Being Well Armed For Now and the Future
by Sean Weiss, Partner & VP of Compliance
Having just returned from the National Alliance of Medical Auditing Specialists (NAMAS – www.namas.co) 11th Annual Conference in Clearwater Beach Florida, I am reinvigorated and armed with more of the latest and greatest information provided by some of the most respected and relevant health care professionals in the industry. Over 2.5 days, speakers with centric focus in areas such as specialty specific audit risk areas, regulatory compliance (OIG and HIPAA), Health Law (Stark, Anti-Kickback, False Claims Act, Health Care Fraud Statute, etc.) and documentation guideline pitfalls (Lab, Counseling, Imaging, etc.), it was clear to see why this conference is trending higher each year and why the NAMAS membership has now exceeded 1800!
Some of the biggest areas of concern raised by attendees were (in no particular order):
- Completion of Medical Documentation and Signature Requirements by Payors
- Statistical Sampling based on Sustained or High Error Rate
- Cloning and Clinical Plagiarism
- Medical Necessity and its Impact on the False Claims Act
As a presenter and attendee myself, it was mind blowing to see the level of interaction. From session to session the attendees were engaged and asking brilliant questions, which in turn got the speakers more amped up and engaged. What I thought I would do is use this Blog Post to highlight the topics outlined above for you all so that you’re armed with the same great information the attendees received and were able to bring back to their practices/organizations to ensure things are being done right and that they remain in compliance. Because there are four topics outlined above I will only be able to hit the highlights of each but, if there is a topic you wish for me to do a deeper dive into, all you have to do is ask!
Completion of Medical Records and Signature Requirements by Payors:
Medicaid in many states as well as commercial payors across the country are calling this the 72-hour rule (not to be mistaken with the 72-hour rule for hospitals). With some of the Medicare payors they require documentation to be completed at the time of the encounter or within 24-48 hours. This, as you can imagine, became a big discussion but there is authoritative documentation available. Below is a breakdown of a couple of states and several of the MACs:
- Kentucky’s Medicaid rule regarding authentication of medical records and timing requirements, 907 Kentucky Administrative Regulations (KAR) 1:102 §2(4)(b)2 states: “The individual who provided the service shall date and sign the health record within seventy-two (72) hours from the date that the individual provided the service.” Kentucky implemented this rule effective on July 6, 2015.
- Alaska 72 Hour Contemporaneous Documentation FAQs:
Q1. Please clarify the 72 hour requirement for documentation of services; is this a straight 72 hours or is it 72 business hours? The 72 hour requirement applies to the initial documentation of services. The regulation states 72 hours from the end date of service. This is a straight 72 hours from the end of date of service.
An example is the date of service is June 15, 2018, the 72 hour clock starts at 12:00 am June 16, 2018 and is to be documented by 11:59 pm June 18, 2018.
Q2. What about weekends and holidays? The 72 hour requirement does not allow an extension for weekends and holidays.
- Noridian – Q3. After a service has been rendered, what amount of time is acceptable to Medicare for the doctor to sign the notes?
A3. In most cases, Noridian expects that the notes are signed at the time services are rendered. Further delays may require an explanation. See CMS Internet Only Manual (IOM), Publication 100-08, Medicare Program Integrity Manual, Section 220.127.116.11
CMS’s vague guidance is found in Chapter 12 of the Manual in the following statement, “The service should be documented during, or as soon as practicable after it is provided in order to maintain an accurate medical record.”
Check with your MAC. Some give reasonable direction:
- WPS which states, “A reasonable expectation would be no more than a couple of days away from the service itself.”
- Palmetto is a little more direct stating, “Providers should not add a late signature to the medical record, (beyond the short delay that occurs during the transcription process).” It is understood that there are circumstances, like waiting for transcription to be complete that might preclude signing the record at the time of service. In general, it is best to sign the record at the time of service, if not within a day or two at the latest.
- You may not add late signatures to orders or medical records (beyond the short delay that occurs during the transcription process). MLN Fact Sheet – Complying with Medicare Signatures – ICN 905364 May 2018
- FCSO memo (see pages 3-6), followed by practical compliance tips that apply to each issue raised.
