Health Law Blog - Healthcare Legal Issues

Posts Tagged ‘Compliance Programs’

Compliance Program Best Practices Review of Effectiveness

Monday, April 3rd, 2017

Now Is The Time To Re-Examine Compliance “Best Practices” In Your Organization

Historically, compliance programs have not been per se mandatory.  However, most larger health care organizations have established formal compliance programs to foster an atmosphere of compliance and to take advantage of possible benefits under the Federal Sentencing Guidelines.  The Patient Protection and Affordable Care Act of 2010 has made compliance programs mandatory for many providers.  The exact scope of what type of provider will be required to establish formal compliance programs has not yet been set in stone by the Office of Inspector General.  However, it can probably be expected that most providers will be required to formalize their compliance efforts.

Institutional health care compliance has been growing for well over a decade now.  Compliance is becoming of major importance to health care providers of all nature and size.  The OIG has promoted compliance programs by releasing compliance guidance covering a number of industries, including billing companies, physician practices, hospitals, home health agencies, long term care facilities, ambulatory surgery centers and others.  Smaller providers who have previously not had the establishment of formal compliance programs on their radar will now be required to adopt formal plans.

It is not enough to simply adopt a compliance plan, place it on a shelf, and let it collect dust.  A compliance program requires active monitoring.  There are seven basic elements that are necessary for a compliance program to meet regulatory requirements and the requirements under the Federal Sentencing Guidelines.  The seven primary elements of an effective compliance program include:

  • The establishment of written compliance policies and procedures;
  • The designation of a high ranking individual within the organization to serve as compliance officer;
  • The establishment of an effective training and education program for all levels of personnel;
  • The establishment of effective lines of communication, such as a compliance hotline, to enable individuals within the organization to report compliance breaches;
  • Performing ongoing internal auditing and monitoring
  • The creation of a system that enforces breaches of the compliance program including appropriate discipline and corrective measures
  • The establishment of effective measures to respond to compliance problems that are detected.

An effective compliance program establishes an atmosphere of compliance that permeates the entire organization.  A compliance program should be tailored to the specific circumstances of the provider.  The program should also feed and grow on itself.  As problems are detected appropriate changes should be made to the program and related policies and procedures.

Mandatory compliance programs also highlight the importance of compliance on larger institutions who may have already adopted formal programs.  These institutions should take the signal that compliance is of growing importance.   Providers who have already adopted compliance plans should take the opportunity to dust them off and re-examine the role of compliance within their organization.  Now is the time to increase the focus on compliance and assure that compliance is an active system rather than a written plan that is sitting on the shelf.

Dental Practice Compliance Programs – Essential Elements of Compliance Policies

Monday, February 13th, 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.

About Our Dental Practice Attorney Representation

Health Care Compliance Attorney – Certified CHC Lawyer

Tuesday, January 10th, 2017

Health Care Compliance Attorney

Compliance Representation – Certified Health Care Compliance

The Ruder Ware Compliance Team provides a variety of compliance-related services across a number of industry sectors.  Our compliance practice in the health care industry is lead by Attorney John Fisher.  John is a practicing health care attorney who has substantial expertise in the compliance area.  He is certified in both Health Care Compliance and Corporate Compliance and Ethics.

Aggressive Governmental Fraud and Abuse Investigations

Government enforcement practices and ever changing regulatory requirements require health care providers of all types and specialties to function in a highly complex environment.  Government enforcement operates under a “return on investment” mentality which leads to extremely aggressive and sometimes unfairly overbroad enforcement actions.  This leaves even the most well intentioned health care provider feeling targeted and overburdened with regulatory requirements.

Ruder Ware Provides a Full Range of Compliance Services

The Ruder Ware compliance team has provided a broad range of compliance related legal services to a wide range of health care providers such as hospitals, mental health programs, skilled nursing facilities, ambulatory surgery centers, a variety of medical groups, diagnostic facilities, home health care providers, personal care agencies, clinically integrated provider groups, accountable care organizations and other providers.  Each provider that we represent has unique features and characteristics that require creative approaches to mitigate the impact of overzealous governmental enforcement and private whistleblowers.

