit by $50 billion over the same period.

Proponents of the measure said it would help bring down costs of health care and increase the availability of doctors. They pointed to litigation reforms in California to lower medical malpractice liability insurance premiums for health care providers as the basis for the legislation considered on the House floor during debate.

“Health care costs are out of control due in large part to unlimited lawsuits and other problems ObamaCare failed to solve or ObamaCare made worse,” said Rep. Steve King (R-Iowa), the author of the bill.

The Medical Association had requested our Congressional Delegation to support the legislation and would like to thank the following members who voted for the bill: Alabama Reps. Robert Aderholt, Mo Brooks, Bradley Byrne, Gary Palmer, Mike Rogers and Martha Roby.

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What is the ProAssurance Legal Defense Endorsement?

What is the ProAssurance Legal Defense Endorsement?

As a ProAssurance insured, did you know that in addition to medical professional liability coverage your ProAssurance insurance policy also has embedded legal expense coverage for a variety of regulatory risk exposures, certain types of disciplinary proceedings, and other types of covered investigations? It’s called the Legal Defense Endorsement, and it is an automatic part of your policy at no additional cost to you. Generally speaking – and subject to applicable deductibles, policy period aggregates, and other terms and conditions – the Legal Defense Endorsement provides up to $25,000 of legal expense coverage on a per claim basis for a laundry list of “covered investigations” specifically listed in the endorsement.*

Many of the covered investigations are of the regulatory risk variety – like HIPAA, EMTALA, the federal Anti-Kickback and False Claims Act statutes, the Patient Protection and Affordable Care Act, and others. In the event of an investigation or proceeding commenced against you by a governmental or regulatory agency charged with the enforcement of compliance with those laws and regulations, call ProAssurance because your Legal Defense Endorsement could provide up to $25,000 of legal expense coverage to help you navigate the investigative process.

Several other covered investigations relate specifically to Medicare and Medicaid. Again, in the event of an investigation or proceeding commenced against you by any federal or state agency charged with the enforcement of compliance with certain laws regulating Medicare or Medicaid and the rules and regulations related to billing and reimbursement for medical services under those programs, your Legal Defense Endorsement could provide up to $25,000 of coverage for legal expenses you incur as a result of such investigations.

Some of the remaining covered investigations include disciplinary proceedings commenced by the state’s medical licensure commission investigating alleged unprofessional conduct that could result in action being taken against your license to practice medicine. Disciplinary proceedings commenced by a hospital or its medical staff for the purpose of suspending, modifying, restricting, revoking, non-renewing, or terminating your staff privileges are also covered investigations under your Legal Defense Endorsement. Many an unwitting physician has tried to represent him or herself in these types of proceedings, only to later regret not enlisting the assistance of legal counsel.

There are additional covered investigations in the Legal Defense Endorsement not mentioned in this article. If you want to read your Legal Defense Endorsement look for the form titled “Professional Legal Defense Coverage Part” in your current ProAssurance policy. The endorsement itself is about two-and-a-half pages. You can always access your policy documents online through the ProAssurance secure customer portal at www.proassurance.com.

Knowing and understanding how the coverage in your Legal Defense Endorsement works can help you to avoid spending money out of your own pocket on legal expenses that could be covered by the endorsement. More importantly, taking advantage of the coverage in your Legal Defense Endorsement can help you to avoid digging yourself into a deeper hole by attempting to handle a covered investigation on your own without the assistance of legal counsel.

For more information about your Legal Defense Endorsement or if you have questions about the coverage in the endorsement, contact your ProAssurance representative for assistance.

*Please note that legal counsel must be either appointed directly by ProAssurance or if selected by the insured, appointed by ProAssurance with prior written approval before their legal expenses can be covered under the Legal Defense Endorsement.

Posted in: Liability

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Texting and Emailing in the World of HIPAA

Texting and Emailing in the World of HIPAA

If you experience anxiety every time you consider texting and/or emailing in your health care setting, you are not alone. On one hand, the world that we live in necessitates that information is communicated in a quick and easy manner. The ability to text or email staff and patients has become a high priority for many health care entities. On the other hand, patient privacy and confidentiality is essential to meeting compliance standards. Though emailing and texting are convenient, it certainly does not come without the possibility of pitfalls. It is a complex issue that requires meeting several factors in order to be implemented properly.

