Category Archives: Medicaid Providers
E/M Codes and When You Should NOT Fire Your Attorney!
Lately, I have been inundated with Medicare and Medicaid health care providers getting audited for E/M codes. I know Dr. Hirsh has spoken often about the perils of e/m codes. The thing about e/m codes is that everyone uses them. Hospitals, family physicians, urgent care centers, specialists, like cardiologists. Obviously, for a specialist, like cardiology, the higher level codes will be more common. A 99214 will be common compared to a generalist like a primary care physician, where a 99213 may be more common.
Here’s a little secret: the difference between a 99214 and 99213 is subjective. It’s so subjective that I have seen auditors who are hired by private companies to audit on behalf of CMS and are financially incentivized to find fault find 100% error rates. Who finds a 100% error rate? Not one claim out of 150 was compliant. Then, I come in and hire the best independent auditors or coders. There are generally two companies that I always use. The independent auditors are so good. Most importantly, they come in and find a much more probable error rate of almost zero.
Hiring an independent, expert coder to ensure that the RAC, MAC, UPIC, or TPE audits accurately is always part of my defense.
Recently, I learned what I should have known a long time ago, but is essential for our listeners to know. If your medical malpractice is with The Doctors Company, for free, you get $25k of – what TDC calls – Medi-Guard or regulatory compliance protection. In other words, you get audited by a UPIC and are informed that you owe an alleged $5 million, extrapolated, of course, you get $25k to pay an attorney for defense. Sadly, $25k will not come close to paying your whole defense, but it’s a start. No one scoffs at “free” money.
When accused of an alleged overpayment, placed on prepayment review, or accused of a credible allegation of fraud, your reimbursements could be in imminent danger of being suspended or recouped. It is imperative for the health care provider to stay apprised of what penalties they are facing. You want to know: “best case scenario and worst case scenario.”
And, providers, be cognizant of the gravity of your situation. Infringement of the false claims act can result in high penalties or jail, depending on the circumstances and the provider’s attorney. I had a client, who is an M.D. psychiatrist. She asked me what is the worst penalty possible. I am blunt and honest, apparently to a fault. I didn’t miss a beat. “Jail,” I said. She was horrified, called her insurance company, and requested a new attorney. TDC refused to fire me, so the doctor said that she will draft the self-disclosure herself. She also said that she submitted the falsified documents to the UPIC, so she was confident that the UPIC would not notice, but see below, time stamps are a bitch.
When I told the doctor that we needed to self-disclose to OIG because she had some Medicare claims, she screamed, “No! No! NO!” It was a video call and my sound wasn’t up loud, and I just watch her on the screen with her face all contorted and her mouth getting really big, then contract, then get really big, then contract, then get really big and then even bigger. The expert certified coder was present for the call, and he called me afterward asking me: “What was that?” And his wife, who overheard, said, “OMG. I would have lashed out.” I kept my cool. Honestly, I just felt bad for her because I can see the writing on the wall.
Obviously, a new attorney is not going to change the outcome. She falsified 17 dates of service because she wanted the service notes to be “perfect.” Well, providers, there is no such thing as perfect and changing diagnoses and CPT codes and adding details to the notes that, supposedly, you remember from a month ago is not ok.
I did feel bad for her for leaving me. I could have gotten her off without any penalties.
You see, English is not her first language. She misinterpreted an email from the UPIC and thought it said that you can fix any errors before submitting the documents. She fabricated 17 claims before I was hired instructed her to stop. I had a solid defense prepared. I was going to hire an independent auditor to audit her 147 claims with the 17 falsified claims. I would have hoped for a low error rate. Then, I would have conducted a self-audit and self-disclosed the fabrications to the UPIC with the explanation that it was a nonintentional harmless error that we are admitting. Self-disclosure can, sometimes, save you from penalties! However, if she doesn’t self-disclose, she will be caught. Unbeknownst to her, on page 6 of the service notes, it is time and date stamped. It revealed on what day she changed the data and what data she changed. Those of you who would also terminate your attorney because you think you can get by with the fraud without anyone noticing, think hard about whether you would like to suffer the worst penalty – jail – or have your attorney be honest and upfront and get you off without penalties by following the rules and self-disclosing any problems uncovered.
I have no idea what will happen to the doctor, but had she stayed with me, she would have escaped without penalty. When not to fire your attorney!
Medicare Extrapolation Under 50% Error Rate? No Extrapolation ALLOWED!
Earlier this year, I reported on the new extrapolation rules for all audits, including RAC, UPIC, TPE, CERT, etc. You know, that alphabet soup. The biggest change was that no extrapolation may be run if the error rate is under 50%. This was an exciting and unexpected new protection for health care providers. Now I have seen it in action and want to tell you about it.