We Help You Prepare for an Eventual External Examination of Your Compliance Process

Our compliance practice functions under the philosophy that all providers will eventually be called upon to defend their compliance programs.  This may come through a self-disclosure after an infraction that is discovered through self assessment or audit.  Less ideally, it could come from a money hungry whistleblower who will not let go of a case until there is a payday.  It could also come at the hands of a government criminal or civil prosecutor.  Regardless of the source of challenge, at some point in the future, a compliance program will be put to the test.  When this happens, it must be effective to detect and correct potential compliance problems.  This requires both a well designed plan.  It also requires a showing that the plan is actively operating to identify risk areas, audit for anomalies in areas where risk may be present, and comes full circle to take appropriate action to correct potential problems that are identified.  If this is happening when your time comes; when your compliance program is put to the test, you will have gone a long ways toward mitigation of potential negative consequences.

Penalties Are Increasing and the Scope Activity Considered Abusive Continues to Expand

Some may wonder how the government plans to pay for changes in the health care system.  One of the primary sources of payment in the future will be through enforcement of actual or perceived fraud and abuse.  Currently, the Federal government received an 800% return on every dollar that it invests on pursuing health care fraud and abuse.  With increased penalties and more draconian enforcement systems in place, the government is poised to turn the enforcement business into an even more lucrative proposition.  The stage is set with laws that increase penalties to such an astronomical level that even a much less than certain case will be settled rather that risk being dragged through a proceeding that a provider is likely to lose in the end.

The Danger of Whistleblower Claimants

Whistleblowers also are incentivized to file cases as they seek to benefit personally from provider activity that may not fully conform to regulatory expectations. No provider is immune, no matter how effective its corporate responsibility program. For these reasons, all providers need experienced Compliance Counsel to assist them in trying to prevent regulatory violations, to determine the scope of and assist with correcting identified compliance issues and to defend them in the event they do become a target of government investigative activities.

Whistleblowers can come from a number of different places.  Disgruntled employees are a prime candidate to bring a whistleblower complaint.  How these complaints are handled is extremely important to minimizing their potential negative impact on you operations.  Once a Whistleblower attorney becomes financially committed to a case, they tend not to let go easily.  Settlement can be very difficult to attain on reasonable terms.  It is fair to say that in many cases the government gives more latitude to settle cases if the provider cooperates.

There are some reasonable government enforcement individuals who appropriately utilize their discretion when a provider cooperates and has not intentionally bilked the system.  Whistleblowers on the other hand, have their sites set on the full maximum amount of calculated False Claims Act damages.  They are looking for a pay day.  We can help you avoid this type of situation altogether by helping establish an effective compliance program that takes appropriate action to mitigate exposure if infractions are discovered.

General Compliance Counsel Services

We act as general compliance counsel to numerous health care providers and companies as well as business in other industries such as transportation, finance, manufacturing, securities, and other industry areas.  Ruder Ware represents businesses with worldwide operations who we routinely counsel regarding the impact of anti-bribery laws and other laws that impact international operations.  Our multidisciplinary approach enables us to apply our expertise in compliance process and investigations to various industry sectors that are represented by other attorneys in our firm who have extensive knowledge of the regulatory requirements that impact their business or industry sector.  For example, we have applied our compliance knowledge with our significant clientele in the transportation industry, paper manufacturing industry, financial sector, and heavy manufacturing for international distribution.

Roots in the Highly Regulated and Ever Changing Health Care Industry

Our compliance practice got its start primarily in the health care industry and has flourished into other areas building on our experience and success in health care.  The health care industry has historically been out in front of many other industries which enabled our firm to get into the compliance service industry early and gained significant experience that has served our team well. Our compliance team has gained substantial experience handling compliance that impact the Federal False Claims Act, Civil Monetary Penalties Law, Stark Law and Anti-Kickback Statute. We routinely counsel our clients on how to apply systems to proactively comply with a multitude of regulations that apply to their regulations.  We recommend processes that apply to all types of health care providers and across all industry sectors.

Proactive and Aggressive Risk Identification Process

Our recommended process creates a “living and breathing” process that is continually at work within an organization to identify potential risk areas.  Those identified areas where risk is likely to be present can then be further analyzed to ascertain the types of potential risks and a behaviors that create those risks.  A process can then be applied to mitigate risk through establishment of policies and procedures, checklists, and process flow that are intended to reduce risk.  Employees are trained on these processes and monitoring and auditing occurs to assure that processes are being regularly followed.  The entire process must be documented to the detail.  If incidents occur in spite of the risk reduction process, proof of the proactive activities that were taken to prevent these occurrences will be of great assistance in mitigating the negative consequences of the discovered infraction.  Generally, self disclosure, with confidence that you are backed up by a continually operating compliance system are your best defensing most cases to the negative consequences of the discovered non-compliance.