But Everybody Is Doing It, Right?

The perception is that many health care entities are already taking advantage of emailing and texting capabilities.  That may be accurate.  But the bigger question is whether they are utilizing those tools in accordance with HIPAA Privacy and Security requirements.  Health care entities should consider the following:

A Risk Analysis is key.  An adequate Risk Analysis is required to be performed at the outset of the practice, prior to developing a HIPAA policy.  This Risk Analysis identifies the type of information that you maintain or access and the areas within your entity where protected health information (PHI) is vulnerable. The Risk Analysis should be reviewed, and amended if necessary, whenever there is a change in your information technology environment.  This includes adopting the use of email and text messaging. The entity will need to consider potential vulnerabilities and threats, then document their plan to ensure that health information stays secure.

Show me the policy.  The HIPAA Privacy and Security policy must document your entity’s use of these services and define how employees are to utilize them.  This includes specifying whether only business owned devices can be used or whether the entity allows employees to utilize their own personal device (BYOD). The policy should also be specific about any differences in procedure for emailing and texting internally, versus outside communication with patients and other health care providers.  The policy requirement should be followed by adequate training.

Encryption, encryption, encryption.  Many entities that utilize PHI in email communications secure the information via encryption.  Within health care entities, the information is often secured by firewalls.  Firewalls make it much easier to implement security measures, oversee procedures and secure information.  Some health care entities choose to transmit PHI via electronic health records and customized patient portals. However, using emails to properly transmit PHI outside the entity is a much more complicated process.  To properly transmit PHI via email, encryption must be utilized.  Encryption software will resolve security issues because the patient receives an email containing a link which requires a unique username and password to access the PHI. Some patients find the process of logging in and remembering required passwords to be cumbersome, but others appreciate knowing that their information is secure.

Less is moreWhen communicating with individuals outside of your entity about PHI, utilize the Minimum Necessary Rule.  The Minimum Necessary Rule requires health care entities to limit the PHI produced to the amount of information necessary for the recipient to carry out their function.  For example, if another provider requests a patient’s diabetes lab work, only provide the requested lab work and not the patient’s entire medical record.  Also, it is recommended that you not share sensitive information including, but not limited to, a patient’s mental health, communicable disease status, child or elder abuse, and substance abuse issues.  The entity’s policies/procedures should define and describe how sensitive information should be transmitted.

The patient gets their way. HIPAA requires entities to communicate with patients in the manner determined by the patient, so long as it is reasonable. An entity’s Notice of Privacy Practices will generally articulate methods of intended communication by the entity.  However, a patient may choose not to receive communications through a traditional method. An example would be a patient request not to use U.S. mail, but to use email instead.  That entity may find that they do not have encrypted email capabilities that would appropriately safeguard the information. In this scenario, the health care entity must still comply with the patient’s request; however, they should have the patient sign a form that memorializes the patient’s request to use email communication and documents the risks associated with this request.

The guidance above does not apply to patient initiated communications. Patients are not considered to be HIPAA covered entities and therefore, their actions are not HIPAA violations.  Thus, patients are free to initiate emails or text messages with health care providers at their pleasure. Health care entities should have a form on hand for the patient to sign prior to responding to an email or text message from the patient. This form documents that the patient is aware of the inherent risk of email or text message communications, but wishes to receive the communication in that form anyway. This will help to satisfy the patient’s preference while helping to shield the health care entity from liability if communications are intercepted beyond the entity’s control.

Texting Has Added Risks

Text messages are generally available to anyone who utilizes that person’s phone because there is generally not separate password security for access to the text messaging feature.  Additionally, because the text messages do not pass through the entity’s servers, it is difficult, if not impossible, for IT staff and Security Officers to audit the texts.  And if these communications are intended to be a part of the patient’s record to demonstrate communication, the patient loses the right to amend the communication if it is not readily available in the paper or electronic record. There are vendors who offer “secure texting” solutions. If a health care entity is considering a secure texting vendor, have your designated Security Officer review their system carefully and converse extensively with the vendor about whether their product is indeed secure. A BAA with the vendor is also required. Finally, the entity should revisit its written policy and retrain when necessary.

