By Fisher, JD, CHC, CCEP

Self-Disclosure Has Become a Normal Part of the Compliance Process

As the OIG and CMS make self-disclosure easier for providers, we have noticed an increase in the rate of cases that are being filed.  Assisting providers in making decisions whether to self-disclose, conducting internal investigations, and guiding the self-disclosure process when appropriate has become a large part of our compliance practice.  Here are just a few of the articles and other resources that we have released regarding self-disclosure issues:

Exercising Reasonable Care to Identify and Address Potential Overpayments

Criminal Exposure for Failing to Repay Known Overpayment

When to Use the OIG’s Self Disclosure Protocols

Excluded Party Cases Dominate OIG Published Self Disclosure Settlements

Self-Disclosure Process – Voluntary Self Disclosure Decisions are not Always Easy

When Does An Overpayment Become Fraud? How Simple Inattention Can Expose You to Penalties for Fraudulent Activities

Provider Self-Disclosure Decisions – Voluntary Disclosure Process

Provider Self Disclosure Process

For more information on the self-disclosure process and legal updates impacting the process, watch this space.

linkscolor = “000000”; highlightscolor = “888888”; backgroundcolor = “FFFFFF”; channel = “none”;

<!– Please place the above code into your site where you want to

Read more here: Health Law Blog

Disputing Inaccurate Reports Under the Physician Payment Sunshine Act

In 2013, CMS issued final regulations interpreting and clarifying the requirements of the Physician Payment Sunshine Act (“Sunshine Act”) .  The final regulations clarify the reporting process, identifies exceptions and exclusions from the reporting requirements, and provides further details regarding what constitutes a reportable relationship.  The final rule delineates the specific data elements that reporting organizations are required to include and the reporting format that is required.  Reporting organizations that fail to make required reports are subject to potential civil monetary penalties.

Physicians are often surprised to see the information that reporting agencies submit.  Early on, errors in reporting were frequent as reporting companies struggled to integrate reporting requirements into their compliance process.  Reports tend to be more accurate now, but there are certainly instances where reporting organizations make reports that should be questioned.  A process is included to afford physicians and teaching hospitals to review and dispute the information that a reporting organization proposes to report.  The regulations require physicians to exercise diligence to review the information that is being submitted describing items of benefit that they are alleged to have received.  The regulations include a 45-day review and correction period, but report information does not automatically come to a physician unless affirmative action is taken to sign up to receive this information.

If the physician or teaching hospital receives notification, a process can be used to dispute the proposed disclosure with the applicable manufacturer.  There is a very short time window to dispute and resolve the issue before publication is made for the applicable year so it is critical that a dispute be invoked promptly upon receipt of notice of the proposed report.  Signing up for notifications also permits access to the web based dispute system.  The review period lasts for 45 days and reporting organizations have 15 days after the end of that period to correct data to resolve disputes.

Errors in amount, the nature of items reported, and methodology of calculating or allocating expenditures among numerous recipients are frequent areas of error.  For example, situations have occurred where expenditures that benefitted numerous physicians were allocated to a single physician.  The opportunity for error in reporting are endless; particularly given the multiple parties that can be involved in the reporting chain for the reporting company.

Inaccurate reporting is not without consequence to the subject of the report.  Inaccurate reports can be indicative of conflict of interest and can impact publication or reviewer credibility.  A report can also be an indication of further potential fraudulent payments and can result in further government investigation regarding the fair market value of services provided in a consulting or other relationship.  In extreme cases, payments that are inflated over fair market value for services that are actually and legitimately provided can indicate potential Anti-Kickback Statute and other compliance violations that can carry significant penalties.  If a review is based on an inaccurate or inflated report, a positive resolution can likely be reached with investigators.  However, anyone who has ever been involved in a government compliance investigation understands the intangible damage that the process can create.

In order to avoid complication that could result from inaccurate reports, physicians and other reporting subjects should be certain to register to receive notification of proposed Physician Sunshine Act reports.  Any inaccuracies should be disputed promptly.

