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Alabama SB39: Another Shot in the Opioid Battle

Alabama SB39: Another Shot in the Opioid Battle

On March 28, 2018, Alabama Senate Bill 39 was sent to Governor Ivey’s desk for signature. SB39 introduces stiffer penalties related to fentanyl possession and distribution. It amounts to a local effort forming part of a nationwide, multi-pronged response to the opioid epidemic that has plagued the country in recent years. While this bill is not yet law as of the date of this article, it came to the Governor’s desk with broad support from both the House and Senate, and an awareness of its contents (and its place in the larger opioid crisis) is valuable.

Fentanyl is a particularly strong opioid that has of recent been the target of much abuse. The National Institute on Drug Abuse notes that in 2016, fentanyl contributed to more than 20,000 overdose deaths; medical examiners reported that fentanyl or fentanyl mixtures were involved in the deaths of the musicians Prince and Tom Petty. SB39 includes several related features stiffening enforcement of abuses of fentanyl and related drugs: the bill would:

  1. add fentanyl and related analogues (e.g., butyrfentanyl and acetyl fentanyl) to Schedule I of the controlled substances list;
  2. make a person (unless otherwise authorized by law) who possesses, distributes, or traffics such drugs guilty of a felony, and conviction for distribution subject to enhanced penalties;
  3. include under the meaning of “trafficking” possession of fifty or more individual packages of the substance

A related proposal that was introduced but ultimately rejected by the legislature was a change to allow prosecution of physicians for over-prescribing opioids.

Of particular note are the low thresholds set for amounts of fentanyl and fentanyl analogues — an acknowledgment of both the potency of the drug and the severity of the current crisis. The bill would amend §13A-12-231 of the Alabama Code to make possession of one gram or more of fentanyl or a fentanyl analogue a felony of “trafficking in illegal drugs,” and includes substantial fines. As noted above, conviction can also occur if one is in possession of 50 or more individual packages of fentanyl or a fentanyl analogue, notwithstanding the fact the combined weight of the fentanyl or fentanyl analogues in the packages may be less than one gram.

At this point of the opioid epidemic, some physicians may well be experiencing opioid fatigue. News articles, legislative and regulatory initiatives, personal testimonies, seminar topics, and other avenues have been bringing this issue to the health care industry’s attention for years now. It is a complex problem, with a multiplicity of root causes and a variety of faces. The several penalties included in this recent bill are a reminder that staying abreast of all the many changes, initiatives and tools aimed at addressing opioid abuse is well worth the time and attention.

Whatever the eventual fate of SB39, this will not be the last shot fired in the response to opioid abuse. This bill is a reminder that the responses to this crisis are varied, and that although the opioid epidemic is a national problem, it also plays out on the state and local level. As “opioid” refers to a diverse range of drugs, the “opioid epidemic” refers to a complex quagmire. Being well aware of the problem, in general, is no substitute for familiarity with the many paths being carved through it. In addition to introducing potential changes to the criminal law code such as SB39, Alabama has also taken such steps as forming the Alabama Opioid Overdose and Addiction Council, formed in August 2017 by Governor Ivey, which has made such recommendations as improving and modernizing Alabama’s prescription drug monitoring program; the Alabama Department of Public Health is leveraging funding from the CDC’s Data-Driven Prevention Initiative (DDPI) on Opioid and Heroin Abuse to identify stakeholders of and solutions to the problem; Alabama Attorney General Steve Marshall filed a lawsuit in February 2018 against one of the largest drug manufacturers in the nation.

This is a constantly changing landscape, and the opportunity for missteps abound. Some of these missteps have consequences that reach beyond issues of reimbursement and licensure. The fate of SB39 is worth watching — its wide support in both chambers of the Alabama Legislature make it a prime candidate for signing into law by the governor. However, beyond offering a description of this one bill, this present article should serve as a reminder that opioid-related news deserves close attention because of, not despite, the frequency of the topic. New laws and initiatives are coming out regularly, and if you’ve seen one you have not seen them all.

Article written by Chris Thompson, an attorney with Burr & Forman LLP practicing in the firm’s healthcare group. Burr & Forman, LLP, is a partner with the Medical Association. Read other articles from Burr & Forman LLP.

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Alabama Legislature Considers State Law on Cybersecurity

Alabama Legislature Considers State Law on Cybersecurity

At the time of the writing of this article, Alabama is one step closer to having a law on the books related to cybersecurity. As one of only two states without a state data breach law, Alabama is considering legislation that requires certain entities, “covered entities,” to report to state agencies and affected individuals when there has been an unauthorized acquisition of “electronic, sensitive personally identifying information.”

On March 1, 2018, the Alabama Senate passed SB318, and if passed by the House and signed by the Governor, it would require “covered entities” to notify Alabama’s Attorney General, Alabama residents whose information has been compromised, and consumer credit-reporting agencies of a data breach. For health care providers covered by the Health Insurance Portability and Accountability Act (“HIPAA”), federal law already requires notification when they experience unauthorized disclosures of protected health information. In addition to HIPAA’s breach notification requirements, the new Alabama law would require reporting at the state level for healthcare providers who experience a data breach. It is important to note that the term “covered entities” in the proposed legislation is much broader and applies to persons or business entities that acquire or use personally identifiable information.

Investigation and Reporting

Under SB318, a covered entity is required to investigate any data breach and in some instances report the breach. The investigation must include:

  1.  an assessment of the nature and scope of the breach,
  2.  identification of any sensitive personally identifying information involved and the individuals involved,
  3.  a determination as to whether the information was acquired by an unauthorized individual and could result in substantial harm, and
  4.  identify and implement measures to restore security and confidentiality of the system involved in the breach.

It is the second factor that determines whether the breach is reportable:  Is the sensitive information reasonably believed to have been acquired by an unauthorized person? And is the unauthorized acquisition reasonably likely to cause substantial harm to the individuals?

The law sets forth four factors to consider when evaluating whether the information is “reasonably believed” to have been acquired by an unauthorized individual. In making this determination, the covered entity must evaluate “indications that the information is in the physical possession and control of a person without valid authorization, such as a lost or stolen computer or other device containing information; indications that the information has been downloaded or copied; indications that the information was used by an unauthorized person, such as fraudulent accounts opened or instances of identity theft reported; and whether the information has been made public.” Unfortunately, the law does not provide guidance on whether the breach is reasonably likely to cause substantial harm to the affected individual.

Even if a breach is not a reportable event, the covered entity must maintain relevant records for at least five years. For instance, if the covered entity determines the breach is not reasonably likely to cause substantial harm then no notification is required, but the entity should keep all records related to the breach and their determination that notification was not necessary for five years following the incident.

