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CMS Position On Texting Physician Orders

Monday, January 29th, 2018

Texting of Physician Orders : CMS Statement Clarifies Position on Texting

Physician Order Texting RegulationsThe CMS Center for Clinical Standards and Quality/Survey & Certification Group recently released a Memorandum clarifying its position regarding texting of health care information. In S&C 18-10-ALL, dated December 28, 2017, CMS clarifies the following issues:

  • Texting of PHI Within Health Care Team.  CMS says that this is permissible on a secure platform.  Providers should develop policies covering texting among the care team.  Providers may want to consider special conditions, or even limiting or prohibiting this practice.  CMS, HIPAA and other standards need to be considered when developing provider specific policy.  State laws may differ and certain types of information may be subject to special restrictions.
  • Texting of Patient Orders.  Even though texting communication between care team members is permissible, CMS clarifies that texting patient orders is always prohibited; even on a secure platform.
  • Preferred Use of CPOE.  CMS clarifies that Computerized Provider Order Entry (CPOE) is the preferred method for a provider to enter a patient order.  Providers should review their policies regarding acceptable order platforms.  Special attention should be paid to texting practices.  Verbal orders are also an area of significant compliance and liability concerns.  Over-use of verbal orders and non-compliance with authentication requirements is very common and is a significant risk area.

You can reference the CMS Texting Guidance Letter on this issue directly.

I have been posting a series of articles on compliance issues relating to physician orders that you can also reference for additional guidance.  And as always, if you have additional questions, please do not hesitate to contact me thhrough the contact form on this blog or directly through contact information on my law firm web site.

 

Physician Orders Legal and Regulatory Article Series

Physician Order Reimbursement Issues

Physician Orders – Why Are They So Important?

The Verbal Order Minefield

Authenticating Verbal Orders : Compliance Requirements

Third Party Authentication of Verbal Orders

Physician Order – CMS Guidelines on Texting Physician Orders

 

Authentication of Verbal Orders by Other Responsible Practitioner

Wednesday, January 24th, 2018

Authentication of Verbal Orders

Authenticating Verbal OrdersIn a past blog article, I discussed the need for physicians to promptly authenticate verbal orders. The failure of a physician to timely sign a verbal order can have reimbursement implications. In some cases, in some states, another responsible provider can sign a verbal order that is originally given by another practitioner. This option is not always available and depends a lot on whether state law permits the practice. Some states require the practitioner who gave the verbal order to authenticate the order. With the use of electronic medical records, practitioners cannot expect leniency on these types of requirements.

In states that permit one practitioner to authenticate for another, the authenticating proxy practitioner should understand that he or she is accepting responsibility for the authenticated verbal order. State scope of practice rules apply to cross authentication of orders. In otherwords, the practitioner authenticating the order must have practice authority to have provided the original verbal order. Facilities can develop policies that a more restrictive then what the law permits. Policy can eliminate or restrict cross authentication practices. There is inherent risk in permitting cross authentication because the authenticating provider did not give the original verbal order. Additionally, as covered in previous blog articles, verbal orders are over-used in many facilities and carry inherent risks. Facilities can enact policies to curtail the use of verbal orders. At minimum, facility policy should echo the CMS comments regarding the appropriate scope of use of verbal orders. Practices can be audited to determine whether a practitioner is overusing verbal orders.

Physician Orders Legal and Regulatory Article Series

Physician Order Reimbursement Issues

Physician Orders – Why Are They So Important?

The Verbal Order Minefield

Authenticating Verbal Orders : Compliance Requirements

Third Party Authentication of Verbal Orders

Physician Order – CMS Guidelines on Texting Physician Orders

Physician Orders : Why Are They So Important?

Wednesday, January 24th, 2018

The Importance of Physician Orders in Health Care

importance of physician ordersIn my last article on physician orders, I more or less ranted about the lack of a clear regulatory definition of physician orders. Yet, physician orders serve a variety of important purposes including communicating the physician’s direction for ancillary services and required diagnostic tests and securing the ability to receive reimbursement for services that flow from the physician’s encounter with the patient. The systematic use of physician orders also serves as proof that the physician is directing services to the patient and that conditions of participation of the facility, which require a physician driven process, are being complied with on a systematic basis.

