Health Law Blog - Healthcare Legal Issues

Distant Site Telemedicine Credentialing Conditions

April 17th, 2014

Reliance On Distant-Site Hospital or Telemedicine Entity Credentialing

Reliance On Distant Site for Telemedicine Credentialing

The 2011 CMS regulation modified conditions of the participation for hospitals and critical access hospitals to permit the hospital to have its medical staff rely on the distant-site hospital credentialing decisions when making recommendations on privileges for individual physicians and practitioners providing telemedicine services. However, this process is only permitted when a number of conditions are met:

  • The telemedicine services must be provided pursuant to a written agreement with the Medicare participating distant-site hospital or qualifying distant-site telemedicine entity.
  • The agreement must specify that it is the responsibility of the governing body of the distant-site hospital to meet the existing requirements for credentialing of providers who are providing telemedicine service.
  • The distant-site hospital providing the telemedicine services must be another Medicare participating hospital or a “telemedicine entity.”
  • The distant-site physician or other practitioner must have been privileged at the distant-site hospital providing telemedicine services and the distant-site hospital must provide a current list of telemedicine physicians and practitioners who are privileged there and their current privileges at the distant-site hospital or entity to the hospital or CAH.
  • The distance site practitioner must hold a license that is recognized by the state in which the hospital whose patients are receiving telemedicine services is located
  • The hospital must have evidence of an internal review of the distant-site physician’s or practitioner’s performance under telemedicine privileges and must send this information to the distance site hospital for use in the distant-site hospital’s periodic appraisal of the distant-site physician’s provision of telemedicine services.
  • Information sent for use in the periodic appraisal must at a minimum have included all adverse events that resulted or could have resulted from telemedicine services provided by the distance site provider to the originating hospital’s patients and all complaints received by the originating hospital with respect to the distance site physician or practitioner.

Credentialing Rules for Telemedicine Providers

April 17th, 2014

Telemedicine Credentialing CMS Credentialing Rules

Credentialing Telemedicine providersAt the present time, CMS conditions of participation are the primary regulatory source governing the process of credentialing telemedicine providers.  The Joint Commission has revised its requirements to be consistent with CMS rules.  In regulations dated May 5, 2011 (effective July 5, 2011), CMS provided final regulations that somewhat streamline the credentialing process and which comply with the Medicare Conditions of Participation.  CMS regulations give providers some options regarding credentialing of telemedicine including:

  • Retaining complete credentialing of all telemedicine providers using the credentialing process that is applicable to all other medical staff members.  The direct credentialing option is still the safest route for hospital’s to take from a liability standpoint.
  • Rely on the credentialing decision of another Medicare certified hospital when granting telemedicine privileges, subject to certain specific conditions including entering into a written agreement with the other facility.
  • Rely on the credentialing decisions of other “telemedicine entities” when granting telemedicine privileges, subject to certain conditions including entering into a written agreement.

In short, provided that all of the specific requirements contained in CMS regulations are met, a receiving hospital is permitted for purposes of Medicare participation to rely on the credentialing decisions that have been made by the “distant-site” telemedicine provider.  Note, however, that when the other facility is located out of state, the provider will still need to independently verify licensure under Wisconsin law.  The credentialing process conducted in a different state may not be a reliable source of assuring Wisconsin licensure.  In most cases, the distant-site provider will require full Wisconsin licensure to perform and permit billing for the applicable service.

Two Midnight Rule Exceptions CMS Inpatient Only

April 17th, 2014

Exceptions to Two Midnight Rule 

exceptions cms two midnight ruleCMS recently updated its frequently asked questions regarding the two midnight rule.  The two midnight rule requires a patient to require hospitalization, including two midnights, in order to qualify for inpatient hospital Medicare reimbursement.  Numerous questions have been raised about details of how the rule is applied.

CMS has recently stated two exceptions to the two midnight rule:

1.         One exception relates to patients who require mechanical ventilation that is initialed during a visit may be admitted even if the inpatient stay is not expected to remain or two midnights.  This exception does not apply as a result of anticipated intubations during minor surgery or other treatments.

2.         Procedures that are listed on the “inpatient only” list may be reimbursed even though the stay is not anticipated to meet the two midnight rule.

Providers should review the transcripts from the January 21, 2014, open door call for more details regarding the application of the two midnight rule.  The call clarified several issues of how to apply the rule.  For example:

  • Providers can assume that a patient will survive, even in cases where it is reasonably likely that the patient may not survive following admission.
  • CMS is still working on details of how to apply the role where patient transfer takes place.  Transfer cases will not be reviewed at least for the initial audits (through March 31, 2014).

CMS is requiring a 0.2% reduction to IPPS payments as part of the Final Fiscal Year 2014 IPPS rules.  Hospitals who wish to challenge the reduction amount should preserve their appeal rights by indentifying the reduced amount as being protested on their cost report.  The protest should be indicated commencing October 1, 2013, the effective date of the two midnight rules.

