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.
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
What options do doctors have in determining if a patient has the flu or COVID-19?
The days of assuming a sniffle and low fever during the Fall are just signs of the common flu are long gone. The challenge doctors now face is determining whether a cough, temperature and sore throat is the flu or COVID-19. If the symptoms are essentially the same for both illnesses, what’s a doctor to do? In the old days before Fall of 2019, a doctor would order a lab test to see if the patient tested positive for the flu. Today, a doctor who is faced (in person or virtually) with a patient with fever, chills, cough, runny nose, headaches and fatigue now must know if it is the seasonal flu or COVID-19. Ordering a COVID-19 test may seem like the obvious choice, but a more efficient alternative exists. Instead of a standalone COVID-19 test, ordering a comprehensive respiratory pathogen panel is a better decision. read more
Many business people involved in some aspect of the recovery business world (e.g. IOPs, PHPs, Detox) are not aware of the punishing laws that apply to their marketing arrangements. Simply paying someone a commission based sales compensation without fully appreciate the applicable laws is dangerous and costly.
The Supreme Court upheld President Obama’s health care law today in a splintered, complex opinion that gives Obama a major election-year victory.
Basically. the justices said that the individual mandate — the requirement that most Americans buy health insurance or pay a fine — is constitutional as a tax.
Chief Justice John Roberts — a conservative appointed by President George W. Bush — provided the key vote to preserve the landmark health care law, which figures to be a major issue in Obama’s re-election bid against Republican opponent Mitt Romney.
The government had argued that Congress had the authority to pass the individual mandate as part of its power to regulate interstate commerce; the court disagreed with that analysis, but preserved the mandate because the fine amounts to a tax that is within Congress’ constitutional taxing powers.
The announcement will have a major impact on the nation’s health care system, the actions of both federal and state governments, and the course of the November presidential and congressional elections.
A key question for the high court: The law’s individual mandate, the requirement that nearly all Americans buy health insurance, or pay a penalty.
Critics call the requirement an unconstitutional overreach by Congress and the Obama administration; supporters say it is necessary to finance the health care plan, and well within the government’s powers under the Commerce Clause of the U.S. Constitution.
While the individual mandate remained 18 months away from implementation, many other provisions already have gone into effect, such as free wellness exams for seniors and allowing children up to age 26 to remain on their parents’ health insurance policies. Some of those provisions are likely to be retained by some insurance companies.
Other impacts will sort themselves out, once the court rules:
— Health care millions of Americans will be affected – coverage for some, premiums for others. Doctors, hospitals, drug makers, insurers, and employers large and small all will feel the impact.
— States — some of which have moved ahead with the health care overhaul while others have held back — now have decisions to make. A deeply divided Congress could decide to re-enter the debate with legislation.
— The presidential race between Obama and Republican challenger Mitt Romney is sure to feel the repercussions. Obama’s health care law has proven to be slightly more unpopular than popular among Americans.
(Delray Beach, FL) June 21st, 2012 – The Florida Healthcare Law Firm, one of Florida’s leading healthcare law firms, today announced a major increase in their legal practice capabilities with the official launch of the National Healthcare Law Firm, a d/b/a and new portal of the firm. The expansion to a national platform providing healthcare legal services to physicians and healthcare businesses is one that significantly increases resources for clients who lack qualified local healthcare counsel. While the Florida Healthcare Law Firm has for years assisted clients outside the state of Florida*, this new development further cements the firm’s commitment to providing ethical legal counsel in the healthcare industry.
“We are very excited about it. The fact that we serve clients all over the country has been a small secret for a while but we realized there’s a huge demand and decided to just go for it,” said Jeffrey L. Cohen, Esq. Founder and President of Florida Healthcare Law Firm.
According to Cohen, “It’s just a strange area of the law. Nearly everything in healthcare business is regulated; leases, employment agreements, compensation. Things you wouldn’t think are regulated are strongly regulated. And there are large fines and criminal penalties for getting it wrong! Our clients understand that healthcare business of any kind has serious legal risks and that they need uniquely qualified help.”
Acknowledged throughout the country for its service and excellence, Florida Healthcare Law Firm is one of the nation’s leading providers of healthcare legal services. Founded by Jeffrey L. Cohen, Esq and headquartered in South Florida, FHLF provides legal services to physicians and healthcare businesses with the right pricing responsiveness and ethics. From healthcare clinic regulation, home health agency representation and physician contracting to medical practice formation/representation and federal and state compliance matters, the Florida Healthcare Law Firm is committed to bringing knowledge and experience to a diverse group of clients.
The Florida Medicaid program does not enroll or reimburse for the services performed by an Independent Diagnostic Testing Facility (IDTF). Medicaid policy allows physicians practicing in an IDTF to enroll as a physician group so that they may only bill Medicaid for the professional component when services are rendered at the IDTF. Florida Medicaid does not reimburse for the technical component or global fee for services performed by an IDTF. This is not a new policy and it applies to both physician-owned and non-physician-owned IDTFs. This notice is being provided to you in anticipation of Agency-conducted audits regarding this policy.
