Category Archives: Physician

WHAT ABOUT A MANAGEMENT SERVICES ORGANIZATION?

AVOIDING THE PROHIBITION AGAINST NON-PHYSICIAN OWNERSHIP OF MEDICAL ORGANIZATIONS

A management services organization (“MSO”) is an entity which would contract with a physician or a medical corporation owned and operated by physicians. The MSO could be owned by non-physicians.  The physician or medical corporation can pay the MSO for everything. Employees would work for the MSO; the MSO would pay for the lease.  The MSO would pay for all significant expenses and receive a fee for its services.

The Corporate Practice Medicine Doctrine (CPOM) is strong in California. Under this doctrine, physicians must control clinical decisions. The concern is that if business entities owned by non-physicians are permitted to control the rendering of care, they will subordinate clinical care to commercial considerations and profits. The objective, therefore, is to prevent non-physicians and non-physician-owned business entities from influencing treatment decisions.

This presents a significant constraint to physician business ventures. Specifically, if physicians or other clinical personnel work for entities other than professional medical corporations, they may be exposed to disciplinary risks, as well as to forfeiture of revenues.. For non-physician business partners, violating the CPOM may also bring both civil and, in extreme cases, potential criminal liability for engaging in medical practice without a license.

MSO

In California, the solution for avoiding violations of the CPOM in business ventures in which physicians work with businesses owned by unlicensed persons is a contractual relationship between the physician entity and the unlicensed business entity, or a “management services organization (MSO).” This is a business vehicle that permits unlicensed persons to provide services to physicians and their professional medical corporations. In its simplest form, an MSO provides basic practice support services to physicians and professional medical corporations via a contractual relationship, commonly known as a management services agreement. These services frequently include activities such as billing and collection, administrative support in certain areas, and electronic data interchange (e.g. electronic billing). Some MSO’s provide a broader set of services: the MSO may purchase many of the assets in a medical practice, such as office space or equipment. MSO’s can employ office support staff, and assist with a wide range of non-clinical functions. MSO’s can also assist in functions such as marketing. Often, MSO’s can reduce costs by bringing economies of scale and professional management experience into physician practices, thereby improving operational efficiency and reducing overhead costs.

the MSO must be carefully considered and constructed.  Review and application of relevant laws and regulations is a must.

By Matt Kinley, Esq. of the Kinley Law Practice

IS YOUR HEALTHCARE COMPLIANCE PROGRAM COMPLIANT?

HEALTHCARE COMPLIANCE

10 RED FLAGS

Under current law, physicians are required to maintain an effective, comprehensive compliance program to detect, correct and prevent incidences of non-compliance with state and federal regulatory law.  Goals of a comprehensive compliance program is to prevent the significant criminal and civil penalties that might come with a violation of the False Claims Act, Stark, the Anti-Kickback Statutes, HIPAA and state law equivalents. Failure to comply might lead to exclusion from health payments. Here is a summary of the core components of a complete compliance plan:

#1  MISSING OR INCOMPLETE WRITTTEN POLICIES, PROCEDURES AND STANDARDS OF CONDUCT

#2  PEOPLE:   NO COMPLIANCE OFFICER OR COMPLIANCE COMMITTEE

#3  TRAINING:  THE FACILITY LACKS EFFECTIVE TRAINING AND EDUCATION

#4.  COMMUNICATION:  THE FACILITY LACKS

#5.  PERSONEL:  FAILURE TO PUBLISH DISCIPLINARY STANDARDS & TO EFFECTIVELY DISCIPLINE VIOLATORS

#6.  NO SYSTEM TO AUDIT AND MONITOR ORGANIZATION COMPLIANCE AND COMPLIANCE RISKS

 #7  FAILURE TO CREATE PROCEDURES TO PROMPTLY RESPOND TO IDENTIFIED ISSUES AND SELF DISCLOSURE OBLIGATIONS

#8.  LACK OF SUPPORT FROM PHYSICIANS AND LEADERSHIP OF THE ORGANIZATION

#9.  FAILURE TO INSTITUTE PRIVATE HEALTH INFORMATION POLICIES

#10. FAILURE TO MONITOR NEW LAW AND UPDATE COMPLIANCE ACCORDINGLY

By Matt Kinley,Esq., LLM, CHC

562.715.5557

             

 

                

 

 

 

Sterilize Your Potential Liability

Is your business compliant with OSHA’s Bloodborne Pathogens Standard?

