There are many healthcare services that provide medical care away from the standard local doctor’s office. At Cohen Healthcare Law Group, PC, our skilled regulatory and transactional firm represents many different types of healthcare providers including doctors, allied health service providers, concierge services, specialty practices, and medical spas and anti-aging services. We also represent numerous companies that produce and distribute healthcare products such as biotech companies, life science companies, cannabis ventures, managed service organizations (MSOs), dietary and nutrition companies, and ancillary service companies such as imaging centers and blood labs.
One core area of our practice are healthcare practices that are distinct from traditional general practice offices and specialty service offices. Some of the health companies we represent in this arena include:
“Academic medical centers and teaching hospitals have unique legal needs, especially those that train employ medical professionals such as physicians, nurses, and physician assistants.” According to the American Hospital Association, there are more than 1,000 teaching hospitals nationwide. These hospitals are often the biggest employers in a region. Our healthcare compliance lawyers understand and advise on a broad range of compliance issues for these academic medical centers.
One of the core compliance issues that needs review are the employment and other contract needs of all the medical professionals who work for these centers.
Ambulatory Surgery Centers (ASCs)
Ambulatory Surgery Centers help patients get same-day surgery care so that they don’t have to stay overnight at a hospital. Some hospitals have their own ASCs. Many doctors conduct patient surgery at facilities that are separate from the hospitals. Often, multiple doctors in the same practice area, or even different practice areas, may use the same ASCs. Physicians promote ASCs for – better time management, decreased costs of service, and less risk of serious infections. ASCs help millions of Americans but the owners of the ASCs do need to review the unique compliance issues that govern ASCs with experienced healthcare lawyers – so the ASC can start and continue to operate.
Home health care includes many health services in the home or apartment of a patient. It’s usually less costly than nursing home or facility care. Common types of home health services include:
- Caregiving for people with dementia and people with various types of physical problems
- Wound care
- IV and nutritional care
- Injections
- Monitoring illnesses by checking blood pressure, temperature, and other checks
In some cases, home health care helps the patient get better so they can function again. In other cases, home health care helps delay the need to transfer the patient to elderly care or other types of healthcare.
This care is generally provided to people who are near the end of life and who won’t improve with any other medical care. Because of the concerns about how people with terminal illnesses are treated, hospices must comply with numerous regulations which govern:
- The multidisciplinary approach needed to determine the patient’s physical, medical, emotional, psychological, and spiritual needs – along with the needs of the family of the patient.
- A care plan which includes common terminal illness issues such as pain management and support services. Care plans need to consider the services the patient needs because he/she is not at home.
- Palliative medical care
- Bereavement care for the family members when the patient succumbs
- Other care depending on the nature of the patient’s illness and whether the patient has dementia.
These medical facilities generally are walk-in care centers for people with minor illnesses. They may provide some emergency care services even though they’re not a hospital. Urgency care centers are also called quick-care clinics, walk-in clinics, and minor care clinics. Some even advertise that they “Treat Emergencies.”
According to the American College of American Physicians (ACAP), urgent care services may have specific requirements (provided by the state) such as that they:
- Be open every day of the week
- Have diagnostic equipment – on-site
- Have a licensed medical director
- Have more than one examination room
- Treat many different types of illnesses and injuries
- Be able to do minor medical procedures
According to the ACAP, “Medicare, HHS and OIG are increasingly targeting Urgent care centers for audits.” For this reason, urgent care centers need to ensure they comply with:
- HIPAA
- Stark Law
- The Anti-Kickback Statute
- Corporate practice of medicine laws
- Rules on hiring physicians
- Medicare and Medicaid enrollment
- Medicare’s Emergency Medical Treatment & Labor Act (EMTALA)
The health, wellness, and beauty business are booming. People understand that there are treatments, services, and products that can help them look and feel better. These medical treatments such as dermal fillers, Botox injections, and laser hair removal aren’t confined to just women. Men are getting these treatments too. Medical spas combine cosmetic medicine and aesthetic medicine with many non-medical modalities.
The growth in medical spas hasn’t gone unnoticed by medical boards and states. Laws, regulations, and enforcement actions against the doctors who work with medical spas are on the rise.
What types of general regulatory and financial oversight of academic medical centers, ASCs, hospices, urgent care centers, and medical spas do healthcare lawyers review?
Many of the legal issues that apply to physician-run and physician-managed practices also apply to these newer medical services. Experienced healthcare lawyers review what business structures are permitted and the all necessary contracts that must be drafted to operate and improve the medical practice. Our firm also explains the various laws and regulations that apply to these practices including prohibited financial arrangements, the unauthorized practice of medicine, HIPAA protocols, and other issues.
