Archive for the ‘Fraud and Abuse’ Category

Hold On Just a Daw-Gone Minute – Physician Payment Act Dispute Process

Tuesday, April 11th, 2017

Disputing Inaccurate Reports Under the Physician Payment Sunshine Act

disputing sunshine act reportIn 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.

Anti-kickback Statutes – Free Transportation Services to Patients – Safe Harbor Regulations

Wednesday, March 22nd, 2017

Free Patient Transportation Services

Factors to Consider When the Transportation Safe Harbor is Not Satisfied

Health Attorney Wisconsin Health LawHere 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 to Patients and Guests – When Is The Anti-Kickback Statute Violated?

Wednesday, March 22nd, 2017

Free Transportation Services and the Anti-kickback Statute

Advisory Opinions, Safe Harbors, and other Guidance

Free Transportation Safe HarborsIt 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 Regulations – HHA Attorney Wisconsin

Tuesday, February 14th, 2017

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

OIG Releases Annual Work Plan for 2017

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.

Employment Exceptions From Anti-kickback Statute

Tuesday, May 20th, 2014

By John Fisher, JD, CHC, CCEP

employment exception safe harbor regulations

How Broad is the Employee Exception 

Parameters of the Stark Law and Anti-kickback Statute Exception

Both the Anti-Kickback Statute and the Stark Law contain exceptions that apply to employer/employee relationships.  Recent developments in the health law area indicate that there may be limits on the employment exception that were not previously contemplated.  I posted an article on the Health Law Blog that discussed possible limited to compensation structures for employed physicians.

Read more here: Health Law Blog


Voluntary Self Disclosure Decisions Can Be Complicated

Tuesday, April 8th, 2014

By John Fisher, JD, CHC, CCEP

OIG Self Disclosure Decisions

Provider Self Disclosure Decisions – Voluntary Disclosure Process

The decision whether or not to voluntarily disclose to the government can be very difficult.  Not every case is clear.

Clearly not every situation where there has been a billing error amounts to fraud or wrongdoing requiring use of the self-disclosure protocol.  Many over-payments that are identified through audit can be dealt with at the intermediary level.  Where investigation raises questions about whether incorrect bills are “knowingly” submitted, the self disclosure process may provide some mitigation of potential loss.  Situations where the provider perhaps “should have known” raise more difficult issues of analysis.

The situation is also complicated because a potential whistle-blower may view a situation much differently than a provider who finds what it believes to be an innocent mistake through the audit process.  A provider may sincerely believe that there was no “wrongdoing” and that a simple mistake has been identified.  Finding such a mistake may actually be evidence that the provider’s compliance efforts are working.  On the other hand, there is a whole legal profession out there now that is advertising for people to come forward with these types of mistakes.  With potential recover under the False Claims Act of 3 times

Read more here: Health Law Blog


Auditing Physician Payments For Stark Law Compliance

Tuesday, April 8th, 2014

By John Fisher, JD, CHC, CCEP

One area of compliance that is often overlooked involves auditing of physician payments.  Physician contracts are often audited to determine whether they comply with a Stark Law exception.  Compliance should also work in the other direction, from payments that are made back to the existence of a contract that memorializes an applicable Stark Law exception.

Periodic monitoring of payments that are made to physicians should be undertaken.  Payments should be tracked to contracts to assure that the payment is covered by an applicable exception.  If there is no corresponding written agreement or if the written agreement has expired, there could be a potential Stark Law violation.  Further examination concerning the nature and purpose of the payment should be made.  If a Stark Law violation is found, self disclosure should be considered.


