Health Care Compliance Watch : New York Health Care Compliance Lawyer & Attorney : Ilana Sable : NY Physician Representation Law

Following my post titled “Audit Defense-Part I: Monitoring Your Practices Medical Records,” I received several questions and comments concerning a medical practice’s best use of its medical records to fight audits, investigations or reviews. My answer is that the best course of defense is a medical practice’s “offensive” maintenance of clear, well-established, medical records and documentation.

Medical necessity, in terms of medical records and documentation, evaluates whether the services, tests and/or treatment provided to a patient were reasonable and necessary under the circumstances presented. When government and private payors evaluate medical necessity they use Current Procedural Terminology codes (“CPT Codes”) and International Classification of Diseases Diagnosis and Procedure Codes (“ICD Codes”) to conduct their reviews and audits. The CPT Codes and ICD Codes guide payors in determining whether the services provided to the patient were (a) furnished for the diagnosis, direct care and treatment of the patient’s medical condition and (b) compliant with the standards for good medical practices. 

There is no standard definition for medical necessity. For this reason, there is no single, foul-proof, approach to fighting a payor challenge based on “medical necessity.” However, most government and private payors use some variation of the definition used by Medicare and Medicaid (found in the Social Security Act), which reads:

Notwithstanding any other provision of this title, no payment may be made under Part A or Part B for any expenses incurred for the items or services - (1)(A) which… are not reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member…]

Moreover, all medical practices participating in and submitting medical bills to Medicare and Medicaid, among other federally funded programs, must comply with Medicare’s documentation requirements, as follows:

• There must exist sufficient documentation in the provider’s records to verify that the services were provided to eligible beneficiaries;
•  Medicare’s coverage and billing requirements must be met (including that requirement that the services be reasonable and necessary); and
• Services must be provided at the appropriate level of care and must be coded correctly.

These requirements are especially critical when providers receive Additional Documentation Requests (“ADR’s”) from Medicare contractors or are subject to an audit.  Upon request by a Medicare contractor (including a Recovery Audit Contractor), medical documentation must be submitted within forty-five days of the date of the request. If the provider (a) fails to submit documentation or (b) provides insufficient documentation for the services billed, Medicare takes the position that that there is no justification for the services or level of care billed and will either deny the claim or consider any prior payment an “overpayment” and request that the provider repay the amount previously paid on the claim. 

For more information on medical records and documents, please click here and here to review prior posts on this subject.

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Obstetrics practices located in New Jersey and New York can increase revenue and efficiently allocate a substantial portion of their daily patient care by incorporating the services of certified midwives and/or certified nurse-midwives into their practices. Generally speaking, midwives are certified to attend to low risk pregnancies, attend during childbirth and to provide post partum care. Certified nurse-midwives may prescribe certain drugs, as authorized by the licensor-states and as outlined in their governing collaboration and/or affiliation agreements with a supervising physician.

In New Jersey, in order to provide patient care, “certified midwives” are required to enter into a written affiliation agreement with a New Jersey licensed physician who holds hospital privileges in operative obstetrics/gynecology. The affiliation agreement must set forth clinical guidelines that will outline the certified midwife’s scope of practice.

In New York, “licensed midwives” are required to establish and maintain a collaborative relationship with (i) a licensed physician who is board certified as an obstetrician-gynecologist by a national certifying body, (ii) a licensed physician who practices obstetrics or (iii) a hospital that provides obstetrics through a licensed physician having obstetrical privileges at such institution. The collaborative relationship must provide for consultation, collaborative management and referral to address the health status and risks of his or her patients and must include plans for emergency medical gynecological and/or obstetrical coverage.

As with other non-physician practitioners (“NPPs”), obstetrics practices can issue medical bills to commercial payors, Medicare and/or Medicaid for services provided by certified midwives and certified nurse-midwives. Depending on the method by which the midwife services are billed to the insurance carrier (i.e., using the name and national provider identifier (“NPI”) number of the midwife versus the name and NPI of the supervising physician’s as “incident to” the services provided by the physician) the midwife services, on average, will be reimbursed at a rate similar to that which would be paid if the services where performed by a physician. 

The “midwife” license is only offered in a small number of states (New Jersey and New York offer the midwife license). Because these services are payable and reimbursable by insurance carriers and they offer obstetric practices the opportunity to treat patients in an efficient, cost effective, manner without actively utilizing the time and supervising physician(s).