If you operate a business with employees that are exposed to blood or other potentially infectious materials (OPIM), your business is subject to OSHA’s Bloodborne Pathogens Standard (BPS) under the Code of Federal Regulations. In spite of its attempt to simplify these requirements on its online fact sheet, OSHA imposes a minefield of regulations for small to midsize businesses to navigate. This post provides a brief overview of the Bloodborne Pathogens Standard and what it means to your business.

Have an Updated Plan

All good businesses have a plan right? Well, OSHA adds to your plans by requiring an “exposure control plan.” 29 C.F.R. 1910.1030 (c)(1). Under this plan, employers must create a catalogue that classifies the employee positions in the company by the level of blood and OPIM exposure. 29 C.F.R. 1910.1030 (c)(2)(i)(A). Also, this plan must detail the tasks and procedures performed by each classification of employee that causes their exposure. 29 C.F.R. 1910.1030 (c)(2)(i)(C).

The Bloodborne Pathogens Standard not only requires the employer to have an exposure control plan but also requires that it be updated annually “to reflect changes in tasks, procedures, and positions that affect occupational exposure, and also technological changes that eliminate or reduce occupational exposure.” OSHA, OSHA’s Bloodborne Pathogens Standard, OSHA Fact Sheet.

In order to make these updates to the satisfaction of OSHA, the employer must also document in their plan that they both considered and begun using safer medical devices to minimize occupational exposure and engage with their employees “in identifying, evaluating, and selecting effective engineering and work practice controls.” OSHA, OSHA’s Bloodborne Pathogens Standard, OSHA Fact Sheet,  And we’re just getting started.

Don’t Discriminate

It is imperative under the Bloodborne Pathogen Standard that the precautions used to prevent an exposure incident are universal. 29 C.F.R. 1910.1030 (b). As OSHA explains, this means “treating all human blood and OPIM as if known to be infectious for bloodborne pathogens.” OSHA, OSHA’s Bloodborne Pathogens Standard, OSHA Fact Sheet.

Be Well Stocked With the Right Equipment

The Bloodborne Pathogen Standard requires the examination, maintenance, and routine replacement of “engineering controls.” 29 C.F.R. 1910.1030 (d)(2)(ii). What are engineering controls you ask? They are “controls . . . that isolate or remove the bloodborne pathogens hazard from the workplace” such as sharps disposal cleaners and self-sheathing needles among others. 29 C.F.R. 1910.1030 (b). In other words, take the garbage out on a regular basis. Employers must also provide appropriate personal protective equipment (PPEs) for employees with occupational exposure such as “gloves, gowns, laboratory coats, face shields or masks and eye protection, and mouthpieces, resuscitation bags, pocket masks, or other ventilation devices.” 29 C.F.R. 1910.1030 (d)(3)(i). These PPEs must be provided by the employer at no cost to its employees. Id.

Take Preventative and Remedial Measures

Hepatitis B vaccinations must be made available to all employees with occupational exposure after they have received training and within 10 working days of their initial assignment. 29 C.F.R. 1910.1030 (f)(2)(i). Should there be an exposure incident, you must “make available post-exposure evaluation and follow-up to any occupationally exposed worker who experiences an exposure incident.” OSHA, OSHA’s Bloodborne Pathogens Standard, OSHA Fact Sheet. The procedures the employer must follow after an exposure incident can become complicated with consent and health-related confidentiality issues regarding investigations of the source individual and the employee.