To ensure that your practice is in compliance, and for assistance with determining whether your entity should proceed with implementing text or email communications, please consult a health care compliance professional.

Samarria Dunson, J.D., CHC, CHPC is attorney/principal of Dunson Group, LLC, a health care compliance consulting and law firm in Montgomery, Alabama.  www.dunsongroup.com

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ProAssurance: When Treated Fairly® is More than a Promise

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Editor’s Note: This article was originally published in the 2016 Winter Issue of Alabama Medicine magazine.

Choosing the right company for your professional liability insurance is one of the most important decisions you make as a physician. With multimillion dollar jury verdicts on the rise again – Alabama has seen eight in the last 36 months alone – professional liability remains a significant threat to Alabama physicians. Yet given today’s financial pressures, it’s tempting to think of only price when considering professional liability insurance; for now is when the urge to cut a corner with a cheaper insurance choice can appear to make sense. But that’s the kind of short-term thinking that gets some insurance companies and, unwittingly, their insureds in trouble. When policies are sold on price alone, those who buy them may be left with a worthless piece of paper and myriad resulting problems.

Lured by low-cost premiums some physicians and physician groups in Alabama have switched insurance companies in recent years only to discover — sometimes mere months into the new relationship — that the new company’s idea of an unbridled defense in the event of a claim or lawsuit pales in comparison to the same promise ProAssurance makes and has consistently delivered to physicians in Alabama for more than 35 years. Dismayed, discouraged and dissatisfied with their new company’s inability to deliver the same quality of claims handling and legal defense, many of these same physicians have decided to return to ProAssurance, sometimes after having been insured by their new companies less than one year.

Founded by Alabama physicians in the 1970s when other insurance companies had left the state, ProAssurance has worked to level the legal playing field over the years and has helped make Alabama a safer and more predictable place to practice medicine. ProAssurance pioneered the aggressive defense of physicians in Alabama with a steadfast resolve to defend good medicine, discourage the filing of non-meritorious claims, and force plaintiff lawyers to think twice before suing a physician for malpractice — a time-tested and proven defense philosophy that has served well the physicians of Alabama. We don’t spare expenses, and we ensure that our defense lawyers have the resources necessary to defend our insured physicians. To date, ProAssurance and its exclusive panel of highly experienced defense lawyers have secured more than 1,300 defense verdicts at trial on behalf of Alabama physicians.

No other medical professional liability insurance company has committed anywhere near the time, effort, and financial resources that ProAssurance has committed to create, support, protect and defend the more favorable environment in which Alabama physicians now practice. What assurances are there other companies would do the same? None; but ProAssurance’s track record in Alabama speaks for itself.

ProAssurance understands the economic realities and challenging health care environment you face every day. The need for financial discipline is, in many ways, more urgent now than ever before — which is why you should seek full value in your professional liability insurance policy, demanding that every dollar you pay for that insurance purchases the full promise of an unfettered defense and the peace of mind that comes from knowing your insurance company is devoted to maintaining the financial strength to be here for you many years from now. You get that with ProAssurance. We don’t compromise the defense of a case for cost-saving reasons; other companies have, and still do — sometimes with catastrophic results. Furthermore, part of our commitment to you is that we will maintain the discipline and stability to do what’s right for you in the long-term.

ProAssurance exists to protect others. Our physician-focused mission is crystallized in the company’s guiding principle Treated Fairly®. Everything we do in Alabama — from our relationship with the Medical Association, to physician involvement on our Claims & Underwriting Committee and Regional Advisory Boards, to our unparalleled track record for successfully defending physicians in lawsuits, including at trial — underscores our Treated Fairly® pledge to you. Your policy will always be priced at a reasonable premium, but we will never risk your future by endangering the financial strength and long-term viability of the very company you trust to protect it.

Contributed by Hayes V. Whiteside, M.D., Medical Director, ProAssurance

platinummvpProAssurance-insured physicians and their practice managers may contact Risk Resource for prompt answers to liability questions by calling (205) 877-5015 or email at riskadvisor@proassurance.com. ProAssurance is an official Platinum Partner with the Medical Association.

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