Physician Orders as Conditions of Participation

Medicare law draws a distinction between conditions of participation and conditions of payment. Conditions of participation are compliance items, failure of which can result in corrective action and citations on survey. Failure of physician orders can result in survey deficiencies. The good news here is that a facility will normally be able to take action to correct a cited deficiency. If the failure of physician orders is systematic, other sanctions can attach; even including exclusion from governmental health program. But the garden variety, relatively isolated failure of a physician to timely sign an order can normally be corrected without devastating consequences.

Physician Orders As Condition of Payment

Physician orders can also be conditions of payment for specific services flowing from the physician’s encounter with the patient. This is where the real, serious regulatory exposure for failure to document physician orders occurs. Where an order is a condition of payment, claiming and accepting reimbursement results in an overpayment that should be repaid to Medicare. Failing to repay within 60 days of identification of the overpayment results in significant False Claims Act penalties that can far outweigh the original overpayment amount. Identification occurs when a provider “should know” that an overpayment exists which is why health care providers need to proactively look for missing physician orders as an identified risk as part of their compliance programs.

Physician Order Documentation Requirements

Health care providers will be familiar with the adage that “if it is not documented, it didn’t happen.” The same is true with respect to physician orders. A physician order that is not properly documented will be treated by payors as if the order does not exist. Even failure of seemingly technical failures to sign orders on a timely basis can result in payment denial or overpayment claims. In these cases, the provider is not entitled to reimbursement. If reimbursement is received, an overpayment will exist and I describe above the consequences of not repaying overpayments.

So it is important for physicians and other providers to understand the requirements for physician orders as they pertain to the services that they provide. Not getting it right can have very serious consequences. False Claims Act penalties are triple the original overpayment, plus up to $22,000 per claim. A systematic failure to properly use physician’s orders can result in draconian levels of damages under the False Claims Act.

Physician Orders Legal and Regulatory Article Series

Physician Order Reimbursement Issues

Physician Orders – Why Are They So Important?

The Verbal Order Minefield

Authenticating Verbal Orders : Compliance Requirements

Third Party Authentication of Verbal Orders

Physician Order – CMS Guidelines on Texting Physician Orders

Physician Orders – Definition and Reimbursement Implications

Wednesday, January 24th, 2018

Physician Orders – Big Implications but Few Definitions

Physician Ordering Services Physician OrdersI wanted to talk a bit about physician orders. Physician orders hold a great deal of significance in health care. The root purpose of a physician order is to direct other providers to furnish certain services. Services ordered by a physician might include things like therapy services, skilled nursing services, home health, diagnostic testing, and a variety of other therapeutic and/or diagnostic services that might flow from the physician’s examination of the patient.

In addition to the practical application of directing care, health care payors look to physician orders to make payment determinations. The Medicare program places a great deal of importance on physician orders to support claims for ancillary and diagnostic services. Certain services require a physician’s order as a prerequisite to payment on a claim for service. In other cases there may be no direct, fee-for-service payment implication to a physician’s order, but they are still critical to patient safety and to communicate matters that may impact care and treatment of patients.

A few weeks back, my trials and tribulations as a health care compliance lawyer resulted in my need to locate a definition of what constitutes a physician’s order. I looked in the Medicare regulations and was surprised to find that there is no statutory or regulatory definition of what constitutes the order of a physician. This seemed odd given the importance of physician orders as conditions for payment of many Medicare claims. There are references throughout the regulations that require physician orders. I was finally able to locate a definition in a CMS Policy Manual. But if push comes to shove in the context of a case, these policy manuals are not binding on the interpretation of regulatory terms. CMS may define physician orders internally, but that does not necessarilly mean that a court will uphold that definition.

Some states do a better job than Medicare at defining what constitutes a physician’s order. Medicare policy sometimes defers to state law, particularly regarding some of the technical aspects of physician orders such as what constitutes a valid electronic signature. State law should always be referenced when determining issues relating to physician orders, attestation, signatures, and other issues. This does not always provide clarification and, in fact, sometimes it causes confusion. But it is necessary for a full analysis and identification of where there may be uncertainty.

So no I am inspired to do some further exploration on physician orders. When are they necessary? When are they required? What technical requirements apply? Stay tuned to this blog for additional articles and hopefully some fairly comprehensive coverage of physician orders.

Physician Orders Legal and Regulatory Article Series

Physician Order Reimbursement Issues

Physician Orders – Why Are They So Important?

