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.
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:
Regulatory compliance audits can help you head off lawsuits before they get started. Learn how to set a schedule based on your organization’s unique risks and benefits, and let trained legal counsel help you.
As a healthcare executive, it’s your job to craft policies that protect your patients, your staff, and your community. Regulatory compliance audits help you do your work effectively. But if you dread them, you’re not alone.
It’s not uncommon for organizations to postpone and delay compliance work. No one likes the hassle. But a healthcare practice attorney could help you both set up an audit schedule and complete your tasks with ease.
When Is a Regulatory Compliance Audit Required?
Every healthcare organization faces a unique set of compliance risks. It’s critical for you to understand your environment intimately and design your audit schedule accordingly.
Typically, regulatory compliance audits are performed:
On a schedule. If your organization is large and includes plenty of service lines, you’ll need to assess risks more frequently than a smaller, targeted organization.
After an issue is detected. Some healthcare legislation requires proof that you’ve learned from your mistakes. If a compliance problem appears, an audit can help you determine how it happened and what you can do to prevent the next issue.
After hefty staff turnover. Everyone on your team must understand how the rules work and why they are important. That’s not always easy for health professionals. Attorney support can be critical.
Your schedule may change as your organization grows or shrinks. And you may need more audits one year than another. Flexibility is critical.
Why Do Healthcare Practice Attorneys Perform Audits?
If you’re a do-it-yourself executive, the thought of hiring someone to help you achieve compliance may seem unusual or strange. But the benefits are both real and plentiful.
Expertise. The rules and regulations you must follow can be hard to both read and understand. Healthcare practice attorneys specialize in these sorts of documents, and they can explain them to you quickly and carefully.
Impartiality. It’s easy to make excuses for your employees (and yourself). Professionals can look over your records dispassionately, so you can make smart decisions.
At Florida Healthcare Law Firm, we specialize in regulatory compliance audits. Our healthcare practice attorneys can walk you through the laws and help you stay on the right side of the law. Contact us to find out more about how these audits work and how you can get started.
Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988. CLIA established quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. In 2003, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) published the CLIA Quality Systems laboratory regulations. The quality system approach includes a laboratory’s policies, processes, procedures, and resources needed to obtain consistent, high quality testing services.
The laboratory must be under the direction of a qualified person and that person must fulfill all responsibilities of the lab director as outlined by CLIA. CLIA prohibits a laboratory director from directing more than five non-waived laboratories. Some states may have additional restrictions regarding the number of labs the lab director can direct. The lab director must meet education and experience requirements to hold the position and meet all requirements of the position. The responsibilities include ensuring that there are sufficient personnel with adequate experience and training and make sure that every position in the lab is staffed by a person who is qualified to have the position and can perform all tasks required of the position. read more
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
Pharmacies and their pharmacists are in a very tough spot in the current regulatory enforcement environment. This is particularly true with dispensing controlled substances. Headlines like the below are commonplace:
DEA RAIDS PHARMACY AS PART OF LOCAL DRUG SWEEP
PHARMACY PAYS $500,000 IN PENALTIES FOR CONTROLLED SUBSTANCES ACT VIOLATIONS
MAN ARRESTED USING DOCTOR’S PRESCRIPTION PAD TO WRITE FRAUDULENT RX’S
So, how do you avoid filling a fraudulent prescription for controlled substances? Before getting into the nitty gritty, it is important to lay the foundation of standard of care and the corresponding responsibility so pharmacies and pharmacists can evaluate what steps are most likely to mitigate these risks.
As background, federal law states that the primary responsibility for prescribing controlled substances rests with the prescriber. However, that same law places a “corresponding responsibility” on the pharmacist to assure each prescription is written for a legitimate medical purpose pursuant to a valid patient-prescriber relationship. 21 CFR §1306.04(a).
Under Florida law:
A pharmacist may not dispense a Schedule II-IV controlled substance to any patient or patient’s agent without first determining, in the exercise of her or his professional judgment, that the prescription is valid. F.S. §893.04 (2)(a).