The requirements surrounding warning labels and signs communicating hazards are lengthy enough to warrant their own blog post. The main takeaway from the BPS requirements for labels and signs is this: Anything that comes into contact in any way with blood or OPIM must have a label or sign that warns against the dangers of exposure. As the Code of Federal Regulations states, warning labels must be affixed to “containers of regulated waste, refrigerators and freezers containing blood or other potentially infectious material; and other containers used to store, transport or ship blood or other potentially infectious materials. 29 C.F. R. 1910.1030 (g)(1)(i). There are also specific regulations relating to warning signs for all entry ways in HIV and HBV research laboratories and production facilities. See 29 C.F.R. 1910.1030 (g)(1)(ii).

This post only scratches the surface of OSHA’s Bloodborne Pathogens Standard. If you run a business that exposes its employees to blood and other potentially infectious materials, you must comply with these regulations under federal law. Operating a healthcare facility is no simple task even before considering regulations such as the Bloodborne Pathogens Standard. Protect your business and ensure you are complying with these detailed requirements.

By Matt Kinley,Esq., LLM, CHC

562.715.5557

California Physicians May Be Asked to Help with Assisted Suicide

PHYSICIANS CAN OPT OUT OF ASSISTED SUICIDE LAW

California was the most recent state to adopt the End of Life Option Act, codified at Health & Safety Code section 443. It basically allows a competent patient who has been diagnosed with a terminal illness to seek and obtain a prescription for the necessary drugs to be self administered.  The law is effective on June 9, 2016.

Aid-in-dying legislation has passed in Oregon, Washington, Vermont, and Montana.   Doctors in those states are permitted to prescribe drugs to terminal patients that they will use to end their lives.  The patients must meet certain requirements and undergo a set process to receive the medication.

California’s procedures, like the other states, seek to protect terminal patients from rash decisions or over-anxious relatives.  While patients may designate agents to make all sorts of health care decisions on the patient’s behalf, an agent is not able to request aid-in-dying drugs on behalf of a patient, and therefore these drugs cannot be requested through an advanced healthcare directive.

The  Act allows doctors, medical groups and hospitals to opt out of the law.    Most, if not all, religious hospitals are expected to reject the law.  Physicians are not required to prescribe life ending drugs to patients.  The California Medical Association dropped it’s opposition to the bill.  According to news reports, the state of California will pay for the costs of the drugs to be utilized.

According to the Act, the “aid-in-dying drug” means a “drug determined and prescribed by a physician for a qualified individual, which the qualified individual may choose to self-administer to bring about his or her death due to a terminal disease.”  The Act does not describe what the appropriate drug might be.

Health and Safety Code section 443.22 provides the physician with a checklist to be used if a patient seeks the end of life drug.  See, AttendingPhysicianChecklist

To summarize the requirements, in order for a person to seek aid-in-dying drugs, they must meet the following criteria:

  • The patient must be at least 18 years old
  • They must have capacity to make medical decisions
  • Diagnosed with a terminal illness by an attending AND consulting physician
  • The individual must voluntarily express the wish to receive the aid-in-dying drug
  • They must request the drug twice orally—such requests should be made 15 days apart
  • Must request by written request which is signed/dated and witnessed by two adults
  • Must be California resident (and provide proof of such residency)
  • Must have physical and mental ability to self-administer the drug
  • The decision must be confirmed that it is not due to coercion or undue influence
  • The attending physician must offer the qualified individual to withdraw or rescind the request

Upon filling the aid-in-dying prescription, the patient must complete a “Final Attestation for an Aid-in-Dying drug to End My Life in a Humane and Dignified Manner” form 48 hours prior to self-administering the drug.

Developments in the law should be closely monitored as it is likely that that state regulators may develop more detailed and specific standards when facing a terminal patient seeking end of life drugs.