Required Security Measures

The proposed legislation also requires covered entities to implement “reasonable security measures” to protect an individual’s data.  Similar to HIPAA, the bill requires the covered entity to designate an employee to coordinate security measures (i.e. HIPAA Security Officer) and to identify risks of data breaches. In recognizing that not all covered entities face the same risks or have the same resources, the required “reasonable” security measures should take into account the size of the covered entity, the amount of data maintained and stored by the covered entity and the cost to implement security measures. Good news for healthcare providers, if a healthcare provider has performed the necessary security and risk assessments required under HIPAA, it should easily meet the standards required in SB318.

Information that Triggers Notification

Not all information qualifies as “sensitive personally identifiable information.” To meet this definition, the accessed information must consist of the individual’s first name or initial and last name in combination with any one of these data elements:

  • A non-truncated (or shortened) Social Security or tax identification number;
  • Non-truncated driver’s license, state-issued identification card number, passport number, military identification number or any unique, government-issued number used to verify identity;
  • A financial account, credit or debit card number along with a required security code, expiration date, PIN, access code or password necessary to access a financial account or conduct a transaction;
  • Individual medical or mental history or treatment information;
  • A health insurance policy or identification number; and
  • A username or email address along with a password or security question and answer that gives access to an online account that is likely to contain sensitive personal information.

Elements and Method of Notification

If the investigation concludes that notification must be made, the covered entity must provide notification as “expeditiously as possible but no more than 45 days after the determination of the breach. The notification may be made by mail or email and must include the following elements: 

  • The date, estimated date, or estimated date range of the breach;
  • A description of the sensitive personally identifying information that was acquired by an unauthorized person as part of the breach;
  • A general description of the actions taken by a covered entity to restore the security and confidentiality of the personal information involved in the breach;
  • A general description of steps a consumer can take to protect himself or herself from identity theft; and
  • Information that the individual can use to contact the covered entity to inquire about the breach.

Penalties

The legislation also includes penalties for failing to provide the required notifications, including a potential violation of the Alabama Deceptive Trade Practices Act (“ADTPA”). The Deceptive Trade Practice Act penalties would apply for willful or reckless disregard of the notification requirements. Civil money penalties are capped at $5,000 per day for each consecutive day the covered entity fails to comply with the notice provisions and there is a $500,000 cap for violations under the ADTPA. A violation does not constitute a criminal offense and does not provide for a private right of action.  In other words, a patient/consumer cannot sue the covered entity for the breach.

The bill is currently pending before the Alabama House of Representatives, bill number HB410.

Article contributed by Burr & Forman, LLP. Burr & Forman, LLP, is a partner with the Medical Association. Please read other articles from Burr & Forman, LLP, here.

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Twenty States File Lawsuit against Government for the Affordable Care Act

Twenty States File Lawsuit against Government for the Affordable Care Act

Twenty states, including Alabama, have formed a coalition to file a lawsuit against the government claiming that the Affordable Care Act is now unconstitutional.

According to the lawsuit, the states are claiming that since the GOP eliminated the tax penalty associated with the individual mandate, ObamaCare itself is no longer constitutional.

The Tax Cuts and Jobs Act, signed into law by President Donald Trump on Dec. 22, 2017, eliminated the tax penalty of the ACA, without eliminating the individual mandate itself, according to the lawsuit filed in U.S. District Court in the Northern District of Texas.

In 2012, the Supreme Court ruled 5-4 that ObamaCare’s individual mandate was constitutional because Congress has the power to levy taxes. The lawsuit points to that part of the ruling in its argument that the law is no longer constitutional.

“Following the enactment of the Tax Cuts and Jobs Act of 2017, the country is left with an individual mandate to buy health insurance that lacks any constitutional basis,” the lawsuit states. “Once the heart of the ACA — the individual mandate — is declared unconstitutional, the remainder of the ACA must also fall.”

In its current form, the ACA imposes rising costs and transfers an enormous amount of regulatory power to the federal government, according to a statement by Texas Attorney General Ken Paxton and Wisconsin Attorney General Brad Schimel, who are leading the 20-state coalition lawsuit.

The lawsuit was filed by the attorneys general for the states of Wisconsin, Alabama, Arkansas, Arizona, Florida, Georgia, Indiana, Kansas, Louisiana, Missouri, Nebraska, South Carolina, South Dakota, Tennessee, Utah, West Virginia, Texas, and by the governors of Maine and Mississippi.

The Medical Association is closely monitoring the lawsuit and will report more information as it becomes available.

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Just What the Doctor Ordered: An Alabama Perspective on the Opioid Epidemic

Just What the Doctor Ordered: An Alabama Perspective on the Opioid Epidemic

Sometimes, Alabama is No. 1. In 2012, Alabama was the highest per capita painkiller prescribing state, with an average of 143 prescriptions written per 100 people — almost three times the rate of the lowest prescribing state.1 Alabama has been home to other No. 1s, too. In 2012, Dr. Shelinder Aggarwal, a former Huntsville-area pain doctor, was the top Medicare prescriber of prescription painkillers in the United States, until he was sentenced to 15 years in prison, had to pay back some $9.5 million in fraudulently billed claims, and surrendered his medical license in the wake of an examination by the Board of Medical Examiners.2

Many aspects of Aggarwal’s practice, which was described in the charging documents against him as a “pill mill,” are almost beyond belief. Aggarwal was seeing 80 to 145 patients in his office each day in 2012. Alabama pharmacies filled about 110,013 prescriptions (12,313,984 pills) in calendar year 2012 for controlled substances prescribed by Aggarwal. That equates to 423 prescriptions and 144 patients per day, assuming Aggarwal worked a five-day work week and wrote about three prescriptions per patient.3

Exactly how Aggarwal was able to prescribe controlled substances in such volumes is no less shocking. According to charging documents, initial visits entailed little more than a superficial physical exam and a urine drug test and lasted only five minutes. Follow-up visits could last as little as two minutes. Aggarwal allegedly did not retrieve a patient’s medical history, nor did he treat his patients with anything other than controlled substances. He was known to ask patients what medications they wanted, and he even wrote prescriptions for controlled substances to patients who admitted to using illegal drugs, or whose drug screen showed illegal drugs in their system.4

Aggarwal’s example, perhaps, is on the extreme end of the spectrum, but it highlights the gravity of the “opioid epidemic” Alabama and the United States are facing right now. Every physician has a role to play combating these opioid problems, and there are tools out there to help.