Medicare Comment No. 1
“Medicare expects the documentation to be generated at the time of service or shortly thereafter. Delayed entries within a reasonable time frame (24 to 48 hours) are acceptable for purposes of clarification, error correction, the addition of information not initially available, and if certain unusual circumstances prevented the generation of the note at the time of service.”
Medicare Comment No. 2
“The medical record cannot be altered. Errors must be legibly corrected so that the reviewer can draw an inference as to their origin. These corrections or additions must be dated, preferably timed, and legibly signed or initialed.”
Medicare Comment No. 3
“Every note must stand alone, i.e., the performed services must be documented at the outset. Delayed written explanations will be considered. They serve for clarification only and cannot be used to add and authenticate services billed and not documented at the time of service or to retrospectively substantiate medical necessity. For that, the medical record must stand on its own with the original entry corroborating that the service was rendered and was medically necessary.”
Statistical Sampling based on Sustained or High Error Rate:
More and more practices are receiving notice of audit that the payor, contractor and/or OIG are going to perform a Statistically Valid Sampling (SVS) for audit. However, in order for them to do so under CMS guidelines, they need to follow specifically section 18.104.22.168 Determining When a Statistical Sampling May Be Used. Under the new guidance, a contractor “shall use statistical sampling when it has been determined that a sustained or high level of payment error exists. The use of statistical sampling may be used after documented educational intervention has failed to correct the payment error.” This guidance now creates a three-tier structure:
- Extrapolation shall be used when a sustained or high level of payment error exists.
- Extrapolation may be used after documented educational intervention (such as in the Targeted Probe and Educate (TPE) program).
- It follows that extrapolation should not be used if there is not a sustained or high level of payment error or evidence that documented educational intervention has failed.
- What is a “sustained or high level of payment error?” The PIM now specifies this can be when the sample review error rate is “greater than or equal to 50[%].” This is a significant difference from error rates Medicare auditors have previously used to justify a high error rate and may provide some relief as to the punitive effects of extrapolation.
- However, the “50% or greater” test is not the only method CMS permits to determine a sustained or high level of payment error. The TPE Program differs in that it ranges from 15% – 20% billed error rate.
- The PIM also states that the contractor may look to the provider’s history of noncompliance for the same or similar billing issues, or a historical pattern of noncompliant billing practice.
Also important is to understand that the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), mandates that before using extrapolation (i.e., projection, extension, or expansion of known data) to determine overpayment amounts to be recovered by recoupment, offset, or otherwise, there must be a determination of sustained or high level of payment error, or documentation that educational intervention has failed to correct the payment error. By law, the determination that a sustained or high level of payment error exists is not subject to administrative or judicial review. More specifically CMS Manual, Pub. 100-08, Program Integrity Manual (“PIM”), Chapter 22.214.171.124: (http://www.cms.gov/manuals)
C. Threshold Determination Not Subject to Review:
The Medicare Act, CMS regulations and manual provisions state that the threshold determination made pursuant to 42 U.S.C. § 1395fff(d)(3) is not subject to administrative or judicial review.
- 42 U.S.C. § 1395ddd(f)(3)(B):
“There shall be no administrative or judicial review under section 1395ff of this title, section 1395oo of this title, or otherwise, of determinations by the Secretary of sustained or high levels of payment errors under this paragraph.”
- 42 C.F.R. § 405.926(p): “Determinations by the Secretary of sustained or high levels of payment errors in accordance with section 1893(f)(3)(A) of the Act” are not “initial determinations” and “are not appealable under this subpart.”
- MPIM, Ch. 126.96.36.199:1 “By law, the determination that a sustained or high level of payment error exists is not subject to administrative or judicial review.”
Development of a Corrective Action Plan (CAP)
Practices, as part of completing an audit review or focused education in order for the case to be closed, are required to submit a Corrective Action Plan (CAP) to the payor to demonstrate the process undertaken and the go-forward. Many times, I am contacted by a staff member of a practice or organization concerned that they have to self-disclose to the OIG when an identified overpayment is made. However, this should be a last resort and again, development of a CAP can help counsel determine the best course of handling an overpayment (Refund, Corrected Claim or OIG Disclosure). CAPs are a critical component to sending a clear message that we are committed to doing the right thing. It shows our compliance plan is a living breathing document that’s ever adjusting and growing with the organization.