A client of mine, an internal medicine facility in Alabama, received a notice of overpayment for over $3 million. This is the first case in which I saw the 50% error rate rule in action. Normally, I always tell clients that the first two levels of appeals are rubber-stamps. In other words, don’t expect to win. The QIC and the entity that conducted the audit saying you owe money are not going to overturn themselves. However, in this case, we were “partially favorable” at the QIC level. “Partially favorable” normally means mostly unfavorable. However, the partially favorable decision took the error rate from over 50% to under 50%. We re-grouped. Obviously, we were going to appeal because the new extrapolation was still over $1 million. However, before our ALJ hearing, we received correspondence from Palmetto that said our overpayment was $0. Confused, we wrote to the ALJ pointing out that Palmetto said our balance was zero. The Judge wrote back saying that, certainly, the money has already been recouped and the practice would get a refund if he reversed the denials.” “Ok,” we said and attended a telephonic hearing. We were unsuccessful at the hearing, and the ALJ upheld an alleged overpayment of over $1 million. We argued that the extrapolation should be thrown out due to the error rate being under 50%. The Judge still ruled against us, saying that CMS has the right to extrapolate, and the courts have upheld CMS’ ability to extrapolate. Ok, but what about the NEW RULE?
Later, we contacted Palmetto to confirm what the zero-balance meant. The letter read as if we did not owe anything, yet we had an ALJ decision mandating us to pay over a $1million. There was serious juxtaposition. After many hours of chasing answers on hold with multiple telephone answerers of Palmetto, we learned that, apparently, because the error rate dropped below 50% after the QIC level, Palmetto “wrote off” the nominal balance. Since an extrapolation was no longer allowed, the miniscule amount that Palmetto thought we owed wasn’t enough to pursue. However, the letter sent to us from Palmetto did not explain, “hey, we are writing off your overpayment because the error rate fell below 50%.” No, it was vague. We didn’t even know if it were true.
It took us reaching out to Palmetto and getting an email confirmation that Palmetto had written off the alleged overpayment due to the error rate dropping. Even the ALJ misinterpreted the letter, which tells me that Palmetto should revise its notices of write offs.
If Palmetto unilaterally dismisses or writes off any balance that is allegedly owed, the letter should explicitly explain this. Because providers and attorneys are not accustomed to receiving correspondence from a MAC, CMS, Palmetto, or any other auditing entity with GOOD NEWS. If we get GOOD NEWS from an auditing entity, that correspondence should be explicit.
Regardless, this was a huge win for me and my client, who was positively ecstatic with the outcome. Tune in next week, during which I will tell a story of how we battled successfully a qui tam action against a facility of 9 specialists due to a disgruntled employee who tried to blow the whistle on my specialists and their facility…falsely!
Watch AND Listen to RACMonitor Mondays!!
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Preparing for Post-PHE Medicare and Medicaid Audits
Hello and happy RACMonitor Monday! As the nation forges ahead in the wake of the COVID-19 pandemic, the audits continue after that brief hiatus in March 2020. Recovery Audit Contractors (RACs), UPICs, and other auditors are dutifully reviewing claims on a post-payment basis. However, since COVID, there is a staffing shortage, which have many provider facilities scrambling on a normal basis. Throw in an audit of 150 claims and you’ve got serious souff-laying.
Yes, audit preparation has changed since COVID. Now you have more to do to prepare. Audits create more work when you have less staff. Well, suck it up sippy-cup because post-PHE audits are here.
The most important pre-audit preparation is knowing the COVID exceptions germane to your health care services. During PHE over the last two years, there has been a firehose of regulatory exceptions. You need to use these exceptions to your advantage because, let’s face it, the exceptions made regulatory compliance easier. For the period of time during which the exceptions applied, you didn’t have to get some signatures, meet face-to-face, have supervision, or what not. The dates during which these exceptions apply is also pertinent. I suggest creating a folder for all the COVID exceptions that apply to your facility. While I would like to assume that whatever lawyer that you hire, because, yes, you need to hire a lawyer, would know all the COVID exceptions – or, at least, know to research them, you never know. It only benefits you to be prepared.
Any medical provider that submits claims to a government program may be subject to a Medicare or Medicaid audit. Just because you have been audited in the past, doesn’t change the fact that you may be audited again in the future. RAC audits are not one-time or intermittent reviews and can be triggered by anything from an innocent documentation error to outright fraud. I get that questions a lot: This is my 3rd audit. At what point is this harassment. I’ve never researched the answer to that question, but I would venture that auditors get tons of latitude. So, don’t be that provider that is low-hanging fruit and simply pays post-payment reviews.
While reduced staff, high patient loads or other challenges may be bogging down your team, it’s important to remember that timeliness is crucial for CMS audit responses.
Locating the corresponding medical records and information can be a hassle at the best of times, but there are a few key things your organization can do to better prepare for a RAC Audit:
According to CMS, if selected for review, providers should discuss with their contractor any COVID-19-related hardships they are experiencing that could affect audit response timeliness. CMS notes that all reviews will be conducted in accordance with statutory and regulatory provisions, as well as related billing and coding requirements. Waivers and flexibilities will also be applied if they were in place on the dates of service for any claims potentially selected for review.
Ensure that the auditor has the appropriate contact information for requesting audit-related documentation. With so many changes to hospitals teams, it’s important to make sure that auditors’ requests for medical records are actually making it to the correct person or team in a timely manner.
Provide your internal audit review teams with proper access to data and other software tools like those used to ensure timely electronic audit responses. With a mix of teams working from home and in the office, it’s a good idea to make sure that teams handling Additional Documentation Requests (ADRs) and audit responses have the necessary access to the data they will need to respond to requests.
Review and document any changes to your audit review team processes.
Meet with your teams to ensure they fully understand the processes and are poised to respond within the required timeframes.
Successfully completing these audits in a timely manner is made much easier when the above processes and steps are in place.
NC Medicaid Expansion: More Consumers, Not More Providers!
Republican-run Congress passed Medicaid expansion today, March 23, 2023.
Today North Carolina took a commendable step forward in healthcare by expanding Medicaid to cover more low-income individuals. Now there are 10 States that have not expanded Medicaid. This decision will provide much-needed healthcare coverage to over 600,000 people in the state who previously did not have access to affordable healthcare. North Carolina has 2.9 million enrollees in traditional Medicaid coverage. Advocates have estimated that expansion could help 600,000 adults. In theory. On paper.
As a legal professional, I commend the North Carolina lawmakers for making this decision. The expansion of Medicaid will go a long way in improving the health and wellbeing of North Carolinians. It is well known that access to quality healthcare is critical for people to lead healthy and productive lives. By expanding Medicaid, the state is taking a proactive step towards ensuring that its citizens have access to the healthcare they need.
However, it is important to note that despite this expansion, many healthcare providers still do not accept Medicaid due to low reimbursement rates and regulatory burdens. This is a major issue that must be addressed if the benefits of the expansion are to be fully realized.
According to a report by the Kaiser Family Foundation, Medicaid patients often face significant challenges in accessing healthcare services due to a shortage of healthcare providers who accept Medicaid. In North Carolina, as of 2021, only 52% of primary care physicians accept Medicaid patients, while only 45% of specialists accept Medicaid patients. 600,000 North Carolinians will get a Medicaid card. A card does not guarantee health care services. See blog.
One area that has been severely impacted by the shortage of Medicaid providers is dental care. According to the American Dental Association, only 38% of dentists in the United States accept Medicaid patients. This has led to many low-income individuals going without essential dental care, which can lead to more serious health issues down the line. Remember, Deamante Driver? See blog.
Another area that has been impacted by the shortage of Medicaid providers is nursing homes. In many cases, nursing homes that accept Medicaid patients struggle to find healthcare providers willing to provide care to their residents. This can lead to residents going without essential medical care, which can have severe consequences.
Specialists are another area where the shortage of Medicaid providers is particularly acute. According to the Kaiser Family Foundation, only 45% of specialists accept Medicaid patients. This can be especially challenging for patients with complex medical needs, who often require specialized care.
The shortage of Medicaid providers is a complex issue that requires a multifaceted solution. One approach is to increase reimbursement rates for healthcare providers who accept Medicaid patients. This would incentivize more healthcare providers to accept Medicaid patients, thereby increasing access to healthcare services for low-income individuals.
Another approach is to reduce regulatory burdens for healthcare providers. This would make it easier for healthcare providers to participate in Medicaid, thereby increasing access to healthcare services for low-income individuals.
These statistics highlight the urgent need to address the issue of low reimbursement rates and regulatory burdens faced by healthcare providers. If more providers are incentivized to accept Medicaid patients, more people will have access to the care they need, and the benefits of the expansion will be fully realized.
In conclusion, North Carolina’s decision to expand Medicaid is a significant step forward in healthcare, and it should be applauded. However, it is crucial that policy change to incentivize providers to accept Medicaid. From dental care to nursing homes and specialists, low-income individuals who rely on Medicaid face significant challenges in accessing essential healthcare services.
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
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. 🙂
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?