Prescription Drug Monitoring Program

The Alabama Prescription Drug Monitoring Program, or PDMP, is designed to “promote the public health and welfare by detecting diversion, abuse and misuse of prescription medications classified as controlled substances under the Alabama Uniform Controlled Substances Act.”5 Under the authorizing act and implementing regulations for the PDMP, any dispenser of Class II, III, IV or V controlled substances must report the dispensing of these drugs to the PDMP.6 Therefore, in most cases, you should be able to see any controlled substance (e.g. opioids) that have been dispensed to a patient if you check the PDMP. Although the PDMP authorizing act does not require prescribers to check the PDMP, they are allowed to access PDMP
information for a current or prospective patient,7 and their applicable licensure board may impose requirements to check the PDMP by regulation. Prescribers and dispensers should consult the PDMP and may suggest other health providers also consult the PDMP if there is information that may be important to the other health provider. Note: Neither the PDMP report nor any information from the PDMP report should be disclosed — that’s why you should suggest the other health provider consult the PDMP if you have a concern, rather than revealing information directly from the report.8

BME Risk and Mitigation Strategies Rule

The PDMP statute does not require prescribers to consult the PDMP, but certain licensure boards do. For instance, the BME recently finalized a new rule on risk and mitigation strategies (RMS) for prescribing physicians.9 The new rule requires prescribers to check the PDMP at frequencies that vary based on the morphine milligram equivalency (MME) of medications they are prescribing: (1) upon each prescription for controlled substances greater than 90 MME; (2) at least twice each year for controlled substances between 30 and 90 MME; and (3) consistent with “good clinical practice” for controlled substances less than 30 MME. Additionally, physicians are required to document the use of RMS in the patient’s medical record. Physicians should take care to adequately document appropriate RMS without running afoul of the PDMP prohibition on disclosing the PDMP report or the information contained therein. This can be a difficult task to fulfill when you can’t keep a copy of the PDMP report in the patient’s medical record.10 A simple notation in the patient’s medical record that you have checked the PDMP and that there are no contraindicated prescriptions likely would suffice.

The new RMS rule sets forth other RMS, including pill counts, urine drug screenings, patient education, and others, some of which are described below from the CDC. Physicians should note that failure to fulfill their obligations under this rule could lead to adverse licensure actions.11

CDC Guidelines for Prescribing Opioids for Chronic Pain

The Centers for Disease Control and Prevention, after a rigorous period of research, consultation and public comment, has also issued opioid prescribing guidelines for primary care physicians treating patients with chronic pain.12 Below is a brief description of the guidelines:

  • Consider nonpharmacologic therapy; only prescribe opioids if risks outweigh benefits;
  • Establish treatment goals;
  • Discuss known risks and benefits of opioid therapy with patients, as well as clinician responsibilities for managing therapy;
  • Consider prescribing immediate-release, rather than extended-release opioids;
  • Prescribe the lowest-effective dosage;
  • For short-term (acute) pain, prescribe the lowest-effective dose and only in the quantity needed for the expected duration of pain severe enough to require opioids;
  • Evaluate risk factors for opioid-related harms and implement a risk mitigation plan;
  • Review the PDMP for harmful quantities or combinations of controlled substances;
  • Conduct urine drug testing before starting opioid therapy;
  • Avoid prescribing opioids and benzodiazepines concurrently, if possible;
  • Offer evidence-based treatment for patients with opioid-use disorder.

A full report listing methods, clinical evidence, and a full discussion of the above recommendations are available from the CDC (see link in footnote 12 below for reference).

These are just a few tools to help you help your patients and mitigate the opioid epidemic. Let’s not win anymore No. 1s of the kind described above for the State of Alabama.

References

1 Prescribing Data, Centers for Disease Control and Prevention (Dec. 20, 2016), https://www.cdc.gov/drugoverdose/data/prescribing.html; Leonard J. Paulozzi, MD et al., Vital Signs: Variation Among States in Prescribing Opioid Pain Relievers and Benzodiazepines—United States, 2012, CDC: Morbidity and Mortality Weekly Report (July 4, 2014), available at https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6326a2.htm?s_cid=mm6326a2_w.

2 Huntsville Pill Mill Doctor Sentenced to 15 Years in Prison for Illegal Prescribing and Health Care Fraud, Department of Justice: U.S. Attorney’s Office, Northern District of Alabama (February 7, 2017), available at https://www.justice.gov/usao-ndal/pr/huntsville-pill-mill-doctor-sentenced-15-years-prison-illegal-prescribing-and-health.

3 United States v. Shelinder Aggarwal, Information Against Shelinder Aggarwal, Sept. 22, 2016.

4 Id.

5 Alabama Department of Public Health: Prescription Drug Monitoring Program Home (June 23, 2017), http://www.alabamapublichealth.gov/pdmp/index.html.

6 Ala. Code § 20-2-213 (1975); Ala. Admin. Code r. 420-7-2-.12 (Nov. 24, 2014).

7 Ala. Code § 20-2-214(2) (1975); Ala. Admin. Code r. 420-7-2-.13 (Nov. 24, 2014).

8 See Ala. Code §§ 20-2-215 to 20-2-216 (1975) (making records and information in the PDMP privileged and confidential and creating a Class A Misdemeanor for individuals who intentionally make an unauthorized disclosure of information from the PDMP); see also FAQ, Alabama Department of Public Health: Prescription Drug Monitoring Program (May 31, 2017), http://www.alabamapublichealth.gov/pdmp/faq.html.

9 See Ala. Admin. Code r. 540-X-4-.09 (March 9, 2017).

10 See FAQ, Alabama Department of Public Health: Prescription Drug Monitoring Program (May 31, 2017), http://www.alabamapublichealth.gov/pdmp/faq.html.

11 Ala. Admin. Code r. 540-X-4-.09(8) (March 9, 2017).

12 Deborah Dowell, MD et al., CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016, CDC: Morbidity and Mortality Weekly Report (March 18, 2016), available at https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm#suggestedcitation.

 

Article contributed by Christopher L. Richard with Gilpin Givhan, P.C. Gilpin Givhan, P.C., is a Bronze Partner with the Medical Association.

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Liquid Gold or Reimbursement Trap? Payor Reimbursement Policies for Urine Drug Testing

Liquid Gold or Reimbursement Trap? Payor Reimbursement Policies for Urine Drug Testing

Last summer, we wrote about physician roles and responsibilities to implement best practices in pain management programs and other treatments involving the prescription of opioids.1 Here we discuss issues related to getting paid to implement one of these best practices — appropriate urine drug testing.

The urine drug testing field has been described as a huge profit center with a growing number of clinics that run their own testing operations instead of farming them out to independent labs;2 but the numbers don’t always add up. This article takes a closer look at urine drug testing guidance from the Alabama Board of Medical Examiners and the Centers for Disease Control and Prevention and examines the urine drug testing policies for Medicare and Blue Cross & Blue Shield of Alabama to highlight an area where best practice and payor policies don’t always agree.

The “Best Practices”

When the BME finalized a new rule last year regarding risk mitigation strategies (RMS) for physicians prescribing controlled substances, urine drug testing was one of several recommended aspects of the RMS.3 The BME’s rule does not specify the frequency with which physicians should use urine drug testing in their RMS, but the CDC’s guidance4 on opioid prescribing best practices is informative.

According to the CDC’s study, experts agreed clinicians should use urine drug testing before the initiation of treatment using opioids and periodically thereafter to assess for prescribed opioids, other controlled substances, and illicit substances that may increase the risk of overdose when
combined with opioids. However, experts disagreed on the frequency with which urine drug testing should be used to monitor treatment regimens
and patient compliance, as well as on the degree to which urine drug testing should apply to all patients uniformly, as compared to individual case-by-case determinations.