Compliance Program Development and Assessment

Our compliance attorneys have experience creating and implementing compliance programs to fit the specific needs of our business and health care clients.  Compliance programs are not “one size fits all.”  A program must be tailored to address the specific risks that are presented by the type and scope of business.   We are adept at creating solutions that leverage compliance resources to achieve the most efficient and effective compliance operation.  We have developed compliance programs for national and multinational business in a variety of industries.  We have also helped small businesses develop compliance programs that are scaled to the size of their businesses and the resources that are necessary to mitigate compliance risk.  Contrary to some professional, legal forms sites, and novice compliance professionals, there is no single set of forms that can be used to craft a proper compliance program.  Some elements are common in most plans, but the failure to customize a compliance program to the specific business is perhaps the most common mistake that can be made and results in a major threat to the effectiveness of the program and the ability to use the program to mitigate potential legal exposure.

In additions to creating compliance program structures, Ruder Ware’s compliance team has developed a series of comprehensive compliance program assessment and effectiveness tools that we use to identify gaps in compliance program operations.  We use a systematic approach to evaluating compliance programs to assure that they are operated effectively to identify and mitigate compliance risk.  A compliance program is of little value if it cannot be demonstrated to be effective.  We can provide an independent, detailed and systematic evaluation of any compliance program.  The results of this assessment can be integrated into the compliance cycle to enhance effectiveness and improve efficiencies.  We also use variations on this process to assist clients in creating compliance work plans that identify and prioritize compliance operations, audit and monitoring areas, and achievement of specific compliance goals.

Our compliance attorneys are active in national compliance organizations.  We are also committed to maintaining active certifications in compliance and ethics as a means to assure that we are up to date on legal and regulatory requirements as well as the standards that must be met to achieve effective compliance operations.

Internal Compliance Audits Under the Attorney-Client Privilege/Work Product Doctrine

We regularly work through the attorney-client privilege and work product doctrine, as necessary, to internally investigate compliance issues with the provider. We are familiar with the intricacies of various state and federal laws that relate to privilege.  We are also attuned to enforcement policies relating to waiver of privilege and the relationship of privilege to the ability to secure cooperation credit from investigative agencies.

Privilege issues are intricately involved with internal investigations and we take great pains to assure that the process that we use to conduct investigation maintain privilege to the greatest extent possible.  In order to maintain privilege, it is generally necessary to retain outside counsel to direct and control the investigation including securing necessary consultants, experts, and support personnel.  We have relationships with external support consultants and experts in several industries and technical areas.

Educating Clients and Their Employees On Compliance Related Issues

Education of staff is a critical element of an effective compliance program.  Without training individuals within the organization, a compliance plan is little more than a set of policies gathering dust on a shelf.

Our compliance team can assist clients in creating training systems, preparing training material, and performing training programs.  Out compliance attorneys will often provide training sessions on compliance oversight responsibilities to the Board of Directors of a company or to key committee members, officers, and upper management staff.  It is critical for the success of a compliance program that there be acceptance from the top of the organization.  This is where the environment of compliance is created.

We have assisted clients conducting in person compliance training and have conducted web based compliance training modules in basic and special compliance subject areas.  We have also been called in to provide training as part of a corrective action program after compliance risks are detected.  We are also involved in specialized training on issues such as Stark Law compliance, physician compensation, and other issues that are unique to the provider but present unusually complex regulatory requirements.

Extension to Provider Certification and Deficient Surveys

In addition to providing proactive compliance advice, our team provides legal representation in connection with deficiency reports and survey findings.  We can assist providers through the informal dispute resolution process in connection with state and federal surveys.  In cases of serious deficiencies we can represent providers in the appeal process and related proceedings.  Where Civil Monetary Penalties are assessed, we can often negotiate as part of the appeal process for a reduction in penalties, severity or scope of findings.   In extreme cases, deficiencies can also involve overpayments and self-disclosure.  We have can assist providers in the assessment of whether a self-disclosure may be necessary and in appropriate cases, we can conduct the necessary investigations and prepare self disclosure submissions.

