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

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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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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Daniel Cook of Outpatient Surgery Magazine recently reported on a pending New Jersey State bill that may effectually close many single-room surgery centers in the State of New Jersey.  On May 26, 2011, the New Jersey State Senate introduced an amended bill that proposes to increase regulation and taxation to single-room surgery centers and, most critically, requires all surgery centers to be licensed by the New Jersey Department of Health and Senior Services regardless of their size.  Licensure would be contingent upon the surgery center's fulfillment of certain design standards and, in many cases, will require complicated re-designs of certain single-room surgery centers that existing locations cannot support.

For more information on the amended bill see Mr. Cook’s full report in Outpatient Surgery Magazine.

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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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With hundreds of millions of dollars lost to health care related fraud and abuse, the Office of Inspector General (“OIG)” of the Department of Health & Human Services (“HHS”) launched its first ever “Most Wanted Fugitives List” this month.  Of the 170 fugitives that the OIG is currently seeking on charges related to health care fraud and abuse, it is reported that the 10 individuals on the Most Wanted list make up the lion’s share of the amount lost - allegedly defrauding taxpayers of more than $124 million.

The Most Wanted list is the latest of several social outreach tools recently implemented by the HHS OIG and various other government agencies to aim at the end-consumer – namely, the tax payer, the recipient of government sponsored health care and/or the provider of services  - in an effort to foster consumer involvement, fraud prevention and accountability.  

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The Centers for Medicare and Medicaid Services ("CMS") have launched a series of outreach tools and social networking initiatives in an effort to effectively educate and update providers on the constantly changing rules, regulation and coverage activities affecting their practices. Below are three new informational tools that providers are encouraged to access and follow:

(1)   CMS YouTube Channel. While geared toward both beneficiaries and providers, the CMS You Tube channel features a catalog of educational videos on an array of healthcare-related topics, including Recovery Audit Contractors and Process Based Quality Improvements. The YouTube Channel is a recommended for providers looking to access basic information on key media issues.

(2)   Medicare Quarterly Provider Compliance Newsletter. The quarterly newsletter is intended to help physicians, providers, suppliers and their billing staffs understand how to avoid certain billing errors and other improper coverage activities when dealing with the Medicare Fee-For-Service program. You can find Volume 1, Issue 1 here (pdf). 

(3)   MLN Matters Articles. MLN Matters are national articles designed to inform the physician, provider, and supplier community about the latest changes to the Medicare program and are prepared in consultation with clinicians, billing experts, and CMS subject matter experts.  The MLN Matters Articles provide ready access to Medicare coverage and reimbursement rules in brief, accurate and easy to understand format and explain critical and up-to-date provider information in an effort to reduce the amount of time that providers need to incorporate these changes into their Medicare-related business functions. 

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In the largest federal health care takedown in the history of the Medicare Fraud Strike Force, ninety-four people throughout Baton Rouge, Brooklyn, Detroit, Houston and Miami were charged for their alleged participation in schemes to collectively submit more than $251 million in false claims to the Medicare program

The charges stemmed from various Medicare fraud-related offenses, including conspiracy to defraud the Medicare program, criminal false claims, violations of the anti-kickback statute and money laundering. The false claims identified and targeted by the Medicare Fraud Strike Force directly mirror the “issues under review” identified by Medicare’s Recovery Audit Contractors (“RACs”), including the RAC for Region A (covering New York and New Jersey). Practices looking to identify procedures and/or services that are being targeted by auditors, investigators and/or reviewers should see the issues under review for their regional RAC and, in particular, the targeted abuse discussed by the RAC.

In this historic takedown, the Medicare Strike Force identified participation in schemes to submit claims to Medicare for treatments that were medically unnecessary and oftentimes never provided for the following procedures and/or services:

• physical therapy and occupational therapy schemes
• home health care services
• HIV infusion fraud
• Durable Medical Equipment (DME)
• Nerve conduction tests
• IV infusion therapy

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While it is impossible to pinpoint the exact areas that Recovery Audit Contractors (“RACs") will target when reviewing medical bills sent to Medicare, each regional RAC is required to post its current “issues under review” and disclose to the public the specific codes and/or procedures currently being audited by automated reviews (where no medical record is involved in the review). 

