Health Care Law Questions and Answers

(Note: These health care law questions and answers have been published in the "Ask the Professionals" section of the Orlando Business Journal. Please consult the Orlando Business Journal for the latest one.)

Question 1:

I received in the mail a letter from the Florida Department of Health with "Nondisciplinary Citation" in it. What is this and what should I do?

Answer 1:

In certain "minor" disciplinary infractions, the Florida Department of Health (DOH) is authorized to offer the option of accepting a Nondisciplinary Citation or a Notice of Noncompliance. This will often carry with it a small fine. Timely acceptance and compliance will not result in discipline being reflected on your professional license under present laws and regulations.

Physicians, dentists, nurses and other licensed health professionals may be offered these in the event of minor advertising infractions, failure to have the required continuing education courses or requirements, failure to renew a license on time, or other minor infractions. In all cases the licensed health professional will be required to correct the deficiency as part of the process of disposing of the offense in this manner. It is usually advisable to accept such a Nondisciplinary Citation or a Notice of Noncompliance, provided you can pay the fine and obtain documented proof you have corrected the deficiency within the time specified in the document. If you do, you must be sure to promptly and properly comply with every requirement contained in the document.

If you have proof that you did not commit the offense in the first place or there is other litigation involved, you may desire to not accept the offered disposition of your case. However, we recommend that you consult with an experienced health attorney familiar with such matters prior to making such a decision. If you have received one of these, this will mean that a review of the case by a staff member of the Florida DOH indicates that you were out of compliance with laws or rules and there is a superficial case against you. You may not completely understand the violation or your documentation may not meet DOH requirements. It is important to have an attorney familiar with such cases review your case before acting.

If you send in additional documentation instead of accepting and submitting the offered Nondisciplinary Citation or a Notice of Noncompliance, if you write a letter explaining why you did not commit the offense, or if you take any other action other than accepting, executing and returning the Nondisciplinary Citation or a Notice of Noncompliance in a timely manner, you will be considered to have rejected it. You will not be given a second chance later to accept it later. Then, if you are later determined to have committed the offense, no matter how minor, this will probably result in your having permanent disciplinary action reflected on your license. Don't take a chance, consult an experienced health attorney on this issue.

Question 2:

I am a physician working as an employee in a pain management clinic. Recently, the clinic has received a number of subpoenas from the Department of Health for copies of patient records? Why is this? Am I in jeopardy of being investigated or disciplined by the Board of Medicine for working here? Of being arrested for or charged with over-prescribing pain medications?

Answer 2:

We are aware of a number of initiatives to curtail the writing of prescriptions for narcotics and pain medications by Florida physicians as well as attempts to shut down pain management clinics. A number of our physician clients who work in pain management clinics have recently received letters from the Florida Department of Health advising them they are under investigation for writing prescriptions for an "excessive" amount of narcotics and pain medications for a patient. We have been advised by auditors working for the government that any physician who writes a large amount of narcotic prescriptions for patients seen in clinics or physician offices whose care is paid for by the Medicare Program, Medicaid Program or any other state or federal health care program is likely to be audited or investigated. We are aware of several investigations commenced against physicians because of the death of a patient from drugs, either accidental or by suspected suicide. Additionally, state and county law enforcement authorities appear to be more aggressive in investigating and charging doctors and clinics involved in pain management prescribing and dispensing. With the new law in Florida that requires every pain management clinic to be registered as of January 4, 2010, more and more enforcement actions are likely. Many of these involve the use of undercover agents posing as patients. Physicians who treat a large number of pain patients with prescription medications should be very careful ensuring their patients are legitimate patients with legitimate medical problems and that they are following proper pain management protocols in their prescribing practices. At the first indication of a subpoena, search warrant, or investigation of any type, it is critical to retain an appropriately experienced health attorney to represent you before you respond.

Question 3:

I have received a letter from the Agency for Health Care Administration (AHCA) requesting copies of patient medical records for a Medicaid audit. What should I do?

Answer 3:

This is a serious matter and we would advise anyone receiving such a letter to immediately consult with health care counsel experienced in Medicaid audits. The states are being placed under an extreme amount of pressure to recover money into their Medicaid programs because of budget shortfalls and the federal deficit. This has resulted in an unprecedented number of Medicaid audits, Medicare audits and audits by Zone Program Integrity Contractors (ZPIC) and Recovery Audit Contractors (RAC) seeking to recover money from physicians, dentists and other health providers for the state and federal government. We have a process we follow to ensure that complete documentation for all care that has been billed to such programs is provided and that any "hot" issues that we know are being scrutinized by auditors are properly addressed. Because of the extrapolation formulas that are used by government auditors each dollar that is disallowed by the auditor can equate to many times the amount that you are determined to owe back. For example, if a claim for a procedure that you were paid $100 to perform is disallowed, this may be extrapolated to a $5,000 repayment using a statistical formula. In addition, you can be assessed fines (for failing to comply with documentation requirements) and the costs of the audit and experts' reviews, as well. Because of recent changes in Florida laws, the amounts disallowed must be paid back to AHCA within thirty (30) days, even if the provider requests a hearing to challenge the findings. If the audit is wrong and you do not owe the money the agency says, it is imperative that a formal administrative hearing is properly requested in a timely manner so that you have the proper opportunity to prove your entitlement to the money.

Question 4:

I received a letter from a company claiming to be a Zone Program Integrity Contractor (ZPIC) for the Medicare Program stating it wanted to audit my practice. It was on a letterhead that included a CMS (Centers for Medicare and Medicaid Services) logo. What is a ZPIC? Is this legitimate?