As I said, most compliance professionals want to self-disclose when an error is identified but self-disclosure is not always warranted and OIG SDP should be a last resort reserved for if we believe there was intent or that the government can make a case that knowledge existed to the falsity of the claims. Oftentimes, things we make mistakes on don’t lead to undeserved remunerations. They could simply be a breakdown in process that needs to be better defined or clarified. Before a decision is made about self-disclosure, you should speak with your health care attorney to determine the best course of action. However, regardless of what the final determination is, you still need to develop a CAP.
There are 5 basic aspects of a CAP:
- Issue/Problem Definition – Identify the potential problem and provide a lay explanation of the problem (e.g. Cloning)
- Root Cause – Identify what led to the potential problem (e.g. The ease of cutting and pasting or carry forward within an EMR)
- Action Steps – Identify the steps taken to correct or reverse the potential problem (e.g. Training and Education for all providers documenting within the EMR)
- Improvement Benchmark(s) and Timeframes – How you will monitor the situation going forward to ensure compliance (e.g. Re-review of provider documentation within 30-days after training and education)
- Certification – The compliance officer or responsible party for ensuring compliance signs off on the CAP
Cloning and Clinical Plagiarism
Electronic Health Records (EHRs) – The gift that keeps on giving. By now those of you who follow me, heard me speak or read my position papers on EHRs know that for many reasons I am not a fan. Sure, there are definitive pros when using one of these systems but for every pro there are multiple cons that exist. One of the biggest problems for providers is Cloning and Clinical Plagiarism. According to First Coast Service Options (FCSO) of Florida in their Q&A they state on Medicare Comment No. 5, “Documentation is considered cloned when each entry in the medical record for a patient is worded exactly alike or similar to the previous entries. Cloning also occurs when medical documentation is exactly the same from patient to patient. It would not be expected that every patient had the exact same problem, symptoms, and required the exact same treatment. Cloned documentation does not meet medical necessity requirements for coverage of services rendered due to the lack of specific, individual information. All documentation in the medical record must be specific to the patient and her/his situation at the time of the encounter. Cloning of documentation is considered a misrepresentation of the medical necessity requirement for coverage of services. Identification of this type of documentation will lead to denial of services for lack of medical necessity and recoupment of all overpayments made.”
So, to take it a bit further and play off of FCSO stance on cloning, we need to further define it and some of the reasons it is problematic. The word ‘cloning’ refers to documentation that is worded exactly like previous entries. This may also be referred to as ‘cut and paste’, ‘copy and paste’, or ‘carried forward.’ Cloned documentation may be handwritten, but generally occurs when using a preprinted template or a Promoting Interoperability (PI) Programs electronic record. Promoting Interoperability (PI) Programs electronic records replace traditional paper medical records with computerized record keeping to document and store patient health information. EHRs may include patient demographics, progress notes, medications, medical history, and clinical test results from any health care encounter. While these methods of documenting are acceptable, it would not be expected the same patient had the same exact problem, symptoms, and required the exact same treatment or the same patient had the same problem/situation on every encounter. Authorship and documentation in an EHR must be authentic. Cloned documentation does not meet medical necessity requirements for coverage of services. Identification of this type of documentation will lead to denial of services for lack of medical necessity and recoupment of all overpayments made. I personally do not believe in the word “Over-Coded”; I’d much rather we transition to the term “Over-documentation”, which is the practice of inserting false or irrelevant documentation to create the appearance of support for billing higher level services. Some PI Programs technologies auto-populate fields when using templates built into the system. Other systems generate extensive documentation on the basis of a single click of a checkbox, which if not appropriately edited by the provider may be inaccurate.
