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Posts Tagged ‘certified healthcare compliance’

Compliance Program Best Practices Tips

Friday, July 13th, 2012

Tips For Best Practices In Compliance Program Operation

Here are a few tips to help you attempt to meet the “best practices” standard:

1.         Act as if you are under a Corporate Integrity Agreement.  Always assume that the government is looking over your shoulder and that you will be called upon at some point to justify the effectiveness of your compliance program.

2.         Follow the government guidelines to the tee.  Familiarize yourself with the Federal Sentencing Guidelines and OIG Industry Guidance and integrate these requirements into your compliance plan.

3.         Keep up with government releases, speeches, regulations, comments, advisory opinions, and all other communication that help to define your obligations.

4.         Make your compliance plan a “living and breathing” documents that is continually up for revision based on specific things that you learn about your specific organizations.

5.         Make sure your compliance officer focuses on compliance and does not wear other hats that compete for time, attention or perspective.

6.         Make certain that sufficient resources are devoted to compliance.  Adopt the view that it is better to spend money on compliance that to pay for mistakes down the road.

If there is any area where you are not able to achieve “best practices” for financial or other reasons, be prepared to justify your shortcomings.  Key to all of this is to operate as if you will someday be required to defend the effectiveness of your compliance program.  In all likelihood you will someday be in exactly that position given the current state of the health care industry and mentality of the governmental agencies that are charged with enforcement.

These are just a few tips to get you thinking about your compliance approach.  Health care reform has made compliance programs mandatory for the first time.  There are also multiple indications that the government wants organizations to devote more to compliance as a way to save health care costs.  It is clearly time for organizations of all types and sizes to re-focus their efforts on compliance within their organizations.

Compliance Program Best Practices

Wednesday, July 11th, 2012

Compliance Program Best Practicescompliance programs - best practices in compliance

 Given the increased importance of compliance, it is helpful for providers to get a feel for what constitutes “best practice” when operating a compliance program.  “Best Practices” is a term that is thrown around all of the time in the business world.  It is used in many contexts and takes on a variety of meanings depending on who is using it and for what purpose.  Wikipedia defines “best practices” as follows:

 Best practices are generally-accepted, informally-standardized techniques, methods or processes that have proven themselves over time to accomplish given tasks. Often based upon common sense, these practices are commonly used where no specific formal methodology is in place or the existing methodology does not sufficiently address the issue. The idea is that with proper processes, checks and testing, a desired outcome can be delivered more effectively with fewer problems and unforeseen complications. In addition, a “best” practice can evolve to become better as improvements are discovered.  Best practice is considered by some as a business buzzword, used to describe the process of developing and following a standard way of doing things that multiple organizations can use.

 As I was thinking about the concept of “best practices” in health care compliance, the Wikipedia definition seems to fall al little bit short of what I would have in mind when discussing “best practices” in health care compliance programs.

 The Miriam-Webster Dictionary defines “best” as the superlative form of “good.”  “best” means “excelling all others” and “offering or producing the greatest advantage, utility, or satisfaction.”  I believe that the definition from Wikipedia is an accurate depiction of what the term “best practices” has become in the business world.  The term has been thrown around loosely to the  point that it no longer carries the meaning of the plain words that make up the two word “buzzword.”

 In the health care compliance context, I believe that it is not advisable to direct your efforts toward the standard “buzzword” meaning of “best practices.”  Instead, you should focus toward attempting to achieve the meaning of “best practices” that is tied to the superlative form of the word “good.”  You should not focus on the “we are doing what everyone else is doing” or the “what we are doing will pass by in most cases” version of best practices when looking at your compliance plan.  The consequences of that approach could easily come back to bite you in the superlative.

 In reality, you may never be able to meet the truly “best” standard.  However, the point of the compliance program requirement is that you are trying to make your compliance program and your organization “the best” when it comes to compliance.

Mandatory Compliance Programs – CMS Regulatory Requirements

Monday, July 9th, 2012

Supreme Court Says “Game On” for Mandatory Compliance Programs

Compliance programs were made mandatory for all providers as a condition of participation in the Medicare program under the patient protection and affordable care act of 2010. With the recent Supreme Court decision upholding the affordable care act,  any uncertainty as to whether the mandatory compliance programs will become a reality has been lifted.

