In giving consideration to whether healthcare regulations apply to a proposed course of conduct it’s absolutely vital for a pharmacy to know its payor! This is especially so in the context of patient marketing and the various regulatory prohibitions on paying for healthcare referrals. Unfortunately, some pharmacy owners remain a bit mixed up about who the ultimate payor is for the medications they dispense, and, depending on that pharmacy’s billing operations, such mistakes can have devastating consequences.
A large part of this confusion might be attributed to the fact that in most instances, a pharmacy is not billing the ultimate payor directly (unlike a DMEPOS provider that may be directly submitting claims to Medicare Part B), but rather, the pharmacy is billing an intermediary entity called a Pharmacy Benefit Manager (“PBM”), which is usually a commercially run entity (non-government owned) that manages and adjudicates claims on behalf of health insurance plans that cover pharmacy benefits.
A recent whistleblower action (by UnitedHealthcare Medical Director, Tina Groat) against Boston Heart (laboratory) was brought under the federal False Claims Act and deals with medical necessity issues. As part of the analysis, the Court reviewed whether a laboratory [or supplier like DME] must determine the medical necessity of the ordering physician. Boston Heart contended that a doctor, not a laboratory, determines the medical necessity of a test. Boston Heart argued that when a laboratory bills Medicare for testing ordered by a physician, it must only maintain documentation it receives from the ordering physician and ensure that the information that it submitted with the claim accurately reflects the information it received from the ordering physician. It noted that the CMS-1500 form certification does not require that the billing lab to make the medical necessity determination. The lab certifies that the services are medically necessary by relying on the clinical determination of the treating physician.
The US Department of Health and Human Services, Office of Inspector General (OIG) reports that as part of its 2017 Work Plan it will be reviewing Medicare Part B payments for telehealth services. These services support rural access to care and Medicare pays telehealth services provided through live, interactive videoconferencing between a Medicare beneficiary located at an origination site and a healthcare provider located at a distant site.
The OIG is reviewing Medicare claims that have been paid for telehealth services that are not eligible for payment because the beneficiary was not at an originating site when the consultation occurred. A beneficiary’s home or office is not an originating site, an eligible originating site must be a practitioner’s office or a specified medical facility.
I had a law school professor who repeatedly referred to his class as “Doom at Noon.” The topic was dry, the cases were boring and, if not for the professor himself, the class would have been unbearable. I think of that, all these years later, every time I have to counsel a client on a topic that makes his or her eyes glaze over, like healthcare compliance.
Compliance means that you’re operating within the bounds of law. Sure, it sounds boring, but it’s a giant undertaking for any business, and especially for one so regulated as healthcare. Over the last three decades, the Department of Health and Human Services’ Office of the Inspector General has urged the private healthcare community in to take steps to combat fraudulent conduct and prevent the submission of erroneous claims.
The issue of whether a medical provider can provide free patient transport is one that we are asked to look into a few times every year. Aside from the liability issues that it raises, it is one that we have never been able to justify from an Anti-Kickback and Patient Brokering perspective. The fact is, even given the good intentions of most providers to allow their patients easier access to healthcare, transporting patients to and from your facility or practice is providing them with something of value in return for coming to see you. However, under slightly different facts than we are usually asked to consider the question, last week, the Department of Health and Human Services Office of the Inspector General (“OIG”) came to a different conclusion.
The OIG issued an advisory opinion upon the request of a hospital system who had asked whether it could provide free transportation to persons who had limited access to public transportation to access the hospital’s facilities. The hospital system offered that the town had inadequate and infrequent public transportation services which would act as a barrier to healthcare for local residents. The hospital system offered the following facts for consideration:
USA v. Pediatric Services of America – settlement under the False Claims Act involving a health provider’s failure to investigate credit balances on its books to determine whether they resulted from overpayment by a federal health care program.