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A persistent concern for many health care entity-employers (“Entity-Employers”) is retaliation from a disgruntled former employee after the Entity-Employer responds to a “reference request” with negative, albeit truthful, information about the former employee. Often times, the Entity-Employer will choose not to respond to the reference request or will omit key information found in the former employees personnel file in the hopes of avoiding future conflict or retaliation (usually in the form of a lawsuit).  However, the State of New Jersey found any failure to report on the part of Entity-Employer to be a danger to patient safety and welfare and, accordingly, enacted the Health Care Professional Responsibility and Reporting Act (“HCPRREA”) in response.

In New Jersey, pursuant to the HCPRREA, Entity-Employers are prohibited from, among other things, withholding certain information about current or former employees from other health care entities that request information. Entity-Employers are further provided with immunity from civil liability for reporting employment related information to another health care entity. 

In Senisch v. Carlino, et. al., 2011 N.J. Super. Lexis 211 (Decided December 1, 2011 Superior Court of New Jersey, Appellate Division), the Appellate Division upheld a finding that, pursuant to HCPRREA and related case law, Entity-Employers are immunized from civil liability for reporting to another health care entity if said reporting complies with the HCPRREA’s provisions.

In Senisch, Plaintiff was a physician assistant formerly employed by Defendant Deborah Heart and Lung Center (the “Cardiology Center”). Plaintiff had been terminated from his employment with the Cardiology Center because of stated deficiencies in his performance. When Plaintiff attempted to obtain different employment the new employer sought a reference from the Cardiology Center. The Cardiology Center responded to the request with negative information from the personnel file of Plaintiff.

The Appellate Division affirmed the trial court’s findings and held that:

[The HCPRREA] … prohibits health care entities from withholding certain information about current or former employees from other health care entities that request the information. The relevant parts of the Act state:

a. A health care entity, upon the inquiry of another health care entity, shall truthfully:

. . . .

(2) provide information about a current or former employee's job performance as it relates to patient care, as provided in this section, and, in the case of a former employee, the reason for the employee's separation.

. . . .

c. A health care entity, or any employee designated by the entity, which, pursuant to this section, provides information in good faith and without malice to another health care entity concerning a health care professional, including information about a current or former employee's job performance as it relates to patient care, is not liable for civil damages in any cause of action arising out of the provision or reporting of the information.

Accordingly, the Appellate Division concluded that the Defendants could not be held liable in a civil lawsuit for responding to a reference request with negative information from the personnel file of Plaintiff. 

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Traditionally, it was only “doctors” that provided medical care to patients – likely with the help of some sort of unlicensed assistant – and doctors would, therefore, limit their billing (and revenue) to the services that they, individually, provided. In recent years licensed and/or certified non-physician practitioners (“NPP’s”) have begun to provide an increasing amount and variety of medical care to patients and, accordingly, increase the amount of reimbursement and revenue to health care practices that utilize the services of an NPP.

The regulations and statutes regarding NNP education, scope of practice, supervision and training are primarily based on state laws and, in many ways, differ from state to state. The designation and variety of NPP’s also vary from state to state, but, generally speaking, NPP’s can be categorized as follows:

• Advanced Practice Nurse
• Certified Registered Nurse Anesthetist
• Clinical Nurse Specialist
• Clinical Psychologist
• Clinical Social Worker
• Nurse Midwife
• Nurse Practitioner
• Occupational Therapist
• Physician Assistant
• Physical Therapist
• Speech Pathologist
• Surgery Assistant

Billing and Reimbursement for Non-Physician Practitioner Services

Reimbursement received by health care practices for services provided by NPP’s varies substantially among federal, state and commercial payors, and should be thoroughly evaluated prior to submission of medical bills. For instance, Medicare will reimburse for services provided by certain NPP’s in private physician practices when:

(1) The bill for NPP services is submitted using the NPP’s own name and national provider identifier (“NPI”) number. The NPP is reimbursed at eighty-five (85%) percent of the Medicare physician fee schedule.

(2) The bill for NPP services is submitted using the supervising physician’s NPI as “incident to” the services provided by the physician. The NPP’s services will be reimbursed at One Hundred (100%) percent of the Medicare physician fee schedule. Further, if covered NPP services are furnished, then services and supplies furnished incident to the NPP’s services may also be covered.