The affordable care act also required the CMS to promulgate regulations that establish the core elements for providers and suppliers to meet with respect to the mandatory compliance programs. CMS is authorized to determine the timing and core elements of the required compliance programs. The first industry segment that are required to adopt compliance programs are nursing facilities which must comply with mandatory compliance program requirements by March 23, 2013. However, CMS missed it statutory deadline (March 23, 2012) for promulgating detailed regulations to guide nursing facilities in the creation of compliance programs. It is expected that these regulations as well as the requirements for other providers will be forthcoming soon now that the Supreme Court has upheld the Affordable Care Act.

The Office of Inspector General has in the past issue compliance program guidance for various industry segments.  We can expect at least some of these requirements to be part of the regulatory clarification coming from CMS under its authority to enforce mandatory compliance programs. We can also expect additional requirements to be added based upon a parallel recent promulgation from CMS that is applicable to Medicare advantage managed-care plans and prescription drug part D plan entities. Although not directly applicable to organizations other than Medicare Advantage Programs and Part D prescription drug programs, the regulatory proposals are instructive of the current thinking of CMS with respect to required elements of compliance programs.

Some key elements of the recent regulatory proposal which were not included in previous OIG compliance program guidance include:

  •  A strong recommendation that there be standardized process for the governing body to review the compliance program documents at least annually. Current guidance is much more permissive and only suggests periodic reviews. The new regulations would require a complete effectiveness review and a detailed “gap analysis” to the Board of Directors on an at least an annual basis.
  • More details concerning distribution of standards of conduct and policies and procedures to new employees. The new proposed regulations required distribution of these materials within 90 days of initial hire and at least annually thereafter.  Distribution of policies and procedures will be an “obligation” rather than simply a “suggestion” once the new proposed regulations are finalized.
  •  The proposed regulations contain the clearest statement to date from CMS that “dual role” compliance officers, where the compliance officer is also the CFO, CEO or General Counsel, present a built-in conflict of interest and are not permitted. This has been a controversial topic in the past as many organizations still maintain their general counsel as their compliance officer. If the recent proposed regulations are any indication, many “dual role” compliance officers will be the way of the past. It appears that it will still be permissible for divisional  managers, such as quality assurance managers, to act in a dual role. However, operational management will not be permitted to act in his rules. This clearly includes CFOs, COOs and General Counsel who are specifically mentioned in the proposed regulations

There are many additional details that are contained in the most recent proposed regulations. There’s every indication that these proposed regulations are a foreshadowing of the eventual requirements that CMS will release under the mandatory compliance program authority that will be applicable to other providers such as nursing homes, physician groups, hospice, DME providers and other health care providers.

In view of these pending requirements and in light of the apparent expansion of compliance program requirements that is being hinted at by CMS,  providers should conduct an effectiveness review of their compliance programs now and begin the ongoing process of conducting such reviews on an at least an annual basis.  Reviews should be conducted with the requirements of the new proposed regulations in mind.

Small organizations, such as physician practices and smaller healthcare organizations should begin immediately to implement scalable compliance program structures that are focused on the specific risk areas that affect their organizations and begin to create an infrastructure for an effective compliance program.

 Organizations who still have their General Counsel, CFO, or COO acting as their compliance officer should begin to set the stage to undo that structure.  A separate office of Chief Compliance Officer should be created and separately budgeted.  The CCO should have autonomy from other operational offices and should have direct access to the Board of Directors, a Compliance Committee and the CEO.  This issue can be politically difficult within an organization and should be addressed soon rather than later.  Ultimately, this is an issue that must be firmly addressed by the Board of Directors under its responsibility to oversee the compliance program.

Hiring Individuals With Access to Controlled Substances – DEA Waivers

Tuesday, March 13th, 2012

DEA Waivers Necessary For Access To Controlled Substances

What is a “Convicted Felon” in the Eyes of the DEA

Most health care providers have implemented some sort of screening process for new employees, contractors and medical staff members.  The screening process usually involves some sort of criminal background check along with review of the OIG and GSA exclusion lists.

One aspect of criminal background checks is rarely discussed and involves individuals who will have “access to controlled substances.”  The Drug Enforcement Agency has rules that prohibit any DEA registrant from employing, as an employee or agent, any party who has ever been “convicted” of a felony involving controlled substances.  No such person may ever be employed in a position where they will have “access to controlled substances” unless a waiver is obtained from the Administrator of the DEA.