Read more here: Health Law Blog


Chiropractic Services oig work plan 2014

Tuesday, April 1st, 2014

Chiropractic Billing and Payments

OIG Annual Work Plan 2014


We will compile the results of prior OIG audits, evaluations, and investigations of chiropractic services paid by Medicare to identify trends in payment, compliance, and fraud vulnerabilities and offer recommendations to improve detected vulnerabilities. Context—Prior OIG work identified inappropriate payments for chiropractic services that were medically unnecessary, were not documented in accordance with Medicare requirements, or were fraudulent. Medicare does not pay for items or services that are “not reasonable an d necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member.” (Social Security Act, § 1862(a)(1)(A).) Part B pays only for a chiropractor’s manual manipulation of the spine to correct a subluxation if there is a neuro-musculoskeletal condition for which such manipulation is appropriate treatment. (42 CFR § 410.21(b).) CMS’s Medicare Benefit Policy Manual, Pub. No. 100- 02, ch. 15, § 30.5, states that chiropractic maintenance therapy is not considered to be medically reasonable or necessary and is therefore not payable. Further, § 240.1.2 of the Manual establishes Medicare requirements for documenting chiropractic services. This planned portfolio document will offer new recommendations to improve Medicare chiropractic vulnerabilities detected in prior OIG work. (OAS; OIG-12-14-03; expected issue date: FY 2014; work in progress)
Chiropractic services—Part B payments for noncovered services
Billing and Payments. We will review Medicare Part B payments for chiropractic services to determine whether such payments were claimed in accordance with Medicare requirements. Context—Prior OIG work identified inappropriate payments for chiropractic services furnished during calendar year (CY) 2006. Subsequent OIG work (CY 2013) also identified unallowable Medicare payments for chiropractic services. Part B pays only for a chiropractor’s manual manipulation of the spine to correct a subluxation if there is a neuro-musculoskeletal condition for which such manipulation is appropriate treatment. (42 CFR § 410.21(b).) Chiropractic maintenance therapy is not considered to be medically reasonable or necessary and is therefore not payable. (CMS’s Medicare Benefit Policy Manual, Pub. No. 100-02, ch. 15, § 30.5B.) Medicare will not pay for items or services that are “not reasonable and necessary.” (Social Security Act, § 1862(a)(1)(A).) (OAS; W-00-12-35606; W-00-13-35606; various reviews; expected issue date: FY 2014; work in progress)
hiropractic services—Questionable billing and maintenance therapy (new)
Billing and Payments. We will determine the extent of questionable billing for chiropractic services. We will also identify trends suggestive of maintenance therapy billing. Context—Previous OIG work has demonstrated a history of vulnerabilities relative to inappropriate payments for chiropractic services, including recent work that identified a chiropractor with a 93-percent claim error rate and inappropriate Medicare payments of about $700,000. Although chiropractors may submit claims for any number of services, Medicare reimburses claims only for manual manipulations or treatment of subluxations of the spine that provides “a reasonable expectation of recovery or improvement of function.” Moreover, Medicare does not reimburse for chiropractic maintenance therapy. (CMS’s Medicare Benefit Policy Manual, Pub. No. 100 02, ch. 15, § 30.5B.) (OEI; 01-14-00200; expected issue date: FY 2015, work in progress)

Power Mobility Devices OIG Annual Work Plan

Tuesday, April 1st, 2014
Power mobility devices—Add-on payment for face-to-face examination

From 2014 PIG Annual Work Plan

Billing and Payments. We will review Medicare Part B payments for PMD to determine whether the Medicare requirements for a face-to-face examination were met. Context—Medicare requires that the treating physician, when prescribing a PMD, conduct a face-to-face examination to determine the medical necessity of the PMD and write a prescription for the PMD. (42 CFR § 410.38(c)(2).) To receive compensation for conducting the face-to-face examination, the prescribing physician can bill for an evaluation and management (E/M) service and has the option of billing Medicare for an add- on payment for the sole purpose of documenting the need for the PMD. Prior OIG work found that when the prescribing physician did not bill the code for the add-on payment in addition to the evaluation and management (E/M) code, the resulting PMD claim was likely to be
unallowable. (OAS; W-00-14-35460; expected issue date: FY 2014; work in progress)