Medical Necessity and its Impact on the False Claims Act
I saved the best for last or at least that is what it is in my mind. Medical Necessity as it relates to coding – 30.6.1 – Evaluation and Management Services – Medical Necessity is the overarching criteria in addition to the individual elements of the CPT Codes… to further define the term(s) “Medically Necessary” or “Medical Necessity” “it shall mean health care services that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury, disease or its symptoms, and that are: a) in accordance with generally accepted standards of medical practice; b) clinically appropriate, in terms of type, frequency, extent, site and duration, and considered effective for the patient’s illness, injury or disease; and c) not primarily for the convenience of the patient, physician or other health care provider, and not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.” “Generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer‐reviewed medical literature generally recognized by the relevant medical community or otherwise consistent with the standards set forth in policy issues involving clinical judgment. Under the FCA, a person is deemed to have acted “knowingly” when the person “acts in deliberate ignorance of the truth or falsity of the information; or acts in reckless disregard of the truth or falsity of the information.” 31 U.S.C. § 3729(b). As the Ninth Circuit has pointed out, the FCA knowledge standard does not extend to honest mistakes, but only to “lies.” “Claims are not ‘false’ under the FCA unless they are furnished in violation of some controlling rule, regulation or standard”. See, e.g., United States ex rel. Local 342 v. Caputo Co., 321 F.3d 926, 933 (9th Cir.2003); United States v. Southland Mgmt. Corp., 326 F.3d 669, 674-75 (5th Cir.2003) (“[W]hether a claim is valid depends on the contract, regulation, or statute that supposedly warrants it. It is only those claims for money or property to which a Defendant is not entitled that are ‘false’ for purposes of the False Claims Act”) (citation omitted) (en banc); United States ex rel. Hochman v. Nackman, 145 F.3d 1069, 1073-74 (9th Cir.1998) (no falsity when Defendants’ acts conformed with Veteran Administration payment guidelines); United States ex rel. Lindenthal v. Gen. Dynamics Corp., 61 F.3d 1402, 1412 (9th Cir.1995) (whistleblower’s FCA claims for payment based on work that satisfied contractual obligations “could not have been ‘false or fraudulent’ within the meaning of the [False Claims Act]”); United States ex rel. Glass v. Medtronic, Inc., 957 F.2d 605, 608 (8th Cir.1992) (a statement cannot be “false” or “fraudulent” under FCA when the statement is consistent with regulations governing program). Additionally, a Defendant does not knowingly submit false claims when he follows Government instructions regarding the claims. See United States ex rel. Butler v. Hughes Helicopters, Inc., 71 F.3d 321 (9th Cir.1995); Wang v. FMC Corp., 975 F.2d 1412, 1421 (9th Cir.1992).
Clinical review judgment involves two steps:
- The synthesis of all submitted medical record information (e.g. progress notes, diagnostic findings, medications, nursing notes, etc.) to create a longitudinal clinical picture of the patient and,
- The application of this clinical picture to the review criteria is to make a reviewer determination on whether the clinical requirements in the relevant policy have been met. MAC, CERT, RAC, and ZPIC/UPIC clinical review staff shall use clinical review judgment when making medical record review determinations about a claim.
So, how do we defend medical necessity based on Documentation within the Medical Record? The first question to ask is does “Medical Necessity” exist or likely exist but the issue is lacking documentation in the medical record? It is critical that physicians understand they have a responsibility to provide sufficient documentation that paints a clear picture of each and encounter. Beyond that, auditors and coders must determine whether the procedures in question are truly clinically necessary or if the issue is documentation related, which is critical to the defense of any investigation. Compliance professionals (Auditors and Coders) need to make sure that all relevant medical records have been retrieved and reviewed to ensure a complete understanding for what transpired exists. This means office notes, hospital notes, nursing home, rehabilitation, etc. More importantly, do LCDs or NCDs exist to provide documentation requirements because as we all know many times the payors and their contractors fail to follow internal guidelines. And, finally. if the allegations are that documentation is inaccurate, have we generated clinical summaries/rebuttals to further clarify the need for services and state the physicians’ opinion clearly?
As you can see from just four topics there is so much information to disseminate and thanks to the tremendous presenters at the 11th Annual Conference I, along with the 190 attendees, are better prepared and well-armed to take these topics on head-first.
What to do next…
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