Other  Areas Handled By Compliance Team

Although our compliance practice grew originally out of our health care practice, it now extends beyond the health care industry into manufacturing, global transportation, relocation services, financial institutions, and other industry segments.  Our systematic approach to compliance can be applied to virtually any industry together with regulatory experts in that area.

Our health care compliance attorney has also received certification in Corporate Compliance and Ethics which includes global compliance issues.  We are routinely called upon to apply our industry and compliance knowledge to develop compliance operations across a variety of industries.

Beyond the false claim and fraud and abuse inquiries, our compliance team also routinely handles a number of other regulatory compliance matters such as provider certification, provider specific requirements, Sarbanes-Oxley and international compliance areas such as the Foreign Corrupt Practices Act, the UK Anti-Bribery Act, and a variety of other laws that require  effective compliance efforts application to identify and systematically address mitigation of risk.

Government Investigations and Defense

Federal and state governmental regulatory agencies have become very aggressive in investigating and prosecuting compliance failures.  Our compliance investigation team can conduct internal investigations and can often work with governmental agencies to coordinate investigative functions.   We can assist providers who are under scrutiny of the governmental in formulating a proper response to governmental audits, formal and informal investigations, subpoenas and other information requests. We can work with provider clients to shape appropriate response depending on the issues involved and the positions and approach being taken by governmental authorities.  We are also able to coordinate internal investigations to assure that privilege is retained where necessary and to preserve the ability to obtain cooperation credit from the government.

Compliance With Voluntary Self Disclosure Protocols and Process

We have experience with the self disclosure protocol and processes established by the Office of Inspector General and Center for Medicare and Medicaid Services.  We have assisted clients in the assessment of potential compliance risks to determine whether self-disclosure is necessary or appropriate.   We have also conducted investigations of various issues to assess the nature and extent of potential risk.  When it is determined that self disclosure is prudent, we assist clients in preparing necessary disclosure documents and support.  We also interact with governmental agencies to resolve issues through self-disclosure.

Compliance Team Subject Areas

  • Compliance Plan Structure and Operation
  • Compliance Auditing and Monitoring Programs
  • Compliance Work Plan and Task Prioritization
  • Risk Area identification, Scoring and Prioritization
  • Compliance Process Trainings
  • Compliance Risk Area Specific Training
  • Regulatory Interpretation and Guidance
  • Structuring Policies and Procedures
  • Governmental Investigations
  • Internal Investigations
  • Cooperation and Coordination With Governmental Investigators
  • Joint Defense Agreements and Cooperation With Joint Defendants
  • Civil Monetary Defense and Appeal
  • Foreign Corrupt Practices Act
  • International Anti-Bribery Law Compliance
  • Compliance Coordination with Subcontractors and Downstream Entities
  • Health Care Compliance Issues
  • Transportation and Global Relocation Compliance
  • Privacy Act and Health Information Compliance
  • False Claims Act Investigations and Enforcement Actions
  • Survey, Certification and Deficiency Citations
  • Breach Disclosure Assessment and Notification

 

John H. Fisher, CHC, CCEP is a health care attorney at the Ruder Ware law firm.  John is actively involved representing clients on legal and compliance issues.  He has represented clients in creating compliance programs and in a variety of operational issues.  He also assists providers in addressing risk areas and potential compliance issues including preparing self-disclosure and working with the government to resolve disclosed compliance issues and overpayment.  John consults as a subject matter expert and provider legal backup to other attorneys and law firms from around the country on specialized compliance, regulatory and health care issues.  John has followed legal issues impacting health care provider for over 25 years.  As such, he is knowledgeable on the current legal standards as well as the historic perspective that is often relevant to an appropriate analysis. 

Hospice and Home Health Areas of Review Risk

Wednesday, September 18th, 2013

Home Health and Hospice Review Areas

home health hospice fraud reviewsThere are several areas applicable to home health and hospice that are susceptible to review.  Hospice reviews have tended to focus on whether patients actual meet criteria to be eligible to receive hospice benefits.  The focus on hospice arises, at least in part, due to the expansion of this segment of health care industry and the relatively rapid increase in spending for hospice care.  The government’s audit and enforcement trends indicate a deep suspicion that hospice are admitting patients who are not terminal or do not otherwise meet eligibility criteria.  The government points to the relatively large number of hospice patients who are discharged from hospice care alive.

