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Archive for the ‘Manufacturing Compliance’ Category

Creating A Compliance Program That Fits Your Organization

Wednesday, August 1st, 2012

Creating a Compliance Program That is Right for Your Organization

compliance program scaleAn important part of developing an effective compliance program is to make the program scalable and effective for the operations of the specific provider.  In some ways, creating compliance program for a large health system is the easiest because you have the resources and breadth of operations to recommend everything; also known as the “kitchen sink” model.  The real art in my opinion comes when developing programs for smaller hospitals, physician groups and other organizations that do not have the resources to “do it all.”  Taking an overbroad approach to compliance with smaller organizations can actually create additional risk because you are creating a “roadmap” of items that are not being done and which you will never have the resources to complete.

Our job as compliance attorneys is to recommend systems that are workable within the resources and specific risk areas that are relevant to the provider.  This takes a level of judgment that is not necessary where the size and resources of the organization permit the “kitchen sink” approach to be taken.

The development of compliance programs for smaller organizations take a surgical approach.  Care must be taken to develop systems for identifying the risk areas that are specific to the organization.  Risks should be scored and prioritized and the results of this process should be included into a plan to accomplish audits, reviews or monitoring of the various identified risk areas.  Small organizations cannot hit every risk area during every budgeting cycle.  A longer term approach is called for with the most urgent risks requiring closer and faster review.  This all ties into the budgeting process.  The work plan needs to be adequately budgeted.  The size of the organization will have an effect on the amount that is budgeted for compliance.

The point of a compliance program is not that every problem area will be found.  It is most important that a logical system be developed that prioritizes risk and addresses risk areas in a logical fashion.  The other side of the coin is that a substantial organization should not hide behind lack of resources for not addressing significant risk areas.  A small physician practice is at one end of the spectrum.  A hospital system with several facilities, attached physician network, and an array of ancillary services would have little excuse for not allocating sufficient budget amounts to compliance to enable the organization to meet its compliance needs.

Issues of scalability also come into the general structure of the compliance program.  A small physician practice will not have the resources to hire a chief compliance officer.  Rather, a small practice might designate a partner or administrator as a “compliance responsible individual.”  On the other hand, a substantial hospital system should implement a robust structure including a full-time chief compliance officer, a compliance committee and compliance staff.  The compliance officer should not serve a dual role in positions that create an inherent conflict of interest such as general counsel, chief financial officer or chief operating officer.

Issues of scope and scalability are at the center of most compliance efforts.  These issues require careful and judiciously made decisions.  These decisions are important and must be faced by providers of all size, from the smallest medical practice through the largest health system as mandatory affective compliance programs become a requirement.

Compliance Legal Practice and Effectiveness Review

Wednesday, August 1st, 2012

Compliance Program Development and Effectiveness Review

A significant part of our health law practice involves the creation, implementation, and review of compliance programs for health care providers and other businesses.  Some of our compliance practice is devoted to institutional provides such as hospitals, health systems and nursing homes.  We are increasingly advising our smaller health care clients, such as physician groups, home health agencies and other providers on establishing appropriate compliance programs.  The entire industry is trending toward the adoption of compliance programs spurred on by a true desire to reduce risk as well as recent legal changes that mandate the adoption of compliance programs for most health care providers.

We have made a major firm committment to our compliance practice.  Health care attorney John Fisher recently obtained national certification in health care compliance through the Health Care Compliance Association.  We have assembled a team attorneys with various legal backgrounds, including health law, employment law, non-profit tax law and other areas to complement Mr. Fisher’s focus on compliance issues faced by health care providers.

We provide compliance program development and review services to hospitals, individual physicians and group practices, dental groups, chiropractic groups, home health agencies, skilled nursing facilities, durable medical equipment suppliers, ambulance providers, therapy clinics, ambulatory surgery centers, and behavioral health care providers.  We assist providers in conducting internal audits, internal investigations, compliance program gap analysis and effectiveness reviews. We have also assisted providers who are the subject of reviews by institutions where they may be employed or have staff privileges.

Examples of some of our compliance program related involvement in the health care area include:

  • Conducting effectiveness reviews and making suggestions for enhancements to existing compliance programs.
  • Working with governing bodies to develop initial compliance programs.
  • Advising compliance officers and governance with respect to ongoing monitoring and auditing.
  • Assisting providers to conduct internal audits and assessments.
  • Assisting providers to focus on specific risk areas that may affect their practices.
  • Assisting providers in the reacting to compliance reports including investigations and corrective action plan development.
  • Conducting detailed compliance related research in the course of acquisitions of other providers.
  • Creating programs that leverage existing resources and expertise into an enterprise management system addressed at compliance issues.
  • Compliance Programs Are An Essential Element of Health Care Operations

Effective compliance programs have become an essential element of an effective regulatory risk reduction program.  The importance of compliance programs have been repeatedly emphasised by government officials over the past decade.  Recently, Marilyn Tavenner, Acting Administrator of the Centers for Medicare & Medicaid Services (CMS) released a brief article on the CMS Blog emphasizing the use of “predictive modeling” technologies to identify specific providers that warrant further investigation.  The Acting Administrator touts that predictive modeling has already identified 2,500 leads for further investigation, 600 preliminary law enforcement cases, and 400 direct interviews with providers that have taken place due to the use of predictive modeling.

The 2012 Office of Inspector General Annual Work Plan also referred to new methods and programs to detect potential billing anomolies.  The OIG states that it will be using data matching programs to identify not only providers who are at a high risk of having incorrect billings, but also providers who have low risk.  The OIG claims that it will be examining both types of providers to determine the impact that compliance program operations have on the accuracy of billings.  This is alarming because it means that the OIG will be eamining the operations of compliance programs who show low risk of billing anomolies.

The Coming of Mandatory Compliance Programs

The PPACA created the concept of mandatory compliance programs for most providers.  Nursing homes are first on the list and must certify that they have an effective compliance program by 2013.  We are expecting additional regulations on what constitutes and effecive compliance progam as well as specific timelines defining when other provider types will be required to adopt compliance programs as a condition of participation in the Medicare and Medicaid programs.

Compliance Programs – One Size Does Not Fit All

The OIG Guidance on Compliance Programs as well as the Federal Sentencing Guidelines make it clear that one size does not fit all when it comes to compliance program development.  An effective compliance program needs to be strategically developed based on identification of the risk factors that are specific to the size and nature of the organization.  It is not prudent to simply copy the policies of another organization and adopt them as your own.  You should create a structure as well as topical policies that reflect the nature of your particular organization; sometimes right down to the personalities that are involved in the various aspects of your operations.

There are certain core principals that will be common to all compliance programs.  However, your program should be appropriately scaled to the size and resources of your organization.  I am not suggesting that you fail to allocate sufficient resources to compliance.  Decisions regarding allocation of resources are difficult but must be addressed.  At the same time, you do not want to develop policies that you will never have the resources to appropriately follow.  This carries the risk of creating a “Roadmap” that demonstrators to investigators the things that you are NOT doing.  Policies that you do not follows are argueably worse than having no policies at all; at least in some areas.

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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