Stark Law Self Disclosures Through 2013

April 17th, 2014

Self Disclosure Under Stark Law – Disclosures Made and Settled Through 2013

self disclosure protocols 2013 update oigCMS issued its Stark Law self-disclosure protocols in 2010.  Through the end of 2013, there have been a total of 37 self-disclosure settlement with CMS using this process.  Some of the areas covered by self disclosures have included the following:

  • Failure to comply with the personal service exception in connection with electrocardiogram interpretations;
  • Emergency department “on-call” arrangements that did not comply with an exception;
  • Arrangement with physicians to provide utilization review services;
  • Medical director services, medical coding and consulting services, and office space lease;
  • Psychiatric services;
  • Office space rental and support services;
  • Failure to comply with the in-office ancillary services exception;
  • Case management physician advisor services;
  • EKG interpretation, medical director services, and hospital services;
  • Medical director services;
  • Supervision of cardiac stress tests;
  • Emergency call services at an adjacent walk-in clinic;
  • Space rental agreement;
  • Residency program services, electronic health records expert services, medical director services, leadership services;
  • Emergency cardiology call services;
  • Office space rental agreement;
  • Ownership interests in a rehabilitation hospital;
  • Physician recruitment exception;
  • Professional service agreements;
  • Fair market value compensation issue;
  • On-call payment arrangement;
  • Physician recruitment exception;
  • Dental services;
  • Equipment rental;
  • Non-monetary compensation violation;
  • Personal service agreement;
  • DME supply arrangement;
  • On-site overnight coverage violations.

Voluntary Self Disclosure Decisions Can Be Complicated

April 8th, 2014

Provider Self Disclosure Decisions – Voluntary Disclosure Process

OIG Self Disclosure DecisionsThe 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 the over-payment plus $11,000 per claim, these lawyers have strong incentive to attempt to turn what the provider believes to be an innocent mistake into a false claim.  This presents risk, even in the more innocent cases involving billing errors.

Generally speaking, when errors are discovered, the providers best bet is to be forthright and deal with the matter “head on.”  A complete internal investigation should be conducted to determine the precise nature of the issues and to identify the extent of wrongdoing.  Based on the outcome of the investigation, the provider can determine whether a simple repayment can be used or whether there may be reason to go through the formal self disclosure process.

Anyone who has worked with reimbursement rules will realize that payment policies, rules and regulations are not always clear.  At times it is difficult to determine whether there is even a violation of applicable rules.  Legal ambiguities further complicate the self disclosure decision.  The precise nature of any legal ambiguities involved in the specific case need to be completely documented.  If a decision is made that there has been no wrongdoing, the legal analysis should be laid out in writing and in detail and a reasonable judgment should be made regarding the interpretation of applicable legal standards.  If self disclosure is made in situations involving legal ambiguities, those ambiguities should be explained in detail as part of the self disclosure.

In the end, a provider facing potential self disclosure must follow a reasonable process to make a reasoned decision.  All elements forming the basis for the reasonable determination must be documented.  In cases of apparent wrongdoing, the provider can expect that its decision will be questioned at some point in the future.  Every step should be taken under that assumption.

OIG Self Disclosure Protocol Revisions Explained

April 8th, 2014

OIG Self Disclosure Protocol – OIG Explains at HCCA Conference

self disclosure protocols 2013 update oigAn OIG representative spoke about the new revised self disclosure protocols at a recent HCCA seminar that I attended.  The OIG felt it was appropriate to be more transparent regarding the process for self disclosure.  A few points were highlighted in this session:

  1. The OIG held its own feet to the fire by acknowledging the 1.5 damage multiplier when the self disclosure protocol is used.  They will need to justify if they are going to ask for more.
  2. Self disclosure is not an admission of liability.  However, you will be required to make a settlement and payment if you make a self disclosure.
  3. Self disclosure is not to be used to get an interpretation of whether your activity was wrongful or whether a law was violated.
  4. A decision not to self disclose leaves you open to potential whistle-blower complaints.  False Claims Act potential remains for the ten-year False Claims Act statute of limitation.
  5. Repayment can go to the fiscal intermediary if there is no wrongdoing but there is still an overpayment.
  6. Self disclosure requires disclosure of how your investigation was conducted.  If the investigation was conducted under privilege, you will need to disclose privileged information on investigation under privilege.
  7. The only party that can give you a False Claims Act release is the Department of Justice.

 

Auditing Physician Payments For Stark Law Compliance

April 3rd, 2014

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.