By Matt Kinley,Esq., LLM, CHC

562.715.5557

INSURANCE COMPANIES SEEK TO DEFEAT THE SURGERY CENTERS

Various news organizations (for example, Law360) reported on Aetna’s jury verdict against Northern California surgery centers for over-billing the insurer for out-of-network procedures. The jury determined that the surgery center should pay $37.4 million in damages.  The complaint by Aetna included allegations that surgery centers waived patient co-pays and other fees, sales of shares to physicians (who received substantial ROI) in addition to the physician’s own fee for service and other “fraud.”

Other lawsuits with similar allegations are pending. United Healthcare Services has a complaint against several Bay Area ASC’s claiming the ASCs’ bills are artificially inflated, that the providers utilizes different charges for different patients (out-of-network charges being the highest), that the ASCs failed to disclose waiver of co-pays, and inappropriate incentives to physicians for referring patients to the ASC.

The insurers in these cases are attempting to utilize the courts to stop out-of-network billings, especially for ASCs.   The conduct they are complaining about is a common issue of our medical landscape.  Surgery centers are typically physician owned and tend not to have insurance with the typical plans that exist.  Physicians will often promote the ASC as providing superior service, especially compared with alternative medical centers and hospitals.  In order to encourage the patient to have procedures at a facility which does not accept their insurance, the physician and the ASCs will often assure the patient that they will seek reimbursement from the out-of-network insurance provider and that any service received will be at no cost to the patient.  Freed from in-network contracts, these facilities seek their “reasonable fees” from the insurer.

The current litigation will certainly lead to appeals and opinions by courts that will alter the legal landscape. The facts in the Aetna case appear to include evidence of communications between physicians encouraging referrals to the surgery centers, which would appear inflammatory to the jury.

 

However existing law does not appear to support the insurers claims.  For instance, the Accountable Care Act actually requires discounting co-payments for out-of-network emergencies. (“Any cost-sharing requirement expressed as a copayment or coinsurance rate imposed with respect to a participant, beneficiary, or enrollee for out-of-network emergency services cannot exceed the cost-sharing requirement imposed with respect to a patient, beneficiary or enrollee if the services were provided in network.” 45 C.F.R. 147.138.)  The California Attorney General that waiver of copayments for out-of-network insurance companies was appropriate.  (Dentists routine waiver of co-pay appropriate. 64 Ops. Cal. Atty. Gen. 782 (1981).) Discounts to encourage patient referrals is not impermissible. (People v. Duz-Mor Diagnostic Laboratory, Inc. (1998) 68 Cal. App. 4th 654.)  Likewise, it is legal for physicians to refer to surgery centers where they have a financial interest. (California Business Code section 650(d).)

Providers who routinely bill to out-of-network providers should monitor these cases closely. The Courts will be making ground-making decisions in this area in coming months.

By Matt Kinley, Esq, LL.M.  Mr. Kinley represents health care clients in Southern California.

Los Angeles Medical Association: Navigating the Hornet’s Nest of Reimbursement

Matt Kinley Speaks to Los Angeles County Medical Association on March 23, 2016.  Contact Mr. Kinley at mkinley@tldlaw.com if your interested in attending.

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HHS TO CREATE NEW CYBERSECURITY REGULATIONS FOR HEALTH CARE

CONGRESS DIRECTS ACTION IN HEALTHCARE CYBERSECURITY

In December of 2015 Congress passed a 2000-page spending bill which was enacted into law. Included in the text was the Cybersecurity Information Sharing Act of 2015 (CISA). While that legislation received most of the headlines, the spending bill also implemented some major developments in the field of privacy for the healthcare industry. Section 405 of Title IV directs the Department of Health and Human Services (HHS) to develop best practices for organizations in the healthcare industry.

