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.
Have a question regarding Medicare recoupment, hiring a new physician, selling a practice, licensing or anything else? You have plenty of resources to get information from and you can hire the assistance of an attorney. However, those avenues can only help so much and you eventually will need the guidance and help of an experienced legal team that can help you in multiple areas including:
Get exact information: Rather than getting your information from a blog site or forum, you are getting it from an experienced attorney who knows exactly what it takes to get a favorable outcome in your case. The problem with blogs isn’t that the information is wrong; it’s that it sometimes doesn’t apply to your circumstances which is why you want to avoid relying on it.
Multiple areas to cover: Have a single problem, a lawyer will handle it. Have multiple problems over the next several years and you want to work with a legal team that can handle each and every one of them, saving you time and money and making the entire experience very simple.
Be ready for the next issue: Again, you are running a business in the medical field. You will have several matters that come up which require legal assistance. Having a legal team you already have experience with, who knows the ins and outs of every type of case or situation you may need assistance with is a great benefit to have.
When it comes to Medicare recoupment cases, you want to make sure that you can rely on an experienced legal team to handle your case from beginning to end. Our team is not only well experienced in handling these cases, but we have a high success rate. When you are searching for an attorney, you should always base your decision on the track record of that lawyer, the services they can provide you as well as their ability to take on any challenge and provide you with the best representation possible.
What separates The Florida Healthcare Law Firm from other attorney’s is that we have an entire team of dedicated lawyers who specialize in multiple areas of medical law including; implementing policies and procedures, selling or buying a healthcare business, opening a treatment center, Medicare recoupment and so much more. If you would like to learn more about our services, how we can assist you with your case as well as your legal options, contact us today to speak with an experienced counselor or visit our site to learn more. We have the resources, dedication and experience needed to help you win your case and we are ready to help you.
Medical devices of all kinds are regulated by the Food and Drug Administration (FDA) in the United States.
Healthcare businesses that create medical device products are required to stay up-to-date with current medical device development regulation and law and to ensure that they are in compliance at all times.
It is also important for healthcare businesses that use medical devices to stay in the know when it comes to product regulation changes and updates.
What Are Medical Devices?
Medical devices include any component, accessory, part, machine, instrument, apparatus, implant, or in vitro reagent that is used for the purposes of diagnosing, preventing, mitigating, or treating a medical condition or disease.
Some combination productsthat are a device but also biologically inserted into the body and/or release a drug into the body are included in medical device laws.
Medical device regulations exclude drugs and certain software that manage administration of a medical office or support the storage of patient records.
What Is Pharmaceutical and Medical Device Law?
Medical device law and pharmaceutical device law codify medical devices according to different levels of risk and controls. For example, Class I medical devices are the lowest risk, and Class III medical devices have the highest risk.
Depending on the class of the medical device, medical device law and regulations may require:
Labeling that provides user information.
Medical device reporting of injuries or death that are related to use of the device.
Registering the business and all devices with the FDA.
Implementing a quality control system.
Avoiding misbranding or other misinformation.
Does Your Business Need Help Maintaining Medical Device Regulation Compliance?
Contact Florida Healthcare Law Firm today to discuss potential issues you may be facing due to medical and pharmaceutical device law. You’ll get the support you need to create a compliance plan and avoid any potential legal violations and legal restraints from the FDA.
There might be times when Medicare denies coverage for an item, service, or test that you or your company provided. In the event this occurs you have the right to formally disagree wit the decision and encourage Medicare to change it. Therefore, understanding the appeals process for Medicare claims is vital for all providers. The aim of this article is to give providers a better understanding of the five (5) levels of the Medicare Appeal process, and what must occur at each level.
The Medicare Fee-For-Service (FFS) has five levels in the claims appeal process:
Level 1 – Redetermination by a Medicare Administrative Contractor (MAC)
Level 2 – Reconsideration by a Qualified Independent Contractor (QIC)
Level 3 – Disposition by Office of Medicare Hearings and Appeals (OMHA)
Level 4 – Review by the Medicare Appeals Council (Council)
Level 5 – Judicial review in U.S. District Court read more
Does your office treat Medicare or Medicaid beneficiaries? If so, this article is vital to you and your staff. The first question that I want all of you to ask yourself is if your practice treats Medicare or Medicaid beneficiaries do you know what an ABN is, and why they are vital for your practice? The acronym ABN stands for Advance Beneficiary Notice of Non-coverage. ABNs safeguard your practice’s right to collect on non-covered services (other than statutorily excluded services) from patients who have Medicare or Medicaid. Multiple organizations I have worked with throughout my career had never been informed about ABNs or had never been properly educated on how utilize them. This article is intended to provide you and your practice with the most recent information regarding the renewed ABN form that became mandatory for use on January 1, 2021.
