Category Archives: Media
CMS Issues Interim Rule in Response to State Medicaid Disenrollment Trend
When the COVID-19 Public Health Emergency (PHE) ended in April 2023, the Families First Coronavirus Response Act’s Medicaid continuous enrollment condition also came to an end. The condition had allowed States to claim a temporary monetary incentive for not disenrolling persons enrolled in Medicaid during the PHE, among other conditions. When this monetary incentive disappeared, many States moved quickly to disenroll recipients from the Medicaid program. In response to this trend, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule (Rule) on Dec. 6, implementing reporting requirements and enforcement authorities created by the Consolidated Appropriations Act of 2023.
The Rule seeks to limit the extent to which states are removing Medicaid recipients from the program by instituting punishments for states that kick recipients out of the program for procedural reasons as opposed to eligibility considerations. For example, some states had been using procedural or administrative issues, such as the failure to renew within the required timeline or not updating contact information, as justification for disenrollment. Any noncompliance or failure to reinstate eligibility for affected individuals could subject the state to enforcement authorities, including requiring states to submit and participate in a corrective action plan, suspending disenrollments from Medicaid for procedural reasons, imposing fees on the state via civil money penalties, and applying a reduction to the State’s Federal Medical Assistance Percentage.
In order to promote transparency and hold States accountable for adhering to redetermination requirements, the Rule also requires that States submit to CMS a report on the activities of the State relating to eligibility redeterminations conducted between April 1, and June 30, 2024. The reports require several specific data elements, such as the number of eligibility renewals initiated or the number of individuals determined eligible for a qualified health plan, and CMS intends to make such reports public. Failure to follow reporting requirements could similarly result in enforcement actions taken against the State by CMS, including the application of a reduction to the State specific FMAP.
The regulations became effective on December 6, with public comments due by February 2, 2024. If you have questions about implications or requirements associated with the Rule, reach out to one of the authors.
By Cara N. Ludwig, Knicole Emanuel, Shane M. Duer, JD, CIPP/US
Medicaid Expansion Set To Take Effect In North Carolina Today!
The AP (11/30, Schoenbaum) reports that “hundreds of thousands of adults in North Carolina” are set to receive Medicaid benefits, “a development that boosters say will aid hospitals and local economies in addition to the long-term uninsured.” As of Friday, “more than 600,000 North Carolinians are ultimately expected to qualify, with roughly half to be automatically enrolled.” The AP notes that “a 2022 report from the National Center for Health Statistics estimated North Carolina’s uninsured population at 17.6%, significantly above the national average of 12.6%.”
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.
Provider Medicaid Contract Termination Reversed in Court!
First and foremost, important, health care news:
The Medicare Administrative Contractors (MACs) have full authority to renew post-payments reviews of dates of service (DOS) during the COVID pandemic. The COVID pause is entirely off. It is going to be a mess to wade through the thousands of exceptions. RAC audits of COVID DOS will be, at best, placing a finger on a piece of mercury. I hope that the auditors remember that everyone was scrambling to do their best during the past year and a half. In the upcoming weeks, I will keep you posted.
I am especially excited today. Last week, I won a permanent injunction for a health care facility that but for this injunction, the facility would be closed, its 300 staff unemployed, and its 600 Medicare and Medicaid consumers without access to their mental health and substance abuse providers, their primary care physicians, and the Suboxone clinic. The Judge’s clerk emailed us on Friday. The email was terse although the clerk signified that the email was important by clicking the little, red, exclamation point. It simply stated: After speaking with Judge X, she is dismissing the government’s MTD and granting Petitioner’s permanent injunction. Petitioner’s counsel can send a proposed decision within 10 days. Such a simple email affected so many lives!
We hear Ellen Fink-Samnick MSW, ACSW, LCSW, CCM, CRP, speak about social determinants of health (SDoH) on RACMonitor. Well, this company is minority-owned and the mass percentage of staff and consumers are minorities.
Why was this company on the brink of closing down? The managed care organization (MCO) terminated the company’s Medicaid contract. Medicaid comprised the majority of its revenue. The MCO’s reason was that the company violated 42 CFR §455.106, which states:
“Information that must be disclosed. Before the Medicaid agency enters into or renews a provider agreement, or at any time upon written request by the Medicaid agency, the provider must disclose to the Medicaid agency the identity of any person who:
(1) Has ownership or control interest in the provider, or is an agent or managing employee of the provider; and
(2) Has been convicted of a criminal offense related to that person‘s involvement in any program under Medicare, Medicaid, or the title XX services program since the inception of those programs.”
The former CEO – for years – he relied on professional tax accountants for the company’s taxes and his own personal family’s taxes. His wife, who is a physician, relied on her husband to do their personal taxes as one of his “honey-do” tasks. CEO relied on a sub-par accountant for a couple years and pled guilty to failing to pay personal taxes for two years. The plea ended up in the newspaper and the MCO terminated the facility.