The Verbal Order Minefield

Authenticating Verbal Orders : Compliance Requirements

Third Party Authentication of Verbal Orders

Physician Order – CMS Guidelines on Texting Physician Orders

Gainsharing Arrangement Addressed in New Advisory Opinion

Thursday, January 11th, 2018

 OIG Advisory Opinion 17-09

OIG Advisory Opinion Gain SharingThe Office of Inspector General (“OIG”) recently released a new advisory opinion (Advisory Opinion 17-09 – January 5, 2018), addressing a gainsharing arrangement between a group of neurosurgeons and a health center.  Under the proposed arrangement, a neurosurgery group agreed to implement measures to reduce the costs associated with a defined scope of surgical procedures.  As part of its agreement with the health center, the neurosurgeons were to participate in a portion of the cost savings that resulted from the implementation of the measures.

The OIG has historically issued around a dozen Advisory Opinions addressing gainsharing arrangements.  However, the OIG had not issued an advisory opinion in the gainsharing area since the passage of the Medicare Access and CHIP Reauthorization Act (known as MACRA) in 2015.  That law made modifications to Civil Monetary Penalty provisions that are applicable in the gainsharing area by removing some of the impediments to gainsharing arrangements that previously existing in the Civil Monetary Penalty laws.

Gainsharing arrangements have emerged as a way to align the economic interests of hospitals and physicians in efforts to work together to reduce cost and enhance quality of care.  A gainsharing arrangements provides doctors with economic incentives to adhere to practices that reduce the hospital’s costs associated with defined procedures or treatment courses.  Under traditional fee-for-service reimbursement, a financial incentive is created for physicians to provide more service to maximize reimbursement.  A properly structured gainsharing arrangement creates incentives for appropriate levels of service and rewards physicians for efficiencies and quality outcomes.  Interests are aligned because the facility and the physician, who is often the engine driving the level of care, share in the savings.

Prior to the passage of MACRA in 2015, the OIG expressed suspicion about gainsharing through Special Advisory Bulletins as well as advisory opinions.  This has the effect of chilling the proliferation of gainsharing arrangements because providers were cautious about potential regulatory issues. A major impediment prior to 2015 was the CMP law that restricted hospitals from compensating physicians in order to induce a reduction or limitation on services provided to Medicare and Medicaid beneficiaries.  MACRA clarified that the CMP law was only violated if the payment to the physician is for purposes of reducing services that are medically necessary.  This subtle yet significant change opened the door for the proliferation of gainsharing arrangements.

Coming full circle to Advisory Opinion 17-09, the OIG concluded that the specific gainsharing arrangement described in the opinion would not result in sanctions under the Civil Monetary Penalty rules or the Federal Anti-kickback Statute.  The OIG acknowledged that both the CMP laws and the Anti-kickback had potential implication but that the structural issues of the particular arrangement between the neurosurgeons and the health system would not result in the OIG pursuing sanctions.

By their very nature, Advisory Opinions only apply to the requesting party.  However, we can gain useful concepts from the analysis and conclusions of the OIG relating to the specific facts that formed the basis of their opinions.

Fair market value will always remain an issue in gainsharing arrangements.  The Federal Stark Law, Anti-kickback Statutes, and applicable state laws will require adherence to fair market value standards when payment is made between a referring party and the provider of a service. Advisory Opinion 17-09 provides us with some useful guidance regarding some of the consideration that should go into establishing fair market value and structuring a gainsharing arrangements.  Fair market value concepts in these arrangements are often subtle and must be well thought out to avoid regulatory issues. In addition, concepts of commercial reasonableness, which has emerged as a related but distinct issue impacting payments must be considered in addition to fair market value.

Advisory Opinion 17-09 is worth a review to anyone involved in structuring gainsharing arrangements. By no means should 17-09 be the only guidance that you rely upon because the opinion only touches on a few considerations that were relevant to the structure of the specific arrangement.  Some important factors to keep on your radar when structuring a gainsharing arrangement relate to the determination of baselines that are used to measure cost savings through program implementation.  The frequency and method of calculating available gainsharing amounts is subtle but important for regulatory compliance.  Of course the specific protocols or description of the method for reducing costs should be described in detail, together with a method for determining the level of compliance with those protocols.  Another issue that often arises in these arrangements involves the scope of costs that are allocated to the program.  It is important that costs allocated be reasonable to avoid potential disguised kickbacks.

If you require additional information regarding this article, gainsharing arrangements, or health care issues in general, please contact us through the contact section of this blog.

