Health care compliance program

There is additional potential exposure under other healthcare laws. For example, under the AKS a claim that includes items or services resulting from a violation of the AKS constitutes a false or fraudulent claim under the False Claims Act. Many states have similar anti-kickback laws, and in some cases these laws apply regardless of the payor i.

This Health Care Compliance Program is designed to ensure, to the maximum extent possible, that payments to Health Care Professionals do not run afoul of anti-kickback and similar laws.

Arrangements of this nature and involving these services are referred to for purposes of this policy as consulting arrangements. It is appropriate to pay Health Care Professionals fair market value compensation for performing these services intended to fulfill a legitimate business need.

However, consulting arrangements must be bona fide and not be used to incentivize or reward or pay Health Care Professionals for purchasing CONMED products or services or to influence such purchasing decisions. Such programs may occur at centralized locations requiring out-of-town travel for some participants , and may extend more than one day. For local and State-specific restrictions in this area, if any, please refer to Exhibit A. CONMED may provide monetary, in-kind, and other contributions to third parties in support of their educational, charitable, and research programs as described in this section.

A Third-Party Program Organizer could include, for example, a health care professional society, institution, and association, medical trust fund, continuing medical education provider, or hospital or other health care entity.

This term includes programs that are accredited to provide continuing education credits and programs that are not accredited.

An Educational Grant is not offered for Commercial Sponsorship opportunities. Additional key principles are addressed below, and additional examples and Frequently Asked Questions about appropriate practices are provided in the AdvaMed Code. Educational grants may be provided for legitimate purposes, including but not limited to the examples below.

Supporting Other Third-Party Programs through Educational Grants CONMED may provide Educational Grants to training institutions such as medical schools and teaching hospitals and to other third-party entities in support of their legitimate educational and training programs and activities.

This includes, but is not limited to, Educational Grants to support the education and training of health care and medical personnel for example, physicians, medical students, residents, fellows, or other Health Care Professionals-in-training , patients, and the public about important health care topics.

Research provides valuable scientific and clinical information, improves clinical care, leads to promising new treatments, promotes improved delivery of health care, and otherwise benefits patients.

In furtherance of these objectives, CONMED may provide research grants to support independent medical research with scientific merit and has established controls for reviewing requests for research grants.

Unrestricted research grants are not permitted. Donations should be made only to charitable organizations that are separate from, and not related to, a Health Care Professional e. CONMED may pay for modest and reasonable travel and lodging costs for Health Care Professionals to attend Company-conducted programs or meetings under certain circumstances.

CONMED will follow all applicable state and federal laws and regulations related to paying for Health Care Professional travel and lodging, and will also apply the following principles:. In connection with product training, conferences, business meetings, and other interactions with Health Care Professionals described herein, CONMED may provide modest meals and refreshments to Health Care Professionals as an occasional business courtesy consistent with the limitations in this section.

For local and State-specific restrictions, refer to Exhibit A. Notwithstanding the foregoing, under no circumstances may meals be provided to a Health Care Professional in violation of state law. For example, Massachusetts prohibits companies from providing or paying for meals for a Health Care Professional in certain settings, and Vermont prohibits companies from providing meals directly to Health Care Professionals altogether.

Because state laws vary, all requests for reimbursement of a meal provided to a Health Care Professional must be on a Company-approved form available on the Company intranet. A limited exception is that, except where prohibited by local or state law see Exhibit A , CONMED may occasionally provide items to Health Care Professionals that benefit patients or serve a genuine educational function. Examples of such items include medical textbooks, anatomical models, and short-term subscriptions to scientific, industry or peer-related publications.

CONMED also may not give a Health Care Professional gifts such as cookies, wine, flowers, chocolates, gift baskets, holiday gifts or cash or cash equivalents, regardless of the occasion. Finally, CONMED may not provide items that are capable of use by the Health Care Professional or his or her family members, office staff or friends for non-educational or non-patient-related purposes, such as office supplies, scrubs, a tablet, Smart Phone, laptop, or other mobile device capable of personal use.

This section is not intended to address the legitimate practice of providing products for evaluation and demonstration purposes, which is addressed in Section XIII.

Some examples of entertainment and recreational activities which are prohibited include, among others, theater, sporting events, golf, skiing, hunting, or vacation trips.

This prohibition applies regardless of : 1 the value of the activity; 2 whether CONMED engages the Health Care Professional as a consultant; or 3 whether the entertainment or recreation is secondary to an educational purpose. Health Care Professionals may use a product for any use that they determine is in the best medical interests of their patients. As recognized under U. CONMED has developed policies and controls that incorporate principles of applicable law and guidance relative to communications about its medical devices.

CONMED may engage in industry-appropriate communications of information, which can include, among other activities:.