Answer 4:

Zone Program Integrity Contractors (ZPIC) and Recovery Audit Contractors (RAC) are private companies or business entities that have contracted with CMS to carry out certain functions that the Medicare regional carriers have traditionally in the past been expected to accomplish. Most recently, these have involved audits for overpayments and detection of and recovery for possibly fraudulent activities. In some cases the contractors (especially the RACs) receive a percentage of any recovery they obtain. CMS's "Zone 7" includes Florida, Puerto Rico and the Virgin Islands; the Zone 7 ZPIC for 2010 is SafeGuard Services, LLC, with several offices in Florida, including in Jacksonville, Florida, and the Miami area. Zone 5 includes Alabama, Arkansas, Georgia, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, Virginia and West Virginia; the Zone 5 ZPIC for 2010 is AdvanceMed which has its main headquarters in Nashville, Tennessee. If you are contacted by a ZPIC or receive a letter advising you of an audit, you should immediately contact a health care attorney familiar with ZPIC audits or one of the very few Medicare audit consultants who specialize in ZPIC audits.

Question 5:

Is it true that a Medicare provider can have its Medicare number revoked if mail from a Medicare carrier (such as First Coast Service Options, Inc. or Palmetto GBA) is returned?

Answer 5:

Yes, Medicare regulations and guidelines require that you notify the carrier of any address change within thirty (30) days. Mail that is returned to the Medicare carrier because of an address change or an unknown address routinely causes the Carrier to immediately begin the process to revoke the Medicare provider's number. The only recourse is to immediately request a reconsideration in writing and to immediately request a hearing on this in writing. We always do this by mail sending such requests by at least two different methods (e.g., Federal Express, overnight delivery and U.S. Express Mail, return receipt requested) so that we can prove it was timely sent and timely delivered. It is most strongly advised that if you are in this situation, you obtain the advice and representation of experienced health care counsel to do this for you and follow-up in representing you in the subsequent hearing.

Question 6:

Is it correct that Medicare will deactivate a provider's Medicare number if the Medicare carriers' (such as First Coast Service Options, Inc. or Palmetto GBA) solo practitioners' brochure is returned to the sender because of an invalid address? How do I ensure this never happens?

Answer 6:

Medicare MUST have your correct address on file. All Medicare program practitioners are cautioned to verify through the Internet-based Medicare Provider Enrollment Chain Ownership System (PECOS) or by calling their carriers, that all of their Medicare carriers must have their current correct enrollment information, including correct physical and mailing addresses, on file now and within thirty (30) days of any address change. Information on enrollment in the Internet-based PECOS can be found at: http://www.cms.hhs.gov/MedicareProviderSupEnroll/

Question 7:

I have heard there is no longer a statutory requirement that a supervising physician review and co-sign all of the charts and medical record entries of a physician assistant under the physician's supervision in Florida. Is this true? If so, what does this mean for a supervising physician?

Answer 7:

Yes, many states have long had no requirement that a supervising physician is required to sign or co-sign a physician assistant's records. On June 16, 2009, Governor Crist signed Senate Bill 720 which removes the statutory requirement that a supervising physician review and co-sign charts and medical records of a physician assistant under the supervising physician's supervision in Florida. This was previously required by Florida law. Also, a supervising physician is no longer required to review and sign the notes or prescriptions written by a physician assistant for prescription medication. However, this does not change the authority of a supervising physicians to require such review and co-signature for the physician assistants they employ or who work under their supervision within a practice protocol. This is within the authority of the supervising physician to decide.

Question 8:

I have been reading about a lawsuit which is challenging the constitutionality of Florida's "Three Strikes Rule." Could you explain the "Three Strikes Rule" and how it affects a physician licensed in the State of Florida?

Answer 8:

If you are a physician you should be extremely interested in the current litigation surrounding the Florida's "Three Strikes Law." First, Amendment 8 to the Florida Constitution, (which is what has come to be known as the "Three Strikes Law" in Florida), passed in 2004, provides that physicians who have three medical liability judgments against them during the course of their careers will automatically lose their medical license. The Florida Constitution amendment was enacted into law in 2005 in Section 456.50, Florida Statutes. A "strike," for purposes of this law, can include:

1. A judgment in a civil medical malpractice trial;
2. A decision of an arbitrator or arbitrators in a medical negligence case; or
3. A finding in an administrative hearing involving a complaint against the physician's license that the physician has committed medical negligence.

Settlements and settlement agreements are specifically excluded from being classified as a "strike."

However, the Florida law which was enacted as a result of the constitutional amendment (which was passed by popular vote) raises the standard for what constitutes a "strike" from the lower standard of "preponderance of evidence" to a higher, harder to meet standard of "clear and convincing evidence."

In October 2009 an Orlando trial lawyer filed a medical malpractice lawsuit challenging the "Three Strikes Rule" as enacted into law. The basis is that the statute requires a much higher standard than is actually used by the courts, arbitrators and, sometimes, the administrative bodies which decide such matters, and is not the standard envisioned by the Constitutional amendment. In effect, this would require any such case to be tried again and proven to the higher standard before it would count as a "strike."

As a physician here are some things to remember about the current law: 1) should a physician lose a malpractice claim, it won't count as a strike unless the jury reaches a verdict based on the "clear and convincing evidence" standard which is almost never used in a civil case; 2) medical malpractice lawsuits and arbitrations are normally not tried under the clear and convincing evidence standard; and 3) if the malpractice lawsuit is settled out of court it does not count as a strike against the physician.

Question 9:

I am a physician and am concerned about the Federal Trade Commission "Red Flag Rules" that require creditors to institute programs to prevent identify theft. I was told this will apply to physicians but I do not understand how this differs from the HIPAA Privacy Rule and the HIPAA Security Rule. What do the "Red Flag Rules" require of physicians and medical groups and what is the deadline to implement the "Red Flag Rules"?

