FAQs For Oncology Practitioners – Part One

The practice of oncology is expanding as the population ages. Oncology is the branch of medicine that focuses on the study, treatment, diagnosis, and prevention of cancer. There are generally three types of oncology practices – medical oncology, radiation oncology, and surgical oncology:

• Medical oncologists use chemotherapy, immunotherapy, and targeted therapy to treat cancer.
• Radiation oncologists use radiation therapy, which is the use of high-energy x-rays or other particles: to destroy cancer cells.
• Surgical oncologists perform surgeries to remove tumors and nearby tissue. Surgeons also diagnose cancer through the use of certain types of biopsies.

Oncologists are also categorized by the type of cancer the oncologist treats, the person treated, and other by other factors. Oncologists include:

• Geriatric oncologists. These doctors work with anyone 65 or older who has cancer. Older patients with cancer have unique challenges such as other diseases like heart disease and weakened immune systems.
• Gynecologic oncologists. These doctors “treat cancers in such reproductive organs as the cervix, fallopian tubes, ovaries, uterus, vagina, and vulva.”
• Hematologist-oncologists. These physicians treat leukemia, lymphoma, myeloma, and other blood cancers.
• Neuro-oncologist. These doctors treat cancers of the brain, spine, and nervous system.
• Pediatric oncologists. These physicians treat cancer in children and teens.
• Thoracic oncologists treat lung cancer, esophageal cancer, and other chest area cancers.
• Urologic oncologists, these oncologists treat “cancers in the genitourinary system, such as the bladder, kidneys, penis, prostate gland, and testicles.”

There are many different types of healthcare providers that are part of the oncology team including the physicians, oncology nurses, and radiologists.

Oncology practices should speak with an experienced healthcare compliance lawyer who can answer the questions most practices have. We’ll review what federal and state laws govern the practice of oncology including laws that regulate referrals and proper billing to federal agencies. We’ll explain the relationship between the business side of medicine and the practice of medicine side. Our lawyers will review the qualifications and certifications that each type of oncology healthcare provider must have.

We understand many of the practical issues such as payments, who has the authority to discuss oncology care with patients, FDA and FTC oversight issues, the daily involvement with cancer patients, and many other concerns. We’ll review your compliance requirements, what strategies you can use to show you’re in compliance, and we’ll help you respond if compliance issues are asserted by federal agencies, medical boards, or the state where you practice medicine.

Some of the common oncology questions our lawyers review includes the following

What are some of the concerns between the practice of oncology medicine and the business practice of medicine?

There are many issues involved with the relationship between the physician and the ancillary services needed to diagnose and treat cancer.

Doctors often prescribe medications: recommend that patients obtain diagnostic imaging tests, blood tests, and biopsies; and recommend various integrative medicine services. According to Penn Medicine, common integrative services include:

• Acupuncture
• Aromatherapy
• Art Therapy
• Guided Meditation and a Mindfulness Program
• Massage Therapy
• Reiki Therapy
• Yoga

Doctors also need to make recommendations for radiology evaluations and treatments among other types of recommendations.

The federal government, state governments, and medical bills have laws and regulations in place to help ensure these recommendations are based on what is in the best interests of the patient and not the doctor that is making the referral. These laws and regulations include:

• Stark Law. The Stark Law examines the relationship between medical practices and “Designated Health Services (DHS).” A DHS includes radiology, laboratory, therapy, and other services including integrated services. If a doctor (or a close relative) has a financial relationship with a DHS, then Stark Law may forbid any referrals by the physician to the DHS. There are strict penalties for violating Stark Law. In addition to large financial penalties, a physician/practice could be barred from participating in Medicare and Medicaid (which covers many oncology patients). There are exceptions to Stark Law that our skilled healthcare lawyers can explain. These exceptions may permit referrals to a DHS if very specific requirements are met.
• The Anti-Kickback Statute (AKS). The Anti-Kickback Act of 1986 prohibits the payment of financial incentives to encourage doctors to make referrals that favor the entity that made the kickback over others. The AKS is a criminal statute. Kickbacks include “any money, fees, commission, credit, gift, gratuity, thing of value, or compensation of any kind. The act also provides that the inclusion of kickback amounts in contract prices is prohibited conduct in itself.” The AKS applies to payments under any government contract (not just negotiated contracts). The act does require knowledge and willfulness. There are safe harbors that are similar, but not identical, to the Stark Law exceptions.
• Corporate practice of medicine laws. These state laws require that medical practices separate the medical practice from the financial side of the practice. The corporate practice of medicine laws generally governs who can and who can’t (and in what percentages and circumstances) own a medical practice.

There are other federal and state laws that regulate referrals and many other parts of a medical practice.

One common strategy used to address these referral issues and the corporate practice of medicine is to create a managed service organization (MSO). We’ll discuss oncology and MSOs soon in an upcoming article.

How do oncology providers get paid?

A related question is – Is it possible to create a separate direct pay integrative oncology practice with an insurance-based oncology practice?

The National Institutes of Health addressed some of the issues involved with paying for integrative and complementary health care – for oncology and many other healthcare disorders. Our experienced healthcare issues will explain how the NIH analysis applies to oncology practices.