In order for a health care practice to submit a bill to Medicare for NPP services provided “incident to” the services of the supervising physician, the following criteria must be met:

(a)   The NPP services must be performed under the direct supervision of the physician as an integral part of the physician’s personal in-office service (this does not mean that each occasion of an incidental service performed by a NPP must always be the occasion of a service actually rendered by the physician.

(b) There must be a direct, personal, professional service furnished by the physician to initiate the course of treatment of which the service being performed by the NPP is an incidental part, and there must be subsequent services by the physician of a frequency that reflects the physician’s continuing active participation in and management of the course of treatment;

(c)   The supervising physician must be physically present in the same office suite and be immediately available to render assistance if that becomes necessary;

(d) Also, a physician might render a physician’s service that can be covered even though another service furnished by a NPP as incident to the physician’s service might not be covered.

In practice, this translates to the following criteria:

(1) The supervising physician initially sees the patient (or sees the patient at a previous visit) and initiates the plan of care that the NPP is carrying out.

(2)The supervising physician remains involved in the patient’s care and continuously documents this involvement in the patient’s medical record.

(3)The NPP is an employee and/or independent contractor associated with the physician practice.

(4)The supervising physician (or another physician of the physician practice) must be in the medical office at all times that the NPP provides services and must be immediately available to intervene in the patient’s care if medically necessary.

Commercial payors, on the other hand, are free to set their own policies and guidelines for credentialing NPP’s and providing reimbursement for their services. Some commercial payors are willing to credential NPP’s and allow NPP services to be reimbursed using the NPP’s own provider number or instruct physician practices to bill for services provided by the NPP under the supervising physician’s provider number as “incident to” the services provided by the supervising physician. Other commercial payors simply refuse to reimburse for services provided by an NPP altogether. It is also important to note that a health care practice may be able to negotiate the reimbursement rate provided by certain commercial carriers for services provided by NPP’s.

Additionally, federal, state and commercial payors each have unique restrictions and guidelines concerning an NPP’s ability to examine and treat new patients, patients with new or worsening conditions, and so forth. Accordingly, health care practices should always request and keep on file each payor’s written policy concerning qualification, billing, coding and reimbursement of NPP services.  

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Over the past few years health care providers have reported an increasing surge in the outsourcing of medical billing and collections  to third party medical billing companies.  The outsourcing surge stems from a number of factors, most of which are focused on increasing revenue and surviving payor scrutiny.  

First, health care providers rely on medical billing companies to assist them with processing claims in accordance with applicable rules, regulations, laws and statutes (“health care laws”).  With the increasing complexity of the health care industry, the demand for familiarity with health care laws can be overwhelming for health care providers and will often require the education, knowledge and skill of an independent professional.

Second, health care providers are increasingly consulting with medical billing companies to provide them with timely and accurate advice regarding reimbursement matters and overall business decisions.  Medical billing companies normally support a variety of providers and organizations with different specialties and, therefore, have a unique insight to reimbursement issues, as well as diagnosis and procedure code utilization and optimization.  The critical component is a medical billing company’s ability to conduct practice-to-practice comparisons and data mining of coding, billing and collection patterns.

Third, medical billing companies normally have professionals dedicated to specific specialist and/or process areas, thereby increasing employee efficiency, skill and knowledge within the assigned area.  For instance, professionals skilled in collecting unpaid cardiology claims will have the benefit of uncovering and monitoring payor patterns of rejection and denial, and will have the insight to determine which coverage determinations are worth fighting or which coding practices to alter.  

Fourth, in most cases a medical billing company will consistently provide clients with customized practice reports and analytics that offer an in depth look at key metrics an allow the provider to make informed, strategic, decisions concerning billing, coding and collections.  While most of this data and analysis can be conducted in-house, is often underutilized or overlooked altogether with small physician practices. 

Finally, another issue that small physician practices face with in-house medical billing is hiring, training and maintaining an adequate medical billing staff.  Normally, small physician practices allocate one to two designated staff members for medical billing and collection purposes and suffer the consequences of insufficient and inefficient staff in the form of timely filing issues, timely appeal issues, lack of follow up and collections, contractual allowances and, ultimately, write offs.