If your practice is performing diagnostic testing, the global fee (or technical component) is only properly reimbursed when your practices’ physicians are also the treating providers (for the patient’s condition that warranted the testing). Physician practices that do not include the treating provider should immediately stop billing Medicaid for the global fee and/or technical component for diagnostic testing. Also, providers may choose to voluntarily conduct a self-audit and repay any overpayments prior to an Agency-conducted audit. When the Agency conducts an audit, it is entitled to recover the costs of the audit and is required to assess sanctions for the non-compliance.
It is recommended that you review claims from January 1, 2011, to present and submit self-audit findings as well as a refund check to the Agency for any improper payments detected in the audit. A provider who conducts a self-audit, submits the results, and remits payment, may avoid sanctions for the voluntary disclosure and repayment of overpayments. Information about conducting self audits, as well as the contact information for your local area office, is available on the agency’s website.
Questions specific to the anticipated recoupment project may be directed to Kelly Bennett via email at Kelly.Bennett@ahca.myflorida.com. Please include the question in the email as opposed to a request for a return phone call.
Super groups are in vogue as physicians do their best to reduce costs and enhance revenues. A “super group” is essentially a collection of previously separate competitors who have joined a single legal entity in order to achieve certain advantages. Those advantages tend to be (1) reducing overhead expense associated with economies of scale. Buying insurance for a group of 100 doctors should be far less expensive per doctor than a group of three doctors; (2) gaining leverage in managed care contracting. 20 groups of five physicians each cannot contract with a payer with “one voice” due to the antitrust restrictions, but a single group of 100 doctors can; and (3) finding new revenue sources. Small groups and solo practices cannot afford revenue producing services like surgery centers, imaging services and such. When practices combine, they have a greater patient base, which makes the development of new revenue sources feasible.
When a doctor joins a super group, she stops billing through her old practice (the “P.A.”) and starts billing through a new group (the “LLC”). The LLC has a tax ID number and a Medicare group number. And the LLC enters into lots of managed care payer agreements. Simply put, the doctor puts all of her eggs in the LLC basket. So what’s the risk?
When physicians depart super groups, they have to confront difficult facts, like:
It will take months to get a new Medicare provider number. If they haven’t billed through their “old entity” for a while, that number is gone. And getting a new number for the departing physician takes time, during which revenues associated with Medicare patients are lost (until the number is obtained);
It takes even longer to get on insurance plans. If the LLC is contracted (they usually are), how long will it take to get the P.A. fired back up? It can take as long as six months (and sometimes even more)? That means the departed doctor is out of network with all the plans! This exposes her patients to higher costs and may affect referral patterns. This alone can be crippling to a physician who has left the super group.
Leaving can also mean ending access to patient scheduling and electronic medical records. Many super groups do not ensure access to patient scheduling or billing to enable a departing physician to get back on their feet; and this can be devastating.
Super groups exist to benefit physicians. It makes no sense that they would be used to harm them, which is precisely what can happen (and sometimes does happen) if physicians do not pay good attention to the “back end” as well as they do to the “front.” That means things like—
Making sure that, wherever possible, the departing physician is afforded enough time to get back on her feet professionally. She will need time to get a new practice formed, to get a new Medicare provider number and to get back on insurance plans;
Ensuring the departing physician has adequate access to medical and scheduling records;
Carefully considering whether or not noncompetes make any sense. Some may say that it is important to protect the new practice (like the old one), but these are different sorts of practices. They are not built from the ground up. They are built because successful competitors who have been in business for years decided essentially to “loan” their practices to the super group in order to obtain certain unique advantages.
Super group arrangements continue to grow. Some of them even develop into fully integrated and sophisticated businesses. Physicians who join them have to consider all “angles,” not just how good it will be or can be when they join.
The economy has heated up the marketing activity of many healthcare businesses, including physicians. Marketing devices like Groupon have become commonplace, but raise some significant legal issues. So.one such business requested guidance from the Office of the Inspector General of the Department of Health and Human Services and got a nice response.
The requestor operates a website that includes coupons for healthcare items and services and also advertising on behalf of individuals and businesses in the healthcare industry. The healthcare professionals and business people would post coupons on the website, which would give discounts, including discounts on items and services that are covered by Medicare and other state or federal healthcare programs. The website business would have different levels of membership and would charge flat fees for each level of membership. Additionally, the requestor would sell advertising on the website.
The arrangement had certain limitations, including:
1. The providers would not advertise free services, only discounted services; and
2. The providers would be required to give the same discount to any third party payer or insurance carrier, not just to the patient.
The OIG approved the proposal and noted the following key things:
1. The requestor is not a healthcare provider;
2. Payments from providers and advertisers are a set fee, are consistent with fair market value and don’t depend on customers (patients) using coupons or buying services;
3. Advertising would only be received by customers that elected to receive it; and
4. The business structure is not likely to increase utilization.
In short, the OIG thought the requestor was serving only as a conduit of advertising and was not paying anyone to influence any patient’s choice of a provider or supplier.