The study also addresses the appropriate use of qualitative “screening” panels and quantitative “confirmatory” or “definitive” testing. The CDC recommends relatively inexpensive screening panels for illicit drugs and commonly prescribed opioids prior to initiation of treatment. More expensive confirmatory testing should be reserved “for situations and substances for which results can reasonably be expected to affect patient management” (e.g. in the case of positive screenings or unexpected negative screenings).

These suggested best practices can have a positive impact on patient treatment involving opioids and other controlled substances, but they may put
physicians in the position of ordering tests for which reimbursement is not available. In fact, as the CDC report acknowledged, the direct costs of urine drug testing “often are not covered fully by insurance.”

Sometimes, it just doesn’t pay…

Payors impose different requirements regarding medical necessity and frequency of drug testing. If you read through the BCBSAL and Medicare urine drug testing policies, it may seem the differences between the two policies are minor. However, these two payors differ on the frequency of monitoring screenings (after the initiation of treatment) that are considered medically necessary, as well as on their coverage policies for confirmatory tests.5

The most notable coverage difference we have seen between the two programs is in their application of the confirmatory testing policies,
specifically each payor’s interpretation of the word “test.” To illustrate, consider the following G-codes for confirmatory/definitive drug testing: G0480 (definitive drug test for 1-7 drug class(es)), G0481 (definitive drug test for 8-14 drug class(es)), G0482 (definitive drug test for 15-21 drug class(es)), and G0483 (definitive drug test for 22 or more drug class(es)). Medicare treats each G-code as a “test” for purposes of counting tests toward a coverage or benefit limit.6

By contrast, it is our understanding from conversations with BCBSAL that they consider each drug or drug class to represent a “test” for coverage and benefit limits, despite the fact that each G-code comprises a range of drug classes in multiples of seven. Because BCBSAL limits coverage of confirmatory tests to three tests per qualitative drug screen, in theory, reimbursement to providers would only be covered by BCBSAL under G-code G0480 for up to three drug classes tested per qualitative screening. To the extent providers bill BCBSAL for additional confirmatory tests beyond the three-test limit, they would likely be non-covered or result in an overpayment. BCBSAL’s restrictive policies are certainly a limiting factor on physicians trying to implement the best practices described above, and physicians should be aware of the different coverage policies between Medicare and BCBSAL with regard to confirmatory tests.

We chose to highlight this particular coverage policy difference between Medicare and BCBSAL because it is not readily apparent from a reading of the two policies. However, there are other nuanced aspects of payor policies on urine drug testing. Physicians and billing/coding personnel should consult the relevant payor billing guidelines, with the assistance of counsel as necessary, in order to determine coverage for a particular test or service.

Sources

1 Christopher L. Richard, Just What the Doctor Ordered: An Alabama Perspective on the Opioid Epidemic, Alabama Medicine, Summer 2017, at 4.

2 See, e.g. David Segal, In Pursuit of Liquid Gold, New York Times (December 27, 2017), https://www.nytimes.com/interactive/2017/12/27/business/urine-test-cost.html.

3 Ala. Admin. Code r. 540-X-4-.09(2)(b) (March 9, 2017).

4 Deborah Dowell, MD et al., CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016, CDC: Morbidity and Mortality Weekly Report (March 18, 2016), available at https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm#suggestedcitation.

5 See BlueCross BlueShield of Alabama Policy No. 566, Drug Testing (last reviewed December 2016), available at https://providers.bcbsal.org/portal/documents/10226/1791629/Drug+Testing/1c67985a-0c5d-4be9-aa3c-c49677cf6a93?version=1.1; Local Coverage Determination (LCD): Controlled Substance Monitoring and Drugs of Abuse Testing (L35724), CMS.gov, https://www.cms.gov/medicare-coverage-database/license/cpt-license.aspx?from=~/overview-and-quick-search.aspx&npage=/medicare-coverage-database/details/lcd-details.aspx&LCDId=35724&ver=41&CntrctrSelected=381*1&Cntrctr=381&name=&DocType=Active&s=34%7c48%7c53%7c58&bc=AggAAAQBAAAA&.

6 2017 Controlled Substance Monitoring and Drugs of Abuse Coding and Billing Guidelines (M00128 V5), Palmetto GBA, https://www.palmettogba.com/palmetto/providers.nsf/docscat/Providers~JM%20Part%20B~Browse%20by%20Topic~Lab~2017%20Controlled%20Substance%20Monitoring%20and%20Drugs%20of%20Abuse%20Coding%20and%20Billing%20Guidelines%20(M00128%20V5) (describing each G-code as a “service” and providing that providers may only perform and report one G-code per date of service).

Article contributed by Christopher L. Richard with Gilpin Givhan, P.C. Gilpin Givhan, P.C., is an official Bronze Partner with the Medical Association

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MACRA: Rolled Out and Still Rolling

MACRA: Rolled Out and Still Rolling

Most physicians have, by this point, gained some familiarity with the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The name of this law has appeared frequently in commentary over the past several years, and the changes it imposes are well on their way. However, many of the details concerning MACRA’s implementation—how it affects physicians on the ground and what they need to do on a practical and technical level in order to comply with its requirements—deserve additional attention. It is, after all, a law that changes much about the Medicare payment landscape, and new guidance from the government continues to appear.

This article will discuss three recent releases from the Centers for Medicare & Medicaid Services (CMS) that concern MACRA, dating from the end of 2017 through the beginning of 2018. There is obviously much more that physicians should note about MACRA as we head further into 2018, but hopefully, this very brief article can serve as a springboard into the many features of this multifaceted new legal scheme.

  1. Starting with the most recent news release, on Jan. 3, 2018, of this year CMS announced that it had launched a new system for clinicians in the Quality Payment Program to submit their 2017 performance data. This system is located on the Quality Payment Program website, and because it replaces an array of former systems on multiple websites, it should make such data submission easier. For most clinicians, the 2017 submission period runs from Jan. 2, 2018, to March 31, 2018. Therefore, exploring this website’s new system for submission — including developing familiarity with the log-in and submission procedures — sooner rather than later is advisable. There are multiple data submission options embedded in the website, and thus having some advance knowledge of the preferred method should benefit a clinician. Eligible clinicians will see in real time the initial scoring, which may later change, for each of the Merit-based Incentive Payment System (MIPS) performance categories as they submit their data. CMS’ news release included a link to a fact sheet on this new system, which can be accessed here.
  2. On Dec. 19, 2017, CMS published the “2018 Medicare Electronic Health Record (EHR) Incentive Program Payment Adjustment Fact Sheet for Eligible Clinicians.” The referenced Payment Adjustment relates to the reduced Medicare payments for clinicians who do not demonstrate that they are meaningful users of Certified Electronic Health Record (EHR) Technology. This year is the final year of meaningful-use payment adjustments under the Medicare EHR Incentive Program, but the need to meet EHR standards is not going away: MACRA combines certain aspects of this Medicare EHR Incentive Program with other programs into MIPS, and the basic requirements that established meaningful use will still factor in as a percentage of a clinician’s MIPS score. The MIPS payment adjustments will be applied to Medicare Part B payments in 2019 for the 2017 performance period. CMS’ news release containing additional details can be accessed here.
  3. On Nov. 2, 2017, CMS issued a rule containing updates to the payment policies, payment rates, and quality provisions for services furnished under the Medicare Physician Fee Schedule for this year. This is not a MACRA-specific rule; instead, it demonstrates how MACRA has already become incorporated into the Medicare payment landscape as a whole. For example, MACRA helped determine the overall update to payments under the Fee Schedule, which is +0.41 percent for this year; the rule discusses the replacement of the Physician Quality Reporting System by MIPS; the rule also discusses the patient relationship code categories required under MACRA. In short, MACRA’s impact on the payment landscape is varied and pervasive. The time for getting up to speed on the practical implementation of this law has certainly arrived.

