On November 8, 2021, The Department of Health & Human Services (HHS), Office of Inspector General (OIG) released a revised and renamed Provider Self-Disclosure Protocol (SDP), now known as the “Health Care Fraud Self Disclosure “protocol. The SDP was created in 1998, and the protocol can be used to voluntarily identify, disclose and resolve instances of potential fraud involving federal healthcare programs. As described on the OIG website, “Self-disclosures give persons the opportunity to avoid the costs and disruptions associated with a Government-directed investigation and civil or administrative litigation.” read more
Genetic tests are valuable because they can provide important information to patients and their medical providers regarding diagnoses, treatment, and disease prevention. However, the rapid growth in the number of tests ordered, especially in light of the telemedicine expansion during the pandemic, has invited well-earned scrutiny to the industry.
Make no mistake: genetic testing is heavily regulated (and enforced). The Federal Anti-Kickback Statute, Eliminating Kickbacks in Recovery Act, and Commercial Insurance Fraud Law have all been used to prosecute unscrupulous marketers, call centers, and telemedicine providers in the last few months. Kickbacks in exchange for genetic specimens are just as illegal as kickbacks for patients. Three months ago, a Florida man was sentenced to 10 years in prison for conspiracy to commit health care fraud. His actions resulted in the submission of approximately $3.3 million in fraudulent claims to Medicare for genetic testing. read more
Healthcare officials often chuckle when they see questions like, “Who regulates health care?” If only one law or organization oversaw every aspect of healthcare in this country, life would be a lot simpler for medical professionals and the organizations in which they work.
In reality, many different organizations are involved with regulating healthcare. And they enforce rules and regulations that may appear at the federal, state, or local level.
Who Regulates Health Care at the Federal Level?
The largest and most complex healthcare laws originate at the federal level. They are enforced by a variety of different agencies.
These three main federal agencies oversee healthcare organizations:
- The U.S. Department of Health and Human Services: The Health Insurance Portability and Accountability Act (HIPAA) passed in 1996 includes multiple rules regarding patient privacy and recordkeeping. The DHS is responsible for enforcing those laws.
- The U.S. Inspector General: Seated within the DHS, the Office of the Inspector General creates compliance documents to help hospitals and doctors comply with a bevy of federal laws.
- The United States Department of Labor: The Occupational Safety and Health Administration creates rules that ensure a safe workplace. Since so many people work in healthcare, the rules are critical.
All of these groups offer guidance to help organizations comply with their rules and regulations. But compliance means paperwork. Hospitals and other care organizations must prove that they both understand and comply with the rules.
Who Else Is Involved in Regulating Health Care?
Healthcare providers are also required to abide by laws that originate from outside the federal system. The landscape varies from organization to organization.
A provider might have rules that originate in:
- State agencies. Some states have rules regarding workers’ rights, patient access, and payment caps.
- Federal payors, like Medicare. Some organizations must follow rules about payment options.
- Private payors. Some companies like Blue Cross have rules about payments and access.
- Nonprofit boards. Some hospitals and other care organizations are ruled by a board of directors. That group may also have compliance rules.
The landscape can be complex. An organization may face competing or conflicting rules regarding patient care and payments.
Navigate Health Care Industry Regulations
Healthcare providers need to focus on patient care, not paperwork. As one of the largest healthcare law firms in the nation, we can help. Let us assess your regulatory environment and help you come up with a comprehensive compliance plan. We can help you craft appropriate reports too, so you can prove you’re doing your job. Contact us to find out more.
By: Zach Simpson
As you train your staff on the changes that were recently made regarding evaluation and management coding it is very important to ensure that your staff understands the auditor’s perspective as well. There are four distinct portions of an auditor’s tool when evaluating the documentation guidelines for office/outpatient evaluation and management (E/M) services (99202-99215). The four distinct portions are diagnoses, data, risk, and calculation of medical decision making (MDM). In order to ensure that a provider’s progress note is complete in the auditor’s eyes the provider should ask themselves the following six questions to create the best chances of successfully meeting the auditors expectations:
- Does my progress note contain a medically appropriate history and examination?
- Were my diagnoses addressed appropriately?
- Did I document all orders and data reviewed?
- Were other professionals included in my documentation that I worked with?
- Was an independent historian used?
- Does the documentation support the level of risk I chose?
For the remainder of the article, I am going to dive deeper into each question above so that you, as providers are able to recognize insufficient areas in a provider’s E/M documentation when you perform a self audit to better your practice. read more
By: Chase Howard
Whether you’ve been in practice for years or you’re just graduating, buying an existing dental practice can be a great way to quickly enter into an already established patient base without the pains of starting up from scratch. While it may seem like a daunting task, the right team can make the purchase transaction flow as smoothly as possible. Here’s a list of important things to consider when negotiating the purchase.