We argued that the company, as an entity, was bigger than just the CEO. Quickly, we filed for a TRO to keep the company open. Concurrently, we transitioned the company from the CEO to Dr. wife. Dr became CEO in a seamless transition. A long-time executive stepped up as HR management.
Yet, according to testimony, the MCO terminated the company’s contract when the newspaper published the article about CEO’s guilty plea. The article was published in a local paper on April 9 and the termination notice was sent out April 19th. It was a quick decision.
We argued that 42 CFR §455.106 didn’t apply because CEO’s guilty plea was:
- Personal and not related to Medicare or Medicaid; and
- Not a conviction but a voluntary plea agreement.
The Judge agreed. We won the TRO for immediate relief. After a four-day hearing and 22 witnesses for Petitioner, we won the preliminary injunction. At this point, the MCO hired outside counsel with our tax dollars, which I did bring up in the final hearing on the merits.
New outside counsel was super excited to be involved. He immediately propounded a ton of discovery asking for things that he already had and for criminal documents that we had no access to because, by law, the government has possession of and CEO never had. Well, new lawyer was really excited, so he filed motions to compel us to produce these unobtainable documents. He filed for sanctions. We filed for sanctions back.
It grew more litigious as the final hearing on the merits approached.
Finally, we presented our case for a permanent injunction, emphasizing the importance of the company and the smooth transition to the new, Dr. CEO. We won! Because we won, the company is open and providing medically necessary services to our most needy population.
And…I get to draft the proposed decision.
Medicare TPE Audits: A Wolf in Sheep’s Clothing (Part II)
Let’s talk targeted probe-and-educate (“TPE”) audits – again.
I received quite a bit of feedback on my RACMonitor article regarding Medicare TPE audits being a “Wolf in Sheep’s Clothing.” So, I decided to delve into more depth by contacting providers who reached out to me to discuss specific issues. My intent is to shed the sheep’s clothing and show the big, pointy ears, big, round eyes, and big, sharp teeth that the MACs will hear, see, and eat you through the Medicare TPE audits. So, call the Woodsman, arm yourself with a hatchet, and get ready to be prepared for TPE audits. I cannot stress enough the importance of being proactive.
The very first way to rebut a TPE audit is to challenge the reason you were selected, which includes challenging the data supporting the reason that you were chosen. A poor TPE audit can easily result in termination of your Medicare contract, so it is imperative that you are prepared and appeal adverse results. 42 C.F.R. § 424.535, “Revocation of enrollment in the Medicare program” outlines the reasons for termination. Failing the audit process – even if the results are incorrect – can result in termination of your Medicare contract. Be prepared and appeal.
In 2014, the Center for Medicare and Medicaid Services (“CMS”) began the TPE program that combines a review of a sample of claims with “education” to allegedly reduce errors in the Medicare claims submission process; however, it took years to get the program off the ground. But off the ground it is. It seems, however, that CMS pushed the TPE program off the ground and then allowed the MACs to dictate the terms. CMS claims that the results of the TPE program are favorable, basing its determination of success on the decrease in the number of claim errors after providers receive education. But providers undergoing the TPE audit process face tedious and burdensome deadlines to submit documents and to undergo the “education” process. These 45-day deadlines to submit documents are not supported by federal law or regulation; they are arbitrary deadlines. Yet, these deadlines must be met by the providers or the MACs will aver a 0% accuracy. Private payors may create and enforce arbitrary deadlines; they don’t have to follow federal Medicare regulations. But Medicare and Medicaid auditors must obey federal regulations. A quick search on Westlaw confirms that no provider has challenged the MACs’ TPE rules, at least, litigiously.
The TPE process begins by the MAC selecting a CPT/HCPC code and a provider. This selection process is a mystery. How the MACs decide to audit sleep studies versus chemotherapy administration or a 93675 versus a 93674 remains to be seen. According to one health care provider, which has undergone multiple TPE audits and has Noridian Healthcare Solutions as its MAC informed me that, at times, they may have 4 -5 TPE audits ongoing at the same time. CMS has touted that TPE audits do not overlap claims or cause the providers to undergo redundant audits. But if a provider bills numerous CPT codes, the provider can undergo multiple TPE audits concurrently, which is clearly not the intent of the TPE audits, in general. The provider has questioned ad nauseam the data analysis that alerted Noridian to assign the TPE to them in the first place. Supposedly, MACs target providers with claim activity that contractors deem as unusual. The usual TPE notification letter contains a six-month comparison table purportedly demonstrating the paid amount and number of claims for a particular CPT/HCPC code, but its accuracy is questionable. See below.