As noted above, MACRA is here among us, and it touches upon many facets of a physician’s practice. In order to avoid the various causes of decreased reimbursement, it benefits physicians to proactively seek to understand the ongoing requirements ushered in by the law.

Article contributed by Chris Thompson, an attorney at Burr & Forman LLP practicing within the firm’s Health Care Industry Group. Burr & Forman LLP is an official partner with the Medical Association.

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The New Department of Justice Initiative: Aggressively Investigating and Prosecuting Opioid-Related Cases

The New Department of Justice Initiative: Aggressively Investigating and Prosecuting Opioid-Related Cases

Before joining Burr & Forman, LLP, I was a federal prosecutor for a little over a decade specializing in health care fraud and general white collar matters. In that role, I was the member of a prosecution team that secured guilty verdicts earlier this year against two pain management doctors in Mobile, Ala., following a protracted jury trial. The doctors were convicted of a litany of federal crimes arising from their operation of a pain management clinic, including, among others, violations of the Controlled Substances Act and the Anti-Kickback Statute. The doctors received substantial prison sentences of 20 and 21 years, respectively, and forfeited virtually all of their assets (including bank accounts, houses and cars) to the government.

The doctors in this case were convicted of running what the government calls a “pill mill,” a pain management clinic that allegedly prescribes narcotics for illegitimate purposes. Pain management professionals should be aware this is just one example of what will likely be an onslaught of “pill mill” and other opioid-related prosecutions by the Department of Justice (DOJ) during the current administration. In fact, just a few months after the convictions in the Mobile case, Attorney General Jeff Sessions announced a nationwide takedown of 120 doctors, pharmacists and nurses – dubbed “Operation Pilluted” – who were charged with various federal crimes related to their alleged “unlawful distribution of opioids and other prescription narcotics.” In announcing the takedown, Sessions noted the DOJ would continue to “aggressively pursue corrupt medical professionals,” and “the Department’s work is not finished. In fact, it is just beginning.”

On the heels of that announcement, in August of this year, Sessions heralded a new DOJ pilot program called the “Opioid Fraud and Abuse Detection Unit.” According to Sessions, the unit “will focus specifically on opioid-related health care fraud using data to identify and prosecute individuals that are contributing to the opioid epidemic.” Sessions warned, “If you are a doctor illegally prescribing opioids or a pharmacist letting these pills walk out the door and onto our streets based on prescriptions you know were obtained under false pretenses, we are coming after you.” Sessions explained the DOJ would be appointing a special federal prosecutor in 12 select districts across the country whose sole purpose will be to prosecute “pill mill” and other opioid-related cases.

One of the districts, which has received one of the special “pill mill” prosecutors, is the Northern District of Alabama, in Birmingham. The U.S. Attorney for that district, Jay Town, separately confirmed the new prosecutor will spend “100 percent of their time working these types of cases…What we’re going after is the medical providers who are operating outside the boundaries of the law and the medical practice.” Echoing the Attorney General’s statements, Town vowed, “We’re going to rid the Northern District of these pill mills.”

Note “pill mills” are not the only opioid-related cases on the DOJ’s radar. In fact, it is also concentrating on the “diversion” of opioids in hospital settings. Such “diversion” schemes include, for instance, the theft of opioids from a hospital “Pxyis” machine (a device hospitals utilize to regulate the dispensing of controlled substances) by nurses, or the forgery or fraudulent creation of opioid prescriptions by hospital personnel.

In sum, the DOJ has fired a warning shot that physicians, pharmacists and other medical professionals involved in the treatment of patients will be under intense scrutiny for the foreseeable future. This is especially true for physicians who operate pain management clinics. These doctors should, in general, prescribe opioids reasonably and carefully in the context of each patient’s presentation and thoroughly document their treatment.

To that end, doctors should, among other things: maintain a thorough intake procedure, which requires the patient to give a detailed medical history and provide previous diagnostic studies; have the patient sign, if applicable, an “opioid treatment agreement” requiring the patient to abide by certain opioid use guidelines; perform exhaustive physical examinations during the initial visit and at regular intervals during the patient’s treatment (which should be carefully documented); consider alternatives to opioid treatment, such as non-narcotics drugs, physical therapy and surgery (and, where applicable, carefully document why alternative treatments would be ineffective); prescribe the lowest dosage and quantity of opioids possible to treat the patient’s condition; closely monitor for signs of diversion and addiction by regularly ordering urine drug screens and reviewing the patient’s prescription drug monitoring data; and have regular independent audits conducted by a billing consultant or another pain management specialist to ensure compliance with all regulations and laws. Implementing these practices should help doctors avoid government scrutiny as part of the DOJ’s new initiative to crack down on alleged “pill mill” operations.

Adam Overstreet is counsel at Burr & Forman, LLP. Prior to joining Burr, Adam practiced with the U.S. Attorney’s office and gained extensive experience with health care fraud matters. Burr & Forman, LLP, is a partner with the Medical Association. Please read other articles from Burr & Forman, LLP, here.

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Before You Lock the Door and Turn Out the Lights . . .

Before You Lock the Door and Turn Out the Lights . . .

Necessary Steps When Closing a Physician Practice

The Gilberto Sanchez Story [1]

Shortly after a group of DEA agents and other law enforcement personnel sporting tactical gear arrived in the parking lot with search and arrest warrants on a Tuesday early in August, Dr. Gilberto Sanchez was hauled away from his medical practice in the 4100 block of Atlanta Highway in Montgomery, Ala. Dr. Sanchez had been indicted for operating a medical clinic that dispensed controlled substances inappropriately, unlawfully, and for non-medical reasons. Since his arrest, Sanchez has pled not guilty and been released on bond.