New 2013 Self Disclosure Protocols

April 2nd, 2014

An OIG representative spoke about the new revised self disclosure protocols at a recent HCCA seminar that I attended.  The OIG felt it was appropriate to be more transparent regarding the process for self disclosure.  A few points were highlighted in this session:

  1. The OIG held its own feet to the fire by acknowledging the 1.5 damage multiplier when the self disclosure protocol is used.  They will need to justify if they are going to ask for more.
  2. Self disclosure is not admission of liability.  However, you will be required to make a settlement and payment if you make a self disclosure.
  3. Self disclosure is not to be used to get an interpretation of whether your activity was wrongful or whether a law was violated.
  4. Decision not to self disclose leaves you open to potential whistleblower complaints.  False Claims Act potential remains for the ten-year False Claims Act statute of limitation.
  5. Repayment can go to the fiscal intermediary if there is no wrongdoing but there is still an overpayment.
  6. Self disclosure requires disclosure of how your investigation was conducted.  If the investigation was conducted under privilege, you will need to disclose privileged information on investigation under privilege.
  7. The only party that can give you a False Claims Act release is the Department of Justice (“DOJ”).  The DOJ does not have a formal process for obtaining a signoff from the DOJ.  There is an option to go to the DOJ to get a waiver of False Claims Act remedies.
  8. Protocol requires the provider to have done some level of fraud investigation before they self disclose.  OIG likes to see more work done on the front end.
  9. The OIG coordinates with the DOJ on all investigations.  The DOJ may elect to defer or to participate.  If the DOJ participates, there will also be a False Claims Act issue.
  10. Even if you enter a settlement with the OIG, you may still be open to a False Claims Act action by a whistleblower.  However, there would have been a public disclosure which may cut off a potential whistleblower.
  11. OIG does not go to DOJ until they develop the case and know what they are dealing with.
  12. Intent to make calculation of damages simpler.  They now use 100 claim sample to determine damages.  They tend to take the midpoint on damage calculations.
  13. Thirty to forty percent of self disclosures involve excluded parties.  The new protocols includes more detail on how to self disclose based on excluded parties, OIG requires exclusion checks for all providers are required before submitting a self disclosure.
  14. The self disclosure protocols include a formula for calculating damages when there is no direct billing for an excluded party.  The formula includes multiplying the total cost of employment by the payor mix percentage for federal health care programs.

Specialty Compliance Risk – Data Mining Used to Identify Practice Outliers

April 1st, 2014

A Note From the OIG Presentation at the HCCA Compliance Institute

The federal governmoig excluded party screening compliance programsent is actively using data to identify providers who perform outlier billing.  If your billing patterns reflect a pattern that is greatly outside of norms, you should be prepared to defend the deviation from the norm.  Certainly not every practice pattern that falls outside of norm indicate nefarious wrongdoing.  What is important is that your practice maintain awareness of and understand the reasons why billings may be picked up as falling outside of industry norms.  You must be prepared to educate government officials as to the reasons for having outlier claims data.

Primary care and pediatric practices will have very little opportunity to deviate from norms in most cases.  Highly trained specialists such as neurological surgeons can easily have unusual practice patterns that translate into outlier data that could trigger further government inquiry into billings.  Proactive audits performed as part of active compliance program will help the provider identify potential issues.  If abnormal data is identified through this process, the provider can address the situation in a proactive manner before the government becomes involved.

If there is an explanation for the anomalies, the provider can establish it in advance.  This type of practice approach strengthens the case if the government later raises the issue.  The provider should be fully prepared to explain the reasons for the apparent anomalies.  In a small and highly specialized practice, data anomalies can easily result from numerous possible non-nefarious reasons.  Because the government is actively using data analysis to identify fraud, the provider should assume that data that falls outside of norms will eventually be questioned.  Preparation, readiness, and proactivity are the keys to resolving issues with government investigators. 

One message was loud and clear when OIG and DOJ lawyers spoke at the HCCA compliance institute.  The government is increasingly looking at data to identify inherent billing patterns, referral patterns and other information that could be reflective of improper billings, kickbacks, or other violations. 

This information spotlights the need for providers to take a proactive approach in identify their own errors before the government brings these errors forward in a much less friendly manner.  If errors or overpayments are identified, repayment should be made promptly.  Repayments that are not made promptly are deemed to become false claims and expose the provider to much more severe penalties.

If the circumstances warrant, it may also be necessary to consider using the OIG or CMS self disclosure process to investigate potential penalties.

Health Care

April 1st, 2014

Ruder_HCad_blog

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

Search
Disclaimer
The Health Care Law Blog is made available by Ruder Ware for educational purposes and to provide a general understanding of some of the legal issues relating to the health care industry. This site does not provide specific legal advice and you should not use the information contained on this site to address your specific situation without consulting with legal counsel that is well versed in health care law and regulation. By using the Health Care Law Blog site you understand that there is no attorney client relationship between you and Ruder Ware or any individual attorney. Postings on this site do not represent the views of our clients. This site links to other information resources on the Internet; these sites are not endorsed or supported by Ruder Ware, and Ruder Ware does not vouch for the accuracy or reliability of any information provided therein. For further information regarding the articles on this blog, contact Ruder Ware through our primary website.