DOJ Skilled Nursing Facility Settlement Involving Rehab – Highest Ever

Thursday, December 28th, 2017

Skilled Nursing Facility Single Highest False Claims Act Settlements to Date

Personal Care Agency Fraud2017 saw the largest recovery from a skilled nursing facility under the False Claim Act.  Life Care Centers of America Inc. and its owner agreed to pay $145 million to settle allegations that it caused skilled nursing facilities to submit false claims for rehabilitation therapy services that were not reasonable, necessary, or skilled.  The government’s case alleged that Life Care instituted corporate-wide policies and practices designed to place beneficiaries in the highest level of Medicare reimbursement.  High reimbursement categories were encouraged irrespective of the clinical needs of the patients.  The case alleged that this resulted unreasonable and unnecessary therapy to to be provided to many beneficiaries.

Health Care Leads in Fraud Recoveries in 2017

Thursday, December 28th, 2017

fraud recovery doj report 2017Health Care Leads With $2.4 Billion Fraud Recoveries in 2017

The United States Department of Justice recently released a summary of recoveries from False Claims Act cases for Fiscal Year 2017.  The report, which was released in late December 2017, indicates that the DOJ recovered over $3.7 billion in settlements and judgments from civil cases involving fraud and false claims during 2017.

One thing is evident when examining the report.  The lion’s share of recoveries come from the health care industry.  Almost $2.5 billion of the $3.7 billion in total recoveries involved health care providers and others in the health care industry.  This is not a new trend.  Health care has led in recoveries with over $2 billion per year for the past 8 years in a row.

The department’s health care fraud program is intended to restore assets to federally funded programs, such as Medicare, Medicaid, and TRICARE.  By all reports, health care fraud and abuse recovery is big business for the Federal government.  The details vary, but reports indicate that the government receives between seven and ten times return on every dollar it spends on pursuing health care fraud and abuse cases.  Recent revisions to Federal False Claims Act penalties increased the maximum penalty per claim from $11,000 to $22,000.  This increase is likely to result in even more aggressive enforcement and an even higher percentage return on the government’s investment in this area.

The high potential financial exposure is intended to deter others from committing health care fraud.  Additionally, the high potential exposure provides an incentive for providers to put in place proactive compliance programs to help identify errors and instances of noncompliance that could eventually result in unmanageable penalties if allowed to emerge through discovery by government audits or a whistleblower complaint.  It is generally much preferable for a provider to discover and correct a problem on its own initiative rather than exposing itself to draconian penalties.

Federal Government Will Seek Dismissal of False Claims Act Cases That Lack Merit

Monday, December 11th, 2017

The FCA is a federal law aimed at combatting fraud against the U.S. government.  The FCA has been around since 1863, in response to contractors who defrauded the Union Army by selling it defective weapons, ammunition, and equipment and unhealthy and unfit food and animals.

A prime feature of the FCA is what is called the “qui tam” provision, under which a private citizen, known as a “relator” (otherwise known as a whistleblower), can sue on behalf of the government and be paid a percentage of the amount recovered (generally 15% to 30%) plus legal fees.  Health care and military-related industries have been particularly popular targets of FCA whistleblower actions.  Under the FCA, the DOJ has 60 days within which to decide to prosecute the claim or decline involvement.  If the DOJ decides not to be involved, the relator has to decide whether to proceed alone.

Up to now, it has been the position of the government that the relator is free to continue a case that the government declines to prosecute.  Now, however, the DOJ will file a motion with the court urging it to dismiss the case if it believes it is frivolous.  The DOJ’s rationale for its new policy is that frivolous litigation imposes a burden on the government, the courts, and the health care industry.

It is important to note that this change in policy affects only those cases that the DOJ believes have no merit.  By no means should this cause any reduced emphasis on compliance activities.  It is also not known how DOJ will determine that a case is frivolous.  What is known is that this is a major shift from the policy of the previous administration and could have significant implications for the health care sector.

Dental Practice Compliance Programs

Saturday, November 18th, 2017

Should a Dental Practice Have a Compliance Program?

Compliance programs are an accepted requirement in most of the health care industry.  There seems to have been less importance attached to the establishment of systematic compliance programs in the dental practice area.  I believe part of the reason why the dental industry has lagged behind other health care providers in the compliance area is that there is very little Medicare reimbursement involved in the usual dental practice.  Certainly much of the reason for compliance program involve Medicare enforcement actions.  However, dental practice that under-emphasize compliance are assuming a great deal of unnecessary risk.