Look-back Period for Self-Disclosures Increased from 4 Years to 6 Years

On February 12, 2016, CMS published a final rule for the reporting and returning of overpayments (the “final overpayment rule”). See 81 FR 7653. The effective date for this rule was March 14, 2016. Among other things, the final overpayment rule established a 6-year lookback period for the reporting and returning of overpayments under regulations at 42 CFR 401.305(f). Prior to March 14, 2016, CMS used the time frame established under the reopening regulations at 42 CFR 405.980(b) as a guide to determine the time frame of the SRDP. As such, the time frame of the SRDP was limited to 4 years from the date that the disclosing party submitted the disclosure to the SRDP, unless reliable evidence of fraud or similar fault existed.

Self-referral overpayments reported to CMS in accordance with the SRDP prior to March 14, 2016 are not governed by the 6-year lookback period specified in the final overpayment rule. This includes both overpayments reported and returned (via compromise and settlement) as well as those reported and still in the process of being reviewed through the SRDP. Providers and suppliers that reported self-referral overpayments to the SRDP prior to March 14, 2016 are not expected to return overpayments from the fifth and sixth years. Providers and suppliers reporting overpayments to the SRDP on or after March 14, 2016 are subject to the 6-year lookback period specified in the final overpayment rule.

Free Patient Transportation Services

Factors to Consider When the Transportation Safe Harbor is Not Satisfied

Here are some factors pulled from various OIG Advisory Opinions on free patient transportation.  The safe harbors for patient transportation should also be consulted, but these factors may be relevant in cases where not all safe harbor elements can be met.  Some factors identify criteria that makes an arrangement suspect.

• Offering out of state patients free transportation to receive services.
• Compensating drivers of vans or other vehicles on a per patient basis for patients that are brought to the facility.
• Offering free luxury transportation.
• Offering free transportation to the patients of physicians or other referral sources in order to induce them to refer to the facility.
• Free ambulance services without making any determination of financial need.
• Offering free transportation to nursing home residents to a facility,especially for services of questionable necessity.
• The costs of the free transportation must be borne by the facility and should not be passed on to any Federal health care program.
• Higher levels of advertising and marketing of the transportation service will raise more concern.
• Transportation from one provider to another raise a higher level of concern than transportation directly to the facility. In other words, where the transportation is from the place of business of a potential referral source (i.e. physician or other health care provider) the fraud and abuse risk is higher.
• Whether there are other methods of affordable transportation in the area. If affordable transportation options are not readily available, the arrangement will raise less concern.
• Whether the services are offered and/or marketed outside of the facilities normal service area. The OIG looks with disfavor on “leap-frog” arrangements that induce patients to bypass other closer providers due to the free or low cost transportation arrangement.
• The OIG also raised general concerns about the provider who uses free transportation to gain access to patients, potentially for unnecessary or questionable services.

Free Transportation Services and the Anti-kickback Statute

Advisory Opinions, Safe Harbors, and other Guidance

It is a fairly common practice for healthcare facilities, whether long term care facilities, hospitals, or large clinics, to offer free transportation services to patients and sometimes the visitors or guests of the patients. These arrangements require analysis under the Medicare Anti-Kickback Statute because a free service is being provided to the patient and could be viewed to at least partially be for the purpose of inducing the patient to seek services or for referral sources of these patients to refer them for services of the facility.

The OIG has viewed some arrangements where free or low cost transportation is provided to be a violation of the Anti-Kickback Statute and other arrangments to be permissible, even though arguably there is some element of remuneration to induce referrals. The OIG has issued advisory opinions that provide a great deal of guidance on the factors that the OIG will examine when determining which free transportation services are abusive and which will be permitted. Most recently, the OIG released a safe harbor provision that describes the conditions for safe harbor coverage of shuttle services and transportation of existing patients.

Failure to comply with a safe harbor does not necessarily mean that an arrangement violates the AKS. The advisory opinion that have been issued in this area are very instructive of the types of arrangements and various factors that the OIG considers to be suspect.

The particular case involved in the advisory opinion involved a skilled nursing facility that proposed offering local transportation to friends and family of nursing facility residents. The facility is located in an area that is not easy to access and requires payment of a $9 toll to cross a bridge. The service was to be provided uniformly regardless of income level or the source of payment for the residents’ care. There would be no charge for the transportation services and the cost would not be claimed on any Federal health program cost report. The value of the service to the families and friends of each patient is estimated to be over $50 per year. The facility did not plan to advertise the service broadly and advertising would be limited to its normal service area. A written policy would govern the operation of the transportation program.

The OIG found that the particular transportation arrangement would not violate the Anti-Kickback Statute.

