Category Archives: CMS
Ding Dong! PHE Is Dead!!!
The federal Public Health Emergency (PHE) for COVID-19, declared under Section 319 of the Public Health Service (PHS) Act, is expiring at the end of the day on May 11, 2023, today! This is huge. There have been thousands of exceptions and waivers due to COVID throughout the last 2 1/2 years. But on the end of the day on May 11, 2023…POOF….
Most exceptions or waivers will immediately cease.
The Department claims it has been working closely with partners—including Governors; state, local, Tribal, and territorial agencies; industry; and advocates—to ensure an orderly transition out of the COVID PHE.
Yesterday, HHS released a Fact Sheet. It is quite extensive, as it should be considering the amount of regulatory compliance changes that will happen overnight!
Since January 2021, COVID deaths have declined by 95% and hospitalizations are down nearly 91%.
There are some flexibilities and actions that will not be affected on May 11.
Access to COVID vaccinations and certain treatments, such as Paxlovid and Lagevrio, will generally not be affected.
At the end of the PHE on May 11, Americans will continue to be able to access COVID vaccines at no cost, just as they have during the COVID PHE. People will also continue to be able to access COVID treatments just as they have during the COVID PHE.
At some point, the federal government will no longer purchase or distribute COVID vaccines and treatments, payment, coverage, and access may change.
On April 18, 2023, HHS announced the “HHS Bridge Access Program for COVID-19 Vaccines and Treatments.” to maintain broad access to vaccines and treatments for uninsured Americans after the transition to the traditional health care market. For those with most types of private insurance, COVID vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) are a preventive health service and will be fully covered without a co-pay when provided by an in-network provider. Currently, COVID vaccinations are covered under Medicare Part B without cost sharing, and this will continue. Medicare Advantage plans must also cover COVID vaccinations in-network without cost sharing, and this will continue. Medicaid will continue to cover COVID vaccinations without a co-pay or cost sharing through September 30, 2024, and will generally cover ACIP-recommended vaccines for most beneficiaries thereafter.
After the transition to the traditional health care market, out-of-pocket expenses for certain treatments, such as Paxlovid and Lagevrio, may change, depending on an individual’s health care coverage, similar to costs that one may experience for other covered drugs. Medicaid programs will continue to cover COVID treatments without cost sharing through September 30, 2024. After that, coverage and cost sharing may vary by state.
Major telehealth flexibilities will not be affected. The vast majority of current Medicare telehealth flexibilities that people with Medicare—particularly those in rural areas and others who struggle to find access to care—have come to rely upon throughout the PHE, will remain in place through December 2024. Plus, States already have significant flexibility with respect to covering and paying for Medicaid services delivered via telehealth. This flexibility was available prior to the COVID PHE and will continue to be available after the COVID PHE ends.
What will be affected by the end of the COVID-19 PHE:
Many COVID PHE flexibilities and policies have already been made permanent or otherwise extended for some time, with others expiring after May 11.
Certain Medicare and Medicaid waivers and broad flexibilities for health care providers are no longer necessary and will end. During the COVID PHE, CMS used a combination of emergency authority waivers, regulations, and sub-regulatory guidance to ensure and expand access to care and to give health care providers the flexibilities needed to help keep people safe. States, hospitals, nursing homes, and others are currently operating under hundreds of these waivers that affect care delivery and payment and that are integrated into patient care and provider systems. Many of these waivers and flexibilities were necessary to expand facility capacity for the health care system and to allow the health care system to weather the heightened strain created by COVID-19; given the current state of COVID-19, this excess capacity is no longer necessary.
For Medicaid, some additional COVID PHE waivers and flexibilities will end on May 11, while others will remain in place for six months following the end of the COVID PHE. But many of the Medicaid waivers and flexibilities, including those that support home and community-based services, are available for states to continue beyond the COVID PHE, if they choose to do so. For example, States have used COVID PHE-related flexibilities to increase the number of individuals served under a waiver, expand provider qualifications, and other flexibilities. Many of these options may be extended beyond the PHE.
Coverage for COVID-19 testing will change.
