Archive for the ‘Compliance Issues’ Category

RCS-1 Model Worksheet Gives a Glimpse of a World Without RUG

Monday, March 12th, 2018

By Fisher, JD, CHC, CCEP

RCS-1 Sample Worksheet

RUG System for Skilled Nursing Facility Reimbursement – Time is Running Out

It is currently anticipated that the RUG system, which is currently used to calculate reimbursement for Medicare Part A skilled nursing services, will be changed over the next year.  CMS is currently considering a new Resident Classification System that will completely change the way SNFs are reimbursed for their services.

Providers are getting glimpses of what may be included in the new calculation system.  CMS issued a draft sample worksheet using the RCS-1 system.  The stated purpose is to give providers a description of how the new system would work.  The worksheet gives a description of how a manual calculation would take place using the RCS-I methodology.

The sample draft worksheet that was issued by CMS is available here.  RCS_I_Logic-508_Final

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

Read more here: Health Law Blog

  

Applying Section 1557 Discrimination Rules to Employer Sponsored Health Plans

Sunday, February 11th, 2018

By Fisher, JD, CHC, CCEP

Health Plan 1557 Compliance

Section 1557 Covered Entities and Employer Sponsored Health Plans

Section 1557 of the Affordable Care Act (ACA) prohibits “covered entities” discrimination in health programs that receive federal financial assistance from the Department of Human and Health Services.  Regulations were issued in 2016 that define the details of compliance with Section 1557 which prohibits discrimination based on race, color, national origin, age, disability and sex.  (including discrimination based on pregnancy, gender identity and sex stereotyping).  The stated purpose for the rules is to expand access and eliminate barriers to the ability to obtain health care coverage.

The definition of “covered entities” to which Section 1557 apply is extremely broad.  Through the broad definition, the requirements of Section 1557 apply to any health program or activity that received federal financial assistance through the Department of Health and Human Service.  This definition includes most health care providers, such as hospitals, nursing homes, and physician, who receive Medicare or Medicaid reimbursement, insurance marketplace and exchanges and participating health plans.

The Section 1557 rules extend to some (but not all) employers that are group health plan sponsors.  Determining whether Section 1557 applies to a specific employer can be quite complicated and is based on several factors such as

Read more here: Health Law Blog

  

Using Self-Disclosure Protocols – CMS and OIG Self Disclosure Process

Tuesday, April 11th, 2017

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

  

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.

6 Year Lookback Period Under Self Disclosure Protocol

Tuesday, April 11th, 2017

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

6 year lookback Self disclosureOn 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 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.

Maneuvers and Techniques Prohibited in Community Based Programs and Facilities

Thursday, February 9th, 2017

Wisconsin Prohibited Maneuvers and Techniques in Community Based Programs

Wisconsin Behavioral Health Managing Aggressive Behaviors

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.

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.

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