The unfortunate saga of Dr. Sanchez highlights a difficult issue for both physicians and patients — who takes care of a physician’s patients when his or her practice closes shop, whether voluntarily or otherwise? Montgomery news sources reported on a patient of Dr. Sanchez who encountered this exact struggle. After Sanchez was arrested, the patient and his wife (also a patient of Sanchez) began the arduous search for another physician. They also encountered trouble getting their medical records from Sanchez’s office, reporting that they received no answers beyond a voicemail box too full to receive additional messages.

Dr. Sanchez’s story is unique in many regards, but it highlights the need for an effective transition plan upon the closing of a physician practice. Doctors sell practices, retire, die, seek the protection of the United States bankruptcy laws, and generally quit practicing medicine all the time. Whether you’re packing up to hit the links or being packed up and hauled to jail like Dr. Sanchez (let’s hope it’s not the latter), here are a few things to think about in order to wind up your practice’s affairs in accordance with applicable legal and ethical considerations.

A Few Things Before You Leave

A number of factors come into play when you decide to close your practice. Below we consider legal and ethical requirements regarding continuity of patient care and access to records from the Alabama Board of Medical Examiners (“BME”) and the American Medical Association (“AMA”), notification requirements for various government and third-party payors, and miscellaneous corporate formalities that must be undertaken when dissolving a business.

Board of Medical Examiners Requirements and AMA Ethical Considerations

Perhaps the most important part of closing down your practice (maybe for you, but certainly for your patients) is making sure that your patients have adequate notice and opportunity to find a new doctor, as well as access to their medical records. These notice and access considerations are addressed on the state level by the BME in accordance with ethical opinions issued by the AMA.

Consider the following items when closing your practice. Take note of whether each is a suggested best practice or a mandatory requirement.[2]

  1. Notify the BME. You need to advise the BME of any change in your status (closing practice, retiring, etc.) and of your new address, if applicable, and you are required to notify the Medical Licensure Commission within 15 days of a change in your address.[3] You may also submit a request for the removal and disposal of unused medications, especially controlled substances.
  2. Notify Your Patients. To ensure continuity of care for your patients, they have to receive a reasonable notification that your practice is closing and an opportunity to arrange for the transfer of their medical records.[4] The BME recommends that (i) each active patient of the practice receive a direct mail notification of the practice’s closing at their last known address and that (ii) the practice issue a public advertisement (e.g. in the local newspaper) about the closing of the practice to notify the public more generally. All notices (public or direct notice to active patients) should indicate the expected date the practice will close, and the direct notice to active patients should specifically identify instructions for how patients can access or transfer their medical records, and, if the medical practice is being assumed by another physician or practice, the name, address, and telephone number of that physician or practice.[5]
  3. Notify the Drug Enforcement Administration (“DEA”). Notify the DEA of the closing of your practice. This notification can be especially important as you plan for the appropriate disposition of unused medications, including controlled substances.
  4. Post a Written Notice at the Practice. After you actually close your practice, you should consider posting a written notice of its closing on the door or other visible areas of the office/building where your practice is located. The notice should contain instructions for patients to transfer or obtain copies of their medical records, as well as the current location of such records. These instructions must be made available to leasing agents, new tenants, or new owners of the building where the practice is located.
  5. Records Management. As mentioned briefly in the description of notices above, you have to maintain and provide access to patient medical records for a period of time after you close your practice. The BME generally recommends maintaining such records for a period of 10 years after your practice closes. However, some types of medical records (e.g., pediatric records and immunization records) may have different retention requirements, and records associated with anticipated litigation should be kept until the litigation is resolved, even if such resolution does not occur until after the regular record retention period. In addition, BME regulations and AMA ethics opinions require that you make records available to a patient’s succeeding physician, to third parties as requested by your patients or their authorized representatives, and as otherwise required by law.[6]

These record maintenance practices serve multiple purposes: (i) you can satisfy your ethical obligation to provide access to medical records for your patients so they can obtain copies or transfer copies of their medical records to their new physician; and (ii) you fulfill applicable recordkeeping requirements for government and other third party payors in the event of an audit.

  1. Provide Access to Patient Records.  Your patients have a right to access their medical records, or at least a copy of them. This right extends to any person who has a properly executed authorization from the patient to access such records.[7] According to state law and regulations, when providing copies of patient records, you may charge up to $1.00 per page for the first 25 pages, up to $.50 for each page after that, and up to $5.00 as a search fee.[8] The costs of mailing the medical records to the requestor or their designee may also be included in the copying charges. However, state regulations (and in some cases HIPAA) require physicians to consider the needs of their patients and waive the fees where appropriate.[9]

Notify Government and Third Party Payors

There are several parties in addition to your patients who want to know if you close your practice. Medicare, Medicaid, and private insurers will want to know when you close your practice in order to terminate your provider agreement. There are likely requirements in your provider agreement with each payor regarding what you should do when closing your practice. However, generally you need to take the following steps for each payor below:

  1. Medicare. File a form 855B within 30 days of a change of ownership or practice location and within 90 days of other changes in enrollment, as required by 42 CFR § 424.516.
  2. Medicaid. There are no general requirements for closing a physician practice in the Medicaid Administrative Code or the Medicaid Provider Billing Manual. However, providers should notify HPE/DXC (Medicaid’s fiscal agent) on the provider disenrollment form.[10]
  3. Private Insurers. Frequently, insurance payors require notices prior to termination. For private insurers, such as Blue Cross Blue Shield of Alabama, check your provider agreement for the applicable notice requirements, if any.

The “Business” Side of Things

As if the steps listed above were not enough, you still have to think about what you want to do with the business entity from which you operated your practice. Unless you sold your practice, your name is probably still in a partnership, limited liability company, or professional corporation somewhere. To fully dissolve the business entity that formed your practice, you have to file articles of dissolution (or their comparable form for other types of business entities).[11] Be sure to file a copy of the articles of dissolution (or their comparable form) with the BME within 30 days of the effective date of dissolution.[12] In addition, you may be required to file notices with applicable federal and state taxing authorities, local governmental entities, and other agencies, as well as known creditors.

In addition to the above, there are several other nuances that must be explored when dissolving your practice. These nuances can be different based on the type of entity you chose to form your practice and may very well be different between two practices formed of the same type of entity. Consult counsel to look at the relevant provisions in the applicable statutes and the governing documents for your practice.

Lights Out, Lock the Door

As you can see, closing a physician practice is not as simple as turning off the lights and locking the door when you leave. There are a number of legal, ethical, and practical considerations you have to be aware of as you close or transition away from your practice. It may seem like a daunting task at first, but it has to be done in order to provide continuity of care for your patients and to provide for the orderly winding down of your practice’s affairs. To accomplish these objectives, be sure to plan ahead, consult counsel in the planning and implementation process, and don’t leave any stone unturned. It could be the one that trips you up unexpectedly.