State Medicaid programs must provide coverage without cost sharing for COVID testing until the last day of the first calendar quarter that begins one year after the last day of the PHE. That means with the PHE ending on May 11, 2023, this mandatory coverage will end on September 30, 2024, after which coverage may vary by state.
The requirement for private insurance companies to cover COVID tests without cost sharing, both for OTC and laboratory tests, will end at the expiration of the PHE.
Certain COVID data reporting and surveillance will change. CDC COVID data surveillance has been a cornerstone of our response, and during the PHE, HHS had the authority to require lab test reporting for COVID. At the end of the COVID-19 PHE, HHS will no longer have this express authority to require this data from labs, which will affect the reporting of negative test results and impact the ability to calculate percent positivity for COVID tests in some jurisdictions. Hospital data reporting will continue as required by the CMS conditions of participation through April 30, 2024, but reporting will be reduced from the current daily reporting to weekly.
FDA’s ability to detect shortages of critical devices related to COVID-19 will be more limited. While FDA will still maintain its authority to detect and address other potential medical product shortages, it is seeking congressional authorization to extend the requirement for device manufacturers to notify FDA of interruptions and discontinuances of critical devices outside of a PHE which will strengthen the ability of FDA to help prevent or mitigate device shortages.
Public Readiness and Emergency Preparedness (PREP) Act liability protections will be amended. On April 14, 2023, HHS Secretary Becerra mailed all the governors announcing his intention to amend the PREP Act declaration to extend certain important protections that will continue to facilitate access to convenient and timely COVID vaccines, treatments, and tests for individuals.
More changes are occurring than what I can write in one, little blogpost. Know that auditors will be knocking on your doors, asking for dates of service during the PHE. Be sure to research the policies and exceptions that were pertinent during those DOS. This is imperative for defending yourself against auditors knocking on your doors.
And, as always, lawyer-up fast!
And just like the Wicked With of the West, DING DONG! The PHE is dead.
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!
Texas Judge Poo Poos the ACA Preventable Services Mandate!
In March, the U.S District Court in the Northern District of Texas vacated the requirement that ACA-compliant health plans cover certain U.S. Preventive Services Task Force (USPSTF) recommended preventive services without cost sharing.
The DOJ argued the lower-court ruling from a federal judge in Texas “has no legal justification and threatens the public health.” The Health and Human Services Department estimates the ACA covered preventive services for more than 150 million people in 2020.
I am not taking a stance on the ACA. As a lawyer, I can tell you that to obtain an injunction, you have to prove:
- Likelihood of success on the merits;
- Irreprepable harm;
- Balancing the equities;
- Public interest.
Those standards come from a Supreme Court case called Winter v. Natural Resources Defense Council, 555 U.S. 7 (2008).
I understand that the Texas case vacating that the ACA-compliant health plans cover preventive services has become highly polarizing in politics. Obviously, the Republicans are Plaintiffs in this case and fighting against Obamacare. But I do not care about the politics. My contention with this case is if the government is mandating (well, was mandating before this TX judge’s decision) preventive care to be free, how is that not forcing doctor’s to work for whatever the government deems to be fair. Will they get paid Medicare or Medicaid prices? They should be so lucky. I don’t want to go out on a limb and compare mandating doctors to provide services for Medicare and Medicaid prices, regardless whether that physician is even enrolled in Medicare or Medicaid to slavery, but if the shoe fits…
On another note, the Recovery Audit Contractors (RACs) added hospice to the list of CMS approved audit targets. The review will determine if Hospice General Inpatient Care (GIP) was reasonable and necessary to achieve pain control or acute or chronic symptom management which could not be managed in any other setting. Claims that do not meet the indications of coverage and/or medical necessity will be recoded to Routine Hospice Care 0651 and result in an overpayment.” The affected code will be REV code 0656.
On March 31, CMS issued the FY 2024 proposed rule which includes a 2.8% rate increase and the FY 2024 cap of $33,396.55. The proposed rule also includes updates on the Hospice Outcomes & Patient Evaluation (HOPE) tool, CAHPS® tool, the Hospice Special Focus Program, and a proposed addition of hospice physicians to the Medicare enrollment process. For a full analysis of the proposed rule, view NHPCO’s regulatory alert from April 4. Comments are due by May 30, 2023.