The legislation mandates HHS to report to Congress regarding the preparedness of the health care industry in responding to cybersecurity threats. This includes identifying the HHS official responsible for coordinating threat efforts and including plans on how HHS divisions communicate with one another regarding threats. Congress also mandated a one-year task force to plan a threat reporting system in real time, and to prepare a cybersecurity preparedness information for dissemination in the healthcare industry. Most notably, HHS has been directed to collaborate with other governmental entities and experts to establish a best practices standards specific to healthcare cybersecurity. The intent is to create an industry standard and cost-effective method to reduce cybersecurity risks for healthcare organizations.

Inclusion of Section 405 of the Cybersecurity Act of 2015 reinforces the federal government’s well-established priority of protecting personal health information. Protection is necessary because of the high value of personal health information on the black market. According to the The Insurance Journal, a complete health record containing a patient’s entire health profile can fetch as much as $500. The value is based on the ability of lawbreakers to fraudulently bill insurers for medical services. Compared to industries like the credit card payment industry—which has implemented its own cybersecurity standards—the healthcare industry is woefully behind in its efforts to protect valuable private information.

Healthcare facilities, both public and private, should stay ahead of HHS and develop their own internal policies, security measures, and best practices to protect confidential information of their patients. While guidance form HHS in the future will help establish industry standard best practices, healthcare providers should evaluate their cybersecurity needs and work with experts—attorneys, technologists, and governmental agencies—to stay ahead of the curve. Undoubtedly the attention given to healthcare cybersecurity in the next years will increase the scrutiny on healthcare providers who fail to meet industry standards.

By Matt Kinley,Esq., LLM, CHC

562.715.5557

PHYSICIAN COMPENSATION UNDER OIG REVIEW

Physician Compensation Arrangements Under Scrutiny

On June 9, 2015, the Office of Inspector General issued a special Fraud Alert warning physicians that compensation arrangements (such as medical directorships) must ensure that the arrangement reflects fair market value. Such arrangements “may violate the anti-kickback statute even if one purpose of the arrangement is to compensation a physician for his or her past or future referrals of Federal health care program business.”

California statures and rules can be even stricter.

In this era of merger and consolidation, medical providers must be careful to create appropriate compensation arrangements. They must carefully document attempts at establishing fair market value, or be subject to regulatory prosecution.

This alert comes after the OIG recently reached settlements with 12 physicians who entered into medical directorships and other arrangements, which the OIG concluded violated the Federal Anti-Kickback Statute. In those cases, the arrangements appeared to be illegal for one or more of the following reasons:

• The payments to the physicians took into account the physicians’ volume or value of referrals.

• The payments did not reflect fair market value for the physicians’ services.

• The physicians did not actually provide the services required under the agreements.

• The entities contracting the physicians paid the salaries of the physicians’ front office staff.

Certain physician compensation arrangements – and particularly medical director arrangements – are perceived as risk areas for Anti-Kickback Statute violations. Facilities and physicians entering into such arrangements should review existing and new arrangements for compliance in light of this Fraud Alert and should seek the expertise of health care legal counsel.

By Matt Kinley,Esq., LLM, CHC

562.715.5557

TELEMEDICINE IN CALIFORNIA

DOES THE LAW STRANGLE ATTEMPTS TO SAVE COSTS THROUGH TELEHEALTH?

Telehealth can take different forms.  It’s one thing to offer consultations and second opinions.  But once this useful tool is utilized for diagnosis and treatment, the rules change.

How can a compnay offer telemedicine, including diagnosis, treatment and prescriptions in California?  Does the physician have to be licensed?  How does a telemedicine company avoid the corporate practice of medicine doctrine?

THE PHYSICIAN MUST BE LICENSED IN CALIFORNIA

California’s Medical Board describes telehealth as: “Telehealth (previously called telemedicine) is seen as a tool in medical practice, not a separate form of medicine. There are no legal prohibitions to using technology in the practice of medicine, as long as the practice is done by a California licensed physician.”

Telehealth is not a telephone conversation, email/instant messaging conversation, or fax; it typically involves the application of videoconferencing or store and forward technology to provide or support health care delivery.” One statute states: Any law allowing telehealth shall not be construed to alter the scope of practice of any health care provider.