As of January 1, 2021, a new Fee-for-Service Advanced Beneficiary Notification of Non-coverage became effective until it expires on June 30, 2023. In the event that your practice has been utilizing the same ABN forms for years then listen up. read more
In today’s practices there are many circumstances that call for the discarding of unused portion of drugs, and because of this drug waste can be a big-money issue for many practices. A perfect example is Botox which must be used within five hours of reconstitution, and if it is not used within that timeframe the only option a provider has is to discard the unused supply. What many providers may not be aware of though is that money can be recouped for drugs that have been discarded. The aim of this article is to educate providers that when applicable they may report drug waste in addition to the drug and its administration for Medicare Part B claim reimbursement.
How to Properly Report
For a provider to recoup and report the drug waste they must report the administered drug using the appropriate HCPCS Level II supply code, and the correct number of units in box24D of the CMS-1500 form. As a second line-item providers will want to enter all of the wasted units. It is very important to ensure that the provider documentation verifies the exact dosage of the drug injected, and the exact amount of and any reason for waste. Be aware If the provider did not assume the cost of the drug or administer the drug to the patient they may not bill for the unused portion.
In addition to listing the wasted units as a second line-item certain local contractors may require you to use the modifier JW Drug amount discarded/not administered to any patient to identify an unused drug from single-use vials or single-use packages that are appropriately discarded. Be aware that is inappropriate to use the modifier JW with an unlisted drug code. Therefore, it is imperative to be aware of the local contractor requirements, and appropriate drug codes. read more
As a medical professional, it’s crucial to protect yourself when things go wrong. Most people get that protection through medical malpractice insurance coverage. Florida has very specific rules and regulations about your plans, and ignorance isn’t a defense. If you break the rules, you will be liable.
Working with an expert is always wise, when you’re hoping to buy medical malpractice insurance. Florida Healthcare Law Firm specializes in helping clients buy the right policies at the right time.
These are four questions we can help you answer:
1. Do I Need Medical Malpractice Insurance in Florida?
Most doctors, surgeons, and other healthcare professionals need some kind of insurance coverage. But there are exceptions.
For example, if you’re a medical professional employed by a federal agency, you may not need coverage. The federal government will handle that for you. Similarly, some private companies offer coverage during employment negotiations.
A lawyer can walk through your agreements and help you understand when you absolutely must buy.
Type. Claims-made policies cover incidents that took place when the policy is in effect, and the policy must be in effect when the claim is filed. Occurrence policies cover events that took place when the policy was in effect, no matter when the claim is filed.
Expenses covered. Some policies will take care of everything. Others leave out fees related to punitive damages and liability for sexual misconduct.
Risks covered. If you’re exposed due to cyber issues, some policies will pay and others will not.
A lawyer can walk through these issues and help you make a smart choice.
3. Am I Getting a Good Deal?
Shopping for coverage isn’t easy when you’re also caring for patients. Looking for the right mix of costs and benefits can eat away at the time you need to do your job.
Lawyers look at policies day in and day out, and they’re adept at helping their clients make smart purchase decisions.
4. Does This Policy Meet Florida Statutes?
Florida laws require medical professionals to have coverage, but the language in these bills is complex and hard to parse. A medical professional could get coverage, only to find that it’s not enough to meet the requirements in those bills.
And statutes are filled with requirements regarding escrow accounts, and those can be separate from malpractice coverage.
A lawyer can help to address those issues too. After a supervisory look, a legal professional could help ensure that the policy you buy, and other steps you make, are fully compliant with the law.
At Florida Healthcare Law Firm, we’re prepared to look over any policy you’re considering and counsel you on your purchase decision. Contact us to find out more.
With the current healthcare environment many providers looked to alternative methods of treating patients and achieving outcomes this past year due to the pandemic. To meet the needs of their patients, and their financial obligations many providers implemented services that were not customary to their practice, or their billing departments. As is the case for any office that begins to provide something new there is always the potential for error in any aspect of the practice involved with the patient or claim. Therefore, I believe it is a great time to refresh providers on the procedures for reporting and returning Medicare overpayments as they are discovered moving forward.