Answer 9:

The Federal Trade Commission (FTC) "Red Flag Rules" require "creditors" to institute programs to prevent identify theft. These new federal regulations may apply to physicians and medical groups if they meet the definition of "creditor." A physician or a medical group is a creditor if the physician defers patient payments by billing for services or if the physician accepts the patient's co-pay and bills the insurance company. This means that most physicians and medical groups meet the definition of "creditor" and must comply with the rules. Under the "Red Flag Rules," physicians must implement and maintain identify theft prevention programs designed to detect, prevent and mitigate identity theft. This is different from the requirements of the Health Insurance Portability and Accountability Act (HIPAA) requirements and the requirements of the administrative regulations which implement it.

HIPAA and HIPAA Regulations are intended to protect personal health information (PHI) for security and privacy purposes. The "Red Flag Rules" extend to information including credit cards, social security, driver's license, insurance claims and tax identification numbers. These new policies and procedures implemented by the "Red Flag Rules" should complement your existing HIPAA privacy and security policies and procedures. Those who do not have adequate policies and procedures may face a penalty of up to $2,500.00 per "knowing violation."

At the present time, the FTC has voted to delay implementation of the Red Flag Rules until June 1, 2010. For more information including a sample policy visit the American Medical Association's website at: http://www.ama-assn.org.

Question 10:

I am worried about handling potential violations of patient confidentiality and breaches relating to health data that may occur in my medical office. I understand the U.S. Department of Health and Human Services has now implemented new rules requiring health care providers to notify patients when a breach of a patient's personal health data occurs. What do these new regulations require? What would you suggests is the best way to notify patients if a health data breach should occur?

Answer 10:

This is an important concern that applies to all physicians whether working as a solo practitioner, in a medical group, or employed by a hospital. Starting September 23, 2009, if a patient's personal health data are leaked, notification to the patient is mandatory. The new rule requires every health provider to have a plan in place on how to handle potential breaches that may occur in the future. The regulations require health care providers and other HIPAA covered entities to promptly notify affected individuals of a breach, as well as notification to the Secretary of the U.S. Department of Health and Human Services (HHS) and the media in cases where the breach affects more than 500 individuals. All breaches affecting fewer than 500 individuals must be reported to Secretary of HHS on an annual basis. However, if the sensitive data is maintained in encrypted formats, rendering it unreadable, unusable or indecipherable in an accidental release, there is no need for any breach notification.

In order to notify patients, a physician could send a letter to every individual patient affected. We consider this to be the best method of carrying out the notification requirement. Alternatively, the physician could place an ad in the local newspaper, depending on the type of breach.

Question 11:

I have heard there is a new Florida law requiring insurance companies to send payments for their insured patients' care directly to out-of-network doctors. What does this mean, why is it necessary and when does it become effective?

Answer 11:

Effective July 1, 2009, a new Florida law signed by Governor Crist requires insurers to send payments directly to out-of-network doctors when the patient has assigned the right to receive payment to the doctor. This is an important development for out-of-network doctors because many have frequently gone unpaid when insurers sent payment directly to the patients.

The act amended Section 627.638(2), Florida Statutes, which provides "[t]he insurance contract may not prohibit, and claims forms must provide an option for, the payment of benefits directly to ... physician, dentist, or other person who provided the services in accordance with provisions of the policy for care provided." Therefore, the insurance contract must provide an option for the patient to allow direct payment to the out-of-network doctors.

Question 12:

I heard every privately owned pain-management clinic, facility or office not licensed under Chapter 395, Florida Statutes, must register with the Florida Department of Health (DOH) as a pain clinic. Where can I find more information regarding registration, what is the deadline, and what are some of the requirements?

Answer 12:

An act passed by the Florida Legislature in 2009 requires, as of January 4, 2010, all pain management clinics must be registered with the Florida Department of Health (DOH). A clinic with multiple locations must register each individual location separately with a registration fee of $150.00 per application. The Pain Clinic Registration application is available from the Board of Medicine website.

Any medical doctor or osteopathic physician working at an unregistered clinic is subject to discipline by the DOH. The law further requires the DOH to develop an electronic database to monitor the prescribing of controlled substances.

When the Pain Management Clinic Standards of Practice Joint Committee held its December 2009 meeting in Tampa it began to draft rules requiring doctors who perform pill-related pain management with fifty percent (50%) or more of their patients to get, at a minimum, ongoing continuing medical education (CME) on the topic. These recommendations could be modified when the committee meets again before submitting the proposed rules to the Board of Medicine and Osteopathic Medicine.

This is important of for all doctors in the pain management area because Florida is beginning to crack down on pain management clinics and doctors associated with over-prescribing narcotics. Recently, the news media has had a number of stories involving doctors being arrested for dispensing high volumes of painkillers. If you work at a pain management clinic be sure to read Sections 458.309(4)-(6) and 459.005(3), Florida Statutes. Also, if you are not board certified in pain management, attend continuing medical education on the subject to better familiarize yourself with the area of medicine and ensure compliance with the new regulations.

Question 13:

Is it true that your medical license can be suspended for failure to pay your child support obligations?

Answer 13:

Yes, Section 409.2598, Florida Statutes allows the State to suspend any license, including a medical license, for failure to pay child support. If an individual fails to comply with a support order by at least 30 days the Department of Revenue may begin the proceedings for license suspension. In order to avoid suspension of your license, you must comply with the support obligation or enter into a written agreement with the department within 30 days. Also, you may object to the suspension proceedings by filing a petition in circuit court within 30 days.

