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Excessive Use of Multiple Removal Codes – Dermatology Fraud and Abuse

Tuesday, June 27th, 2017

Criminal Conviction of Dermatologist Excessive Use of Multiple Removal Codes – 2015

dermatology false claimsA Chicago area dermatologist was convicted of committing Medicare fraud by submitting false claims for more than 800 patients that led to payment of reimbursement of approximately $2.6 million.  The doctor was accused of falsely diagnosing patients and submitting bills without proper documentation of the necessary condition.  Most of the claims appear to have involved diagnosis of actinic keratosis, or sun-induced skin lesions that have potential to become cancerous.   The doctor was found guilty of criminal charges arising from this matter in 2015.

The dermatologist was alleged to have falsely documented hundreds of cases of medically unnecessary cosmetic treatments he reported as involving the removal of lesions (CPT 17004).  According to court records, the physician billed under the CPT code applicable to the removal of 15 or more lesions on a more or less routine basis.  These treatments were allegedly performed on hundreds of repeat patients over a number of years.  Many of the patients received this treatment on 10 or more visits.  Medicare reimbursed this treatment by paying up to $352.40 per treatment.  When these numbers are summarized, it becomes difficult to deny that abuse was going on in this case.  Evidence presented suggested the dermatologist falsely claimed to have removed more than 150 pre-cancerous lesions from approximately 350 Medicare patients, more than 450 patients covered by Blue Cross and Blue Shield, and additional patients covered by Aetna and Humana health insurance.

This case appears to have been a relatively clear case of actual fraud rather than failure to properly document the nature of the service.  Even though the case represents an extreme situation, it still holds some lessons for providers who are not attempting to commit fraud.  A few lessons that can be extracted from this case include:

  • Care should be taken when using multiple removal codes such as 17004.  These types of codes should not be used systematically.  Over time, the removal numbers add up to indicate potential fraud.
  • The record should be accurately and completely documented to support use of multiple removal codes.
  • Care should be taken not to bill codes relating to time increments or work units that, in the aggregate, result in an unrealistic amount of time in a given day.  Granted, some providers are more efficient than others, but at some point multiple procedure time units become excessive and can be statistically sampled to determine whether the individual doctor is within a standard range of services.

Differential Valuations and the Anti-kickback Statute

Monday, April 3rd, 2017

Ambulatory Surgery Case Demonstrates Differential Value Theory of Renumeration

ASC Fraud and Abuse RemunerationA relatively recent case involving buy-in terms in an ambulatory surgery center demonstrates how different valuations for referral sources and non-referral sources can be evidence of remuneration under the Medicare Anti-Kickback Statute (42 U.S.C. § 1320a-7b(a)-(b)).  The case also demonstrates how the initial investment terms that favor referral sources can foreclose reliance on safe harbor regulations.

The case involved an ambulatory surgery center management company what purchased an interest in an ambulatory surgery center.  The company then offered shares of the company for investment to physicians who were in a position to refer surgical cases to the surgery center.  The physician investment was structured to meet the terms of the safe harbor regulations for ambulatory surgery center investments (“ASC Safe Harbors”).  The ASC Safe Harbors provide protection from remuneration that is received by a referring physician as a return on investment as long as the physician meets certain minimum practice revenue and surgical volume requirements. Physician investors must generally receive at least 1/3 of their practice income from the provision of surgical procedures and perform at least 1/3 of their surgical procedures in the center in which they hold an investment interest.

The problem with the way that the investment interest was structured was the different valuation that applied to the purchase that was made by the management company and the investment offer made to the referring physicians.  The management company purchased its investment at a much higher price than was offered to the physicians.  The differential valuation violated a threshold requirement of the safe harbor regulations that prohibits the initial investment interest to be based, in whole or in part, on the volume or value of referrals that the investor might make to the entity.  It was very difficult for the parties to justify the different value applied to physician investment.  The only apparent difference appeared to be that the physician investors were the referral sources for the surgery center.

This case specifically involved an ambulatory surgery center investment but the concept of differential valuation could apply in other situations involving the Anti-Kickback Statute.  Different values paid to or received from referral sources and non-referral sources can suggest that at least one of the reasons for the differential is the volume or value of potential referrals.  This points out a general area of risk assessment for all health care providers.  Areas where different pricing is applied to referral sources and non-referral sources could signify a potential violation of the Anti-Kickback Statute.

Anti-Discrimination Plans/Part D Sponsors

Monday, January 30th, 2017

Anti-Discrimination Rules in Medicare Advantage Plans

42 CFR 422.110, 422.2268(c), 423.2268(c)

Plans/Part D Sponsors may not discriminate based on race, ethnicity, national origin, religion, gender, sex, age, mental or physical disability, health status, claims experience, medical history, genetic information, evidence of insurability or geographic location. Plans/Part D Sponsors may not target beneficiaries from higher income areas or state/ imply that plans are only available to seniors rather than to all Medicare beneficiaries. Only Special Needs Plans (SNPs) and MMPs may limit enrollments to individuals meeting eligibility requirements based on health and/or other status. Basic services and information must be made available to individuals with disabilities, upon request.