For instance, the “issues under review” identified by Region A - Diversified Collection Services (which audits New York and New Jersey, among other states) are:

•         IV Hydration

•         Bronchoscopy services

•         Blood transfusions

•         Untimed Codes

•         Neulasta: J2505; injection, Pegfilgrastim, 6mg

•         Once In A Lifetime codes

•         Newborn/Pediatric codes (i.e. newborn pediatric codes Billed for patients exceeding age limits)

•         New patient visits

•         Duplicate claims - Part B only

•         Global billing of radiology or diagnostic tests in the facility setting

•         Add-on codes

If your medical practice provides services that are identified as “issues under review,” the first step in any internal review and self-audit is to have the practices medical biller(s) and performing physician(s) review: (a) the applicable local coverage determinations (“LCDs”) and (b) the “issue description” and “issue references” disclosed with the specific “issue under review.” In most cases, the practice can easily correct the “issue” being audited by using an alternate code, submitting claims that are more detailed and/or limiting the services to allowable: beneficiaries, duration, frequency or levels.

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On July 29, 2009, the Federal Trade Commission ("FTC") announced that it would redouble its efforts to educate small business (including most health care providers) about compliance with the "Red Flags" Rule by providing additional resources and guidance to clarify whether businesses are covered by the Rule, and what they must do to comply. In the spirit of this effort, the FTC has decided to further delay enforcement of the Rule until November 1, 2009.   

I suspect that many health care providers subject to the Red Flag's Rule would not have been in compliance on the original August 1, 2009 enforcement date, and therefore still need to put together a compliance program.  The good news is that compliance is relatively easy and will take very little time to complete.  I recommend reviewing the FTC's newly added Red Flag's Rule: "Frequently Asked Questions" section to determine if your business is subject to compliance under the Rule.  If so, see the FTC's compliance template (pdf) for businesses at low risk for identity theft.  It is short, straightforward and simple to use.

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The FTC has posted a compliance template (pdf) for businesses at low risk for identity theft, such as most health care providers.  The template allows business owners to design their own Identity Theft Prevention Program in accordance with the FTC Red Flags Rule, and consists of two relatively easy to use parts. 

Part A helps users determine if their business is at low risk, and Part B helps users design a written Identity Theft Prevention Program if their business is in a low risk category.

However, like any other compliance regulation, the purpose of the Red Flags Rule is not to inflict more paperwork on affected businesses; its purpose is to foster meaningful use of effective identity theft prevention programs.  At minimum, health care providers must actually adhere to the programs that they develop, and train their employees accordingly.

Remember, the implementation date for the Red Flags Rule is August 1, 2009!
 

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The “Red Flags” Rule, enforced by the Federal Trade Commission (“FTC”), requires many businesses and organizations to implement a written Identity Theft Prevention Program designed to detect the warning signs – or “red flags” – of identity theft in their day-to-day operations, take steps to prevent the crime, and mitigate the damage it inflicts.

The Red Flags Rule applies to financial institutions and creditors. The determination of whether your business or organization is covered by the Red Flags Rule is not based on your industry or sector, but rather on whether your activities fall within the relevant definitions.

The definition of “creditor” is broad and includes businesses or organizations that regularly defer payment for goods or services or provide goods or services and bill customers later. Health care providers are among the entities that may fall within this definition, depending on how and when they collect payment for their services.

For instance, health care providers become third party creditors, like credit card companies, when they extend their services (give value) to patients and then wait to receive payment from their patients’ health insurance carriers. While the health care provider is waiting to receive payment, he or she has “credited” the service to the patient with the expectation of reimbursement from the insurer at some future time.

Another example is health care providers who offer payment plans to their patients. This is often the case with very expensive, and frequently uninsured, dental work, where the health care provider offers the patient a payment plan that the patient pays off over the course of the treatment. Again, the health care provider credits the patient with the service and waits for full reimbursement from the patient.

On April 30, 2009, the FTC announced that it is postponing implementation of its Red Flags Rule until August 1, 2009. For more information of the Red Flags rule – and how it applied to your practice – please see the FTC’s guide on Fighting Fraud with the Red Flags Rule: A How-To Guide for Business (pdf).
 

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After spending a few days absorbing the newly issued Office of the Medicaid Inspector General (“OMIG”) regulations regarding NY State provider compliance programs, I am wondering what the term “Medicaid Providers …” includes.