Certainly some dental providers receive Medicare reimbursement for a portion of their services.  Oral surgeons for example regularly perform services that are covered under the Medicare program.  Many practices accept Medicaid reimbursement or reimbursement from other Federal health programs.  Additionally, practices that receive reimbursement from federally funded health care plans are required under Federal law to establish and effective compliance program that contains the “core elements” set forth in Federal law.  The Federal standard required dental providers who receive this type of reimbursement to actively operate a compliance programs that is effective in preventing and detecting criminal, civil and administrative violations and in promoting the quality of care that is provided by the practice consistent with federal regulations.

There are many reasons beyond reimbursement requirements to operate a compliance program.   Dental practices must maintain systematic process to assure compliance with OSHA regulations, HIPAA and state privacy regulations, and a variety of other federal and state rules and regulations.  Some of these regulatory areas are subject to aggressive governmental oversight including periodic audits and inspections.  Other areas are not subject to aggressive enforcement.  All of these areas, even those where there is no aggressive enforcement, can expose the dental practice to liability if a complaint is made by an employee, former employer, patient, competitor, or other individual.  Some of these potential complainants can even establish whistleblower status and can bring private action for recovery.

Some practices that implement compliance programs and perform audits over billing and collection practices are pleasantly surprised when they discover that they have actually been under-billing.  Audit of potential risk areas can indeed identify missed revenue opportunities.  This does not happen in every instance, but there are circumstances where the audit process actually identifies new revenue streams.

For most providers, operating a compliance program will have the benefit of deterring potential future liability.  If detected early, it is much easier to deal with a potential infraction when it is self-discovered before the potential damages become insurmountable.  It is one thing to deal with potential over-payment or failure to follow a regulation.  It is much more difficult to resolve these issues when they are brought into the open from an outside party.  By that time, potential sanctions may have multiplied to an unmanageable level.  For example, if the False Claims Act applies, a simple over-payment can be multiplied by 3, plus $11,000 to $21,000 per claim can be added to the otherwise manageable over-payment amount.

In summary, there is every reason for a dental practice to actively operate a robust compliance program.  Those that believe that a compliance program is not needed because Medicare reimbursement is not present should think again.  Eventually, it is highly likely that the failure to maintain an active compliance program will catch up with you.  I have represented many health care providers who have been subject to the negative impact of not operating a compliance program.  I can tell you that they all share the same regret that they did not deal with compliance proactively while they had the opportunity.

For those of you who are still reading, I want to briefly describe the 7 basic elements of a compliance program.  Each of these elements can be expounded on further, but I will touch on them briefly here.

  1. Appointment of a high ranking member of management to act as compliance officer. In a smaller practice, a compliance responsible individual can be used.  Compliance program structure can be scalable to the size and resources of the provider and the nature and complexity of the business.
  2. Compliance policies should be put in place that describe the process to be used to conduct ongoing compliance activities. Compliance policies will define compliance operations and will also outline requirements in risk areas that are specific to the nature of the practice.
  3. Employees, contractors and others must be trained on basic compliance program elements and risk areas that are applicable to their job functions.
  4. Creating a compliance reporting system and protecting those who make complaints from retaliation or retribution.
  5. Enforcing disciplinary standards that hold employees responsible for following compliance requirements.
  6. Operating a system to continually identify areas of potential compliance risk within the practice.
  7. Maintaining a system of appropriately responding to identified compliance problems through creation of appropriate corrective action, self-disclosure or other appropriate action.

Putting these elements in place through adoption and operation of appropriate policies and standards establishes the central elements of the compliance process.  It is critical that the activity does not stop at the establishment of policies.  A compliance program must be continually operated as a living a breathing process to identify and address risk in a practice manner.  The compliance officer or responsible individual is responsible for assuring the continued operation of the program.

Risk areas in a dental practice include reimbursement rules, licensing and certification standards, OSHA regulations, HIPAA and state patient privacy laws, infection control standards, radiation regulations and standards, documentation requirements, controlled substance regulations and a host of other state and Federal regulatory requirements.  Your compliance program in effect creates the process to identify risk and proactively examine potential areas of risk to determine compliance.  An actively operating compliance program is a necessary elements of every dental practice.