Requirements Pertaining to Non-English Speaking Populations Medicare Health Plans

Sunday, January 29th, 2017

Requirements Pertaining to Non-English Speaking Populations

42 CFR 422.111(h)(1), 422.112(a)(8), 423.128(d)(1)(iii), 422.2264(e), 423.2264(e)

All Plans’/Part D Sponsors’ call centers must have interpreter services available to call center personnel to answer questions from non-English speaking or limited English proficient (LEP) beneficiaries. Call centers are those centers that receive calls from current and prospective enrollees. This requirement is in place regardless of the percentage of non-English speaking or LEP beneficiaries in a plan benefit package (PBP) service area. Plans/Part D Sponsors must make the marketing materials identified in sections 30.6, 30.7, 30.9, and the Part D Transition Letter(s) available in any language that is the primary language of at least five (5) percent of a Plan’s/Part D Sponsor’s PBP service area. Final populated translations of all marketing materials must be submitted in HPMS (see section 90.2 for material submission process).

Historically, regardless of the five (5) percent service area threshold, CMS required that all Plans/Part D Sponsors communicated the availability of language assistance services in the fifteen most common non-English languages spoken in the US via the Multi-Language Insert (MLI). The MLI was required to accompany the Summary of Benefits (SB), Annual Notice of Change (ANOC)/Evidence of Coverage (EOC), and the enrollment form. Because Section 1557 of the Patient Protection and Affordable Care Act contains a similar yet more robust requirement, CMS will now defer to the requirements under Section 1557 when it comes to communicating the availability of language assistance services. Plans/Part D Sponsors should consult with the Office for Civil Rights (OCR), the Federal Agency responsible for Section 1557, for questions pertaining to Section 1557 Compliance. In addition, OCR has a Section 1557 resource website that can be accessed at: https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html

 

Co-Branding Requirements Under Medicare Advantage Marketing Standards

Sunday, January 29th, 2017

Plans/Part D Sponsors co-branding relationships

Plans are prohibited from displaying the names and/or logos of co-branded providers on the Plan’s member identification card, unless the provider names and/or logos are related to a member’s selection of a specific provider/provider organization, (e.g., physicians, hospitals).

Part D Sponsors are prohibited from displaying the names and/or logos of co-branded providers/pharmacies on the Part D Sponsor’s member identification card. Plans/Part D Sponsors that choose to co-brand with providers/pharmacies must include on marketing materials (other than ID cards) the language in section 50.9.

Neither the Plan/Part D Sponsor nor its co-branding providers/pharmacies, whether through marketing materials or other communications, may imply that the co-branding partner is endorsed by CMS, or that its products or services are Medicare-approved.
Co-branded marketing materials must be submitted to CMS by the Plan/Part D Sponsor.
Note: Consistent with the National Council for Prescription Drug Program’s (NCPDP’s) “Pharmacy and/or Combination ID Card” standard, the Pharmacy Benefit Manager (PBM) name may be included on a enrollee ID card.

Draft 2018 Medicare Marketing Guidelines Medicare Advantage Plans

Sunday, January 29th, 2017

New draft Medicare marketing requirements have been released The Medicare Marketing Guidelines (MMG) implement the Centers for Medicare Advantage Plans, Medicare Prescription Drug Plan, Employer/Union-Sponsored Group Health Plans, and Section 1876 cost plans. These requirements also apply to Medicare-Medicaid
Plans (MMPs), except as modified or clarified in state-specific marketing guidance for each state’s demonstration. I will post various provisions in the propose marketing requirements as I work through them with my review, so keep tune if you are looking for a summary of requirements.  In the meantime, if you want to review the source document yourself, you can download it from this page.

2018 Draft MMG for Industry Comment

Compliance Comittment from the Top – Medical Practice Compliance

Friday, January 27th, 2017

Establishing Commitment From the Top of the Organization

An important and often overlooked aspect of developing a compliance program is the need to obtain commitment from the top of the organization.  Many times in a physician practice this will mean the physician owners of the practice.  It is important that the physician have a clear understanding of the need and benefit of establishing a focused compliance program.

There will inevitably be initial expenditures involved with establishing a compliance system.  In some cases it may even necessitate retaining additional staff.  There will almost certainly be fees to outside attorneys and consultants if the organization is not large enough to hire the needed expertise internally.  It is important that sufficient resources be allocated to compliance and that the physicians and administration understand that in the long term, these expenditures will pay off by reducing the risk of institutional compliance problems.  The difficulty is that if the compliance program works to reduce risks, there will never be a serious event that proves the benefit of the expenditures.  However, if an event occurs in the future and there is no compliance program in place, the regrets will be very deep because compliance issues are much more difficult to solve if there is no compliance plan in place.