A prescriber or dispenser must consult the prescription drug monitoring system, eForce, to review a patient’s controlled substance dispensing history before prescribing or dispensing a controlled substance.S. §893.055
Once you have a clear understanding of a pharmacist’s liability, you can then consider ways to mitigate the inherent risks in filling controlled substance prescriptions. read more
Laboratory buyers and sellers considering a sale or purchase should have knowledge of issues that can affect the transaction. Due diligence requires conducting measures that provide a buyer confidence that the laboratory for sale is being accurately represented by the seller.
The transaction requires consideration, communication and planning between all parties and their representatives. A thorough knowledge of laboratory compliance and rules and regulations is imperative as documentation and information that is provided and reviewed will more than likely change the pricing, value and terms of the deal.
Due diligence is required in any healthcare transaction and is performed so that both the buyer and seller fully understand the transaction. An effective and necessary tool regarding laboratory transactions is a due diligence checklist. The checklist will allow both sides to identify and address issues that may be neglected or overlooked. The categories that compromise a laboratory checklist should include, but are not limited to: read more
Laboratories nationwide are overwhelmed with increased diagnostic testing volume while simultaneously managing regulatory changes in light of the COVID-19 pandemic. It is more essential than ever for clinical laboratories to enforce regulation, have a compliance plan in place and develop or enhance operational policies. Our firm has expert lab lawyers with ‘insider’ healthcare business knowledge to help keep your business compliant while adapting to the rapidly changing healthcare landscape.
Download the laboratory compliance image as a PDF here.
A recent Department of Justice $500,000 settlement with a cardiology practice underscores the need for ensuring tighter compliance by medical practices. There, the practice billed Medicare for cardiology procedures for which interpretive reports were also required. Medicare paid for the procedures, but upon audit, CMS could not find the requisite interpretive reports. The False Claims Act case settled for $500,000, but it’s likely that (1) the reimbursement by Medicare was far less, and (b) the legal fees behind the settlement weren’t too far behind the settlement amount! Had the practice self-audited each year, would they have found the discrepancy?
Medical practices have felt the weight of price compression and regulatory load more than probably any segment in the healthcare sector. They are doing far more for far less. And regulations expand faster than viruses! Hence, many have a strategy of regulatory compliance that can best be characterized as a combination of facial compliance (“We bought the manual and put it on the shelf”) and hope (“They’re not really serious about this, are they?”). Unless you’re part of a practice of more than 20 doctors, it’s likely that you can do more to ensure regulatory compliance.
Inspired by many medical integration consultants and coaching organizations, chiropractors have vigorously pursued medically integrating their practices in the past handful of years. Led by both the desire to provide effective healthcare solutions and to capture more of the healthcare dollar that their patients are already spending (elsewhere), chiropractors are smart to consider it…slowly!
Too often, there are stories of chiropractors who felt both excited and pushed to sign on the dotted line at integration seminars, only to find later on that (1) the advice they got upset their lawyers, (2) they didn’t understand the complexities and risks that accompanied their practice expansion, and (3) it didn’t work! What are some of the greatest areas of disappointment for those where the integration didn’t go smoothly?
A. Using integration to fix an underlying business problem. For instance, if you’re medically integrating your chiropractic practice because your chiropractic patient volume has fallen off, first try to understand why your core business is down. For instance, do you actively pursue marketing? Is it effective? What about someone inside your organization who is responsible for sales? Do you have someone comfortable offering what you provide and talking money? Since it’s typical for medical integration patients to come from your core chiropractic business, a down chiropractic business will not deliver the patients needed to support a robust medical integration line of services and products; and
Since the beginning of the COVID pandemic many healthcare businesses are exploring various ways to increase their referrals, and although exchanging fees and gifts in return for referrals may sound like an easy way to obtain additional business, there are state and federal laws that strictly prohibit such activities that are discussed in greater detail below.
Two of the most important laws that all physical therapists should be aware of are the Anti-Kickback Statute and the Stark Law which are used to ensure that medical decisions are not made based on financial incentives. However, each of the laws do have distinctions that you need to be aware of. read more