The specific reasons given to approve this particular arrangement were (i) that the free transportation was not to assist patients to obtain care or for the benefit of referral sources to the facility, (ii) the program would be offered uniformly, regardless of the payment source for the services to the resident at the facility, (iii) the type of service is reasonable for the circumstances and is not a luxury item, (iv) the arrangement will only be offered and advertised locally and would not be used to expand the service area of the facility, (v) the marketing would be reasonably limited, (vi) local public transportation in the area is limited, (vii) the arrangement is consistent with the mission of providing quality care to patients, and (viii) the costs will not be claimed under any Federal health program.

These factors are instructive, and many are similar to the conditions in the recent safe harbor regulations. Circumstances that do not meet the safe harbor should be structured as close to the safe harbor as possible, but meeting the safe harbor completely is the only way to assure compliance short of requesting an advisory opinion. With all of the various guidance that has been issued in this area, together with the safe harbor regulations and comments, one can gain a very good understanding of the types of arrangements that will gain the disapproval of regulators.

Wisconsin Home Health Quality Reporting Requirements-  OASIS Data Item Set 

The reporting of quality data by home health agencies (HHAs) is mandated by Section 1895(b)(3)(B)(v)(II) of the Social Security Act (“the Act”).  This statute requires that ‘‘each home health agency shall submit to the Secretary such data that the Secretary determines are appropriate for the measurement of health care quality. Such data shall be submitted in a form and manner, and at a time, specified by the Secretary for purposes of this clause.’’

OASIS reporting is mandated in the Medicare regulations at 42 C.F.R.§484.250(a), which requires HHAs to submit OASIS assessments and Home Health Care Consumer Assessment of Healthcare Providers and Systems Survey (HH CAHPS) data to meet the quality reporting requirements of section 1895(b)(3)(B)(v) of the Act.

Home Health Quality Reporting Requirements

Wisconsin Prohibited Maneuvers and Techniques in Community Based Programs

Wisconsin Behavioral Health Lawyer

The Wisconsin Department of Health Services (DHS) as released a memo that specifies maneuvers or techniques that may not be used at any time in community based programs and facilities. DHS deems the prohibited maneuvers or techniques to “present an inherently high risk of serious injury and even death.”  Providers are directed by DHS to immediately discontinue the use of any of the listed maneuvers.  Prohibited maneuvers, techniques, and procedures that may not be used under any circumstances include:

• Any maneuver or technique that does not give adequate attention and care to protection
  of the head.
• Any maneuver or technique that places pressure or weight on the chest, lungs, sternum,
  diaphragm, back, or abdomen.
• Any maneuver or technique that places pressure, weight, or leverage on the neck or throat, on any artery, or on the back of the head or neck, or that otherwise obstructs or restricts the circulation of blood or obstructs an airway, such as straddling or sitting on the torso, or any type of choke hold.
• Any maneuver or technique that involves pushing into a person’s mouth, nose, or eyes.
• Any maneuver or technique that utilizes pain to obtain compliance or control, including punching, hitting, hyperextension of joints, or extended use of pressure points.
• Any maneuver or technique that forcibly takes a person from a standing position to the floor or ground. This includes taking a person from a standing position to a horizontal (prone or supine) position or to a seated position on the floor.
• Any maneuver or technique that creates a motion causing forcible impact on the person’s head or body, or forcibly pushes an individual against a hard surface.
• The use of seclusion where the door to the room would remain locked without someone having to remain present to apply some type of constant pressure or control to the locking mechanism.

DHS explains in the memo that the ultimate goal is to replace such interventions with trauma-informed systems and settings, positive behavior supports, and non-coercive intervention strategies. DHS promotes recovery and healing that is consumer-driven, person-centered, trauma-informed, and recovery-based.

In addition to describing measures that are completely prohibited, DHS states that restrictive measures that are not prohibited may only be used in emergency situations in which there is an imminent risk of serious harm to self or others, or as part of an approved plan. Situations in which the person’s behavior was foreseeable based on his or her
history are not considered an emergency.   Even restrictive measures that are not directly prohibited must be avoided whenever possible and may only be used after all other feasible alternatives, including de-escalation techniques, have been exhausted. When necessary, restrictive measures may only be used with the minimum amount of force needed, and for the shortest duration possible, to restore safety.