As a practical matter, the institutional “buy-in” is often the most difficult hurdle to overcome.  It is somewhat easier now that compliance plans are becoming mandatory.  Yet there is still risks associated with under-funding compliance activities or providing enough resources to do the “bare minimum” when it comes to compliance due to a reluctant attitude on the part of physician leaders who are now being forced to develop compliance programs that they have not fully embraced.

Certain groups may be in a position that they have not been dependent upon institutions who have implemented compliance programs.  Some practices completely reject policies and procedures of any kind that could bind the physicians in their practices.  These organizations present the greatest challenges and unfortunately the greatest potential risk of violations of federal and state laws occurring due to the low level of leadership embracing appropriate compliance activities.  Even as these groups are forced to adopt compliance programs, they present the greatest residual risk because of a low level of physician commitment.

We suggest that physician practices begin the process of implementing formal compliance programs immediately to provide more time to gain physician commitment and appropriately assess the risks associated with the specific practice.  It takes a great deal of time to develop a system for establishing compliance programs, perform a “gap analysis” or other baseline analysis, perform employee interviews and take other steps to identify specific risk areas.  Developing a compliance program is much more than simply adopting a form compliance program.  Even though the precise effective date that compliance programs will become mandatory for physician practices has not yet been set, providers should consider this time a gift to permit them to develop appropriate policies rather than a reprieve.

OIG 2017 Annual Work Plan

Monday, January 23rd, 2017

OIG Annual Work Plan for 2017 – Topics Covered

The Health and Human services Office of Inspector General (OIG) recently released its 2017 Annual Work Plan.  Work planning is an ongoing project within the OIG.  Every year, the OIG publishes a work plan that consolidates the OIG audits and evaluations that are being conducted or planned within the organization.  The annual work plan has become a source that compliance officers look to as a tool for the identification of potential risk areas or areas of emphasis within their organization.  It is obviously not the only source for identifying compliance risk areas, but is certainly one reliable source that providers can draw on when setting their annual compliance priorities.

The 2017 OIG Work Plan can be download through the OIG site.

Ruder Ware’s health care group will continue to put out blogs and articles on various issues identified in the 2017 Annual Work Plan.  We will focus primarily on issues that were introduced for the first time in this year’s plan.

A listing of some of the issues addressed in the 2017 annual work plan include:

Hyperbolic Oxygen Therapy Services – Provider Reimbursement in Compliance with Federal Regulations

Incorrect Medical Assistance Days Claimed by Hospital

Inpatient Psychiatric Facility Outlier Payments

Case Review of Inpatient Rehabilitation Hospital Patients Not Suites for Intensive Therapy

Intensity-Modulated Radiation Therapy

Outpatient Outlier Payments for Short-Stay Claims

Comparison of Provider-Based and Freestanding Clinics

Reconciliation of Outlier Payments

Hospital Use of Outpatient Stays Under Medicare’s Two Midnight Rule

Case Review of Inpatient Rehabilitation Hospital Patients Not Suited for Intensive Therapy

Medicare Costs Associated with Defective Medical Device

Payment Credits for Replaced Medical Device That Were Implanted

Medicare Payment for Overlapping Part A Inpatient Claims and Part B Outpatient Claims

Selected Inpatient and Outpatient Billing Requirements

Duplicate Graduate Medical Education Payments

Indirect Medical Education Payments

Outpatient Dental Claims

Nationwide Review of Cardiac Catheterization and Endomyocardial Biopsies

Payments for Patients Diagnosed with Kwahiorkor

Use if Hospital Wage Data Used to Calculate Medicare Payments

CMS Validation of Hospital-Submitted Quality Reporting Data

Long Term Care Hospitals – Adverse Events in Post-acute-Care for Medicare Beneficiaries

Hospital Preparedness and Response to Emerging Infectious Diseases

Nursing Home Complaint Investigation Data Brief

Skilled Nursing Facilities – Unreported Incidents of Potential Abuse and Neglect

Skilled Nursing Facility Reimbursement

Skilled Nursing Facility Adverse Even Screening Tool

National Background Checks for Long Term Care Employees – Mandatory Review

Skilled Nursing Facility Prospective Payment System Requirements

Potentially Avoidable Hospitalizations of Medicare and Medicaid Eligible Nursing Facility Residents

Medicare Hospice Vulnerabilities and Recommendations for Improvement

Review of Hospices Compliance with Medicare Requirements

Hospice Home Care – Frequency of Nurse On-Site Visits to Assess Quality of Care and Services