Question 14:

I am a medical specialist and I do participate in the Medicare or Medicaid programs. However, I have been told that I will no longer be able to obtain payment from Medicare when I treat a patient who has been referred to me by a general practice physician who is not in the Medicare program. Is this true?

Answer 14:

Florida Medicare Program Part B carrier (First Coast Service Options, Inc.), has begun denying claims for physician specialists' covered services when the ordering physician is not a Medicare participating physician. For example, if a non-participating primary care physician (PCP) (who may, incidentally, be in concierge practice) orders or refers a beneficiary to a gastroenterologist who is a participating Medicare physician or a member of a participating group practice, the Medicare carrier is denying payment for the gastroenterologist's services.

The referring physician does not have to be a Medicare participating provider, but the referring physician does have to be listed in the Internet-based Medicare Provider Enrollment Chain Ownership System (PECOS). Non-par and Opt-Out physicians must still be on file with Medicare or their referred/ordered services (such as durable medical equipment (DME), etc.) will be denied payment by Medicare. This is a recent change in Medicare operating policy.

Question 15:

I am a nurse employed by a hospital. Recently my nurse supervisor came to me and told me the hospital was requiring several nurses to "voluntarily" submit to urinalysis drug tests because the PYXIS (drug dispensing) machine disclosed a number of discrepancies. Should I agree to voluntarily submit to a urinalysis drug test?

Answer 15:

Each set of circumstances is unique and must be separately evaluated. We strongly recommend the Nurse consult with a health lawyer who is experienced in dealing with such matters prior to making any decisions. Additionally, the advice may depend on whether the Nurse is an employee or an independent contractor. In many cases such a request may not be a legitimate request from an employer. In other cases, such a request may fall under the Drug Free Work Place laws and be proper.

We have had cases where hospitals have used urine drug testing and referrals to the Intervention Project for Nurses (IPN) Program as a substitute for spending the time, money and resources of properly investigating their own suspicions of drug diversion by a nurse or nurses. This is clearly inappropriate. We have also represented nurses whom the employer terminated even though the employee consented to the urinalysis test and had a negative test result.

If the Nurse refuses to submit to such a test, the employer will most probably terminate the employee for refusing; however, this may be the better of two evils. We are always concerned that there have been accounts of false positives in urinalysis tests; we have had a number of such cases. We are also always concerned that the Nurse may be producing and disclosing evidence that may be used against the Nurse when none would exist otherwise.

We have also had experience in cases where the nurse was suspected of diverting drugs such as Dilaudid or Percocet and consented to a urinalysis test because of this. The nurse's urinalysis test was negative for the Dilaudid or Percocet but was positive for some other illicit substance (usually cocaine, marijuana or alcohol). The nurse thought she could avoid termination and disciplinary action against her license because her urinalysis test was negative for the diverted drugs; however, this is not the correct.

What many Nurses don't fully understand is that they may also be disclosing evidence in such urinalysis tests of their legal use of controlled substances validly prescribed by their physician. Their medical treatment by their own personal physician should be no one's business but their own, especially if it is not affecting their job performance. However, once a drug test is consented to by the Nurse, if the urinalysis test report comes back positive, even for prescribed medications, both their employer and IPN may consider the drugs to be an impairment for the Nurse. This may cause the Nurse to be required to undergo a suspension or termination and great deal of additional time and costly evaluation, rehabilitation, counseling, and monitoring to ensure he or she is not "impaired" by such drugs.

Question 16:

I recently received a letter from the President of the Medical Staff at a hospital where I hold clinical privileges. It referred to an incident in which I had a disagreement with another physician over a procedure that was being considered from a patient upon whom we are both consulting. The letter makes references to my causing "disruptions" in the hospital and warns me about not being a "disruptive physician." Should I be concerned about this?

Answer 16:

Yes. You should be very concerned. If you are labeled as a "disruptive physician" this could lead to an attempt by the hospital to revoke your medical staff membership and hospital privileges. It could also result in a report being made to your state licensing board and disciplinary action being taken against your license. It could also cause the state impaired physicians program (known as the Professionals Resource Network or "PRN" in Florida) to attempt to force you into its program for disruptive physicians; this is onerous, expensive and carries a great stigma with it. You should take action to document the correct facts in this situation in order to keep your record clean.

We expect to see more of these types of allegations in the future, as a result of recent publications by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). On July 9, 2008, JCAHO issued Sentinel Event Alert, Issue 40, entitled "Behaviors That Undermine a Culture of Safety." It states, in part:

Intimidating and disruptive behaviors can foster medical errors, contribute to poor patient satisfaction and to preventable adverse outcomes, increase the cost of care, and cause qualified clinicians, administrators and managers to seek new positions in more professional environments. Safety and quality of patient care is dependent on teamwork, communication, and a collaborative work environment. To assure quality and to promote a culture of safety, health care organizations must address the problem of behaviors that threaten the performance of the health care team.

We are also aware of incidents in which labeling someone as a "disruptive physician" has been used in a retaliatory or unfair way. We are aware of the economic competitors of a physician using the "disruptive physician" label to attempt to eliminate a competing physician. We have also encountered hospital administrators advising nursing staff to look for and write up a physician for any possible incident in an attempt to have his medical staff membership revoked.

Any correspondence, warning, letter or counseling a physician receives that mentions the word "disruptive" or makes such an insinuation, should be taken very seriously by the physician. It should be responded to immediately, with facts, in an objective and dispassionate manner without attempting to "blame" anyone else. When in doubt, consult with an experienced board certified health law attorney.

