Defending Medicare Providers Against FCA or Qui Tam Lawsuits
As a health care partner at Nelson Mullins, I’ve seen my fair share of False Claims Act (FCA) and Qui Tam actions against health care providers. It’s not uncommon for practices to receive unwarranted accusations of false claims, especially when it comes to billing Medicare. But fear not, my friends, for I’m here to provide some guidance on how to defend yourself. These cases are long and tedious, so it is important to maintain a bit of humor throughout the process – that and hire a really good attorney.
First things first, let’s talk about the False Claims Act. This federal law imposes liability on individuals and companies that defraud the government by submitting false claims for payment. Essentially, if you submit a claim for reimbursement from Medicare that you know is false, you could be on the hook for some serious penalties. However, the government has to prove that you had actual knowledge that the claim was false, which can be a tough burden to meet.
Now, let’s talk about Qui Tam actions. These are lawsuits brought by private individuals, also known as “whistleblowers,” on behalf of the government. The whistleblower stands to receive a percentage of any damages recovered by the government, so there’s a financial incentive for them to pursue these cases. Qui Tam actions can be especially tricky because the whistleblower doesn’t have to prove that you had actual knowledge that the claim was false – they just have to show that you submitted a false claim.
So, what can you do to defend yourself against these accusations? Well, for starters, make sure that you’re submitting accurate claims to Medicare. Seems obvious, right? But you’d be surprised at how many practices make mistakes when it comes to billing. Double-check your codes, make sure you’re only billing for services that were actually provided, and make sure your documentation supports the services you’re billing for.
If you do find yourself facing an FCA or Qui Tam action, don’t panic. You have the right to defend yourself, and there are plenty of strategies that can be employed to fight back. For example, you could argue that the government hasn’t met its burden of proof, or that the whistleblower doesn’t have enough evidence to support their claim. And don’t forget about the power of humor – a well-timed joke can go a long way in disarming your accusers. Obviously, I am kidding. The investigators have no humor.
In all seriousness, though, these cases can be incredibly complex and time-consuming, so it’s important to have experienced legal counsel on your side. At Nelson Mullins, we’ve represented numerous health care providers in FCA and Qui Tam actions, and we have the knowledge and expertise to help you navigate these challenges.
So, to sum it up: be accurate in your billing, be prepared to defend yourself, and don’t be afraid to use a little humor to lighten the mood. And if all else fails, just remember the wise words of Mark Twain: “Humor is the great thing, the saving thing after all. The minute it crops up, all our hardnesses yield, all our irritations and resentments flit away, and a sunny spirit takes their place.”
#FalseClaimsAct #Medicare #QuiTam #HealthcareLaw #NelsonMullins #DefendYourself #AccuracyIsKey #HumorIsTheBestMedicine #MarkTwainQuotes
The Horror Story of 99214 and Insurance to Assist
99214. Is that Jean Valjean’s number? No. It is an E/M code of moderate complexity. Few CPT codes cause goosebumps, chilly air, and a pit in your stomach besides 99214. As I said, 99214 is an E/M code of moderate level of complexity. For a low complexity visit, the code decreases to 99213. Even lower is a 99212, which is considered a straightforward visit. The code goes as high as a 99215, which denotes high complexity. Generally, physicians are good at spotting the 99215s and 99212s; the lowest and highest complexities seem simple to spot. However, the middle complexity codes are a bit subjective. Auditors frequently find 99214s that the auditor thinks should have been a 99213. I am talking about the RACs, MACs, TPEs, UPICs, and other contractors paid with our tax dollars on behalf of CMS. I recently had a BCBS audit, which found that an urgent care center had a 97% error rate. Out of 30 claims, only one claim was considered 99214; 29 claims should have been down coded to a 99213, according to BCBS. Well, my urgent care center disagreed and hired an independent auditor to review the same claims that were audited. The independent audit resulted in vastly different results. According to the independent audit, only 4 of the 30 claims should have been down coded to 99213.