In order to qualify for hospice benefits, a Medicare patient must have an illness that is terminal.  A physician must certify that the patient is terminal and is unlikely to live longer than six months if the illness runs its expected course.  The patient must also waive their right to receive curative treatment for the terminal condition in order to qualify for benefits.  Physician certification must be provided at two 90-day intervals following hospice admission.  After the first 180 days of hospice care, the patient must be seen “face-to-face” by a nurse practitioner who determines continued eligibility for coverage.  This process of certification and admission qualification creates several obvious pouts of risk for providers.  The government seems to be keying in on a few of these points of risk as evidenced by recent enforcement actions.

Payments to physicians for administrative duties should be carefully scrutinized to assure that the compensation arrangement does not create a referral inducement.  Medical director agreements must be analyzed under the Anti-Kickback Statute and applicable Stark Law exceptions.  Compensation should be at fair market value, cannot take into account he volume or value of referrals, and must meet other regulatory requirements.

Physician Practice Compliance Programs – Practical Approach

Wednesday, May 22nd, 2013

Physician Practice Compliance Programs – A Practical Approach

physician group compliance programsThere is currently a lot of hype out there about the need for physicians to establish compliance programs. I agree that each practice should have a compliance program in place. However, I do not agree that the compliance program necessarily needs to be lengthy or complicated. In fact, I believe that it is most important to be focused in on the key elements that are applicable to your practice and that can be followed given the resources that are available. Simply adopting precanned policies will do little more than create a roadmap of items that you cannot possibly achieve.

So what should be included in your compliance program? Your program should certainly include reference to the seven basic elements that are commonly identified as being required in a compliance program. You should describe the steps that you will take to assure that each of the seven elements are achieved. You will also want to prepare a basic code of conduct that reflects your commitment to creating a culture of compliance.

The Office of Inspector General published guidance for physician practice compliance programs in October of 2000. You should read those guidelines and integrate the aspects of the guidance that applies to your practice. The OIG guidance also includes a description of the seven basic compliance program elements. The seven basic elements of a compliance program include:

1. Internal auditing and monitoring,
2. Compliance processes and standards,
3. Appointing a compliance officer or compliance responsible individual,
4. Providing education and training to your staff,
5. Responding to compliance issues in an appropriate fashion and taking corrective action,
6. Creating an open system of communication of compliance issues, and
7. Taking appropriate disciplinary action with respect to compliance infractions.

You will also want to adopt policies to implement some of these general areas. For example, it is crucial that your compliance program include a strong anti-retaliation policy and a system that permits employees to register anonymous complaints. Your compliance policies should also be integrated into your employment and disciplinary procedures so that employees are made aware that non-compliant behavior will not be tolerated. Your policies need to be uniformly applied, from the top to the bottom of your organization.

Applicable guidelines recognize that your compliance program may be scaled to the size of your organization. However, scalability does not permit you to ignore or overlook specific areas that present risk to your business. Your program, regardless of its size or the number of words that are used to convey your standards, must be uniformly and consistently followed and can under no circumstances be left on the shelf collecting dust.

HCCA Compliance Institute Presentation On Compliance Role In Mergers and Acquisitions

Friday, May 3rd, 2013

John Fisher Presents at National Health Care Compliance Institute in Washington, D.C.

John Fisher, JD, CHC

John Fisher, JD, CHC, CCEP

Ruder Ware health care and compliance attorney John Fisher was a featured speaker at the Health Care Compliance Association’s 2013 Compliance Institute.  The Institute was attended by nearly 3,000 compliance officers, attorneys, and vendors from across the country.  Mr. Fisher spoke on the topic “Compliance Issues in Mergers and Acquisitions.”

Mr. Fisher is certified in Health Care Compliance by the Health Care Compliance Association and in Corporate Compliance and Ethics by the Society for Corporate Compliance and Ethics.

Mr. Fisher’s presentation covered some of the following issues:

  • The role of the compliance officer in mergers and acquisitions.
  • Compliance related due diligence requests.
  • The scope of compliance due diligence.
  • Successor liability and assumption of liabilities by purchasers.
  • Compliance impact of deal structure and agreement terms.
  • Compliance effectiveness reviews in mergers and acquisitions.
  • Common due diligence compliance risk areas.