Some of these common regulatory and financial issues include the following:
Regulatory compliance
- HIPAA
- Stark Law
- The Anti-Kickback Statute
- Managed Service Organizations
- FTC and FDA warning letters and compliance
- OTC and off-label marketing
Business formation and operation issues
- Medical corporations, partnerships, and other legal entities
- Employment and staffing contracts
- Rental and real estate agreements
- Licensing
- Property and liability insurance
Issues that are unique or that strongly apply to particular practices
Academic Medical Centers
According to the Academic Medical Center Compliance Program, some key compliance issues for medical centers include:
- Due diligence in hiring requirements
- Incorporating Office of the Inspector General guidelines
- Education, auditing, monitoring, discipline, and prevention of staff and officers
- Understanding Medicare’s rules as they apply to medical students
- Clinical trials
- Relationships with industry
- HIPAA
ASCs
These centers are often made available to multiple doctors. There can be a fine line between permitting doctors to use the facilities and offering an incentive or discount if the doctor refers a certain level or amount of referrals of patients to the ambulatory surgery center. Arrangements to base participation in the ASC based on referrals is a red-flag that an experienced healthcare lawyer will review. Exceptions and safe harbors may apply if the formal requirements of Stark Law and the AKS statute are met. In addition to physician staffing issues, other Stark Law and AKS requirements and exceptions/safe harbors that must be reviewed include renting or leasing equipment, renting or buying office space, and other operational matters.
Generally, ASCs must be approved by the state and/or Medicare before the ASC can offer its services. ASC operation generally requires the employment of anesthesiologists. The financial arrangements with anesthesiologists must be reviewed.
Experienced healthcare lawyers also review the merits and legalities of medical directorships.
Electronic communications of a patient’s health information must comply with the Health Insurance Portability and Accountability Act.
There are several medical staffing issues that may need review such as waiving bylaws to permit a doctor to work in the ASC when the doctor may not meet certain requirements. Many ASCs are created to perform certain types of procedures such as steroid injections by pain management doctors and colonoscopies by a gastroenterologist. The ASC generally must comply with medical procedure requirements for each different specialty. Other staffing issues may include how to fire a doctor who isn’t working out.
Hospices
According to the Health Care Compliance Association, a few key hospice compliance issues involve:
- Fraud and False Claims Act investigations
- Staff credentials
- Medical necessity
- Billing for services actually rendered
- Technical compliance and documentation
- Medicaid home care
- Referrals and kickbacks
- “Billing for Medicaid home care to a Medicaid hospital patient”
- Utilization non-compliance
Urgent Care Centers
There are many legal issues that a skilled healthcare lawyer needs to review including:
- Who can invest in and run the urgent care center
- “In states with a strong corporate practice of medicine doctrine, such as California, Illinois, New York, Massachusetts, or Texas, non-physicians cannot “partner” with MD’s or DO’s, nor can non-physicians hire medical doctors or osteopathic physicians.”
- Fee-splitting and AKS issues. “To help mitigate fee-splitting and anti-kickback issues, the MSO should be paid at fair market value (justified, documented). A flat fee should be paid for marketing services – i.e., no fees on a per-patient basis. This is sometimes trickier than it seems. Ventures come up with all sorts of “per ….” formulas, which is attractive financially but risky legally.”
- State licensing issues for the center, for the clinical laboratories the urgent care center works with (including a state requirements and CMS clearance. If the urgent care center uses a pharmacy, the pharmacy will need a proper license. A license or certificate may also be required if any on-site X-Ray equipment is used. Any non-physician healthcare providers may need to be supervised by a physician.
- A review of any stock purchase or asset purchase agreement.
- Due diligence.
Legal Issues Buying or Selling an Urgent Care Center
When buying, selling, or starting an urgent care center, be sure to handle legal and regulatory pitfalls adroitly.
Medical spas.
Common medical spa healthcare compliance issues that our firm reviews include:
- Medical directorships
- Fee splitting
- Use of Physicians vs. Nurses vs. Physician Assistants
“In medical spas, as in all healthcare ventures, there is often a conflict between what’s most economical – what makes most business sense; and, what makes most sense from the perspective of risk management.”
“Compliance is rarely 1,000%. If you have a physician perform all the procedures, that’s probably playing it safe on the medical and legal side, but hardly leveraging your assets – especially since NPs typically have a very expanded scope of practice. On the other hand, if the MD is never there, you’re highly leveraged economically but in a high-risk category in terms of compliance.”
- FDA and FTC Issues. “In our law practice we deal with healthcare products as well as services. Products include drugs – like Botox; dietary supplements – like multi-vitamins and omegas; and cosmetics.” “Here we look at the marketing materials to see whether any claims run afoul of FDA guidelines, or those by the Federal Trade Commission (FTC) which regulates advertising.”
Non-standard office medical practices need to review their regulatory compliance issues with a premier healthcare lawyer. The attorney will review a range of compliance issues including Stark Law, the Anti-Kickback Statute, HIPAA, the corporate practice of medicine, the unauthorized practice of medicine, telemedicine, staffing contracts, end-of-life care, FTC compliance, FDA warning letters, and other regulatory compliance issues.
Contact Cohen Healthcare Law Group, PC for legal advice on the proactive steps and responsive steps to consider reduce the risk of regulatory compliance complaints and agency or court actions. Our skilled healthcare attorneys explain the federal and state laws and regulations that apply to academic medical centers, ASCs, home health care, hospices, urgent care centers, and medical spas.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