It is important to note that third party medical billing companies significantly vary in terms of the type of services provided and the manner in which these services are provided for their respective clients. For example, some medical billing companies provide coding services for their clients, while others only process pre-arranged Superbills that have already been coded by the provider.  Additionally some medical billing companies offer a spectrum of management services, including patient intake support, accounts receivable management and debt collections. 

The main question to consider when determining whether to use an in-house medical billing professional or to outsource to a outside medical billing company is “what are you coding and billing, and why?” If the answer to this simple question is not supported by customized practice reports and analytics, strategic and informed, decisions concerning the coding, billing and collections choices made for each patient, and driven by the voluminous rules, regulations and statutes affecting health care practice, then the answer is flawed and is likely costing the practice critical revenue.

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Appearance enhancement and weight loss businesses that involve licensed professionals or that require a specialized business license will face complicated regulatory considerations when franchising their business. These regulatory considerations are heightened in states with strong corporate practice of medicine statutes in that the products, procedures and/or services offered by these franchise concepts may implicate what, in certain instances, may be considered the practice of “medicine.”

Is your franchise concept unlawfully practicing medicine or implicating applicable health care related regulations and/or statutes?

If you are starting an appearance enhancement or weight loss franchise, or would like to evaluate your existing concept, you must conduct a comprehensive review with a focus on the following issues:

1.       Corporate Practice of Medicine and Anti-Fee Splitting Statute. In many states, professional health care related services can only be offered by licensed health care professionals or authorized professional health care organizations. Similarly, certain federal and state regulations and statutes further mandate that licensed health care professionals and professional health care organization cannot share the fees that they earn for providing professional services with any individual or organization other than members of their own professional organization.

2.       Implication of Stark Laws and Prohibited Self-Referrals. The Stark laws and anti self-referral statues prohibit, with varying degrees, medical practices and/or facilities from submitting - and Federal and/or state regulated health care programs from paying - any claims for certain designated health service if the referral of the designated health service comes from a physician with whom the medical practice and/or facility has a prohibited financial relationship. Depending on the services being offered by the appearance enhancement center, the Stark laws or anti self-referral statutes can be violated depending on the business arrangements developed for the concept.

3.       Implication of Anti-Kickback Statutes.  Depending on the structure of the arrangement, certain joint ventures, service agreements and/or management arrangements raise a number of compliance concerns and, in many situations, can implicate both the federal and state-specific anti-kickback statutes. Accordingly, once the full appearance enhancement or weight loss concept is outlined, it is important to evaluate the proposed business arrangement in light of these, among other, federal and state-specific regulatory and compliance concerns to determine whether the desired regulatory balance can be reached and maintained.

For more information concerning the franchising of your health care related concept, please contact Ms. Ilana Sable or visit www.hccwlaw.com.

For additional information concerning setting up a franchise the following article is recommended:

How to Franchise Your Business

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Health care providers participating in governmental health care programs, including Medicare or Medicaid, must confirm, when employing or contracting with a physician, employee, vendor or other affiliated party, that the individual or entity is not excluded from participation in any governmental health care program. 

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”)has the authority to impose civil monetary penalties against any health care provider that employs or contracts with an individual or entity that the provider knows or should know is excluded from participating in any federal health care program, including Medicare. Furthermore, most state governments also impose sanctions against health care providers that employ or contract with individuals or entities that are excluded, on either the federal or state level (or both), from participating in governmental health care programs. 

Accordingly, health care providers must, prior to employing or contracting with any individuals or entities and periodically during the term of the employment or contract, confirm whether the individual or entity is excluded, debarred or suspended from participating in any federal or state-specific health care program.

Health care providers can use the following four steps to conduct their participation investigations when employing and/or contracting with individuals or entities:

1.      Initial Review. When conducting your initial review, it is critical that the proposed employee or contractor be reviewed on both a federal and state-specific level.

a.      Federal Review. The following websites contain information concerning individuals and entities excluded from federal health care programs and are excluded from receiving federal contracts, certain subcontracts, and certain federal financial and nonfinancial assistance and benefits:

·         http://oig.hhs.gov/exclusions/exclusions_list.asp

·         https://www.epls.gov/epls/search.do

·        http://www.treasury.gov/resource-center/sanctions/SDNList/Pages/default.aspx 

To obtain the most comprehensive review result, a full criminal background check should be conducted and should incorporate a criminal background review in all fifty states. 