 

For more information on compliance and health law issues, visit our health care law blog at www.healthlaw-blog.com.

Self Disclosure Protocols Revised By OIG

Saturday, April 20th, 2013

Self Disclosure Protocols Revised By OIG

oig self disclosureThe Health and Human Services Office of Inspector General released revised Provider Self-Disclosure Protocol (SDP). The new protocols were released on April 16, 2013. We have not reviewed the protocols in detail at this point and will likely have further information once we review them in depth and compare to previous protocols.  It appears from an initial reading that there were changes in the scope of coverage when there is a violation of the Stark Law. There is also a minimum settlement amount.  More detailed guidelines governing what is applcable in initial submissions are also included.

Stay tuned for more information on the new self-disclosure protocols that were released by the OIG last week.

Long Term Care Compliance Risk Factors

Friday, April 12th, 2013

Nursing Home Compliance Plan Risk Areas Identified in OIG Guidance from 2000

The OIG Guidance to Nursing Homes relative to their compliance plans was issued in 2000.  That document contained the elements that the OIG felt that Nursing Homes should consider in their compliance plans.  Now that the date has passed and nursing facilities and skilled nursing facilities are required to have adopted effective compliance programs, I thought it might be useful to list some of the risk factors that the OIG felt were important in 2000.  Obviously, these factors are not all inclusive and additional risk areas have been identified since that time.  Yet, the items identified in the 2000 OIG Guidance remains a viable starting point to assist facilities in identifiying risk areas that need to be addressed in their compliance programs.

 

Important Statement from the OIG – This factor should be specifically mentioned in all nursing home compliance plans:

The OIG believes that a nursing facility’s compliance policies should start with a statement that affirms the facility’s commitment to providing the care and services necessary to attain or maintain the resident’s ‘‘highest practicable physical, mental and psychosocial well-being.’’

Additional Factors Relative to Quality

  • accurate assessment of each resident’s functional capacity and a comprehensive care plan that includes measurable objectives and timetables to meet the resident’s medical, nursing, and mental and psychosocial needs;
  • inappropriate or insufficient treatment and services to address residents’ clinical conditions, including pressure ulcers, dehydration, malnutrition, incontinence of the bladder, and mental or psychosocial problems;
  • failure to accommodate individual resident needs and preferences;
  • failure to properly prescribe, administer and monitor prescription drug usage;
  • inadequate staffing levels or insufficiently trained or supervised staff to provide medical, nursing, and related services;
  • failure to provide appropriate therapy services;
  • failure to provide appropriate services to assist residents with activities of daily living (e.g., feeding, dressing, bathing, etc.);
  • failure to provide an ongoing activities program to meet the individual needs of all residents; and
  • failure to report incidents of mistreatment, neglect, or abuse to the administrator of the facility and other officials as required by law.

 

Residents Rights.  To protect the rights of each resident, the OIG recommends that a provider address the following risk areas as part of its compliance policies:

 

  •   discriminatory admission or improper denial of access to care;
  • verbal, mental or physical abuse, corporal punishment and involuntary seclusion;
  • inappropriate use of physical or chemical restraints;
  • failure to ensure that residents have personal privacy and access to their personal records upon request and that the privacy and confidentiality of those records are protected;
  • denial of a resident’s right to participate in care and treatment decisions;
  • failure to safeguard residents’ financial affairs.

Billing Issues.

billing for items or services not rendered or provided as claimed;