For additional inquiries regarding this article or the steps to close a medical practice, please contact Christopher Richard or Gregg Everett at:

Christopher Richard, Esquire
Gilpin Givhan, PC
P.O. Drawer 4540 (36103-4540)
2660 EastChase Lane, Suite 300
Montgomery, Alabama  36117
Telephone: (334) 244-1111
Direct Dial: (334) 409-2233
Fax: (334) 244-1969
E-mail: crichard@GilpinGivhan.com

 

Gregg B. Everett, Esquire
Gilpin Givhan, PC
Lakeview Center, Suite 300
2660 EastChase Lane
Montgomery, Alabama  36117
Telephone: (334) 244-1111
Direct Dial: (334) 409-2228
Fax: (334) 244-1969
E-mail: geverett@GilpinGivhan.com

Article contributed by Christopher Richard, an attorney at Gilpin Givhan. Gilpin Givan is a Bronze Partner with the Medical Association.

 

REFERENCES

[1] Jennifer Horton, Alleged AL pill mill doc’s patients lined walls, sat on floor, U.S. attorney says, WSFA12 News (August 1, 2017), http://www.wsfa.com/story/36021670/alleged-al-pill-mill-docs-patients-lined-walls-sat-on-floor-us-attorney-says; Samantha Day, Patient of alleged Montgomery pill mill doctor speaks out, WSFA12 News (August 4, 2017), http://www.wsfa.com/story/36066718/patient-of-alleged-pill-mill-doctor-speaks-out.

[2] These action items come from a publication by the Alabama State Board of Medical Examiners, available on the BME website. Recommended Procedure in Closing/Discontinuing a Medical Practice, Alabama State Board of Medical Examiners, available at http://www.albme.org/closeprac.html (last visited September 5, 2017).

[3] Ala. Code § 32-24-338 (1975).

[4] Ala. Admin. Code r. 540-X-9-.10(3). See also AMA Code of Medical Ethics, Opinion 1.1.3: Patient Rights (stating the patient’s right to continuity of care, as well as sufficient notice and reasonable assistance in making alternative arrangements for care prior to a physician discontinuing care); AMA Code of Medical Ethics, Opinion 1.1.5: Terminating a Patient-Physician Relationship (requiring physicians to notify the patient or an authorized decision maker sufficiently in advance to permit the patient to secure another physician and to facilitate transfer of care where appropriate).

[5] Ala. Admin. Code r. 540-X-9-.10(3); AMA Code of Medical Ethics, Opinion 3.3.1: Management of Medical Records.

[6] Id. With regard to disclosure as required by law, check the record management requirements in your provider agreements with Medicare, Medicaid, and private third party payors, as applicable, to confirm the minimum length of time you should preserve records and make them available for inspection. However, in most cases, the 10 years recommended by the BME should suffice.

[7] See Ala. Admin. Code r. 540-X-9-.10(2); Ala. Admin. Code r. 545-X-4-.06 (including in the definition of “unprofessional conduct” any refusal to comply, within a reasonable time, with a request from another physician for medical records or information when such request is accompanied by a properly executed authorization from the patient).

[8] Ala. Code § 12-21-6.1 (1975); Ala. Admin. Code r. 540-X-9-.10(2).

[9] Ala. Admin. Code r. 540-X-9-.10(2); AMA Code of Medical Ethics, Opinion 3.3.1: Management of Medical Records(d)-(e).

[10] http://medicaid.alabama.gov/content/9.0_Resources/9.4_Forms_Library/9.4.16_Provider_Enrollment_Forms.aspx. The form contains additional instructions regarding the disenrollment process.

[11] As a practical matter, your business will be “dissolved” once the articles of dissolution are approved, but the entity will continue to exist for a period of time for purposes of winding down its affairs by paying off creditors and distributing remaining assets to the owners, among other things.

[12] Ala. Admin. Code r. 540-X-9-.01(5).

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Physicians Maintain High Standards

Physicians Maintain High Standards

By the time this article goes to print, a lot could change, so there’s no apparent use in guessing what will come of the next Repeal and Replace efforts or what’s happening at Main Justice. Nobody knows. The only certainties from Washington are that there will be change in the payment and insurance models, and that there will be more reports of arrests and prosecutions for alleged fraudulent schemes. Some practitioners express concern, but physician quality and innovation do not have to suffer because of these changes in law because physicians maintain high standards.

Neither Obamacare nor Ryancare nor Trumpcare nor the next iteration will actually change health care. Instead, they guide how health care services are paid. Payment certainly can influence quality, just as who pays for care can perhaps impact patient compliance. But quality care is neither guaranteed nor premised on any particular actual or proposed national structure. These laws do not provide anyone health care. You do, as physicians and nurses and hospitals. The Medical Association began with 30 physicians having a common goal of higher standards in an era with no insurance market at all, nor anesthesia like we know it today. It has always been appropriate for physician entrepreneurship to drive innovation and quality care with it, but there are limits.

The limits have always been there. Whether the changes of today will raise or lower the standard of care within any specialty, or chill entrepreneurship and innovation, is up to each provider. Understanding the legal bounds is often difficult for physicians, and sound legal advice is crucial to success because for every one announced prosecution or indictment there are untold stories of civil corporate misdeeds and aggressive strategies where specialized counsel could have maintained the high standard.

The Department of Justice under Attorney General Jeff Sessions announced in a July 13 news conference that 412 people were charged for participating in health care fraud amounting to more than $1.3 Billion. Pharmacists in Mississippi recently pleaded guilty to fraud charges, with one admitting” that he conspired with others to select compounded medication formulas based on profitability, rather than on effectiveness or patient need,” and that he dispensed medically unnecessary medications. The other pharmacist admitted to “soliciting physicians and other medical professionals to write prescriptions without seeing patients for medically unnecessary compounded medications dispensed by the pharmacy.”

In Virginia, “[a] medical doctor and entrepreneur was sentenced to [10 years] in prison . . . for defrauding his former company’s shareholders and for failing to account for and failing to pay employment taxes.” Ohio-based companies and their executives recently “agreed to pay approximately $19.5 million to resolve allegations pertaining to the submission of false claims for medically unnecessary rehabilitation therapy and hospice services to Medicare,” not that the therapy wasn’t performed or quality care – just that it was excessive and driven by profit over patients. Louisiana clinical psychologists were sentenced for a $25.2 million Medicare fraud scheme involving both unnecessary therapy and therapies never performed. A Florida physician pleaded guilty for his role in pain pill diversion and Medicare fraud scheme. An Alabama federal court enjoined a pharmacy from “distributing adulterated, misbranded and unapproved new drugs in violation of the federal Food, Drug, and Cosmetic Act.” A Tennessee physician settled false claims allegations of distributing and billing Medicare for drugs that had not been FDA-approved. This is all according to the Department of Justice in just the last month. Expect more, whether it’s from General Sessions or a successor.

These headlines should educate rather than frighten the physician entrepreneur with high standards. Each case can educate an intelligent professional that while billing guidelines and corporate laws may have positive or negative impacts on quality, usually indirectly, your standard of care owed to your patient and your business partners does not have to regress. These providers who fell into trouble with the Department of Justice may truly be outliers.