b.      State-Specific Review. Each state has its own review regulations concerning provider exclusion, debarment, termination and/or suspension. In the State of New York, health care providers are obligated to conduct participation reviews on a monthly basis and, in addition to conducting the federal reviews, New York State based reviews should, at a minimum, focus on the following lists:

·         http://www.omig.ny.gov/data/content/view/72/52/

·         http://www.op.nysed.gov/opd/rasearch.htm

·         http://www.health.ny.gov/professionals/doctors/conduct/

·         http://www.op.nysed.gov/opsearches.htm

·         http://www.nydoctorprofile.com/welcome.jsp 

For a listing of state-specific Medicaid sanction lists, please see: http://www.omig.ny.gov/data/images/stories//state_sanc_url_list.pdf 

2.      Demand Representations from the Employee or Contractor. Health care providers can ask on employment and/or vendor applications whether the individual or entity is now or has in the past been excluded, debarred or suspended from participating in any federal or state health care program.

3.      Document Every Step of the Participation Review Process. Make sure to print the results of each participation review (including the search parameters and results of each individual website that is visited) that you conduct and that you retain in the individual employee/contractor file the results of each exclusion review. 

4.     Incorporate the Participation Review Plan Into the Organizations Compliance Program. As with any other compliance obligations imposed on a health care provider, it is important to streamline the participation review process by incorporating a set of written guidelines that employees and compliance personnel will follow into the organizations comprehensive compliance program.  For more inforamation about comprehensive compliance programs for all health care practices and facilities, please visit the following website.

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For health care practices and facilities, employing and/or “partnering” with physicians and other licensed health care professionals is a necessary part of doing business. The profitable advantages and increased revenue that come with offering the services of a licensed health care professional often drive health care practices and facilities to find creative methods for proffering these service arrangements. However, depending on the state within which the health care practice of facility sits, many service arrangements implicate “corporate practice of medicine” regulations and must be thoroughly crafted and evaluated to avoid regulatory violations.

Most states have laws and regulations that prohibit – in varying degrees - the “corporate practice of medicine” by certain business entities and unlicensed individuals making it extremely important to fully evaluate the regulatory implications and validity of the proposed corporate structure or partnership. Moreover, while largely dependent on the state within which the health care practice or facility is located, there also exist statutory “exemptions” to the “corporate practice of medicine” and various methods for organizing and structuring a health care practice or facility in order to lawfully employ and/or partner with a physician or other licensed health care professionals.

In the State of New York, individual practitioners, professional partnerships, professional corporations, professional limited liability companies and professional service corporations (where all shareholders are licensees of one profession and whose members practice only that profession) are all authorized to offer professional services. Additionally, several statutory exemptions exist for hospitals and other health care “facilities” allowing these licensed/accredited organizations – often owned and/or managed by unlicensed health care professionals - to offer the services of physicians and other licensed health care professionals.

Most states also maintain “fee-splitting” or profit sharing regulations which mandate that licensed health care professionals or professional firms cannot share with other than members of their own professional firm the fees earned for providing professional services. The fee-splitting regulations normally coincide with the individual state’s corporate practice of medicine regulations and have similar degrees of prohibition.

For more information on the corporate practice of medicine laws and regulations in New Jersey and New York, please visit www.hccwlaw.com.

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For New York State accredited office-based surgery practices (“OBS”), the terms of continued accreditation (varying with an OBS’ specific accrediting agency) often come with strict requirements and guidelines concerning the hiring and retention of employees and independent contractors.  Most unexpected (and often overlooked by OBS employers) are the requirements and guidelines that reach far beyond the customary licensure and/or certification requirements and expand into areas that an OBS employer might consider (understandably) to be “private business decisions” or “matters of professional judgment.” It is in these outlying areas that OBS employers must be well versed in order to avoid inadvertent compliance breaches.