  • submitting claims for equipment, medical supplies and services that are medically unnecessary;
  • submitting claims to Medicare Part A for residents who are not eligible for Part A coverage;
  • duplicate billing;
  • failing to identify and refund credit balances;
  • submitting claims for items or services not ordered;
  • knowingly billing for inadequate or substandard care;
  • providing misleading information about a resident’s medical condition on the MDS or otherwise providing inaccurate information used to determine the RUG assigned to the resident;
  • upcoding the level of service provided;
  • billing for individual items or services when they either are included in the facility’s per diem rate or are of the type of item or service that must be billed as a unit and may not be unbundled;
  • billing residents for items or services that are included in the per diem rate or otherwise covered by the third-party payor;
  • altering documentation or forging a physician signature on documents used to verify that services were ordered and/ or provided;
  • failing to maintain sufficient documentation to support the diagnosis, justify treatment, document the course of treatment and results, and promote continuity of care;
  • false cost reports;
  • routinely waiving coinsurance or deductible amounts without a good faith determination that the resident is in financial need, or absent reasonable efforts to collect the cost-sharing amount;
  • agreements between the facility and a hospital, home health agency, or hospice that involve the referral or transfer of any resident to or by the nursing home;
  • soliciting, accepting or offering any gift or gratuity of more than nominal value to or from residents, potential referral sources, and other individuals and entities with which the nursing facility has a business relationship;
  • conditioning admission or continued stay at a facility on a third-party guarantee of payment, or soliciting payment for services covered by Medicaid, in addition to any amount required to be paid under the State Medicaid plan;
  • arrangements between a nursing facility and a hospital under which the facility will only accept a Medicare beneficiary on the condition that the hospital pays the facility an amount over and above what the facility would receive through PPS;
  • financial arrangements with physicians, including the facility’s medical director;
  • arrangements with vendors that result in the nursing facility receiving non-covered items (such as disposable adult diapers) at below market prices or no charge, provided the facility orders Medicare-reimbursed products;
  • soliciting or receiving items of value in exchange for providing the supplier access to residents’ medical records and other information needed to bill Medicare;
  •  joint ventures with entities supplying goods or services;
  •  swapping.

Nursing Home Compliance Programs – ACA Statutory Mandate

Tuesday, March 26th, 2013

Mandatory Compliance Program Requirements – Affordable Care Act Statutory Mandate

Provisions of Affordable Care Act Relating to Mandatory Compliance Programs For Nursing Facilities

 

SEC. 6102. ACCOUNTABILITY REQUIREMENTS FOR SKILLED NURSING

FACILITIES AND NURSING FACILITIES.

Part A of title XI of the Social Security Act (42 U.S.C. 1301 et seq.), as amended by sections 6002 and 6004, is amended by inserting after section 1128H the following new section:

‘‘SEC. 1128I. ACCOUNTABILITY REQUIREMENTS FOR FACILITIES.

‘‘(a) DEFINITION OF FACILITY.—In this section, the term ‘facility’ means—

‘‘(1) a skilled nursing facility (as defined in section 1819(a)); or

‘‘(2) a nursing facility (as defined in section 1919(a)).

‘‘(b) EFFECTIVE COMPLIANCE AND ETHICS PROGRAMS.—

‘‘(1) REQUIREMENT.—On or after the date that is 36 months after the date of the enactment of this section, a facility shall, with respect to the entity that operates the facility (in this subparagraph referred to as the ‘operating organization’ or ‘organization’), have in operation a compliance and ethics program that is effective in preventing and detecting criminal, civil, and administrative violations under this Act and in promoting quality of care consistent with regulations developed under paragraph (2).

‘‘(2) DEVELOPMENT OF REGULATIONS.—

‘‘(A) IN GENERAL.—Not later than the date that is 2 years after such date of the enactment, the Secretary, working jointly with the Inspector General of the Department of Health and Human Services, shall promulgate regulations for an effective compliance and ethics program for operating organizations, which may include a model compliance program.

‘‘(B) DESIGN OF REGULATIONS.—Such regulations with respect to specific elements or formality of a program shall, in the case of an organization that operates 5 or more facilities, vary with the size of the organization, such that larger organizations should have a more formal program and include established written policies defining the standards and procedures to be followed by its employees. Such requirements may specifically apply to the corporate level management of multi unit nursing home chains.

‘‘(C) EVALUATION.—Not later than 3 years after the date of the promulgation of regulations under this paragraph, the Secretary shall complete an evaluation of the compliance and ethics programs required to be established under this subsection. Such evaluation shall determine if such programs led to changes in deficiency citations, changes in quality performance, or changes in other metrics of patient quality of care. The Secretary shall submit to Congress a report on such evaluation and shall include in such report such recommendations regarding changes in the requirements for such programs as the Secretary determines appropriate.

 

‘‘(3) REQUIREMENTS FOR COMPLIANCE AND ETHICS PROGRAMS.—

In this subsection, the term ‘compliance and ethics program’ means, with respect to a facility, a program of the operating organization that—‘‘(A) has been reasonably designed, implemented, and enforced so that it generally will be effective in preventing and detecting criminal, civil, and administrative violations under this Act and in promoting quality of care; and ‘‘(B) includes at least the required components specified

in paragraph (4).