CONMED has a responsibility to communicate about medical and scientific information to assist in achieving positive patient outcomes and support of the public health, and will do so by ensuring that: 1 only authorized Company personnel provide responses about unapproved or uncleared uses of its medical devices; 2 communications about medical devices are truthful and non-misleading; and 3 information related to unapproved or uncleared uses of its Medical Technology is identified as such.

CONMED may provide Health Care Professionals with timely and complete coverage, reimbursement and health economics information regarding its products if such information is accurate, objective, and readily available.

CONMED may, at the request of a Health Care Professional to facilitate patient access to its products and subject to the appropriate privacy safeguards, assist the patient by facilitating the preparation and submission of requests for coverage determinations, prior authorizations, pre-certifications and appeals of denied claims; however, such assistance may not be provided as an unlawful inducement. For example, CONMED may not provide free services that eliminate an overhead or other expense that a Health Care Professional would otherwise of business prudence or necessity have incurred as part of its business operations if doing so would amount to an unlawful inducement to purchase, lease, recommend or prescribe any CONMED product or service.

Furthermore, CONMED may not suggest a mechanism for billing for services that are not medically necessary, or for engaging in fraudulent practices to achieve inappropriate payment.

CONMED may provide reasonable quantities of products to Health Care Professionals at no charge for evaluation and assessment, and to determine whether to purchase the product. These products may be provided at no charge to allow Health Care Professionals to assess the appropriate use and functionality of the product and determine whether and when to use, order, or recommend the product in the future.

Appropriate documentation and disclosure should be provided to Health Care Professionals regarding the no-charge status of evaluation and demonstration products. CONMED sales representatives may play an important role in the clinical setting by providing technical support on the safe and effective use of Medical Technology. For example, a CONMED sales representative may need to explain the unique settings and technical controls functions of our products, and may also make recommendations.

CONMED will adhere to the following principles when providing technical support in clinical settings:. This Health Care Compliance Program does not and cannot answer every question or address every possible situation. It is important to follow not only the letter of applicable law and guidance, the AdvaMed Code, and the Program, but also the spirit. No payments permitted hereunder may be made by personal checks.

In some instances states impose a specific requirement that regulated companies put in place a Health Care Compliance Program. Connecticut requires medical device manufacturing companies to adopt and maintain a Comprehensive Compliance Program. Vermont requires device manufacturers to designate an individual who is responsible for compliance and reporting activities of the company.

Maine prohibits providing gifts of any kind to health care Practitioners 5 including cash gifts in any amount or a gift for which reciprocity is expected or implied.

Massachusetts Massachusetts has imposed requirements on interactions with Health Care Practitioners 6 licensed in Massachusetts, regardless of whether those interactions occur in Massachusetts or outside of Massachusetts. Key aspects of the law are summarized below, and you should also review and adhere to the full content of the Massachusetts Marketing Code of Conduct.

For further guidance, please contact the Compliance Committee or the Legal Department. When interacting with a Vermont Health Care Professional, 7 you must adhere to the following standards in addition to the requirements set forth generally in the Health Care Compliance Program. These restrictions apply to interactions with Health Care Professionals who are licensed in Vermont and who practice there regularly.

Key aspects of the these requirements are set forth below, and you should also review the Vermont Prescribed Products Gift Ban Guide , which is updated annually by the Vermont Office of the Attorney General, and the Vermont Office of the Attorney General webpage providing up-to-date information on Disclosures by Manufacturers of Prescription Drugs, Biological Products and Medical Devices.

California law requires that a specific maximum annual dollar limit be set on any gifts, promotional materials, or items or activities that a company may give or otherwise provide to an individual California medical or health professional i. Connecticut requires an annual transparency report for any payments or transfers of value to Advanced Practice Registered Nurses not practicing in collaboration with a physician in the state.

What will compliance do when coding and billing errors have been detected? Audits are more formal and sometimes involve an outside consultant. How often will you have an audit to ensure that the monitoring is effective? Example: What steps will you outline in your compliance plan to take when someone has breached your compliance plan?

Will there be a warning or will the person be fired? If the compliance breach is at a high level — CEO or board — how will the compliance point of contact handle that situation?

Is there a compliance committee that reviews and discusses such issues? The Patient Protection and Affordable Care Act ACA , Section , mandated that providers put a compliance plan in place, but an enforcement date has not been issued for that requirement.

The compliance program must contain core elements that the U. Considering the ACA went into effect in , the healthcare industry has had a lot of time to prepare and get compliance programs in place. If your organization still has work to do, resources like the CMS joint presentation with the OIG may assist with designing your compliance program.

We also saw above that the Medicare Advantage contract requirements chapter of the Medicare Managed Care Manual mandates that MA organizations show a demonstrated commitment to compliance. The manual goes on to state that MA plans offered to employees or union members may have different rules. Remember that Medicare is not the only payer that wants you to have a compliance program. Many state Medicaid units and commercial payers also require a compliance program.