Facilities should review their policies and practices to assure compliance with the guidelines set forth in the memo. Additional staff training should be conducted to assure compliance with these standards.   Additionally, providers should become familiar with the changing standards of care and best practices focused on building skills and techniques to de-escalate and redirect behaviors that present safety concerns, and work earnestly to promote a trauma-informed culture of care.

Health Care Blog Articles Published by John Fisher

Here is a list of some of the recent health law related blog articles that I have recently posted across several different blog sites:

HIPAA Breach Notification Settlement – First Case of Untimely Notice of Breach

OIG Annual Work Plan for 2017 – Topics Covered

Skilled Nursing Facility and Nursing Home Initiatives OIG 2017 Annual Work Plan

Don’t Overlook Special Status of Behavioral Health Records

Off-Campus Provider-Based Departments Site-Neutrality

21st Century Cures Act Signed by President Obama

US Attorney Manual Updated to Incorporate Yates Memorandum DOJ Directives Incorporating the Yates Principles

Certification of Investigation of Individual Wrongdoing Under the Yates Memorandum

How Should Compliance Process Integrate the Yates Memorandum?

New Federal Prosecution Standards Require Revisions to Investigation Policies

300 Pages of New Regulations Ruining Health Care Attorney Lives Across the Country

60 Day Repayment Rule Affordable Care Act

ACO Primary Care Exclusivity Requirement – Not As Broad As Some Believe

Ambulatory Surgery Center Advisory Opinions

Antitrust Law Application In Rural Areas- Hospital Mergers

Antitrust Market Analysis In Provider Integration

Antitrust Policies Avoiding Spillover – Clinically Integrated Networks

Auditing Physician Payments For Stark Law

Bundled Payment Arrangements for Clinically Integrated Networks

Certification of Investigation of Individual Wrongdoing Under the Yates Memorandum

Clinical Integration Readiness Analysis CINs

CMS Releases Final Rules Under Medicare Shared Savings Program

CMS Releases the First Comprehensive Overhaul of Nursing Home Conditions of Participation in Over 25 Years

False Claims Act Basics – Known Overpayment Becomes False Claim

False Claims Act Liability – Conditions of Participation and Conditions of Payment

Final Rule Under the Medicare Shared Savings Program Released

HHS Releases Inflation Adjusted Federal Civil Penalties

How Should Compliance Process Integrate the Yates Memorandum?

Incident To Billing Rules Changed In New CMS Regulations

Major Revamp of Nursing Home Regulations Proposed By CMS

Medicare Shared Savings Program Changes Under 2016 Physician Fee Schedule Regulations

Medigap PHO Discount Program Receives OIG Approval

New Federal Prosecution Standards Require Revisions to Investigation Policies

Off-Campus Provider-Based Departments Neutrality

OIG Fraud Alert – Medical Director Compensation Arrangements

Outpatient Surgery Article On Using A Safe Surgery Checklist

Population Health Management and Clinical Integration

President Signs the 21st Century Cures Act

Primary Care Integration Strategies – Divisional Group Practice Mergers

Provider Self-Disclosure Decisions – Voluntary Disclosure Process

Referral Requirements – Can Employed Doctors Be Required to Make Referrals?

Reimbursement for Telemedicine and Telehealth Services

Telemedicine Credentialing By Proxy

When Can Violation of a Condition of Participation Result in False Claims Act Liability? Update on Escobar’s Materiality Standard

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.

Clinical Integration is the word of the day for provider organizations.  Clinical integration projects have emerged in all corners of the State of Wisconsin.  Our law firm has been at the center of many of these clinical integration programs and the creation of Accountable Care Organizations.

In a recent Article published on the Health Law Blog, we cover the issue of Clinical Integration Readiness Assessment.  During early assessment and design stages, we attempt to encourage broad participation by providers.  We will normally recommend the creation of a governance and committee structure that is as inclusive as possible.  Clinical integration is primarily a process that physicians perform.  Mechanisms are created through which physicians collaborate across specialty, in an interdependent way toward the end goals of increasing quality and efficiencies.  Ideally, the process should be collaborative between physicians and institutional providers.  However, the dynamics between hospitals and physicians can sometimes adversely impact the working relationship.

Find more by reading the full post over at the Health Care Blog.  This is an issue that all Wisconsin health care providers will want to follow because it is changing the central dynamic of the health care system.

Are You Ready For Clinical Integration?

Ruder Ware Clinical Integration Practice