The Virginia “physician and entrepreneur” sentenced in July abused his investors’ trust, stole their money, and provided fraudulent financial statements. That’s an extreme case, perhaps, but consider the same case but where the physician and his investors lost trust in each other purely because of a lack of communication after a series of misunderstandings, and maybe some ego or fear. Perhaps the misunderstandings were fueled by further misunderstandings of medicine by the investors and misunderstandings of business by the physician. But I speculate on a hypothetical ripped from these DOJ headlines. Further, though, consider where the physician did not intend to steal anything but made blindly ignorant mistakes because he failed to ask for help or just maintained business as usual despite corporate changes. Consider the same story but where the financials were not intentionally fraudulent but in error or premised on aggressive billing practices, or an unwillingness to fully engage accountants for their services to pinch pennies. These seemingly more benign circumstances could be all too common, aggravated further by ego and competing visions or interests, and if unchecked and don’t make the DOJ alert then they could also lead to civil lawsuits.

A health care lawyer can answer questions and guide physicians to maintain high standards. The honest physician in need of compounded pharmaceuticals for patients could unwittingly become a co-conspirator like the Mississippi physician. The honest clinician is being driven to cut costs and increase revenue. The honest physician is brought into seemingly prudent arrangements that can turn sour. When a physician goes beyond medicine and into business, retaining legal counsel is critical to maintaining the same high business standards as physician strives for high standards in caring for patients. Specialists and trained sub-specialists are available.

Tom Wood is a partner in the Health Care Practice Group at Burr & Forman LLP and represents health care providers in regulatory and litigation matters. Buff & Forman LLP is a partner with the Medical Association.

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Have You Properly Obtained Informed Consent?

Have You Properly Obtained Informed Consent?

In June, the Pennsylvania Supreme Court issued a controversial opinion holding that a physician had to have face-to-face interaction with the patient to effectively obtain informed consent. This has raised heightened awareness of a physician’s obligations to obtain informed consent from their patients and caused many to evaluate their own practice of obtaining informed consent.

In Shinol v. Toms, a patient brought a medical malpractice case against a neurosurgeon alleging he failed to obtain informed consent. (2017 WL 2655387). The record and testimony at trial established that the physician met with the patient on two occasions prior to surgery to discuss potential complications. The physician testified that he explained the different approaches and options for surgery. The patient also had a telephone conversation with a certified physician assistant (“PA”) who worked for the physician, and just before surgery, the patient met with the PA who obtained her medical history, conducted a physical examination and obtained an executed informed consent form. The form gave the physician permission to perform “‘a resection of recurrent craniopharyngioma.” The patient’s signature acknowledged that she had discussed the advantages and disadvantages of alternative treatments, that the form had been fully explained to her, that she had an opportunity to ask questions, and that she had sufficient information to give her informed consent.

Despite her signature on the consent form, the patient alleged in the lawsuit that she was not fully informed of her options (total versus subtotal resection of a non-malignant brain tumor). According to the patient, if she had been given the option of a subtotal resection, she would have chosen the less aggressive form of surgery.

After the physician received a jury verdict in his favor, the state supreme court declared a mistrial based on an improper jury instruction related to informed consent. The jury had been instructed that it could consider any relevant information it found was communicated to the patient by “any qualified person acting as an assistant to the physician.” In granting a new trial, the Pennsylvania Supreme Court held that the surgeon himself had to have face-to-face conversations with the patient about the risks of surgery in order for him to have properly obtained informed consent from his patient. In other words, evidence of the discussions with the PA could not be considered by the jury in their deliberations of whether informed consent was properly obtained. The court’s opinion was an extension of a previous opinion that held informed consent could not be delegated to a hospital; the physician was responsible for obtaining it.

Similar to Pennsylvania, Alabama courts have found that a hospital and its staff do not have an independent obligation to obtain informed consent from a patient.  Wells v. Storey, 792 So. 2d 1034 (Ala. 1999). However, this does not necessarily equate to the ruling in Shinol. Based on Shinol’s strict interpretation and possible increased scrutiny as a result of the holding, a review of Alabama law on informed consent is warranted.

It is the duty of the physician to inform the patient of the risks and obtain their consent, and if the physician fails to get informed consent, a patient has a cause of action under the Alabama Medical Liability Act (“AMLA”). Historically, the cause of action for a failure to obtain informed consent evolved through the legal theory of battery. The reason being that a person has the “‘right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages.'” See Fain v. Smith, 479 So. 2d 1150 (Ala. 1985) (quoting Schloendorff v. Society of New York Hospital, 105 N.E. 92, 93 (1914)).

The elements of the claim are:

  1. the physician’s failure to inform the patient of all material risks associated with the procedure, and
  2. a showing that a reasonably prudent patient, with all the characteristics of the plaintiff and in the position of the plaintiff, would have declined the procedure had the patient been properly informed by the physician.

The test for determining whether the physician has disclosed all material risks to the patient is “a professional one, i.e. whether the physician had disclosed all the risks which a medical doctor practicing in the same field and in the same community would have disclosed. Expert testimony is required to establish what the practice is in the general community.” Giles v. Brookwood Health Services, 5 So. 3d 533 (Ala. 2008).

In one Alabama case, the physician entered into evidence an informed consent form signed by the patient. Although the patient stated she did not give consent, the court found the forms alone sufficient to dismiss the patient’s claims for assault and battery. There was no discussion in the court’s opinion as to how the form was presented to the patient or whether there was detailed discussion between the patient and the physician.

In another Alabama case involving the scope of consent, the physician obtained an executed form from the patient consenting to a specific procedure but also stating that the physician was authorized to perform “such additional operations/procedures during the course of the above as are considered therapeutically necessary or advisable in the exercise of professional judgment.” The patient alleged that the consent form did not give the physician “carte blanche” to perform any procedure. In this case, the physician had mistakenly removed an ectopic kidney the physician thought was a tumor. The Alabama Supreme Court overturned the lower court’s ruling in favor of the patient on the issue of informed consent and stated that there must be expert testimony as to whether the procedure performed by the physician was reasonable in light of the findings during the surgery.

Although the cases and elements mentioned above require the physician to inform the patient, there are no cases in Alabama that specifically require a face-to-face meeting/encounter with the patient to give informed consent (although this is definitely best practice) and certainly nothing in our case law that says a PA or other qualified health care professional may not explain the risks associated with a procedure. The law requires a physician to exercise that level of reasonable care, skill and diligence as a similarly situated physician and this rule should be followed when it comes to informed consent. It would also be wise to review consent forms to ensure they are not too limited in the grant of consent and ensure you are documenting all discussions with patients about the risks of procedures.

Angie Cameron Smith is a partner at Burr & Forman LLP practicing in the firm’s Health Care Industry Group. Burr & Forman LLP is a partner with the Medical Association.

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