For starters, a major concern with integrative healthcare is whether the cost of the care is covered by insurance (private insurance, Medicare, and other coverages). The NIH states that Americans spend about $30.2 billion yearly out-of-pocket on complementary health products and practices. These numbers are likely much higher since the NIH analysis is fairly old. According to a 2012 National Health Interview Survey (NHIS), about 1/3rd of adults and 1/8th of children uses complementary/integrative health services. The most common complementary health service is the use of natural products (dietary supplements, vitamins, and minerals – such as fish oil). Additional approaches that are common include chiropractic care, osteopathic manipulation, massage therapy, meditation, and yoga.

The $30.2 billion includes:

• “$14.7 billion out-of-pocket for visits to complementary and integrative health practitioners such as chiropractors, acupuncturists, and massage therapists
• $12.8 billion out-of-pocket on natural products
• About $2.7 billion on self-care approaches (homeopathic medicines and self-help materials, such as books or CDs, related to complementary health topics).”

This sum is about 9.2 percent of all out-of-pocket spending by Americans on healthcare and about 1.2 percent of total healthcare spending ($2.82 trillion).

Many of the people who use complementary and integrative health treatments do not have insurance coverage for these treatments. Even when the patients do have health coverage, the coverage is generally just partial instead of full coverage.

Patients should be prepared to ask, and doctors should be prepared to answer the following questions about complementary and integrative health treatments:

• Do the treatments need to be preauthorized or preapproved?
• Is a prescription required?
• Is a referral required?
• Does the patient need to see a practitioner in the network
• What limits and conditions apply – such as the number of covered treatments?
• What are the out-of-pocket cost?

The insurance coverage may vary depending on whether the insurance offers a discount program or requires a “rider” to the standard plan. There may also be tax considerations depending on the type of integrative oncology care that is provided.

Generally, Medicare, veterans programs, and other programs such as Medicaid help pay for some complementary and integrative medical services.

What are the concerns oncology practices should consider if the practice chooses to opt out of Medicare?

Normally patients who qualify for Medicare for oncology medical care (diagnostics, surgery, medication, integrative, and other types of care) will file a claim through Medicare. More precisely, the health care provider will file the claim and seek payment from Medicare.

Some oncology providers may want to opt out of Medicare and bill their clients directly. Medicare has its own set of requirements for opting out of its program and for how billing rates operate if the healthcare provider doesn’t opt out.

A critical consideration is how will the bill be paid if Medicare doesn’t pay the bill? Some of the additional questions we’re asked include:

• Are there options to be able to see Medicare patients in a direct pay model without opting out of Medicare
• If a provider does not opt out of Medicare but wants to set their own rates for seeing integrative medicine patients, is this allowed or does the provider have to use Medicare billing rates?
• If a provider opts out of Medicare, can the patient or provider bill their secondary insurance carrier for Medicare?

Doctors can opt out of Medicare according to the Centers for Medicaid and Medicare Services (CMS) provided the doctors meet certain requirements. Doctors and health care providers who don’t want to work with Medicare can generally “opt out” of Medicare – if the doctors otherwise qualify. When a health provider opts out of Medicare, CMS no longer pays for the medical services. Instead, the provider and the patient need to make a separate agreement.

Doctors may opt out of Medicare for many reasons. These reasons can include the estimation that the doctors will be paid better through private insurance, that Medicare isn’t covering their services, that there will be fewer regulations, and other reasons. Doctors who opt out must choose to opt out for two years. The opt-out status is renewed every two years unless the doctor changes his/her mind and wants to start using Medicare for billing. The main risk of choosing to opt-out is that the patient will use a doctor/healthcare provider who does accept Medicare.

Generally, the opt-out provisions do not apply to emergency or urgent need care. Generally, if the oncology provider does not opt out of Medicare, the provider must use the Medicare preset billing rates.

The private contract is a written agreement between the patient and the oncology healthcare provider that the patient will pay the amount the healthcare provider charges for the services involved. The payment terms will be established in the written agreement.  Patients who use an opt-out doctor will also not be able to use their Medicare Supplement plan – since that plan is tied into Medicare billing. Patients should have their own private insurance or be prepared to make the payments out of their own pockets. Healthcare providers must inform their patients if the providers have been excluded from Medicare.

Oncology practice encompasses many different types of treatments and medical professionals. Whether you’re a doctor, a radiologist, a nurse, or an integrative health care professional – you need to understand how to properly balance the medical care you provide with the financial side of your practice. Violations of Stark Law, the AKS, the corporate practice of medicine requirements, or other laws and regulations can have serious consequences for your medical practice. Medicare generally does permit healthcare providers to opt out of Medicare provided the provider meets certain patient care and Medicare requirements and understands some Medicare patients may choose other providers.

Oncology practices that should contact Cohen Healthcare Law Group, PC to discuss how the federal, state, and local laws and regulations affect their practices. Our experienced healthcare attorneys advise doctors, nurses, radiologists, integrative care providers, and other healthcare providers about healthcare compliance laws and regulations.