THE CORPORATE MEDICINE DOCTRINE

California prohibits the corporate practice of medicine, which among other things, requires that business or management decisions and activities resulting in control over a physician’ practice of medicine, be made by a licensed California physician and not by an unlicensed person or entity. In order to avoid the direct violation of state prohibitions on the corporate practice of medicine.  While there are legal structures that may promote non-physician investment in telehealth, (many companies use the so-called “friendly PC” model).

Enforcement by the medical board regarding the prohibition against the corporate practice of medicine generally is inconsistent.
Although there is no hard and fast rule as to when a given arrangement may be deemed to constitute corporate practice, the focus in any enforcement action likely will be on the level of control a physician exercises over the operation of the medical practice, specifically the professional judgment of licensed health care professionals. Where a high level of control exists, the arrangement may be found to be a sham intended to disguise the de facto practice of medicine by an unlicensed entity.

By Matt Kinley, Esq.

Reporting Physician Office Controlled Substance or Prescription Abuse

Physician offices often are hit with an internal crime:  employees utilize the office, its forms, the doctors DEA Number, or even the computers to write unauthorized prescriptions. The physician’s office has the obligation to make sure that forms, computers, and other tools utilized to write prescriptions are carefully safeguards.  Attorneys and malpractice carriers can be consulted for the best practices.

Health and Safety Code Section 11368 states that anyone who forges or alters a prescription or who obtains any narcotic drug by a forged, fictitious, or altered prescription may be punished by imprisonment in the county jail or state prison for not less than six months or more than one year. Since prescription forgery is considered a criminal offense, it is recommended that a report be made to the local law enforcement.

The California Medical Board provides some specific advice:

Federal law requires physicians to report theft or loss of controlled substances and official Federal Order Forms (Form 222) to a regional office of the Drug Enforcement Administration. The DEA has offices located in Los Angeles, San Diego and San Francisco and the office addresses and phone number are available through their website. In addition, the DEA has their reporting forms available online at the following link: http://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html.

While neither the Medical Board nor state law requires that a report of stolen or illegal use of the physician’s DEA number be made to the Board, it is our recommendation that physicians provide the Medical Board with a written narrative of the circumstances and the actions taken by the physician so we may have this information on file. When the written narrative is received, this valuable information will be input into the Medical Board’s internal database for reference, as it is not unusual to receive complaints from pharmacists or law enforcement officers regarding concerns about physicians’ prescribing practices. If a physician has already reported that he/she has experienced a problem related to the illegal use of his/her DEA number, the Board has already been provided with background information on the problem. The written narrative should be forwarded to the Medical Board of California, Central Complaint Unit, 2005 Evergreen Street, Suite 1200, Sacramento, CA 95815.

Once the information has been processed, the physician will receive correspondence from the Central Complaint Unit containing their assigned “Conl Number,” which should be maintained for their records. A carbon copy of this correspondence will also be forwarded to the California Board of Pharmacy so they may notify pharmacies in the physician’s surrounding area of the incident. The notified pharmacies will then contact the physician to verify any prescriptions they receive on the physician’s prescription pad or using the physician’s DEA number. For additional questions or concerns regarding this issue, please contact the Central Complaint Unit through the Medical Board’s toll-free number, 1-800-633-2322.

In addition to the above, if the physician is aware of the theft or loss of the tamper-resistant prescription forms, the State Department of Justice, Bureau of Narcotic Enforcement must be notified. To report the theft or loss of the new tamper-resistant prescription forms, Form JUS MUST be completed. Please complete all applicable fields on the form and forward the form to: California Department of Justice, Bureau of Narcotic Enforcement, CURES Program, P.O. Box 160447, Sacramento, California, 95816, FAX: (916) 319-9448. If you have additional questions or concerns regarding lost or stolen tamper-resistant prescriptions forms, please contact the CURES Program at (916) 319-9062.

Matt Kinley, Esq.