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.
There are very strict rules and regulations in place for any business working in a lab, both to protect the healthcare professionals working in that lab and the clients and customers the lab serves.
To make sure that your company is in compliance with these laws, it is recommended to hire a laboratory compliance specialist to double check the details and make sure that all processes are up to code.
What Is Laboratory Compliance?
Laboratory compliance is an ongoing effort put forth by healthcare businesses to ensure that they are up-to-date on all licensing and regulatory requirements.
State, local, and federal agencies may require compliance with a long list of ever-changing rules and directives. It is the responsibility of the business to maintain awareness of those regulations and to ensure that they are operating according to standards and providing proof of that when necessary.
Laboratory Compliance Specialist Definition
When it comes to maintaining laboratory compliance, a laboratory compliance specialist is essential. Sometimes called compliance officers, these professionals are responsible for keeping up with the latest changes and requirements and making sure that the company is doing everything they need to do.
This doesn’t just mean coming in once a year to check that everything is in compliance or responding when there is a violation. It means creating a compliance program that includes policies, processes, and procedures that ensure continual compliance.
Additionally, if there is an audit, investigation, or suspicion of a violation, the laboratory compliance specialist will dive into the problem, handle whatever results from the audit, and adjust policies and procedures accordingly.
Does Your Healthcare Business Need a Laboratory Compliance Plan?
Learn more about how laboratory compliance can impact your healthcare business legally and create a laboratory compliance plan that will protect you in court when you call Florida Healthcare Law Firm now.
COVID is front and center in all aspects of everyday life and has shined light in the strangest of places that were usually in the dark. In healthcare the laboratory space has always taken a backseat to other sectors in terms of recognition and value. The current climate in the lab space has shifted and it is not an illusion, labs are front and center.
COVID has taken its toll on areas of the economy and investors are certainly one of the first to become aware of this situation. Clinical laboratories are currently an attractive acquisition target and the reasons are numerous, sectors like retail, entertainment and travel are performing poorly and investors are shifting their investment dollars into healthcare and technology. Investors are looking for growth and profitability and are finding it in healthcare. Mergers and Acquisitions (M&A) is nothing new in the lab industry, but now careful consideration is required when it comes to deciding the appropriate time to sell your lab.
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:
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
On November 13, 2020 Centers for Medicare and Medicaid Services (CMS) announced that all Americans will have access to the COVID-19 vaccine at no cost. CMS has clearly communicated to private insurers, Medicaid programs and Medicare that it is their responsibility to cover the vaccine at no charge to beneficiaries. CMS states that Operation Warp Speed ensures that States, provider’s and health plans have the information and direction they need to ensure broad vaccine access and coverages for all. As a condition of receiving free COVID-19 vaccines from the federal government, providers will be prohibited from charging consumers for administration of the vaccine.
Beneficiaries with Medicare will not pay anything for the COVID-19 vaccine and their coinsurance/copayment and deductible amounts will be waived. In 2021, for Medicare Advantage beneficiaries, Medicare will pay directly for the vaccine and its administration for those enrolled in MA plans. MA plans are not responsible for reimbursing providers to administer the vaccine. MA beneficiaries do not pay for the vaccine and copayment/coinsurance and deductibles are waived. 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.
On October 6, 2020, the Unites States Attorney’s Office of the Western District of Louisiana announced that George M “Trey” Fluitt III of Monroe, Louisiana was indicted. The federal grand jury indicted the lab owner for paying bribes and kickbacks in violation of the Anti-Kickback Statute, resulting in improper Medicare billing of approximately $117 million. Fluitt was the owner and operator of Specialty Drug Testing, LLC and is alleged to have solicited paid kickbacks and bribes in return for patient DNA specimens and physicians’ orders for cancer genetic and pharmacogenetic testing. Medicare allegedly paid Specialty Drug Testing, LLC $28,726,299 as a result of the fraudulent claims. If convicted, the defendant faces up to five years in prison for each count of conspiracy to defraud a healthcare program. Fluitt also faces 10 years in prison for illegal kickbacks, a $250,00 fine, forfeiture and restitution.
COVID-19 has affected all aspects of everyday life and healthcare rules and regulations are no exception. All areas of healthcare have been impacted, including the patient’s financial responsibility for healthcare services in the form of co-insurance, copays and deductibles. The waiver of a patient’s financial responsibility for healthcare services is regulated by federal and state law. The waiver of co-pays, co-insurance and deductibles has been deemed a violation of the federal Anti-Kickback statue. A provider who routinely waives the patient’s financial obligation may be violating the participating provider agreement with commercial carriers, state law and federal law with respect to Medicare beneficiaries. Waiving patient fees is seen as an inducement to the patient to prefer one provider over another for financial reasons. However, The Centers for Medicare and Medicaid Services (CMS) and commercial carriers have been authorized by the federal government to waive patient financial responsibility during the pandemic in order to encourage the public to get treated for COVID-19 and non-COVID medical conditions without fear of a hefty bill.
Florida Healthcare Law Firm in Delray Beach, FL has exceeded their 2020 growth plans with the fourth hire this year, seasoned attorney Dean Viskovich, aka “The Lab Guy”. Dean will play an essential role representing healthcare businesses and providers with respect to regulatory compliance matters and is uniquely experienced on issues pertaining to laboratory compliance, as well as laboratory operations. Dean has over 25 years’ experience in the health law space and is licensed in both Florida and New York.
Florida Healthcare Law Firm has announced that they have added Dean Viskovich, “The Lab Guy,” to the team. Dean brings a wealth of healthcare business expertise working on the inside in settings such as laboratories and health insurance companies. Dean has served as a trial attorney on behalf of insurance companies and healthcare providers. He specializes in laboratory compliance and offers education and training programs geared at OIG compliance. Dean’s extensive experience in laboratory compliance and operations includes Stark, Anti-Kickback, Fraudulent Claims Act, Safe Harbor and State regulatory provisions. Additional areas of expertise include billing, reimbursement, charge-master review, CPT, ICD-10, HCPC coding and audits.