 

Exercising Reasonable Care to Identify and Address Potential Overpayments

Monday, July 17th, 2017

When the Center for Medicare and Medicaid Services (CMS) finally issued final regulations under the 60-day repayment rule, it implemented a new standards that requires a provider to affirmatively exercise reasonable diligence to identify potential overpayments.  This was a change from the proposed regulations that held providers to a much lower affirmative duty to exercise diligence to find potential overpayments.  Now, when a provider receives “credible information” that indicates a potential overpayment, affirmative steps must be taken in a timely and good faith manner to investigate.  Failure to meet the standard of reasonable diligence can result in significant penalties under the False Claims Act.  In some cases criminal liability can attach as well; particularly when evidence strongly indicates a problem might exist and a deliberate decision is made not to investigate or repay amount due.

By now most health care providers are at least generally aware of the 60-day repayment rule.  That rule originated as part of the Affordable Care Act in 2010.  The rule provides that the failure to repay a known overpayment within 60 days after discovery results in potential penalties under the False Claims Act.  This means that a simple overpayment is multiplied by a factor of three.  Additionally, penalties can be assessed in amounts ranging from a minimum of $11,000 and a maximum of approximately $22,000 per claim.  Financial exposure under the FCA can be very substantial; particularly when there is a systematic billing error that impacts a large number of claims over a significant period of time.  The lookback period for imputed False Claims is 6 years, which amplifies the potential exposure when the “tip of the iceberg” is discovered in a current year audit.

The initial statutory provision left some ambiguity regarding application of the 60 day repayment rule.  One significant ambiguity related to when the 60 day time period begins to run.  The statute states that the 60 day period commences upon “identification” of the overpayment but included no clarification of when a provider is deemed to have identified an overpayment.  It was not clear whether identification occurred when there was an allegation that an overpayment exists, when an amount of overpayment was calculated, when the existence of the overpayment was verified, or at some other time.  It was also unclear whether actual knowledge of an overpayment was required or whether knowledge could be imputed in certain circumstances.

CMS provided clarification on the issue of identification in the final regulations, but the clarification places significant burdens on providers.  Under the final rules, the provider is deemed to have identified an overpayment, not when actual knowledge is obtained, but rather when the provider “should have” identified the overpayment through the exercise of “reasonable diligence.”  The new standard requires providers to conduct a timely and good faith investigation when it receives credible information that an overpayment might exist.  Failing to take reasonable steps to investigate will result in imputed knowledge and deemed “identification” of the overpayment.  In other-words, the 60 day clock starts to run when the investigation should have commenced.

It is useful at this point to mention what constitutes and overpayment that invokes the statutory requirement.  An overpayment exists when the provider receives any funds to which they are not entitled.  There is no amount threshold, substantiality or materiality requirement.  Any overpayment invokes the statute and becomes a potential false claim if not repaid within the 60 day period.  There are situations where the amount of overpayment is so small that the provider might determine it not to be worth the resources to identify, quantify and repay.  When making this determination, it should be kept in mind that the False Claims Act will apply if a whistleblower case is brought or a government investigation is commenced and finds the overpayment.  False Claims Act liability can result in large penalties; particularly where there are multiple claims involved.  It should also be kept in mind that criminal statutes impose felony penalties for the willful failure to return known overpayments.

Overpayments that are self-discovered and repaid before they become false claims are relatively easy to manage.  Once the False Claims Act potentially attaches, these situations become increasingly complicated to manage.  The OIG Self Disclosure process should be considered where the potential for significant penalties is present.  The SDP permits resolution at a minimum of 1.5 times the amount of the overpayment.  Full disclosure of the facts and investigation is required as part of the self-disclosure process.  Only civil penalties are subject to settlement under the protocol.  The wrong facts disclosed as part of the SDP process can lead to criminal charges against the entity or individuals.  Criminal charges cannot be settled using the SDP.

Where amounts are smaller, a provider may decide to repay without going through the protocol process.  A determination of which option is right in the specific situation should be made with the involvement of legal counsel that has experience with these issues.

Proper operation of a compliance program is the best defense to mitigating exposure under the 60 day rule.  Prompt investigation should be conducted whenever there is a credible allegation of an overpayment.  Compliance risk identification and proactive auditing can also help mitigate risk be identifying problems early and by demonstrating that compliance process is being effectively operated.  This will help avoid allegations that overpayments should have been discovered sooner through the exercise of a reasonable compliance program.  Most importantly, ignoring alleged overpayments is never an answer that mitigates risk.  All credible allegations must be investigated and appropriate repayment should be made using one of the available methods.  The requirements of the final rule should be baked into compliance program policies and procedures and staff should be educated on the need to investigate and return overpayments within required timeframes.

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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