The U.S. Attorney for the Northern District of Georgia announced that Pediatric Services of America Healthcare, Pediatric Services of America, Inc., Pediatric Healthcare, Inc., Pediatric Home Nursing Services (collectively, “PSA”), and Portfolio Logic, LLC agreed to pay $6.88 million ($6,882,387) to resolve allegations that PSA, a provider of home nursing services to medically fragile children, knowingly (1) failed to disclose and return overpayments that it received from federal health care programs such as Medicare and Medicaid, (2) submitted claims under the Georgia Pediatric Program for home nursing care without documenting the requisite monthly supervisory visits by a registered nurse, and (3) submitted claims to federal health care programs that overstated the length of time their staff had provided services, which resulted in PSA being overpaid.
“Participants in federal health care programs are required to actively investigate whether they have received overpayments and, if so, promptly return the overpayments,” said United States Attorney, John Horn. “This settlement is the first of its kind and reflects the serious obligations of health care providers to be responsible stewards of public health funds.”
The HHS Office of Inspector General in a fraud alert released 6-9-15 is telling physicians to be cautious about entering into payment agreements that could violate the Anti-Kickback statute. In the alert, OIG tells physicians entering into such payment arrangements that their compensation must reflect the services’ market values. Further, OIG notes that such an arrangement could violate the Anti-kickback Statute if it seeks to increase the number of referrals the organization receives from those physicians.
Does your healthcare entity have a governing Board? How involved is that Board in overseeing your business? Would your Board members be able to respond to questions about your business’ compliance-related activities? Recently, the Office of the Inspector General (“OIG”), in conjunction with a host of non-profit healthcare associations, released guidance on achieving compliance for healthcare governing boards. The guidance is not based on abstract principals of compliance, instead it points to applicable federal law, OIG guidance, case law, and sentencing guidelines.
Each and every healthcare organization, whether or not it accepts reimbursement from government payors, must have in place regulatory compliance measures designed to protect the population it serves, and the persons paying for and providing those services. All levels of a healthcare organization must be cognizant of their roles in the organization’s continuing commitment to compliance. Even Board members, who often do not experience the inner-workings of the entities they represent, have an obligation and duty to the organization to act in a manner that stressed compliance. Applicable federal and state laws, how they apply to an organization, and how the organization reacts to its obligations imposed by those laws, must be of paramount importance to a governing Board.
The OIG compliance guidance for healthcare Boards tracks 4 areas over which boards should have specific oversight:
When a healthcare provider cares for a patient, many times, the provider will set out directives for the patient to follow in order to live a healthier life. These changes may include changes in lifestyle, eating habits, and obedience in taking medications. A patient’s compliance with these directives instructs the provider on how to care for the patient in the future. A patient who does not follow these directives may suffer health consequences.
Similarly, the government sets out legal regulations for healthcare providers. The government expects healthcare providers to comply with its regulations, and providers who don’t can suffer consequences as a result. The regulations governing health care providers are vast and dynamic. In order to keep abreast of the changes in law, and to evidence an intent to comply with law, healthcare providers should strongly consider instituting compliance programs in their businesses.
Compliance with healthcare laws is important. Any number of consequences can result in the event that a healthcare provider is out of compliance—the most devastating being that the Department of Health and Human Services Office of the Inspector General (“OIG”) has the authority to exclude healthcare providers from participation in Medicare and other federal health care programs. Ignorance of the law does not absolve a healthcare provider of liability.
On February 20, 2014, the Office of the Inspector General posted Advisory Opinion 14-02. The Advisory Opinion reviews the following scenario for compliance with the Federal Anti-Kickback Statute, 42 USC § 1320a-7b. Under the proposed scenario, a Medigap insurance provider participates with a preferred provider organization (“PPO”) which contracts with hospitals (“Network Hospitals”). The Network Hospitals discount Medigap policy-holders’ inpatient deductibles up to 100%. In exchange for each discount, the Medigap plan pays an administrative fee to the PPO. The Medigap plan also pays a portion of the discounted savings directly to the policy-holder who stayed at the Network Hospital.
Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.