Comparing HHS Survey Documents to Medicare Claims Data

Home Health Compliance with Medicare Requirements

Part B Services During Non Part-A Nursing Home Stays; Durable Medical Equipment

Medicare Market Share of Mail-Order Diabetics Testing Strips

Positive Airway Pressure Device Supplier – Supplier Compliance Documentation Requirements for Frequency and Medical Necessity

Orthotic Braces – Reasonableness of Medicare payments Compared to Amount Paid by Other Payors

Osteogenesis Simulators – Lump Sum Purchase Versus Rental

Power Mobility Devices – Lump Sum Purchase Versus Rental

Competitive Machines and Related Drugs – Supplier Compliance with Payment Requirements

Access to Durable Medical Equipment in Competitive Bidding Areas

Orthotic Braces – Supplier Compliance with Payment Requirements

Nebulizer Machines and Related Drugs – Supplier Compliance with Payment Requirements

Access to Durable Medical Equipment in Competitive Bidding Areas

Monitoring Medicare Payments for Clinical Diagnostic Laboratory Tests – Mandatory Review

Medicare Payments for Transitional Care Management

Medicare Payments for Chronic Care Management

Data Brief on Financial Interests Reported Under the Open Payments Program

Yates Memorandum and Compliance Investigations – New Newsletter Released

Tuesday, January 10th, 2017

Health Care Compliance Newsletter Released

Ruder Ware has released a new version of its newsletter covering health care law issues.  The current newsletter covers major changes in government enforcement practices and health care fraud penalties that significantly increase the stakes for health care compliance.  The newsletter contains a series of articles by Health Care Compliance Attorney, John Fisher, CHC, CCEP.

Access the newly released newsletter – Health Law Newsletter 2017

Past Newsletters are also available through this blog. Past Newsletters

Newsletter Signup

 

Don’t Overlook Special Status of Behavioral Health Records

Monday, January 9th, 2017

Most health care providers have implemented HIPAA compliant policies and procedures and have made them operational.  We often see providers who have not given appropriate levels of thought to behavioral health records.  HIPAA and state laws generally provide different levels of protection for patient information that relates to mental health issues or alcohol and drug treatment.  This requires providers to have policies and procedures in place that help employees identify these types of records and which describes appropriate precautions and special rules that apply.

Generally, Federal law treats general mental health records in the same way it treats other types of health information.  Many state statutes require more protection over confidentiality of mental health records than general health information.  Further distinction is made between general mental health/behavioral health records and the subset of those records that include psychotherapy notes.   Psychotherapy notes are rarely subject to disclosure to third parties.  In many cases even the subject patient can be denied access to psychotherapy notes.

It is important that policies and procedures clearly define mental health records and psychotherapy notes and describe the special restrictions that are applicable to both.  Clearly, the special restrictions on psychotherapy notes must be honored.  It is also important that healthcare providers do not apply the broader restrictions that are applicable psychotherapy notes to more general mental health records. Failing to understand the distinction between the various types of records can have adverse consequences under applicable laws and can even put patient care at risk.

This issue is further complicated because State and Federal protections can be different and even conflicting.  This requires providers to perform a preemption analysis to determine which law to follow.  That analysis can be different depending on the type of record involved and the purpose and nature of the contemplated release.

Psychotherapy notes are given special treatment under Federal law.  Psychotherapy notes are defined under Federal law as notes recorded by a health care provider who is a mental health professional documenting or analyzing the contents of a conversation during a private counseling session or a group, joint, or family counseling session and that are separate from the rest of the patient’s medical record.  Psychotherapy notes can rarely be released to a third party and often even the patient can be denied access to these records.  Certain information is not included within the definition of psychotherapy notes such as medical prescriptions, session start and stop times, frequency of treatment, results of clinical tests, summaries of diagnosis, symptoms, prognosis, etc.  This information is considered to be mental health records but does not receive the same special protection as psychotherapy notes.

Organizations should read and understand the distinction between general mental health records and psychotherapy notes.  Separation is key to complying with restrictions that are applicable to psychotherapy notes.  Psychotherapy notes should be stored separately from the patient’s medical records (which includes behavioral and mental health records).

Organizations that use electronic medical records (EMR) system must devise ways to separate psychotherapy notes from other types of medical records.  This might include integration of special naming and filing standards into the electronic record. Staff training is required to assure that the differences between psychotherapy notes and mental health records is maintained.

Some state laws complicate the analysis even further by provided additional restrictions on general mental health records.  Depending on your state, this analysis can become quite complicated and dependent on the purpose and nature of the contemplated release, application of preemption rules, and interpretation of state and Federal statutes and regulations.

John H. Fisher

Health Care Counsel
Ruder Ware, L.L.S.C.
500 First Street, Suite 8000
P.O. Box 8050
Wausau, WI 54402-8050

Tel 715.845.4336
Fax 715.845.2718

Ruder Ware is a member of Meritas Law Firms Worldwide

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