This particular provider ran its own internal reports, and regardless of how many different ways this provider re-calculated the numbers, the provider could not figure out the numbers the TPE letter was alleging they were billing. But, because of the short turnaround deadlines and harsh penalties for failing to adhere to these deadlines, this provider has been unable to challenge the MAC’s comparison table. The MACs have yet to share its algorithm or computer program used to govern (a) which provider to target; (b) what CPT code to target; and (c) how it determines the paid amount and number of claims.
Pushing back on the original data on which the MACs supposedly relied upon to initially target you is an important way to defend yourself against a TPE audit. Unmask the wolf from the beginning. If you can debunk the reason for the TPE audit in the first place, the rest of the findings of the TPE audit cannot be valid. It is the classic “fruit of the poisonous tree” argument. Yet according to a quick search on Westlaw, no provider has appealed the reason for selection yet. For example, in the above image, the MAC compared one CPT code (78452) for this particular provider for dates of services January 1, 2017, through June 30, 2017, and then compared those claims to dates July 1, 2017, through December 31, 2017. Why? How is a comparison of the first half of a year to a second end of a year even relevant to your billing compliance? Before an independent tribunal, this chart, as supposed evidence of wrongdoing, would be thrown out as ridiculous. The point is – the MACs are using similar, yet irrelevant charts as proof of alleged, aberrant billing practices.
Another way to defend yourself is to contest the auditors/surveyors background knowledge. Challenging the knowledge of the nurse reviewer(s) and questioning the denial rate in relation to your TPE denials can also be successful. I had a dentist-client who was audited by a dental hygienist. Not to undermine the intelligence of a dental hygienist, but you can understand the awkwardness of a dental hygienist questioning a dentist’s opinion of the medical necessity of a service. If the auditor/surveyor lacks the same level of education of the health care provider, an independent tribunal will defer to the more educated and experienced decisions. This same provider kept a detailed timeline of their interactions with the hygienist reviewer(s), which included a summary of the conversations. Significantly, notes of conversations with the auditor/surveyor would normally not be allowed as evidence in a Court of law due to the hearsay rules. However, contemporaneous notes of conversations written in close time proximity of the conversation fall within a hearsay exception and can be admitted.
Pushing back on the MACs and/or formally appealing the MAC’s decisions are/is extremely important in getting the correct denial rate. If your appeal is favorable, the MACs will take into your appeal results into account and will factor the appeal decision into the denial rate.
The upshot is – do not accept the sheep’s clothing. Understand that you are under target during this TPE “educational” audit. Understand how to defend yourself and do so. Call the Woodsman. Get the hatchet.
Knicole Emanuel Featured on Hospital Finance Podcast – Medicare Appeal Backlog (Legal Update)
On September 6, 2017, I appeared on the Besler Hospital Finance Podcast regarding:
Update on the Medicare appeals backlog [PODCAST]
Feel free to listen to the podcast, download it, and share with others!
Gordon & Rees Ranked Among 50 Largest U.S. Law Firms by Law360
Here’s a little unabashed, yet well-deserved honor my firm recently obtained. Number 48!! Go Team G&RSM! #Medicaidatty #Medicareatty
“Gordon Rees Scully Mansukhani now ranks as the 48th largest law firm in the United States per Law360 in its annual rankings of the 400 largest law firms in the nation. The firm attained this distinction by moving up five spots from the prior year’s rankings and 23 positions from the 2015 list, and currently comprises some 733 attorneys and 304 partners throughout the U.S.
“This distinction represents an important milestone for the firm,” commented Firmwide Managing Partner Dion N. Cominos. “We continue to have good fortune in growing our platform with outstanding lawyers; most importantly, however, the growth has not occurred for its own sake but instead to allow us to best service our clients on a national stage.”
During the last three years, the firm has expanded its U.S. headcount by more than 26 percent and, since 2000, Gordon & Rees has added more than 30 new offices, and now has a major outpost in eight of the 10 largest cities in the United States. In 2017 alone, the firm has opened five new offices: Cincinnati and Columbus, Ohio; Oklahoma City, Oklahoma; Salt Lake City, Utah; and Milwaukee, Wisconsin.
Gordon & Rees is a national litigation and business transactions firm with more than 700 lawyers in 43 offices across the United States. Our lawyers provide full service representation to public and private companies ranging from the Fortune 500 to start-ups. Founded in 1974, Gordon & Rees is recognized among the fastest growing and largest law firms in the country and continues to climb the ranks of both The Am Law 200 and The National Law Journal.”
Work Requirements for Medicaid?
Under the Trump Administration, some Republican governors may look to move their Medicaid programs in a more conservative direction. In his latest column for Axios, Drew Altman discusses the arguments about Medicaid “work requirements” and why few people are likely to be affected by them in practice.
The False Claims Act: Are You Just Shaking a Magic 8 Ball?
