All You Need to Know About Medical Devices Regulations

regulations on medical devices

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 products that 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.

The Five Levels of The Medicare Appeal Process

medicare appeals pricess

medicare appeals pricessBy: Zach Simpson

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 CourtContinue reading

Is Your Office Utilizing An Outdated Advanced Beneficiary Notice of Non-Coverage Form?

medicare abn

medicare abnBy: Zach Simpson

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.Continue reading

Drug Waste A Big Money Issue & How Providers Can Recoup The Cost of Unused Drugs on Medicare Part B Claims

drug waste

drug wasteBy: Zach Simpson

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.Continue reading

A Quick Refresher On Medicare’s Requirements For Self-Reporting & Returning Overpayments

bribe

By: Zach Simpson

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.

Continue reading

Can Your Florida Medical Business Pass the Legal Test?

florida medical license lawyer

florida medical license lawyerIf 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.

CMS’s Targeted Probe and Educate (TPE) Program: Top 5 Things to Know

Targeted Probe and Educate

Targeted Probe and EducateBy: Matt Fischer

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:

  • Who is selected?

Continue reading

Provider Self-Disclosures of Overpayments for Medicare Part C – Managed Care

medicare part c overpayment

medicare part c overpaymentBy: Karina Gonzalez

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.Continue reading

Medicare Backlog Update: Judge Orders Elimination of the ALJ Backlog by 2022

medicare backlogBy: Matt Fischer

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:Continue reading