Other CMS approved audit targets for 2023 and 2024 are : Ambulance Providers, Ambulatory Surgery Center (ASC), Outpatient Hospital, Inpatient Hospital, Inpatient Hospital, Inpatient Psychiatric Facility, Inpatient, Outpatient, ASC, Physician, IP, OP, SNF, OP Clinics, ORF, CORF, OPH, OP Non-Hospital, SNF, ORF, CORF, Physician, Physician/Non-physician Practitioner (NPP), Physician/NPP, Professional Services (Physician/Non-Physician), and Radiologists/Part B providers.
To name a few.
Supreme Court to Decide Mens Rea in FCA Claims!
First, I would like to give a quick shout out to my husband Scott. It’s his birthday today. Speaking of important days, another important day is imminent. Back in mid-January 2023, the United States Supreme Court granted certiorari in two consolidated cases from the 7th U.S. Circuit Court of Appeals — U.S. ex rel. Schutte v. SuperValu Inc., No. 21-1326, and U.S. ex rel. Proctor v. Safeway, Inc., No. 22-111 — which has teed up a case that could undermine one of the government’s most powerful tools for fighting fraud in government contracts and programs and, dare I say, overreaching tool. The False Claims Act (“FCA”). A jackhammer where a scalpel would suffice.
At issue is whether hundreds of major retail pharmacies across the country knowingly overcharged Medicaid and Medicare by overstating what their usual and customary prices were. In other words, the question presented is: Whether and when a defendant’s contemporaneous subjective understanding or beliefs about the lawfulness of its conduct are relevant to whether it “knowingly” violated the False Claims Act. Unlike most civil fraud actions, the FCA allows treble damages, which in “non-lawyer-ese” equals triple damages.
To Calculate Base Damages, you look at the injury. Determine what damages to the government resulted “because of” the defendant’s acts. The burden is on the government or the relator to prove that the damages sought were caused by the fraud. The defendant will want to be able to distance the alleged damages from the fraudulent acts to the extent possible (such that the damages cannot be said to have been caused by the defendant’s acts) in order to minimize its potential financial liability.
This case essentially began in 2006, when Walmart upended the retail pharmacy world by offering large numbers of frequently used drugs at very cheap prices — $4 for a 30-day supply — with automatic refills. That left the rest of the retail pharmacy industry desperately trying to figure out how to compete.
The pharmacies came up with various offers that matched Walmart’s prices for cash customers, but they billed Medicaid and Medicare using far higher prices, not what are alleged to be their usual and customary prices.
Walmart did report its discounted cash prices as usual and customary, but other chains did not, like Safeway and Supervalu. Even as the discounted prices became the majority of their cash sales, other retail pharmacies continued to bill the government at the previous and far higher prices.
For example, between 2008 and 2012, Safeway charged just $10 for almost all of its cash sales for a 90-day supply of a top-selling drug to reduce cholesterol. But it did not report $10 as its usual and customary price. Instead, Safeway told Medicare and Medicaid that its usual and customary price ranged from $81 to $109. In the Petition, Petitioner’s “expert estimated that Safeway received $127 million more in reimbursements from government health programs than it would have if it reported its price-match and discount club prices as its usual and customary prices.
A decision is expected this summer. Quote from the Petitioner about Safeway trying to hide their price matching policy from media or investigtors:
“With respect to price-matching, Safeway adopted an “official company policy” of denying that it would match Walmart prices “if an unidentified customer calls in. This is to avoid trouble with the media or competitors.” But “[i]f a regular customer known to you asks if we will match . . . the answer is YES.””
I foresee the pharmacies facing a looming overpayment. The Petition explains that, for example, after a pharmacy manager informed executives that Nebraska’s Medicaid program was requiring price-matched discount prices to be reported as U&C prices, an executive asked: “Does anyone think we have an issue here? My question is how the state of Nebraska will know that we offered to match any price out there.” In a follow-up communication, other executives pointed out that advertising their price-matching program would “Alert the Medicaid programs to start looking” into what Safeway was doing, and therefore stressed the “need to keep a low profile.” We shall see in June or July.
Watch AND Listen to RACMonitor Mondays!!
Now you can WATCH and listen to Monitor Monday!
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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.
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!!
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.
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?