I placed a few of the operative terms in quotes above for a reason.  The exact definitions of these the terms “convicted of a felon'” and “access to controlled substances” is what makes application of this rule rather tricky.  The first angle involves whether or not a potential employee, staff physician or other has had a “felony conviction” involving controlled substances.  Oftentimes someone who is accused of a drug related crime under state law will plead “no contest” to a felony but the terms of the sentence will provide that the severity of the sentence will be reduced to a misdomeaner, or sometimes even dismissed, upon completion of terms of probation.  If the terms of probation are successfully completed, a subsequent criminal record search may come up with the action having been dismissed or reduced to a misdemeanor.  No issue, right?  Common sense would dictate that there is no felony conviction and the individual can be employed. 

Wrong.  The DEA rules consider there to have been a felony conviction even though the charges may have eventually been dismissed or reduced.  This is applicable whenever there is a plea of “no contest” or “nolo contendre.”  The DEA considers these please to be an admission of and a conviction of a felony offense.  This can be highly problematic for a health care provider who is doing a record search and comes upon a case that may show up as a misdemeanor or having been dismissed.  The provider must look further to determine whether the event could still be considered to be a felony by the DEA.  If it is considered to be a felony, a Waiver must be sought from the DEA to employ or otherwise permit that individual to use the provider’s facilities.  Waivers can be difficult and costly to obtain.  There are no regulations guiding the process and the final decision is in the sole discretion of the Administrator of the DEA.  There are no meaningful appeal rights.

Another thing that should be pointed out is that once a person is convicted of a felony (as defined by the DEA) that involves controlled substances, the issue carries along with the individual forever.  A waiver only applies to a specific facility.  The employee has no standing to apply for a waiver request.  Every place that the employee wishes to work in the future will need to obtain a waiver.

It should be clarified that a waiver is only required if the individual will have “access to controlled substances.”  This is the second definition that becomes important.  There does not appear to be any regulation or case that defines when an individual is considered to have “access to controlled substances.”  The DEA takes a fairly broad view that would generally prohibit any direct patient care.  Practicing medicine in a hospital and most other settings is likely excluded.  However, this definition probably does not extend to administrative tasks that do not involve seeing patients or being located in areas of the facility that do not hold controlled substances.  Yet, the fact that there is no clear definition of “access to controlled substances” makes this rule very difficult to apply in a specific, practical situation.

The takeaway from all of this is that compliance departments, human resource departments, and credentialing departments may need to take a fresh look at this issue to be certain that they have systems in place to flag cases described in this article.  The DEA may consider even a youthful drug conviction, that shows up as a dismissal or a misdemeanor on a criminal background check to be a felony.  If the event is considered to be a felony, a health care organization cannot employ the individual in a position to have access to controlled substances without first obtaining a waiver from the DEA.

Attorney Certified Health Care Law Health Care Compliance

Sunday, November 27th, 2011

Attorney John Fisher Receives Certification in Health Care Compliance

Health care attorneys health lawAttorney John H. Fisher II, a health care attorney with Ruder Ware in Wausau, Wisconsin, has obtained certification in health care compliance.  Mr. Fisher will now carry the designation of CHC (Certified Healthcare Compliance).  The certification is provided by the Health Care Compliance Association (“HCCA”), a national organization based in Minneapolis.  Mr. Fisher is the fourth attorney resident in the State of Wisconsin to obtain this certification.

The HCCA defined the CHC designation as follows:

 The CHC© is a professional with knowledge of relevant regulations and expertise in compliance processes sufficient to assist the health care industry to understand and address legal obligations, and promote organizational integrity through the operation of effective compliance programs.

The HCCA also states that:

The purpose of certification is to promote health care compliance through the certification of qualified health care compliance professionals by:

  1. Recognizing formally those individuals who meet the eligibility requirements of the CCB and pass the Certified in Healthcare Compliance© (CHC©) Examination.
  2. Encouraging continued personal and professional growth in the practice of health care compliance.
  3. Providing a national standard of requisite knowledge required for certification; thereby assisting employers, the public and members of the health professions in the assessment of a health care compliance professional.

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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