When hiring new employees and/or independent contractors, OBS employers must review their accreditation manuals with a specific focus on the following categories of employees and/or contractors:

(a)          Registered Nurses: when hiring Registered Nurses, OBS employers must confirm, among other things, (i) instances of treatment requiring the presence of a Registered Nurse(s) (including pre and post operative care), (ii) licensure, continuing education and liability insurance requirements, (iii) requirements concerning maintenance of medical records and supporting documentation and (iv) reporting requirements concerning adverse events; 

(b)          Physicians’ Assistants and/or Specialists’ Assistants: with regard to Physicians’ Assistants and/or Specialists’ Assistants, special attention must be give to rules and regulations concerning (i) the presence and/or supervision of a physician at the OBS facility, (ii) availability of and/or access to a physicians upon request of the patient, (iii) maintenance of medical record, auditing and quality control initiatives, (iv) licensure, continuing education and liability insurance and (v) reporting requirements concerning adverse events;

(c)           Anesthesiologists: in addition to the state and federal laws concerning and/or affecting financial and work relationships among physicians (i.e., Stark Laws, Anti-Kickback Statutes, False Claims Act), OBS employers must review all rules and regulations concerning: (i) the Anesthesiologist’s access and availability to patients, (ii) pre and post operative care directives, (iii) directives concerning maintenance and support of Anesthesia equipment, medication and/or supplies, (iv) maintenance of medical records, auditing and quality control initiatives, (v) board certification, licensure, continuing education, and liability insurance and (vi) reporting requirements concerning adverse events;

It is important to note that most of these “employment requirements” can be outlined as conditions of employment in an employment contract or independent contractor agreement between the OBS employer and the employee/contractor.  Documenting and outlining relevant accreditation-mandated employment requirements, in addition to clarifying the potential employee/contractor’s responsibilities and obligations, demonstrates a good faith effort to comply with all applicable accreditation mandates and delegates applicable accountability. 

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Purchasing a piece of medical equipment is often the largest single-item expense for a health care practice and must be treated as any other critical business decision.  The practice’s due diligence investigation must include independent research as to the quality and function of the equipment, a targeted cost-benefit analysis and a thorough review of the lines of business that the practice intends to offer with the new equipment. Unfortunately, practices tend to rely on the “pitch” and representations of the sales rep presenting the equipment and often lose track of the analysis that must be conducted.

Over the past few months I have been meeting with an increasing number of practitioners that, after entering a lease and/or finance for a very expensive piece of medical equipment, find that their practice (a) does not have a sufficient patient base to test/treat with the equipment, (b) has a sufficient patient base to test/treat with the equipment but the testing/treatments do not bring in enough revenue to support the cost of the equipment, (c) need additional equipment, software, and/or professionals to use the new equipment and/or (d) are not being reimbursed by insurance carriers for the testing/treatments. Many practitioners note that the sales reps who originally presented the equipment made certain misrepresentation and/or omitted certain information which later led to the practices inability to recover the expected revenue (i.e. “the rep did not tell me that I needed to buy the software for the equipment separately” or “I did not know that the manufacturer was distributing coupons which I would be obligated to honor.” Most of these practitioners find themselves before a court where the signed contract reigns supreme.

For these reasons, it is always important to approach any medical equipment purchase with the following questions in mind:

1. Is the testing/treatment indicated by the machine a “covered” procedure by major insurance carriers? In particular, practices will need to determine whether carriers readily reimburse for the testing/treatment implicated by the machine and what the average rate of reimbursement is.
2. Is the testing/treatment implicated by the machine considered “experimental” by major insurance carriers for the purposes intended by the practice and what is the “medical necessity” threshold for performing the testing and/or treatment? In most cases, procedures considered “experimental” by the insurance carrier are not payable without prior authorizations, if at all.  Moreover, practices will need to determine how common the intended testing/treatment is and what population of patients are authorized to receive the testing/treatment in the ordinary course of business.
3. What CPT codes and/or diagnosis codes are implicated for the equipment? In particular, practices will need to find out whether the intended CPT codes are considered exploratory "test" codes and what diagnosis codes support the intended CPT codes.
4. What amount of tests/treatments must be performed per month to cover the monthly expense associates with the equipment and whether the practice's current patient base requires that amount of testing/treatment? This information is necessary to budget for the new medical equipment.
5. Did the manufacturer/distributor of the equipment issue any rebates and/or coupons to end-users that the practice will be obligated to honor? If possible, the practice must try to narrow down the manufacturers/distributors prior and future incentives to end-users and incorporate the manufacturers/distributor representations into the written agreement.
6. Is there any additional software, training and/or components that the practice will need to purchase prior to or after using the equipment? Will the manufacturer/distributor provide software/hardware updates when available? Again, the practice can negotiate these issues and memorialize them in the written agreement.

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