Some states require healthcare providers to have a compliance program, too, so organizations need to know both their state and individual payer guidelines. To be clear, even without an enforcement date for the ACA requirement or specific information from states or payers, healthcare organizations need to comply with the rules and regulations that apply to them.

Following the law regarding submitting accurate healthcare claims is not optional. The purpose of healthcare compliance is to assist with the prevention of erroneous healthcare claims submission to healthcare insurance carriers federal, state, and commercial. The ultimate goal is to prevent fraud, waste, and abuse. Below is a quick summary of a few but certainly not all of the acts and statutes related to healthcare compliance.

Healthcare compliance is needed to ensure that healthcare organizations protect federal, state, and commercial insurance dollars from being misused. Organizations also benefit from having a healthcare compliance plan and program.

An effective compliance program helps the organization detect issues early so the organization can fix them, such as medical coding and billing problems. The compliance program also sets a positive tone for the organization, indicating that its leadership and employees care about compliance and want to act ethically. Healthcare organizations cannot reap the benefits of their compliance programs unless they use them.

Having a healthcare compliance program designed to be window dressing, meaning the program was never intended to be as it was portrayed on paper, can cause many problems. Many healthcare entities settings can benefit from an effective healthcare compliance program. The OIG has free resources to assist organizations with guidance on designing a healthcare compliance program.

These settings include:. The OIG has spent many years observing various types of healthcare entities and recognizes that some organizations are more prone to compliance issues. For example, a DME representative may feel pressed to embark on questionable activities to meet sales target goals.

Always keep in mind that a culture of compliance is the foundation for the ethical and legal behavior of your organization.

For healthcare compliance, the size of the organization does matter. If your healthcare organization is small, you need to have a compliance program but may not need to have a compliance committee or dedicated person to handle compliance.

The office manager might wear the compliance hat in smaller healthcare organizations. On the other hand, the larger the healthcare organization, the more compliance risks they face. Larger organizations need to put more checks and balances in place. As an example, teaching facilities have medical residency programs. The medical resident and supervising physician have special documentation and attestation requirements. These facilities also use special medical coding modifiers that nonteaching facilities do not use.

The OIG and CMS provide free resources and tools — checklists, fact sheets, educational videos, and more — to help you create a compliance plan. The best way to start a healthcare compliance plan is to research free compliance plans from organizations like the one you work in. Review what others have written, looking for samples from reputable sources. But you need to customize the plan to your circumstances. You should address all seven core compliance elements in your compliance plan, first deciding how deep and expansive you and your organization want your compliance program to be.

Many states have implemented an eighth core element that addresses nonretaliation. Those that come forward in good faith to report compliance issues should not have to fear retaliation. The average healthcare compliance plan can cover the basics of all eight compliance elements in three to four pages. You will be held accountable for compliance items that you state you deliver, so the plan should include only items you intend to follow through on.

At a minimum, your compliance plan should be reviewed by the compliance point of contact, senior management, and the board if you have one at least once a year. After each review, document the date and include the signatures of those who assisted in reviewing the plan. Effort and professional drive are key to a successful compliance program. Everyone must understand that compliance is part of the culture of your organization, with senior management serving as a driving force.

Your compliance plan should be easy to read by every education level represented in your work force, and all employees need to understand the compliance plan, including all updates each year. A good way to do this is to make compliance fun. A culture of compliance promotes prevention, detection and resolution of instances of conduct that do not conform to government laws, public and private payor health care program requirements, and ethical and business policies.

The scope of compliance extends to many areas including patient care, billing, reimbursement, managed care contracting, research standards, OSHA, The Joint Commission standards, and HIPAA privacy and security, to name a few. Healthcare compliance means meeting all of the rules and requirements applicable to an organization across a broad range of criteria, and that may vary considerably depending on the type of organization and the services it provides.

The biggest challenge for healthcare organizations and their compliance officers is to keep track of all the requirements and regulations, which are extremely numerous. Effective compliance programs are defined as those that avoid or minimize liabilities, including legal or regulatory penalties and potential civil litigation. The challenge for developing an effective program is complicated by the ever-changing legal and regulatory environment.

New laws and regulations come into play on a daily basis from all levels of government. For most organizations, the biggest challenge is to evidence compliance program effectiveness , especially using verifiable metrics , and identify any gaps in the program. It is nearly impossible to define the extent or complexity of the ever-changing healthcare compliance world. As noted above, compliance programs should promote not only compliance with these rules, requirements and standards of ethical conduct, but also a culture that promotes prevention, detection, and resolution of conduct that does not conform to these requirements.

Keeping pace with rapidly changing federal regulations can be difficult for many health care organizations to manage. For questions about our compliance program services, please feel free to contact our experts online , or give us a call at