Often we read in the news stories of hospitals or health care providers paying inordinate amounts to settle cases in which credible allegations of fraud or allegations of false claims preside. Many times the providers actually committed fraud, waste, or abuse. Maybe medical records were falsified, or maybe the documents were created for Medicaid/care recipients that do not exist. Maybe the services claimed to have been rendered were not. In these cases, the provider can be held liable criminally (fraud) and/or civilly (false claims). And these providers should be held accountable to the government and the taxpayers.
It appears that this is not the case for an Ohio hospital that settled a False Claims Act case for $4.1 million last month. Do not get me wrong: The False Claims Act is no joke. Possible penalties imposed by the False Claims Act can be up to $10,000 per claim “plus 3 times the amount of damages which the Government sustains because of the act of that person.” 37 USC §3729. See blog for more explanation.
In the Ohio hospital’s case, the penalty derived from Dr. Abubakar Atiq Durrani, a spinal surgeon, performing spinal surgeries that, allegedly, were not medically necessary.
According to what I’ve read, there is no question that Dr. Durrani actually performed these surgeries. He did. On actual people who exist. Instead, the allegation is that the surgeries were not medically necessary.
I have blogged about medical necessity in the past. Medical necessity is a subjective standard. Medical necessity is defined as reasonable, necessary, and/or appropriate, based on evidence-based clinical standards of care.
But it is still a subjective standard. When you receive news that you suffer from a debilitating disease, what do you do? You get a second opinion. If one doctor recommends brain surgery, what do you do? You get a second opinion.
After that, you grab a handy, dandy Magic 8 Ball and give it a shake. Kidding. Kinda.
My point is that 2 physicians can recommend two different courses of treatment. One physician may practice more defensive medicine, while another may be more cautious. Surgeons will, generally, recommend surgery, more than non-surgeons; it’s what they do.
Going back to Dr. Durrani, who was arrested in 2013 for allegedly “convinc[ing] [patients] they needed spine and neck surgery. However, other doctors later determined those surgeries as unnecessary and damaging to the patient’s health.”
I find two points striking about this case: (1) The allegation that this physician “convinced” people to undergo spine surgery; and (2) The fact that the hospital settled for $4.1 million when no fraud existed or was alleged, only questions as to medical necessity, which is subjective.
As to the first, I am imagining my doctor. I am imagining that I have horrible, chronic back pain. My doctor recommends spinal surgery. There is no way, at all, ever, in this universe, that any doctor would be able to convince me to undergo surgery if I did not want surgery. Period. Who allows themselves to be peer pressured into surgery? Not to knock on my own profession, but I have a sneaky suspicion that this allegation was concocted by the plaintiffs’ attorney(s) and the plaintiffs responded, “Oh, you are right. I was persuaded.”
As to the second…Why did the hospital settle for such a high amount? Couldn’t the hospital have gone to trial and convinced a jury that Dr. Durrani’s surgeries were, in fact, reasonable and/or appropriate, based on evidence-based clinical standards of care?
According to the Magic 8 Ball, “signs point to yes.” Why cave at such a large number where no fraud was alleged?
Whatever happened to Dr. Durrani because of this whole mess? “Following his arraignment, Durrani allegedly fled the United States and remains a fugitive.”
In sum, based on allegations of questionable medical necessity, not fraud, a hospital paid $4.1 million and a U.S. physician fled into hiding…allegedly.
I question this outcome. I even question whether these types of allegations fall within the False Claims Act.
The False Claims Act holds providers liable for (abridged version):
- knowingly presenting a fraudulent claim to the Government;
- knowingly making a fraudulent record or statement to the Government;
- conspiring to do any of the referenced bullet points;
- having possession of Government money and knowingly delivering less than the amount;
- delivering a certified document intending to defraud the Government without completely knowing whether the information was true;
- knowingly buying or receiving as a pledge of debt, public property from the an employee of the Government who does not have the right to pledge that property;
- knowingly making, using, or causing to be made or used, a false record material to an obligation to pay the Government, or knowingly concealing or decreasing an obligation to pay the Government.
I see nothing in the False Claims Act punishing a provider for rendering services that, perhaps, may not be medically necessary.
I actually find questions of medical necessity to be easily defensible. After all, who do we look to for determinations of what are reasonable and/or appropriate services, based on evidence-based clinical standards of care?
Our physicians.
Sure, some physicians may have conflicting views as to what is medically necessary. I see it all the time in court. One expert witness physician testifies that the service was medically necessary and another, equally as qualified, physician testifies to the contrary.
Unless I’m missing something (here, folks, is my “CYA”), I just do not understand why allegations of questionable medical necessity caused an U.S. physician to become a fugitive and a hospital to settle for $4.1 million.
It’s as if the hospital shook the Magic 8 Ball and asked whether it would be able to defend itself and received:
