Charting & Documentation During the Coronavirus COVID-19 Pandemic

The world’s memory of this virus will be different when lawsuits are filed two years from now and juries try the cases two to three years after that. The acuteness of the issues, the confusion, the limited resources and the changing daily directives will not be remembered in any meaningful detail. Accordingly, the Risk Management dogma that has always emphasized charting is more important now than usual. If the standard of care is judged as care “under the same or similar circumstances”, and those circumstances are “delivering care in a COVID-19 pandemic”, how will we show those circumstances in a 2025 jury trial?  We recommend vigilant documentation.

In consideration of Alabama’s sample ventilator allocation guidance, and exemplary language from other states, Starnes, Davis, Florie, LLP. recommends the below language be charted in circumstances where a resource may be diverted away from a patient who could be in need.  The sample language specifically applies to decisions in triaging a patient and any initial treatment decisions regarding a specific (limited) resource.

Sample Language:

In making a clinical judgment regarding the allocation of [resource] during the [COVID-19 pandemic / public health emergency], I have assessed the patient’s history, symptoms, and condition and considered the limited availability of resources and clinical factors associated with the allocation of limited resources.  My clinical judgment, under the totality of the circumstances, is that [clinical decision] is appropriate for this patient as an alternative medical intervention.

We also recommend against language or specific explanations to patients as follows:

·        Language / an explanation to a patient or a patient’s family explicitly referencing financial issues or considerations.

·        Language / an explanation to a patient or patient’s family focusing the considerations on the resource itself as opposed to the specific patient.

·        Language / an explanation to a patient or patient’s family specifically documenting the condition of other patients or the specific condition of other patients receiving resources.

·        Language / an explanation to a patient or a patient’s family specifically quantifying any patient’s likelihood of successful treatment – that being the patient receiving the resource and the patient not receiving the resource.

·        Language / an explanation to a patient or a patient’s family specifically comparing patients or outcomes.

·        Language / an explanation to a patient or a patient’s family specifically referencing medical ethics.  Medical ethics underpins all clinical decisions and does not need to be specifically included in the chart.

This information is not intended to provide legal advice, and no legal or business decision should be based on its content. No representation is made that the quality of legal services to be performed is greater than the quality of legal services performed by other lawyers.  Read full disclaimer.

Shift in Patient’s Right to Access Medical Records

By: Kelli C. Fleming, Burr & Forman

The Office of Civil Rights (“OCR”), the government agency tasked with HIPAA compliance and enforcement, recently announced a change impacting a patient’s right to access his/her medical records—a change which is, given OCR’s history, surprisingly favorable to providers. 

One of the long-standing premises of HIPAA has been a patient’s right to access his/her medical records. For years, the HIPAA regulations have limited the fees that providers can charge patients when they request a copy of their medical records to a reasonable, cost-based fee (regardless of the permitted state law fees). HITECH expanded this right a few years ago by allowing patients to exercise their right to access medical records, but designate a third-party to whom the records should be sent (e.g., the patient’s attorney). These requests from patients to send their records to a designated third-party are oftentimes referred to in the industry as “HITECH” requests. 

Subsequent OCR guidance stated that the historical limitation on fees that applied when a patient exercised his/her right to access medical records would also apply to the situation where a patient requested that his/her records be sent to a designated third-party pursuant to a “HITECH” request. As a result, providers were limited in what they could charge third-parties, such as attorneys, seeking access to medical records by way of a “HITECH” request from a patient, as opposed to by way of a HIPAA authorization. 

However, based on a recent court order, such limitation on fees no longer applies to “HITECH” requests. As a result of the recent court decision, OCR has clarified that “the fee limitation set forth at 45 C.F.R. § 164.524(c)(4) will apply only to an individual’s request for access to their own records, and does not apply to an individual’s request to transmit records to a third party.” Thus, as a result of this recent court decision, providers, and their business associates, are no longer bound by the HIPAA-imposed limitation on fees when a patient requests that a copy of his/her medical records be sent to a designated third party (e.g., attorney). For these “HITECH” requests, providers can now charge fees acceptable under state law, without applying the HIPAA fee limitations. These state law fees are oftentimes higher than the HIPAA fees. Further, the court decision clarified that such “HITECH” requests are limited to requests for an electronic health record with respect to PHI maintained in an electronic format.

OCR has been clear that the  HIPAA limitation on fees, however, will continue to apply to patient requests to access their own medical records when the records are delivered directly to the patient. Nonetheless, this shift in guidance is favorable to providers and much welcomed by the healthcare industry.

Kelli Fleming is a Partner at Burr & Forman LLP practicing exclusively in the firm’s healthcare industry group.

Top 4 Dos and Don’ts For Audits and Investigations

In the spirit of college football season and the inevitable argument about which four college football teams are in the college football playoffs, this article addresses the undisputed top 4 dos and don’ts that physicians should follow during an audit or investigation.  I have represented countless medical practices and individual physicians with a variety of federal payor audits, false claims investigations and DEA investigations.  The following top 4 dos and don’ts are the top issues I see frequently repeated, oftentimes to the detriment of the provider under investigation.

# 4 – Keep an Exact Copy of Everything Produced or Viewed.  Most of the time I am not retained until after the practice has turned over the requested documents and, in some cases, has also turned over non-requested documents. The usual response by the practice, when asked why it did not keep a copy of what was released, is something along the lines of “we did nothing wrong” or “we know what we turned over and can make a copy if needed.”  However, when I ask for the documents produced, the practice oftentimes cannot replicate what was produced. This puts the practice at a competitive disadvantage from the start. It also makes citing to a particular document extremely difficult when legal counsel does not know (1) if a particular document was actually produced, or (2) if it was produced, where in the mountain of records the document is located. Defending the practice’s conduct or fighting a recoupment becomes challenging without a copy of the documents. Thus, the practice should go ahead and make an exact copy of what is produced and maintain the copy until the practice is reasonably sure nothing will come from the audit or investigation. It is also recommended that the practice hire legal counsel before producing records, so as to ensure that only responsive documents are produced.

# 3 – Review All of the Medical Records Before Producing.  While this seems like a no brainer, I cannot state the number of times a medical practice has printed what it believes to be the entire medical record only to learn when receiving a recoupment demand or allegation of false claims that the entire medical record was not produced.  Another common issue in this age of electronic medical records (“EMR”) is that the printed record looks substantially different than the electronic record.  Some EMR systems will print a paper copy differently if the “print” function is used versus the “print screen” function.  I have experienced numerous occasions when the paper copy looks suspicious or incomplete, particularly the patient’s history or prescription records, because of the way the EMR prints the record.  On a related note, if the practice wishes to use a consultant to conduct a simulated audit, it is important to make sure that the consultant either has access to the EMR or that the printed paper records are complete and identical to the electronic records.

# 2 – Maintain Signature Logs of Alabama Medicaid Patients.  The Alabama Medicaid Agency requires that providers maintain evidence that the patient actually attended the appointment.  It does this by requiring providers to keep a signature on file to prove the patient’s attendance at each appointment. I have represented quite a few physicians and practices in Medicaid audits, and I do not recall an audit that did not request copies of the patients’ signatures.  However, the signature requirement is not well known by Alabama providers, as many of my clients are unaware of the requirement and fail to keep a copy of the signatures. While there are other ways to prove that a patient attended the visit, it is very simple to satisfy the signature requirement and avoid having to gather other forms of proof–simply use the removable signature logs and paste the patient’s signature into the record for that particular visit.

#1 Never, Ever, Ever Voluntarily Surrender A License/Permit/Participation Without First Obtaining Advice of Counsel.  Without question, the undisputed defending champion and current #1 is never ever voluntarily surrender a license, permit or participation in a payor’s program without first obtaining advice of counsel. I have heard on multiple occasions that a particular investigator says something along the lines of the following to a licensee “Things will go much easier if you voluntarily surrender your license.”  I have never in my experience seen where things have gone easier for the physician when he/she has voluntarily surrendered his/her license. However, it does is make things easier for the licensing body, so the statement above is true as phrased. The voluntary surrender substantially compromises the physician’s ability to defend his/her case, as the physician has lost any leverage he/she may have had – the agency already has what it wants – the physician’s license.  Most licensing agencies have due process requirements that must be followed before it can revoke, suspend, or take any adverse action on a license.  One of the most important due process requirements is giving the physician the right to a hearing where the physician can be represented by counsel and present evidence. The hearing process affords the physician the ability to test the agency’s evidence and interpretation of its regulations, which are oftentimes flawed.  The hearing process also gives the physician the ability to reach a compromised resolution of the matter, oftentimes allowing the physician to keep his/her license.  By voluntarily surrendering a license, the physician loses such rights and ability.

Jim Hoover practices with Burr & Forman LLP and works exclusively within the firm’s Health Care Industry Group. Jim primarily handles healthcare litigation and compliance matters.

Fraud and Abuse Facelift: Proposed Changes to Stark, AKS, and Beneficiary Inducements CMP

As part of its “Regulatory Sprint to Coordinated Care,” the Centers for Medicare and Medicaid Services (“CMS”) and the Health and Human Services Office of Inspector General (“OIG”) released proposals to modernize the Medicare Physician Self-Referral Law (“Stark Law”), Anti-Kickback Statute (“AKS”), and Beneficiary Inducements Civil Money Penalty (“CMP”) (collectively, the “Proposed Rules”). The Proposed Rules add five new Stark Law exceptions, seven new AKS safe harbors, and an additional exception to the definition of “remuneration” under the CMP. Several of the new Stark exceptions and AKS safe harbors relate to value-based arrangements and largely mirror each other. Other new exceptions and safe harbors relate to the donation or use of cybersecurity items and beneficiary incentives in the coordination of patient care. These proposals are by no means final (stakeholders have until December 31, 2019 to comment on them), but if finalized, they may provide more flexibility for physicians and other providers to pursue value-based arrangements, as well as greater clarity with respect to existing Stark Law requirements.

Value-Based Arrangements under Stark and AKS

Three new Stark exceptions and four new AKS safe harbors relate to value-based arrangements in which one or more participants in a value-based enterprise (“VBE”) pursue one or more value-based activities and purposes. Value-based purposes include coordinating and managing care, improving quality, reducing costs or growth of expenditures (without reducing quality), and transitioning from fee-for-service care to quality care for a target patient population. Value-based activities include providing items or services (not including a referral), taking an action, or refraining from taking an action, in furtherance of a value-based purpose.

There are separate exceptions and safe harbors for value-based arrangements involving: (i) full financial risk, (ii) meaningful/substantial downside financial risk, and (iii) remuneration for improving quality, health outcomes, and efficiency. Full financial risk means that the VBE is prospectively financially responsible for the cost of all patient care items and services covered by the applicable payor for each patient in a target patient population over a specified period of time. Meaningful/substantial financial downside risk means that a physician is responsible to the VBE for specified percentages of the value of the remuneration paid to the physician or is responsible on a prospective basis for the cost of all or a defined set of patient care items and services for each patient in the target patient population over a specified period of time. For value-based arrangements incentivizing improvements in quality, health outcomes, and efficiency, the proposed Stark exception would allow both financial and in-kind remuneration related to value-based activities and meeting objective and measurable quality and performance targets. By contrast, the similar proposed AKS safe harbors focus more on in-kind remuneration, including anything of value given either to VBE participants to help coordinate and manage patient care and patient engagement tools and supports given to patients to address social determinants of health and incentivize the patient’s participation in their health care. In addition to the mirror exceptions and safe harbors generally described above, the AKS Proposed Rule sets forth an additional safe harbor for remuneration exchanged between participants in a CMS-sponsored model, such as an ACO or bundled payment model.

There are common requirements for each of the exceptions and safe harbors listed above. For instance, the VBE must generally set forth in a signed writing the terms of the value-based arrangement, including a description of the nature and extent of the risk assumed under the arrangement, the value-based activities involved, the target patient population, and the type and cost of the remuneration involved. Additionally, the VBE or VBE participant offering remuneration under a value-based arrangement must not take into account the volume or value of referrals or otherwise condition the remuneration on referrals of patients who are not a part of the target patient population or business not covered by the value-based arrangement.

Other Stark Additions and Clarifications

The Stark Proposed Rule contains an additional exception for nominal payments to physicians ($3,500 annually, indexed for inflation) for the provision of items and services to an entity. The new exception applies even if there is no written agreement, provided the compensation does not relate to the volume or value of referrals or other business generated by the physician, does not exceed fair market value, and is commercially reasonable, among other requirements. The Stark Proposal also modifies certain existing Stark exceptions and clarifies a number of definitions. For instance, it adds flexibility to the “Electronic health records items and services” exception to include nonmonetary remuneration in the form of cybersecurity software and services. It also purports to clarify the meaning of “fair market value” and “commercially reasonable.” Although additional clarification of these terms would probably be useful, the Stark Proposed Rule at least clarifies that an arrangement does not have to result in a profit for one or more of the parties in order to be commercially reasonable.

Beneficiary Inducements

The Proposed Rules provide additional protection for remuneration to beneficiaries under AKS and the CMP. Under a new AKS safe harbor, beneficiary incentive payments to beneficiaries assigned to an Accountable Care Organization (“ACO”) under the Medicare Shared Savings Program (“MSSP”) would not constitute “remuneration” for purposes of AKS, if they meet the ACO beneficiary incentive requirements under MSSP. Somewhat similarly, the provision of telehealth technologies to patients with end-stage renal disease (“ESRD”) is not considered “remuneration” for purposes of the CMP if the technologies contribute to the provision of telehealth services related to the patient’s ESRD, is not of excessive value, and meets other requirements.

Conclusion

This article simply provides a high-level overview of the concepts addressed in the Proposed Rule. A more in-depth review of the Proposed Rules reveals additional requirements and subtle differences in the rules that will be material to parties trying to navigate them successfully.  Again, these rules are far from final. However, they indicate an intentional shift toward value-based care and relaxed regulatory requirements to help foster such care. Physicians and other providers have an opportunity to provide feedback on these proposals and hopefully refine them to workable exceptions that will enable the further adoption of value-based arrangements which are being promoted by current payment policy.

Article submitted by Christopher L. Richard, Esq. with Gilpin Givhan, PC in Montgomery, AL.

Guidance on Practice and Ethical Issues

The Medical Association’s Office of General Counsel can help guide members on certain practice and ethical issues.  The Office is comprised of the General Counsel, Cheairs Porter, and Paralegal, Angela Barentine.  The General Counsel is the chief legal advisor to the Board of Censors, and provides legal advice daily to the Executive Director.

Mr. Porter, a Montgomery native, started as General Counsel of the Medical Association in December 2012.  He currently has over 23 years of related legal experience, including an advanced legal degree in health law and substantial practice in regulatory health care matters.

Ms. Barentine, a Milbrook native, graduated Magna Cum Laude in 2002 with a B.S. from Auburn University.  She began work with the Medical Association in April 2015.  She has a Master of Public Administration with a concentration in Health Care, and a Certificate in Non-Profit Management and Leadership.  Ms. Barentine has 20 years of related experience.

While the Office is very busy handling a wide mix of contracts, business issues, legislative, administrative law (agency) matters and matters coming from various departments, as well as staffing the Council on Medical Services, it also can provide general guidance on the law in particular areas, such as:

• Separation from a practice;
• Starting a practice;
• Medical records policy;
• HIPAA issues;
• Certain prescription drug matters;
• Overpayments;
• Ethics;
• Medicaid; and
• Some billing and charging issues.

If you are searching for general guidance, please feel free to contact Cheairs Porter at (334) 954-2540 or Angela Barentine at (334) 954-2541 for assistance.