As many of you are aware in 2016 the Centers for Medicare and Medicaid Services (CMS) published a final rue pursuant to Section 1128J(d) of the Social Security Act (the Act), as amended by the Affordable Care Act, that requires Medicare Parts A and B health care providers to report and return overpayments 60 days after the date an overpayment is identified, or the due date of any corresponding cost report, if applicable, whichever is later. If credible information indicates that an overpayment exists, the rule requires that a reasonably diligent inquiry must be performed.
If you own or operate a florida medical business, contact Florida Healthcare Law Firm to make sure you are legally compliant, up to date with telehealth regulations and ready for your next audit.
If you are the owner or chief operating officer of a florida medical business, then you are likely dealing with a lot more than health care on a daily basis. You’re probably facing an avalanche of ever-changing state and federal policies. Trying to interpret each one is like juggling three balls in the air and waiting for one to drop. But you don’t have to be a master juggler. You’re not expected to understand the nuance of every piece of legislation that comes your way. With the expert attorneys at Florida Healthcare Law Firm, you can concentrate on your practice, while we navigate the landscape of healthcare policy. From regulatory compliance to payor issues, telemedicine, operations, start-ups, technology and ZPIC audits for fraud, we will coach you, prepare you, counsel you and, above all, educate you so you better understand the implications of every future professional decision you make. We even offer free webinars on hot topics such as diagnostic imaging and radiology compliance, lessons learned from 2020 that can make 2021 easier and how to protect your pharmacy from risky prescriptions. From A to Z, we’ve got you covered.
But if you’re interested in something specific, our boutique firm will cater to your needs. For example, when it comes to finding a florida medical license lawyer, our team is unmatched. If you’re like most physicians, the documentation that allows you to practice is one of your most valuable possessions. And you work hard to maintain its integrity. But sadly, one error, one unhappy patient or one miscommunication could be catastrophic and could even cause you to lose your career. If this happens, don’t waste a second in calling the best representation you can find. You can’t count on the board siding with you. You can’t count on dismissal of your case based on what you consider a frivolous complaint. You cannot risk having your credentials revoked. Our team with 150 years of collective experience focuses solely on doctors and their needs. We know your business so let us take care of saving it for you. We’ll partner with you and will work until we achieve success—our guarantee. Be proactive and call Florida Healthcare Law Firm for a complimentary consultation.
In 2014, the Centers for Medicare and Medicaid Services (CMS) started a program that combined the process of reviewing a sample of claims with providing follow up education as a way to help reduce errors in the claim submission process. This is called the Targeted Probe and Educate Program (TPE). The goal of the program is to help providers and suppliers identify errors made and quickly make improvements. CMS has acknowledged that since its inception the program needs improvements and that this type of review can be burdensome. Most providers and suppliers never experience a TPE review; however, for the ones that receive notification, here are the top five things you should know before moving forward:
When providers or suppliers self-report overpayments to Medicare Part C Managed Care organization, there is some uncertainty on what lookback period applies and whether there actually is an overpayment obligation. Is it Medicare’s 60-day overpayment rule that applies or do the Managed Care Part C organizations impose a different lookback period for overpayments?
CMS (The Centers for Medicare & Medicaid Services) published its Final Rule clarifying the procedures applicable to the statutory requirement under the Affordable Care Act (“ACA”) for providers and suppliers to self-report and return overpayments. (The Final Rule was published on February 12, 2016). The Final Rule applies to Medicare Parts A and B and addresses the procedures that a provider or supplier need to follow to investigate, identify, quantify to self-report and return an overpayment. The Final Rule clarifies the obligations of Medicare providers and suppliers to report and return overpayments for claims originating only under Medicare Parts A and B. The final rule does not address, or reference, the obligations of providers to return overpayments to Medicare Advantage organizations for Part C claims. read more
On November 1, 2018, a federal court judge in the U.S. District Court for the District of Columbia granted a motion for summary judgment in favor of the American Hospital Association (AHA) ordering the U.S. Department of Health and Human Services (HHS) to clear the Medicare appeal backlog by fiscal year (FY) 2022. If you have not been following this litigation, the AHA initially filed suit in 2014 against the Secretary of the U.S. Department of Health and Human Services (HHS) requesting an order from the court mandating the Office of Medicare Hearings and Appeals (OMHA) within HHS to comply with its statutory deadlines (i.e. to issue a decision within 90 days). Following brief review by the U.S. Court of Appeals and upon the case being before the district court for a third time, the case has finally reached a resolution.
In short, HHS agreed that due to recent funding, compliance is possible within four years. Accordingly, the judge set the following deadlines for HHS and OMHA: read more