One should ask, how could two separate auditors audit the same documents and issue such disparate results? One reason is that the difference between 99213 and 99214 is subjective. However, subjectiveness was not the only reason for two polar opposite results.
You see, before 2021, facilities had the choice to follow either the 1995 guidelines or the 1997 guidelines for these CPT codes. And, there is a difference between the two guidelines. Instead of choosing either the 1995 or 1997 guidelines, BCBS applied both the 1997 and 1995 guidelines, which falsely created a more stringent criteria for a 99214.
The urgent care center had been verbose about the fact that they use the 1995 guidelines, not the 1997 guidelines. When the independent contractor audited the records, it used the 1995 guidelines only.
All in all, for an accusation of owing $180k, it cost the urgent care center almost $100k to defend itself against what was obviously a faulty audit. So, I’m thinking why in the world is there insurance for physicians for making a mistake in surgery – medical malpractice, but no insurance for False Claims allegations. I mean, med mal allegations mean there is a victim. But you can be accused of false claims unexpectantly and your practice is changed forever.
Recently, I learned of an insurance company that insures doctors and facilities if they are accused of billing Medicare or Medicaid for false claims. Unlike med mal, an accusation of false claims does not yield a victim (unless you see our tax dollars as people); however, an accusation of billing a False Claim can cost a doctor, facility, a hospital hundreds of thousands of dollars. Which, knowing all things are relative, is pennies on the dollar of the penalties under the FCA.
The company’s name is Curi. That is C-U-R-I. Personally, I had never heard of this company. I googled it after I was placed on the panel. This is an insurance company that pays for attorneys’ fees if you are accused of false claims or an overpayment. Personally, I think every listener should procure this insurance directly after RACMonitor. After 23 years of litigating, I have realized the worst part about defending yourself against accusations that you owe the government money is the huge price tag associated with it.
When I presented this story on RACMonitor, David Glaser made a comment about my segment that I would be remiss to omit. SOME med mal insurance policies cover the legal fees for attorneys for regulatory audits. Please review your policy to see whether your insurance company covers the attorneys’ fees for defense of regulatory audits before purchasing more insurance.
Risk Adjustment Audits Are Here!!! Watch Out MAOs!
Risk adjustment is hugely important in Medicare Advantage (MA). Risk adjustment is intended to financially adjust taking into account the underlying severity of beneficiaries’ health conditions and appropriately compensate private insurers with vastly varying expectations for expenditures. In each year, plans receive higher payments in direct proportion to documented risk: A 5 percent increase in documented risk leads to a 5 percent increase in payment. Yet, because MAO have considerable control over the documentation, it is common for insurers to erroneously document patient risk and receive inflated payments from CMS, at least according to several CMS and OIG Reports.
Enter Risk Adjustment Data Validation (RADV) audits.
These are the main corrective action for overpayments made to Medicare Advantage organizations (MAO) when there is a lack of documentation in the medical record to support the diagnoses reported for risk adjustment
CMS has conducted contract-level RADV audits by selecting about 30 contracts for audit annually (roughly 5 percent of MA contracts). CMS then selects samples from each contract of up to 201 beneficiaries divided into three equal strata (low, average, and high risk). Auditors then comb through each beneficiary’s medical records to determine whether diagnoses that the MA plan submitted are supported by documentation in the medical record. From this process, auditors can calculate an error rate for the sample, which can then be extrapolated to the rest of the contract. For instance, if auditors determine that an insurer overcoded a sample’s risk by 5 percent, auditors could infer that plans under that contract were overpaid by 5 percent. Historically, however, CMS has only sought to collect the overpayments identified for the sample of audited beneficiaries. Not any more!
A CMS Final Rule, published February 1, 2023, addresses extrapolation, CMS’ decision to not apply a fee-for-service (FFS Adjuster) in RADV audits, and the payment years in which these policies will apply. Once it goes into effect on April 3, 2023, CMS estimates it will result in the recoupment of $4.7 billion in overpayments from MA insurers over the next decade.
As for extrapolations, CMS will not extrapolate RADV audit findings for PY 2011-2017 and will begin collection of extrapolated overpayment findings for any CMS and OIG audits conducted in PY 2018 and any subsequent payment year.
The improper payment measurements conducted each year by CMS that are included in the HHS Agency Financial Report, as well as audits conducted by the HHS-OIG, have demonstrated that the MA program is at high risk of improper payments. In fiscal year (FY) 2021 (based on calendar year 2019 payments), OIG calculated that CMS made over $15 billion in Part C overpayments, a figure representing nearly 7 percent of total Part C payments.
The HHS-OIG has also released several reports over the past few years that demonstrate a high risk of improper payments in the MA program.
Looking forward – Expect more MAO audits.
P.S. I will be presenting a webinar on Monday, March 20, 2023, via the Assent platform regarding:
FTC ELIMINATING NON-COMPETE AGREEMENTS HOW THAT WILL AFFECT HOSPITALS AND LTC
DATE : MARCH 20, 2023 | EST : 01:00 PM | PST : 10:00 AM | DURATION : 60 MINUTES
Feel free to sign up and listen!!
PRF Audits: If You Did Not Report or Use Properly, You May Have a Recoupment!
Hello, my blog readers. Over the last two weeks, I have joined Nelson Mullins in the Raleigh office, attended Nelson Mullins’ healthcare retreat in Charlotte, and attended the Long Term and Post-Acute Care Law and Compliance conference in New Orleans, LA. It has been quite a whirlwind! I also appeared on RACMonitor, as I do every Monitor Monday.
Joining Nelson Mullins has been fantastic. There is a deep bench of health care attorneys, so now I am able to offer my clients all legal services they may need.
Today I am writing about provider relief funds (“PRF”) audits because, folks, PRF audits are HERE. If providers failed to report their PRF or used the funds for non-allowable items having nothing to do with COVID, HHS and OIG may recoup the funds.
An allowable expense under the PRF must be used to prevent, prepare for, and respond to coronavirus. PRF recipients must follow their basis of accounting (e.g., cash, accrual, or modified accrual) to determine expenses. The cited expenses, as well as losses, must not have been reimbursed from other sources and other sources must not be obligated to reimburse them.
Many providers were recipients of provider relief funds or PRF during the COVID pandemic. If providers received these funds there were reporting requirements and use requirements. Now audits are being conducted to ensure the funds’ proper use and reporting. Audits are being rolled out on two different fronts: (1) HHS; and (2) HRSA – or Health Resources Services Administration.
On Feb. 25, 2022, the American Institute of Certified Public Accountants’ (AICPA) Government Audit Quality Center (GAQC) provided long-awaited guidance to for-profit healthcare organizations that are subject to the Provider Relief Fund (PRF) audit requirements. The guidance came in the form of a practice aid entitled HHS Audit Requirements for For-Profit Entities with Awards from the Provider Relief Fund Program and Other HHS Programs. Its goal is to provide clarity to for-profit healthcare entities that expend $750,000 or more in federal awards in a given reporting period, which includes the PRF and other federal awards included in the Assistance Listing but excludes Paycheck Protection Program funds. Based on the practice aid, here is a summary of audit options available to for-profit entities to meet the audit compliance requirements of the U.S. DHHS.
- Uniform Guidance Audits
- Single Audit – A single audit requires an audit of both the financial statements under Generally Accepted Government Auditing Standards (GAGAS) and a compliance audit under Uniform Guidance. The compliance audit requires testing compliance with any major program(s) as defined by Uniform Guidance as well as obtaining an understanding of internal control over compliance and testing the internal control over compliance for each major program identified. The results are two auditor’s reports: one on the financial statements and one on compliance and internal controls over compliance. This option is necessary if federal regulations require a financial statement audit. This option is available to entities with funding from multiple programs from any federal agency.
- Program-Specific Audit – The program-specific audit is similar to the single audit except that it removes the financial statement audit requirement. Therefore, tests of compliance, an understanding of internal control over compliance, and testing internal control over compliance are required for this engagement. A schedule of a specific element of a financial statement would be prepared. The results are two auditor’s reports: one on the schedule of a specific element of a financial statement (the PRF funding) and one on compliance and internal controls over compliance. This option is only available if the entity has funding under one HHS program, such as the PRF.
- Financial-Related Audit Under GAGAS – A financial-related audit under GAGAS requires an audit to be conducted on only one schedule of a specific element of the financial statements. This option is only available if all federal funds expended during the period were from HHS programs. The schedule (the HHS Schedule) would include all federal awards from HHS, including the PRF. It does not require an audit of the financial statements or any testing of internal controls over compliance. It does require compliance testing, but no opinion on compliance is issued. The result is an auditor’s report only on the HHS Schedule.
There are 4 reporting periods per year that will be audited. Reporting for the 2023 4th period is going on now. Providers who received a PRF (General or Targeted) exceeding $10,000 in the aggregate, from July 1, 2021, to December 31, 2021, are required to report on their use of funds during RP4. The deadline to submit a report is March 31, 2023.
There is an appeal process if you receive a Final Repayment Notice. Once you receive a Final Repayment Notice, you have 60 days to either pay or appeal.
- Providers who do not take one of these actions within 60 days of HRSA’s Final Repayment Notice may be referred by HRSA to the HHS Program Support Center (PSC) for the initiation of debt collection activities.
- PSC, in coordination with the U.S. Department of Treasury, will issue formal debt collection letters to all providers that HRSA refers for debt collection. At this point, PSC and Treasury will take over all debt collection communications with referred providers. Debt collection activities may include accrual of interest, penalties, and recovery of funds by offsetting other Federal payments allocated to the entity.
HRSA cannot establish payment plans for outstanding debts. Once the repayment amount has been referred to PSC and becomes official debt, providers can apply for repayment plans directly with PSC.
Knicole Partners-Up with Nelson Mullins and Questions NC Partial Hospitalization!
I have an announcement! I have the pleasure of joining Nelson Mullins as a partner. You may have heard of Nelson Mullins; it is a nationwide firm, and its health care team is “spot on.” Instead of spinning my own wheels trying to figure out the health care law; I now will be able to collaborate with colleagues and like-minded, health care, geeks. Yes, I will be doing the same thing – Medicare and Medicaid provider appeals and fighting terminations, suspensions, and penalties for long-term care facilities, home health, DME, hospitals, dentists…basically anyone who receives an adverse decision from any state or the federal government or a contracted vendor, such as RACs, MACs, TPE, UPICs, etc.
Now to my blog… Today I want to talk about partial hospitalization and billing to Medicare and Medicaid. One of my clients has been not getting paid for services rendered, which is always a problem. The 3rd party payor claims that substance abuse treatment is not partial hospitalization. 49 States consider substance abuse intensive outpatient services (“SAIOP”) and substance abuse comprehensive outpatient treatment (“SACOT”) partial hospitalization. Do you agree? Because, apparently, NC is the sole State that refuses to identify SAIOP and SACOT as partial hospitalization.
Partial hospitalization is defined as a structured mental health treatment program that runs for several hours each day, three to five days per week. Clients participate in the scheduled treatment sessions during the day and return home at night. This program is a step down from 24-hour care in a psychiatric hospital setting (inpatient treatment). It can also be used to prevent the need for an inpatient hospital stay. In reality, partial hospitalization saves massive amounts of tax dollars by not taking up a bed in an actual hospital.
In NC, partial hospitalization is codified in 10A NCAC 27G.1101, which states “A partial hospitalization facility is a day/night facility which provides a broad range of intensive and therapeutic approaches which may include group, individual, occupational, activity and recreational therapies, training in community living and specific coping skills, and medical services as needed primarily for acutely mentally-ill individuals. This facility provides services to: (1) prevent hospitalization; or (2) to serve as an interim step for those leaving an inpatient hospital. This facility provides a medical component in a less restrictive setting than a hospital or a rehabilitation facility.”
So, why does this 3rd party payor believe that SAIOP and SACOT are not partial hospitalization? I believe this payor’s stance is wrong. I spoke about their wrongness on RACMoniter, and I hope it may give me some “sway.”
Partial hospitalization is considered a short-term treatment. It is supposed to last 2-3 weeks. However, as many of you know substance abuse is not wiped away in 2-3 weeks. It is a long term process to overcome substance abuse issues. States’ Medicaid programs will question why consumers bounce from SAIOP AND SACOT over and over. In fact, another one of clients is being investigated by the Medicaid Investigative Division (“MID”) for having consumers in SAIOP and SACOT too long or too many times.
Substance abuse services are audited a lot. In fact, Medicare and Medicaid audits occur most often in behavioral health care, home health, and hospice. On January 24, 2023, the New York State Comptroller announced it found $22 million in alleged improper payments. I say alleged because, I would say, 90% of alleged overpayments accusations are inaccurate. The poor provider receives a letter saying you owe $12 million dollars, and their hearts drop. They imagine themselves going out of business. Then they hire a lawyer and it turns out that they owe $896.36. I give that example as a real-life example. I actually had a client accused of owing $12 million dollars and after a 2-week trial, the judge decided that this company owed $896.36. A big difference, right? We appealed nonetheless. 🙂
Texas Medical Society Sues CMS Over 600% Spike in Administrative Fees
The Texas Medical Association (TMA) is challenging a 600% hike in administrative fees for seeking federal dispute resolution in the No Surprises Act (NSA) situations. The association seeks relief by filing a fourth lawsuit in the U.S. District Court for the Eastern District of Texas. The Texas Medical Society is the largest state medical society in the nation, even though it is the 2nd largest State followed by Alaska, representing more than 57,000 physicians and medical student members.
The hike only applies to out-of-network physicians or provider and a health plan payor. These situations occur when emergency services are provided by a doctor or health care provider outside of the patient’s insurance network or when out-of-network services are provided at an in-network facility.
The federal agencies set the initial administrative fee at $50 and announced in October 2022 it would remain at $50 for 2023. Two months later the agencies announced a 600% hike in the fee to $350 beginning in January 2023, “due to supplemental data analysis and increasing expenditures in carrying out the Federal IDR process since the development of the prior 2023 guidance.”
The steep jump in fees will dramatically curtail many physicians’ ability to seek arbitration when a health plan offers insufficient payment for care.
The reason that I know the TX Medical Society filed this lawsuit, because it just happened, is because I joined ASMAC, which is the American Society of Medical Association Counsel. It’s an amazing association comprised of Presidents of State medical associations all of whom are lawyers trying to protect physicians. Kelly Walla is the Vice President and General Counsel for the Texas Medical Association, and she circulated an email letting us know. She was a week late in circulating the email because, apparently, the power has been out in Austen.
The association claims that the new uptick in administrative fees violates the notice and comment requirements. I do have a personal question – if the association is successful and gets the fee requirement eradicated due to notice and comment violations, wouldn’t TX just reinstitute the hike in fees, but allow comments next time? If we really ask ourselves, do the comments matter? Who looks at them and do they carry any weight?
Since this hike only applies to out-of-network providers, I wonder if, in TX, the networks are closed. Closed networks means that, supposedly, the network has enough providers and it’s not accepting more providers. What network has “enough providers?” If the law states that everyone has the freedom to pick their provider of choice or “access to care,” then a closed network would fly in the face of that prospect. I have been successful in fighting “closed networks” in the past and gaining access to that “closed network.”
Going back to Texas, the rules include establishing the nonrefundable administrative fee all parties must pay to enter the federal independent dispute resolution (IDR) process in the event of a payment disagreement between an out-of-network physician or provider and a health plan in circumstances covered by the law. The suit lists two radiology groups as plaintiffs: the Texas Radiological Society and Houston Radiology Associated. These groups bill small value claims, so they will be particularly hurt because most claims billed are less than $350, according to the suit. Apparently, the Emergency Department Practice Management Association supports the association’s lawsuit. CMS’ reasoning for the hike is the backlog. But, making independent dispute resolution more expensive, when doctors have a right to IDR, in my opinion, is counterintuitive. Get more arbitrators. Don’t heighten your fences.
CMS Published 2023 Medicare/caid Health Care Providers’ Audit Process
THE CENTER FOR MEDICARE AND MEDICAID SERVICES (“CMS”) 2023 Program Audit Process Overview came out recently. The report is published by the Division of Audit Operations. CMS will send engagement letters to initiate routine audits beginning February 2023 through July 2023. Engagement letters for ad hoc audits may be sent at any time throughout the year. The program areas for the 2023 audits include:
- CDAG: Part D Coverage Determinations, Appeals, and Grievances
- CPE: Compliance Program Effectiveness
- FA: Part D Formulary and Benefit Administration
- MMP-SARAG: Medicare-Medicaid Plan Service Authorization Requests, Appeals, and Grievances
- MMPCC: Medicare-Medicaid Plan Care Coordination
- ODAG: Part C Organization Determinations, Appeals, and Grievances
- SNPCC: Special Needs Plans Care Coordination
The Program Audit Process document is only 13 pages. Yet, it is supposed to set forth the rules that the auditors must abide by in 2023. My question is – what if they don’t. What if the auditors fail to follow proper procedure.
For example, similarly to last year, an audit consists of 4 phases.
- Audit engagement and universe submission
- Audit field work
- Audit reporting
- Audit validation and close out
I would like to add another phase. Phase 5 is appeal.
According to the Report, and this is a quote: “the Audit Engagement and Universe Submission (which is the 1st stage) is a six-week period prior to the field work portion of the audit. During this phase, a Sponsoring organization is notified that it has been selected for a program audit and is required to submit the requested data, which is outlined in the respective Program Audit Protocol and Data Request document.” My question is: The sponsoring organization? CMS is referring to the provider who getting audited as a sponsoring organization. And why does CMS call the provider who is getting audited sponsoring? Is it because after the audit the sponsoring organization will be paying in recoupments?
It is interesting that the first phase “Audit Engagement and Universe Submission,” lasts 6 weeks. At this point, I want to know, does the provider know that the facility has been targeted for an audit? As an attorney, I get to see the process in the aftermath. Folks call me in distress because they got the results of an audit and disagree. I have never had the opportunity to be involved from the get go. So, if any of y’all receive a notice of an audit, please call me. I won’t charge you. I just would love the experience of walking through an audit from the get go. I think it would make me better at my job.
In other news, as you know, CMS may issue civil money penalties to providers for alleged noncompliance. Other penalties exist as well, which may or may not be worse that civil penalties. On January 23, 2023, CMS published a correction that Total Longterm Care, Inc. d/b/a InnovAge Colorado PACE (InnovAge CO) corrected its violations. In 2021, CMS had suspended its ability to re-enroll. Another facility was imposed with pre-payment review, which means that the facility must submit claims to an auditor prior to receiving reimbursements. Pre-payment review is probably the worse penalty in existence. A client of mine was told yesterday that pre-payment review is imminent. The only recourse for pre-payment review is a federal or State injunction Staying the suspension of reimbursements. You cannot appeal being placed on pre-payment review. But you do have a chance to Stay the suspension. The suspension makes no sense to me. It’s as if the government is saying that you are guilty before an ability to prove innocence.
Recoupment, Recoupment, Everywhere and Not a Drop to Keep
The Rime of the Ancient Mariner, a poem written by Samuel Coleridge, states “Water, water everywhere, nor any drop to drink.” It is a tale of retribution. The poem talks about a mariner who is traveling with his fellow sailors. Suddenly, when the mariner finds an albatross chasing them, the mariner at once kills the albatross in cold blood without any major reason. After the killing of the bird, nothing goes well with the mariner. He is not in a position even to hold communion with God. Killing an albatross is symbolic of showing a criminal disregard for a creature of nature.
Now, imagine the mariner is a Medicare or Medicaid auditor. You are the albatross. According to Coleridge, an auditor that needlessly and mindlessly accuses you of owing $1 million in alleged overpayments should suffer dire consequences. However, unlike in poetry, the auditors suffer nothing. The albatross may or may not perish. A health care company may or may not go bankrupt due to the mariner/auditor’s inane actions.
I have a case right now that the auditor applied the 1995 AND 1997 guidelines, instead of only the 1995 or 1997 guidelines. The auditor created a more rigid criteria than what was actually required. Not ok.
So, how do you stop recoupment when you are accused of owing money for allegedly improperly billing Medicare or Medicaid?
- Hire an attorney as soon as you receive a Tentative Notice of Overpayment (“TNO”). Do not do, what multiple clients of mine have done, do not wait until the last few days of being allowed to appeal the TNO until you contact an attorney. You want your attorney to have time on his or her side! And yours!
- Appeal timely or recoupment will begin. If you do not appeal, recoupment will occur.
- Start putting money aside to pay for attorneys’ fees. I hate saying this, but you are only as good (legally) as what you can pay your attorneys. Attorneys have bad reputations regarding billing, but in a situation in which you are accused of owing mass amounts of money or, in the worst case scenario, of fraud against Medicare, you want an experienced, specialized attorney, who understands Medicare and Medicaid. Note: You do not need to hire an attorney licensed or located in your State. Administrative Law Courts (where you go for Medicare and Medicaid legal issues) do not require the attorneys to be legally licensed in the State in which they are practicing. At least, most States do not require attorneys to be licensed in the State in which they are practicing. There are a few exceptions.
- Meditate. The process is tedious.
Advocates Split on the Benefit of Banning Non-Compete Clauses!
The Federal Trade Commission (“FTC”) unilaterally issued a Proposed Rule to ban non-compete clauses in employment contracts. See blog. The first question is: Does the FTC have the legal authority to ban non-compete clauses? As a member of the American Society of Medical Association Counsel (“ASMAC”), the president, Greg Pepe, sent out an informal questionnaire to solicit comments by health care attorneys and heads of medical societies.
Greg said, “The respondents were split 50%/50% between medical society attorney members and private practice attorneys who are members. In general, the most common threads were as follows:
- The most common comment was that non-compete provisions in physician employment contracts impede the physician/patient relationship. This comment came up over and over in a number of ways.
- A few comments pointed out that rural areas were disproportionately harmed by non-competes, with physicians having to move away to comply.
- Hospital-based physician groups need non-competes to protect their arrangements.
- Exemptions for non-profits is a loophole that eviscerates the effort.
- ASMAC should be mindful of the divergent interests of its members and their client when considering this kind of commentary.
Very few people offered specific examples of the ways non-competes in physician contracts harmed physicians. If your organization takes steps to comment please keep ASMAC advised.”
I decided that ASMAC’s findings, even if informal, were important enough to post here on my blog. So, thank you, Greg, for heading this up.
I would like to pay particular attention to #4. Because, a week or so ago, I presented on RACMoniter the story about the FTC banning non-compete clauses, but failed to acknowledge the exemptions for non-profits, which is a HUGE exception. There are 6093 hospitals in the U.S. 1228 of the 6093 hospitals are for profit. The vast majority of hospitals are either government run or non-profit. If you notice above, the “anti-banning comment of non-competes” came from hospital-based physician groups (#3). That makes sense.
Most people, when asked, touts that non-compete agreements impede physician-patient relationships. Personally, as an attorney, non-compete agreements represent requiring me not being able to work at another law firm if I decided Practus, LLP, did not work out. Similarly, if I had attended med school and was working at a hospital in Angier, NC, which was in close proximity to my home, and received a better offer at a nearby hospital, why should I be impeded from working? Obviously, families need to have an income, and what if the physician was the sole breadwinner? The non-compete agreement could really adversely affect a family.
Non-compete agreements, also called restrictive covenants, are an increasingly common requirement for employment in many sectors, including health care. Sometimes non-compete agreements appear as a clause within a contract. Other times, they are separate contracts in and of themselves. Though common, the terms of non-compete agreements vary greatly.
Most people, even physicians, when presented with a contract, “fake” review the contract, and sign without digesting – or even reading – the material. Many don’t even know that a non-compete clause exists in their contracts. Until it’s too late.
Will the FTC’s Proposed Rule become permanent? So far, there have been 4.91k comments. One anonymous person posted: “I am completely in favor of forbidding noncompete agreements.” A woman posted: “I am a veterinarian and have worked close to 40 years. I have been an associate and a practice owner. I see no justification for non-competes and in fact feel it harms the entire profession. Non-competes are pervasive and notoriously difficult to fight. For many years now I have worked for corporations and have watched colleagues both attempt to negotiate non-competes and bear the brunt of legal battles if they attempt to challenge the non-compete. Should you really have to move your entire family to acquire a job? How do I harm a company by working for their competitor?”
A guy wrote: “These should’ve been banned a long time ago. Job mobility is important if we “really” believe in our economic system. Ban NDAs.”
A physician wrote: “As a physician I have suffered significant financial and personal hardship relating to a non-compete agreement. As a result of a non-compete I had to move across the country (twice). I suffered significant loss of income as a result of this not withstanding the expense of relocating twice within a year. My self and my family also suffered significant psycho-social ramifications and de-stabilization. I now also face another non-compete agreement that will essentially render me unable to leave my next position without tremendous harm to my life-long earning potential, credibly rendering me an indentured servant. The presence of a non-compete also removes any leverage an employee such as myself might have to negotiate agains unacceptable working or wage conditions.”
Unlike the commenters from ASMAC, which was split 50-50, it appears that many comments support banning non-compete agreements, but, remember, the not-for-profit exception!! The comment period is open through Mar 10, 2023.
340B Drug Pricing Program: Drug Companies Are Concerned!
The federal 340B Drug Pricing Program allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy outpatient prescription drugs at a discount of 25 percent to 50 percent. The program is intended to help safety-net health care providers stretch their financial resources to reach more financially vulnerable patients and deliver comprehensive services.
The 340B Drug Pricing Program has spiked in use. It has become more and more popular over the years.
In 2020, there were 8,100 provider sites (including both hospitals and pharmacies), but that number rose to 50,000 by 2020. New data released in August 2022 by the Health Resources and Services Administration suggest discounted purchases under the 340B program reached $44 billion in 2021, about 16% more than in 2020. Drug companies are concerned.
On November 30, 2022, the 340B Drug Pricing Program; Administrative Dispute Resolution Notice of Proposed Rulemaking (NPRM) was published in the Federal Register. Section 340B(d)(3) of the Public Health Service Act requires the establishment of an Administrative Dispute Resolution (ADR) process for certain disputes under the 340B Program. Under the statute, the ADR process is designed to resolve:
- Claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers; and
- Claims by manufacturers, after the manufacturer has conducted an audit of a covered entity, that a covered entity has violated the prohibition on diversion or duplicate discounts.
This NPRM proposes new requirements and more efficient procedures to make the 340B Program’s ADR process more accessible and efficient, including ensuring that ADR panels hearing disputes are comprised of subject matter experts on the 340B Program, and establishing an independent HRSA reconsideration process. The NPRM will be open for public comment through January 30, 2023. Please refer to the Federal Register (PDF – 315 KB) publication for instructions about how to submit comments.
The question is how does the new proposed rule mesh with the Inflation Reduction Act of 2022? If you recall, the Inflation Reduction Act of 2022 (IRA) allows Medicare to negotiate drug rates. It has been suggested that the following 10 medications will be the first 10 negotiated:
Does the IRA and 340B conflict? How can you negotiate prices of a drug if the drug is already discounted?