Question 17:

I am a registered nurse. I have received a letter from the Florida Department of Health (DOH) advising me that a complaint has been filed against my license and that I am being investigated for this. The letter requests that I contact the DOH investigator to give her my side of the story and also requests that I send the investigator my resume or CV. Should I do this? What should I do?

Answer 17:

This is a serious matter. The investigation may result in formal proceedings in which permanent disciplinary action is taken against you. This could, in turn, result in elimination of job opportunities, loss of employment, loss of professional liability insurance, being disqualified from hospital positions, being disqualified from working for anyone taking Medicare or Medicaid, disciplinary action being taken against your professional license(es) in other states, and other actions.

You should not call the investigator or send in a written statement of any type. Any statement you make, oral or written, can be used against you to prove a charge or part of a charge.

You should immediately consult with or hire an experienced health attorney who is familiar with DOH investigations and has been involved with actions by your professional board.

If you have professional liability insurance you should notify your insurer and ask if your insurance company will pay for your legal expenses in connection with the investigation. Many professional liability insurance companies will do this. Nurses Service Organization (NSO) Insurance and Health Professionals Service Organization (HPSO) Insurance are two such examples.

If you are unable to hire an attorney, you should write a letter to the DOH Investigator and request that a complete copy of the investigation be provided to you when it is finished. You should also state that you may desire to make a statement or submit additional documents before the case goes to the probable cause panel, after reviewing the investigation. Send this letter by certified mail, return receipt requested, and keep a signed, dated copy of it. You have a right under Florida law to do this. Do not state anything else in your letter requesting a copy of the investigation.

If the investigator contacts you directly (by telephone, by letter or in person) tell the investigator you do not desire to make a statement at this point in time and that you are considering obtaining an attorney to represent you. Do not let the investigator provoke you into making any statement of any kind. Do not chit chat with the investigator. She is not your friend.

We cannot overemphasize the importance of attempting to obtain legal representation by an appropriately qualified and experienced attorney. Such an attorney may be of great assistance in obtaining a dismissal of the case by the probable cause panel or in negotiating a favorable settlement of the case.

Furthermore, in certain types of investigations, the DOH may be attempting to obtain an emergency suspension of your license. This is usually the case if the investigation involves allegations of drug abuse, alcohol abuse, mental impairment, sexual abuse, unpaid student loans or fraud. If there is an emergency suspension of your license, your professional license will be suspended (and you will be unable to work in that profession) until the entire matter is completed and finalized, which may be a year or more, even if you are found to be innocent. An experienced attorney may help prevent this from occurring.

Again, even the most innocuous response on your part could be used against you to prove part of the charges against you. Do not fall into this trap.

Question 18:

What is the difference between "direct supervision" and "indirect supervision" of medical personnel by a physician?

Answer 18:

Direct and indirect supervision are terms referring to how closely a physician is required to supervise his or her employee (usually an advanced registered nurse practitioner (A.R.N.P.), physician assistant (P.A.), medical assistant or other medical personnel. These terms usually acknowledge the experience and skills of a particular medical staff member and their ability to function and make medical decisions independently. They are also used to determine the appropriateness of paying for a certain procedure or service performed by that individual or the amount of payment, by Medicare, Medicaid or third party insurance companies.

Rule 64B8-2.001 (1), Florida Administrative Code (F.A.C.), a state rule (or "regulation") enacted by the Florida Board of Medicine, defines the different levels of supervision in reference to doctors of medicine (M.D.'s).

Rule 64B8-2.001 (1) (a), F.A.C., defines "direct supervision" as follows:

(a) "Direct supervision" shall require the physical presence of the supervising licensee on the premises so that the supervising licensee is reasonably available as needed. When this term is used in probationary terms of a Final Order, it requires that the licensee practice medicine only if the approved supervisor is on the premises.

In other words, the term "direct supervision" usually means that the supervising physician must be present on the premises (i.e., in the same building) so that he or she is immediately available to answer questions or otherwise respond.

Rule 64B8-2.001 (1) (b), F.A.C., defines indirect supervision as follows:

(b) "Indirect supervision" shall require only that the supervising licensee practice at a location which is within close physical proximity of the practice location of the supervised licensee and that the supervising licensee must be readily available for consultation as needed. "Close physical proximity" shall be within 20 miles or 30 minutes unless otherwise authorized by the Board.

Technically, these definitions adopted by the Florida Board of Medicine can only apply to medical doctors and other medical personnel regulated by the Board of Medicine practicing in Florida. However, these definitions are similar to those adopted in Medicare Guidelines applicable to all health care professionals who are Medicaid providers. Additionally, in the absence of similar rules adopted by other professional boards (e.g., Board of Osteopathic Medicine, Board of Chiropractic Medicine, etc.), state and federal regulators and insurance companies may look to these definitions for guidance.

For example, in Florida an unlicensed medical assistant may perform a number of acts and provide a number of services that appear to be medically related, provided these are performed under the direct supervision of a physician. Section 458.3485(2), Florida Statutes, sets forth these as follows:

DUTIES.--Under the direct supervision and responsibility of a licensed physician, a medical assistant may undertake the following duties:

(a) Performing clinical procedures, to include:
1. Performing aseptic procedures.
2. Taking vital signs.
3. Preparing patients for the physician's care.
4. Performing venipunctures and nonintravenous      injections.
5. Observing and reporting patients' signs or      symptoms.
(b) Administering basic first aid.
(c) Assisting with patient examinations or       treatments.
(d) Operating office medical equipment.

(e) Collecting routine laboratory specimens as
      directed by the physician.
(f) Administering medication as directed by the
      physician.
(g) Performing basic laboratory procedures.