‘‘(4) REQUIRED COMPONENTS OF PROGRAM.—The required components of a compliance and ethics program of an operating organization are the following:

‘‘(A) The organization must have established compliance standards and procedures to be followed by its employees and other agents that are reasonably capable of reducing the prospect of criminal, civil, and administrative violations under this Act.

‘‘(B) Specific individuals within high-level personnel of the organization must have been assigned overall responsibility to oversee compliance with such standards and procedures and have sufficient resources and authority to assure such compliance.

‘‘(C) The organization must have used due care not to delegate substantial discretionary authority to individuals whom the organization knew, or should have known through the exercise of due diligence, had a propensity to engage in criminal, civil, and administrative violations under this Act.

‘‘(D) The organization must have taken steps to communicate effectively its standards and procedures to all employees and other agents, such as by requiring participation in training programs or by disseminating publications that explain in a practical manner what is required.

‘‘(E) The organization must have taken reasonable steps to achieve compliance with its standards, such as by utilizing monitoring and auditing systems reasonably designed to detect criminal, civil, and administrative violations under this Act by its employees and other agents and by having in place and publicizing a reporting system whereby employees and other agents could report violations by others within the organization without fear of retribution.

‘‘(F) The standards must have been consistently enforced through appropriate disciplinary mechanisms, including, as appropriate, discipline of individuals responsible for the failure to detect an offense.

‘‘(G) After an offense has been detected, the organization must have taken all reasonable steps to respond appropriately to the offense and to prevent further similar offenses, including any necessary modification to its program to prevent and detect criminal, civil, and administrative violations under this Act.

‘‘(H) The organization must periodically undertake reassessment of its compliance program to identify changes necessary to reflect changes within the organization and its facilities.

Nursing Facility Compliance Program Deadline Is Here!

Friday, March 22nd, 2013

Nursing Facilities Must Have Effective Compliance Programs In Place by March 23, 2013

Nursing Home Compliance ProgramsThe statutory deadline requiring nursing facilities to have formal compliance programs in place is upon us.  The Patient Protection and Affordable Care Act (PPACA) requires all nursing facilities and skilled nursing facilities to have formally adopted effective compliance and ethics programs by March 23, 2013.  To date, the Centers for Medicare & Medicaid Services (CMS) has not released final regulations regarding the required elements of nursing facility compliance programs.  However, the failure of CMS to issue final regulations should not deter nursing facilities from adopting compliance programs.  Even though regulations have not been released, the statutory mandate is in place.  Additionally, there is an abundance of guidelines that define what should be included in the compliance progam of a nursing facility. 

It is unclear how the failure of CMS to issue regulations will impact enforcement in this area.  The statute requires effective compliance programs to be in place by March 23, 2013 regardless of whether regulations are released.  Compliance programs are now a “condition of participation” that can be cited in survey reports.  Directions to survery agencies on this issue is not clear, but it is possible that citations could be issued in this area.  Additionally, if a nursing facility is contemplating a transaction, it is likely that the failure to have a compliance program in place by March 23, 2013 will arise in the course of due diligance.

Remember that it is not enough to simply have the appropriate compliance documents in place.  The compliance program must be demonstrated (and certified) to be “effective.”  Documents alone cannot make a compliance program “effective.”  Compliance program effectiveness requires a specific anlysis of both the content and operation of the compliance program.  Compliance programs that do not have a track record of effective operation cannot be considered to be “effective.”  Organizations need to consider what backup they plan to create to meet the certification requirements under PPACA.  Nursing facilities that do not have compliance programs in place need to address this deficiency immediately.  Those that have compliance programs in place need to assess the effectiveness of their programs.  In either event, experienced compliance counsel should be consulted to determine hat is required in order to meet the statutory mandate.

Ruder Ware offers a full range of compliance attorney services.  Health care attorney John Fisher is certified in Health Care Compliance and Corporate Compliance and Ethics and is one of a handful of attorneys in private practice in the country to hold this dual compliance certification.  You can contact Mr. Fisher through the Ruder Ware web site or through the “Contact” section of this 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.