It is clear that providers who meet the $500,000 minimum simply by billing directly to Medicaid are subject to the regulations, but what about those providers who devote a significant portion of their practice to patients enrolled in Medicaid managed care programs. Most Medicaid eligible people residing in mandatory counties are required to join a managed care health plan, and are therefore utilizing Medicaid benefits through an alternative means. However, the problem is that often times providers cannot distinguish which of their managed care patients are Medicaid recipients.

For example, in Kings County, New York, Medicaid managed care plans are available through managed care providers such as:

• GHI HMO
• Metroplus Health Plan
• Neighborhood Health Providers
• United Healthcare of New York

These managed care plans offer coverage to the general public, as well as Medicaid recipients, thereby making it very difficult for providers to determine when they are providing services to Medicaid recipients.

Furthermore, managed care generally covers most of the benefits recipients will use, including all preventative and primary care, inpatient care, and eye care. Therefore, it is likely that many New York State providers will fall into a category where they meet the $500,000 minimum set by the OMIG simply by providing services to patients enrolled in Medicaid managed care programs. New York State providers are strongly encouraged to further investigate, and prepare for, this possibility.

Whether or not a provider falls into a category of “Medicaid Provider,” as defined by the OMIG, it is highly advisable for all providers to draft and implement a comprehensive compliance program for their practices. At minimum, these programs will ward off potential privacy breaches, detect and prevent improper billing, and educate and train employees in regulatory compliance. The reward will certainly outweigh any investment of time, money and personnel.
 

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On January 14, 2009, the New York State Office of the Medicaid Inspector General (“OMIG”) adopted regulations stating that New York State providers of care, services and supplies for which the Medicaid program constitutes a substantial portion of their business operations are required to adopt and implement effective compliance plans.

The OMIG defines “substantial portion” of business operations to mean any of the following:

1. a person, provider or an affiliate of the provider claims or orders, or has claimed or has         ordered, or should be reasonably expected to claim or order at least $500,000 in a consecutive twelve-month period from the medical assistance program;
2. a person, provider or an affiliate of the provider receives or has received, or should be reasonably expected to receive at least $500,000 in any consecutive twelve-month period directly or indirectly from the medical assistance program; or
3. a person, provider or an affiliate of the provider who submits or has submitted claims for care, services, or supplies to the medical assistance program on behalf of another person or persons in the aggregate of at least $500,000 in a consecutive twelve-month period.

The OMIG regulations also state that the mandatory compliance programs shall be applicable to:

• billings;
• payments;
• medical necessity and quality of care;
• governance;
• mandatory reporting;
• credentialing; and
• other risk areas that are or should with due diligence be identified by the provider.

The OMIG regulations are in line with previous compliance guidance offered by agencies such as the Department of Health and Human Services. Specifically, the OMIG requires that required providers’ compliance programs shall include the following elements:

1. written policies and procedures;
2. designation of a compliance officer;
3. training and education of all affected employees and persons associated with the provider;
4. communication lines to the compliance officer;
5. disciplinary policies to encourage good faith participation in the compliance program;
6. a system of routine identification of compliance risk areas;
7. a system for responding to compliance issues as they are raised; and
8. a policy for non-intimidation and non-retaliation for good faith participation in the compliance program

In the future, the OMIG is expected to issue specific compliance program guidelines for certain types of required providers.

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This post goes out to all those private medical practices that are under the impression that they are too small or too insignificant to draft and implement a comprehensive compliance program. You know who you are.

What are you doing to protect your patients medical records from inappropriate examination or theft? How do you ensure that your practice is consistently billing and coding “clean claims”? How will your prove that your employees are trained in handling protected health information?

Auditors, attorneys and inspectors will not be amused when they ask to see your compliance manual and you, in turn, point to the “employees only” sign on your wall.  Every single private medical practice is subject to the rules and regulations of powerhouses such as HIPAA, and is thereby encouraged to have a formal corporate compliance program. And I am not talking about a 1,000 page binder that would take an entire week to read. To the contrary, a comprehensive compliance program consists of seven fundamental elements:

1. Implement written policies, procedures and standards of conduct
2. Designate a compliance officer to be responsible for execution of the compliance program
3. Conduct effective and consistent employee training and education
4. Develop lines of communication for employees, patients and private citizens
5. Enforce compliance standards through well-publicized disciplinary guidelines
6. Conduct regular internal monitoring and auditing
7. Respond promptly to detected offenses and develop a strategy for corrective action

The trick is to take these seven elements, transform them into a simple set of written guidelines that are tailored to meet the needs of the individual practice, and then incorporate them into the practice's daily routine.

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