(h) Performing office procedures including all
      general administrative duties required by the       physician.
(i) Performing dialysis procedures, including
      home dialysis.

Section 458.3485(1), Florida Statutes, enclosed herein, defines a medical assistant as follows:

DEFINITION.--As used in this section, "medical assistant" means a professional multiskilled person dedicated to assisting in all aspects of medical practice under the direct supervision and responsibility of a physician. This practitioner assists with patient care management, executes administrative and clinical procedures, and often performs managerial and supervisory functions. Competence in the field also requires that a medical assistant adhere to ethical and legal standards of professional practice, recognize and respond to emergencies, and demonstrate professional characteristics.

For further guidance as to the Medicare Program's requirements, you may desire to refer to 42 CFR Section 411.355(a)(ii), 72 Fed. Reg. p. 51088 (Sept. 5, 2007) and Medicare Program Memorandum Carriers Transmittal B-01-28 (April 19, 2001), which discuss the level of supervision required for certain services paid for by Medicare.

Question 19:

I am a doctor contemplating an employment relationship with a hospital. A representative of the hospital sent me a "Physician's Employment Agreement". I was told to sign it if I agree to it. I read it and was somewhat confused by the wording. I have been talking to a representative of hospital about the requirements of the job being offered to me and I would like to work for this hospital. Should I sign the agreement even though I have not had an attorney review it?

Answer 19:

No. A "Physician's Employment Agreement" is a legally enforceable contract. Your signature on the contract is an expression of your agreement to comply with all of the contract's terms and conditions. A court of law will enforce those terms against you even if you later contend the terms were poorly worded, confusing, or you did not read them. The person with whom you have been speaking may be a lawyer or may have legal experience. Regardless, he will be representing the hospital's interests and will not have your best interests in mind.

Often the agreement drafted by the hospital is tailored to address the hospital's objectives and concerns about the proposed employment relationship rather than your specific objectives and concerns and may be completely one-sided. Consultation with an experienced health care attorney will help you understand both the practical and legal meaning of the language in the contract. In turn, this will enable you to negotiate a better terms concerning important issues such as compensation, bonuses, extra duties, benefits, standing call, time off for continuing education, reimbursement of expenses, coverage, and relief in the event the job does not work out. You should, with the help of an experienced attorney, negotiate the best terms you are able, to protect your interests in the event the relationship breaks down at a later point in time.

You should always:

1. Have any significant contract or agreement reviewed by a health care attorney with experience in such matters.
   
   
2. Ensure that the wording of the contract exactly and clearly represents what you were promised orally.
   
   
3. Assume that every part of the contract will be enforceable against you despite promises or rumors to the contrary.
   
   
4. Be sure all blanks are completely filled in and all forms, documents, schedules and exhibits are attached to it before you sign it.
   
   
5. Be sure you receive a copy of any and all regulations, policies, procedures, rules, handbooks, codes of conduct, bylaws, or other documents referenced in the agreement, and review these, before you sign it.
   
   
6. Keep a signed, dated copy of the complete agreement.
   
   
7. Receive back a copy of the agreement, signed and dated by the hospital, before you start work.
   

Question 20:

I am a physician. I received a letter from the Department of Health (DOH). It contained an administrative complaint about my care of a patient. It also contained a statement saying I could request a formal hearing or an informal hearing, and a proposed "consent agreement" in which I would agree to receive a fine. Should I agree to this and the informal hearing?

Answer 20:

No. Since your case has gotten this far, it is a serious matter. If you choose an informal hearing, you are agreeing that all facts in the administrative complaint are true and you are guilty of the allegations; the only issue left undecided is what your punishment is to be. You may have good defenses that could be raised in a formal hearing and you have procedural rights which may result in dismissal of the case. Also, in a formal hearing, the state agency has the burden of proof and may not be able to prove the allegations. Even if you do not decide to pursue the formal hearing, a better deal may be negotiated with DOH or you may submit additional evidence and request a reconsideration of the case by the probable cause panel. Since any disciplinary action taken against your license will be reported to the National Practitioner Data Bank and will be on file forever, you need the advice of an experienced health care attorney in making this decision.

Question 21:

I am a physician. I received a letter from the Department of Health (DOH) indicating it has issued an emergency order to suspend my license to practice medicine. Can it do this? What should I do?

Answer 21:

The Secretary of the DOH has the authority to suspend your license to practice medicine on an emergency basis for a number of different reasons, usually related to safety of patients. These are often used if the physician is found to be impaired from drug or alcohol abuse. An emergency suspension order (ESO) may be used to force the physician to undergo a physical or mental examination. DOH may issue an ESO if a physician pleads guilty to, is convicted or found guilty of, or enters a plea of nolo contendere to a felony, or if a physician has defaulted on a student loan issued or guaranteed by the government. An ESO is a public record that is published in newsletters and released to the media. There are alternatives to ESOs that may keep the matter confidential. Also, ESOs may be challenged in court proceedings. If you suspect that DOH may issue an ESO, you should immediately hire an experienced health care attorney to begin working on your case. Your attorney may be able to help avoid an ESO or to expedite having your license reinstated.

Question 22:

I am a physician. I received a letter from my hospital peer review committee advising me that I was being investigated for concerns that it had about my medical care and advising me of a meeting that I should attend to answer questions. What should I do?

Answer 22:

This type of letter is usually the first step in a process to take adverse (or "disciplinary") action against you in relation to your clinical privileges and medical staff membership at the hospital. This may result in a lengthy, costly "peer review" or "fair hearing" in the hospital followed by an even longer legal battle. It may seem minor to you, but the hospital staff or one or more other physicians involved may consider the matter to be very serious or to indicate a "trend" that needs to be stopped. Adverse findings made by such hospital proceedings are reported to the National Practitioner Data Bank and remain on file forever, haunting the physician throughout his/her career. It is important that you immediately seek the advice of a health care attorney who has experience in hospital credentialing issues and who routinely represents physicians in such hearings. This particular subject is fraught with peril and even a senior, experienced attorney who has not been involved in these before will be at a notable disadvantage.

Question 23:

I am a physician. I received a letter from an investigator advising me that a complaint had been filed against me and asking me to make a statement explaining my side. Should I send the investigator my statement telling my side of the story?

Answer 23:

No. You should not speak with the investigator. Although you may have a very good, logical explanation, you should never communicate directly with an investigator in such a case. Your statement can and will be used against you and serve as proof of certain issues that might not be proved otherwise (such as the fact that you saw a certain patient, that you prescribed a certain medication, that you did or did not do certain things, etc.). Additionally, you may have inadvertently violated a law or regulation that you did not even know existed (such as advertising, billing or solicitation regulations). The fines authorized by law for infractions by health professionals have recently increased to $10,000 per incident and may also include suspension or revocation of your license. What may seem to you to be only a "minor" event may actually be viewed as much more serious by members of your professional board. We recommend that you not respond to the investigator but that you immediately hire an experienced health care attorney to advise you and respond on your behalf if called for. Don't wait.

Question 24:

I am a medical doctor with a solo practice. I have been told I should incorporate my practice as a professional association by some, and as a limited liability company by others. What is the best structure for my medical practice?

Answer 24:

Your medical practice should be organized as some business entity that limits your liability. Both the professional association and the limited liability company limit the personal liability of owners. Most medical practices are organized and operate successfully as professional associations. However, if the practice owns significant assets in the form of real estate or other property, which is often the case with medical practices, we recommend the formation of a limited liability company for those assets. A limited liability company may provide tax advantages when assets such as real estate appreciate in value.

Question 25:

I have heard that there are new Medicare regulations which required physician groups that perform diagnostic testing, such as radiographic studies, to become licensed as Independent Diagnostic testing Facilities. Is this correct? If so, when does this requirement go into effect?

Answer 25:

In 2007, Medicare proposed requiring physician practices that perform diagnostic testing to comply with most of the enrollment requirements Independent Diagnostic Testing Facilities are required to satisfy in order to bill for diagnostic tests provided to Medicare beneficiaries. Medicare recently deferred the implementation of that requirement on physician practices so physician practices are not currently required to enroll in Medicare as IDTFs, as of December 10, 2008.

Medicare is developing an accreditation process for physician practices that perform advanced diagnostic testing. Physician practices performing advanced diagnostic procedures need to consult with their health law attorneys to ensure their practices remain complaint with the Medicare requirements.

Mobile testing is another area that concerns Medicare. Physician practices should reexamine their lease agreements to ensure that they are not inadvertently contracting with a mobile testing facility.

Question 26:

What are the Medicare "Anti-Markup Rules" and what do they prohibit?

Answer 26:

This is a Federal Regulation which governs the amount that the Medicare Program will pay a health care provider as reimbursement for certain diagnostic tests which the provider purchases. The new Federal Regulation goes in to effect on January 1, 2009.

Physicians are permitted to bill Medicare for diagnostic tests performed by the physician, another physician in the ordering physician's office, or by personnel that are supervised by the ordering physician or another physician in the ordering physician's office. Medicare will pay up to the Medicare fee schedule amount for these diagnostic tests.

Physicians are also permitted to bill Medicare for purchased diagnostic tests (excluding clinical laboratory tests). However, the billing physician must bill Medicare the lower of the physician fee schedule, or the actual amount the billing physician paid for the purchased diagnostic test.

Over the last few years, Medicare has seen a significant increase in the number of arrangements whereby physicians were able to significantly expand their traditional practices to include diagnostic testing. Medicare has expressed its concerns that many of those arrangements result in overutilization and abuse of the Medicare trust fund so Medicare made significant changes to the Medicare anti-markup provisions found in the Federal Regulations that become effective on January 1, 2009.

Under the new anti-markup provisions, physician groups may still bill Medicare for diagnostic test the physician group orders if the physician group performs those tests. However, if any portion of the test is performed or supervised by a physician that does not "share a practice" with the ordering physician, then the test is a "purchased test" and the anti-markup provisions apply.

A physician shares a practice with the billing physician, for the purposes of the anti-markup provisions, if the arrangement satisfies one of the following two (2) alternatives. Alternative one, the physician performing or supervising the diagnostic test shares a practice with the billing physician if the performing or supervising physician furnishes substantially all of his or her professional services through the billing physician's practice. Alternative two, the physician performing or supervising the diagnostic test shares a practice with the billing physician if the technical component of the test is performed and supervised, or the professional component of the test is performed, in the office of the billing physician. The office of the billing physician is the office where the ordering physician provides substantially the full range of patient care services that the ordering physician generally provides.

Physician groups should have their arrangements for diagnostic testing reviewed for compliance with the anti-markup provisions of the Federal Regulations on Medicare before the January 1, 2009, effective date.

Question 27:

What are "Recovery Audit Contractor Audits" (RAC Audits) and should I be concerned about them?

Answer 27:

The Centers for Medicare & Medicaid Services (CMS), the federal agency with authority over the Medicare Program, advised that it took administrative measures to in its "comprehensive efforts" to identify "improper Medicare payments and fight fraud, waste and abuse" in the Medicare program by awarding a number of contracts to four permanent Recovery Audit Contractors (RACs) designed to "guard the Medicare Trust Fund."

We consider this nothing more than an attempt by the federal agency to avoid its legal duties by contracting with private corporations to do what it should be doing. RAC's are often referred to as "headhunters" or "bounty hunters" because they are paid a percentage of what they recover for the government.

RAC Audits are specialized Medicare audits that originally began as a demonstration or pilot program. Because the demonstration program resulted in over $900 million in Medicare payments being returned to the Medicare Trust Fund between 2005 and 2008, at no cost to the government, CMS has decided to expand this program.

The RAC Program was developed by Medicare to identify "improper" Medicare Payments not detected using previously existing error detection and prevention program efforts. Section 302 of the Tax Relief Health Care Act of 2006 made the RAC program permanent and required its expansion to all 50 states. By 2010, CMS plans to have four major RACs in place that are responsible for identifying overpayments and underpayments.

On October 6, 2008, CMS announced the names of the four new national RACs. The new RACs are:

(1) Diversified Collection Services, Inc. of Livermore, California. Region A, initially working in Maine, New Hampshire, Vermont, Massachusetts, Rhode Island and New York.

(2) CGI Technologies and Solutions, Inc. of Fairfax, Virginia. Region B, initially working in Michigan, Indiana and Minnesota.

(3) Connolly Consulting Associates, Inc. of Wilton, Connecticut. Region C, initially working in
South Carolina
Florida
Colorado
New Mexico.

(4) Health Data Insights, Inc. of Las Vegas, Nevada. Region D, initially working in
Montana
Wyoming
North Dakota
South Dakota
Utah
Arizona.

It is reported that additional states will be added to each RAC region in 2009.

How are RAC Audits different from regular Medicare audits by CMS or its regional carriers? RAC Contractors are paid on a contingency fee basis. RACs are financially motivated to go out and find errors. RACS can draw on HPMP and CERT methodology and data. RACs are now permanent and will develop an automated, ongoing denial system.

How do RACs operate? RAC's conduct audits by reviewing medical data and billing data. They rely on "automatic" and computerized reviews as opposed to complex medical reviews and complex billing analysis. An "automatic review" is a computerized analysis of claims and coding practices utilizing existing databases. These reviews identify errors such as duplicates in billing and the inappropriate bundling or unbundling of claims. "Complex medical reviews" are a method by which billing and coding experts review samples of medical records and billing documentation. These reviews identify billing errors and also lead to denials in payment based upon assertions of "no medical necessity" and "incomplete documentation." RACs will utilize presently-existing auditing procedures and will, therefore, have an infrastructure to complete audits and demand overpayment from their first day of operation.

RACs determine whether documentation for medical services provided meet the Medicare Guidelines for payment and whether the services are medically necessary.

How can you prepare for a RAC Audit? Consider moving toward and adopting Electronic Medical Records (EMRs). Make sure your billing staff (either internal or external) is properly qualified, trained and provided with continual training/updates. Utilize certified billing and/or coding experts on a yearly or biennial schedule to ensure compliance, update templates and train staff. If you are notified of an audit, immediately contact experienced health care counsel to begin representing you.

Remember, RACs are paid to find errors and alleged overpayments, not to be fair and objective.

Question 28:

What is the HITECH Act and what does it mean to me as a physician?

Answer 28:

The Health Insurance Portability and Accountability Act (HIPAA) was amended in 2009 by the Health Information Technology for Economic and Clinical Health (HITECH) Act. The HITECH Act was part of the American Recovery and Reinvestment Act (ARRA) of 2009. The HITECH Act required the U.S. Department of Health and Human Services (HHS) to modify the HIPAA Privacy, Security and Enforcement Rules (HIPAA Rules). The HITECH Act further strengthens the privacy and security protections for health information and improves the ease of use and effectiveness of the HIPAA Rules. Proposed Federal Regulations have recently been released by HHS.

These proposed Regulations not only make HITECH changes, but they are the first major updating of the HIPAA Privacy Rule and HIPAA Security Rule since 2003. (The Privacy Rule and the Security rules can be found at 45 CFR Sections 160, 162 and 164.) HHS says that it took this opportunity to update the Privacy and Security Rules as HHS "has accumulated a wealth of experience with these rules, both from public contact in various forums and through the process of enforcing the rules."

In the proposed Federal Regulations, HHS solicits comments regarding specific elements of the proposed changes. These comments are due to HHS by September 12, 2010. They could help shape the final Regulations issued by HHS. In the recent past, HHS has seriously considered such comments it received.

The proposed modifications to the HIPAA Rules include:

• expanding the required content of business associate (BA) agreements;
• extending BA associate requirements to subcontractors;
• establishing new limitations on the use and disclosure of protected health information (PHI) for marketing and fund-raising purposes;
• creating additional requirements for Notices of Privacy Practices that covered entities are required to give;
• greatly increasing the possible civil penalties for violations of HIPAA;
• expanding individual patients' rights to access their information and to place restrictions on certain disclosures of PHI to health plans;
• providing more flexibility for research authorizations, including the use of PHI for future, unspecified research;
• providing mandatory notices to patients for breaches or possible breaches of their privacy under certain circumstances;
• allowing for the disclosure of PHI to a decedent's family members, even if they are not personal representatives;
• prohibiting the sale of PHI; and
• adding provisions designed to strengthen and expand HIPAA's enforcement provisions.

If you are a health care provider who is accused by a patient of a breach of the patient's confidentiality, you should immediately retain the services of a qualified health attorney to represent you. If you receive a notice from the Office of Civil Rights (OCR) of the U.S. Department of Health and Human Services that it is investigating a complaint for a violation of HIPAA, you should immediately retain the services of a qualified health attorney to represent you; you could be facing criminal penalties or significant civil fines.

 

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