By: Karen Davila
Healthcare fraud continues to be a significant priority for the U.S. Department of Justice. On February 24, 2021, the DOJ’s Criminal Division Fraud Section published its annual “Fraud Section Year in Review 2020.” While the Fraud Section has three separate enforcement units, the Health Care Fraud (HCF) Unit is responsible for all enforcement activities in the health care industry. The Unit’s focus is to protect against fraud and abuse in federal health care programs and recoup illicit gains.
During 2020, the HCF Unit operated 15 strike forces in 24 federal judicial districts throughout the U.S. The efforts of these strike forces led to charges against 167 individuals alleging $3.77 billion in fraudulent charges for health care paid for by federal and state programs. This should cause any health care provider to stand up and take notice. And enforcement in the health care industry is not likely to go away soon with so many schemes ripe for the government’s picking and generating recoupment on behalf of the federal health care programs.
Here are couple of the latest schemes that have landed pharmacies, pharmacists and other health care professionals squarely in the crosshairs of federal enforcement:
By: Dean Viskovich
The Office of Inspector General (OIG) and other Federal agencies charged with responsibility for enforcement of Federal law have emphasized the importance of voluntarily developed and implemented compliance plans. The government, especially the OIG, has a zero- tolerance policy towards fraud and abuse and uses its extensive statutory authority to reduce fraud in Medicare and other federally funded health care programs. The OIG believes that through a partnership with the private sector, significant reductions in fraud and abuse can be accomplished. Compliance plans offer a vehicle to achieve that goal. The OIG has provided a model compliance plan for clinical laboratories to assist laboratory providers in crafting and refining their own compliance plans.
The OIG suggests that the comprehensive compliance program should include the following elements:
By: Zach Simpson
There have been a rise in cases recently, in which practices that operate under a Health Care Clinic License have been brought under scrutiny by insurance companies trying to recoup funds through any means possible. In an effort to claw back funds insurance companies are beginning to claim that medical directors are failing to meet their statutory obligations under Florida Law which in turn can have serious monetary repercussions. Due to the clinics allegedly failing to meet their statutory obligations the insurance companies are filing suit to recoup any payments made while violating the Health Care Clinic Act obligations, and to stall any future payments due until such cases are heard.
By law, a medical director must be a health care practitioner that holds an active and unencumbered Florida license as a medical physician, osteopathic physician, chiropractic physician, or podiatric physician. The type of services provided at a clinic may dictate who would be able to serve as a clinic’s medical director, because a medical director must be authorized under the law to supervise all services provided at the clinic.
By: Chase Howard
With the passage of autonomous practice ability for nurse practitioners in Florida this year, many are wondering how this will affect the healthcare industry in Florida. In a traditional sense, rural and underserved areas should have the opportunity for growth in healthcare providers. The autonomous practice law removes restrictions on certain nurse practitioners, granting them the ability to practice in primary care practice settings without worrying about supervision restrictions. Outside of that, the application of the new law can expand healthcare business offerings and abilities. read more
By: Karen Davila
You do everything right. You’re careful to dot your i’s and cross your t’s. Compliance is hard-wired because you’re in an industry that’s highly regulated and you’ve built into your operations a series of compliance checks and balances. However, even with strong controls in place, compliance efforts sometimes fall short– and whether you’re a physician group, a pharmacy, a durable medical equipment company, a home health agency, or any other health care provider, someday you might find yourself face-to-face with law enforcement officials or regulatory enforcement authorities. What do you do? How do you assure the most successful outcome with minimal business disruption?
Compliance is the foundation to mitigating the risks inherent in any health care operation. Compliance can reduce the likelihood that regulators or law enforcement suddenly appear on your doorstep. But preparation for emergencies and uncertainties is the key to reducing the risk that non-compliance leads to lengthy business interruption. Although you may be saying “if”, you really should be thinking and acting more like “when”. It costs everything to be ill-prepared and it costs very little to be well-prepared. The following preparation can prevent much of the uncertainty that arises in these cases.
POLICIES AND PROCEDURES
First and foremost, make sure you have well-developed policies and procedures for what to do in such instances. You should review these policies and procedures with your employees regularly, focusing on the importance of compliance. Out of fear and uncertainty, employees can do things that create unnecessary challenges. Educating them as to what their rights and responsibilities are will mitigate those risks. Make sure your policies and procedures include the designation of who is in charge (“person in charge”) when the government does show up. read more