Category Archives: NC DHHS
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.
A Story of Three Medicaid Providers’ Erroneous Terminations
I have a story for you today that affected three, Medicaid, behavioral health care providers back in 2013. Instead of me spouting off legal jargon that no one understands, I am going to tell you a nonfictional story.
Since both stories occurred in NC, we will use DHHS, the Department of Health and Human Services, which is the acronym for NC’s Medicaid agency.
In 2013, a Residential Level IV facility was shut down overnight by the managed care organization (“MCO”), Alliance, which was one of many MCOs that managed all behavioral health care for NC Medicaid recipients within their respective, catchment areas. The facility, we will call Alpha, housed 5-6, at-risk, teenage, African American, males, who could not reside in their family’s home due to mental illness, substance abuse, legal trouble, and/or violence. The owners of Alpha, themselves were large, muscular, African American males, which, I can only imagine, was to their benefit.
Alliance terminated Alpha from its catchment area, but since Alpha only provided Medicaid services in Alliance’s catchment area, Alliance’s decision would close a business immediately, terminate all staff, cause the owners to lose their careers, and the residents would have no home.
Alpha hired me. We were successful in obtaining an injunction. Click on “injunction” to read my blog about this exact situation in 2013, written by me in 2013. I have written numerous blogs on the topic of erroneous terminations of Medicaid providers over the years. Here are a couple: blog and blog.
An Administrative Law Judge (“ALJ”) ruled in our favor that Alliance does not have the legal authority to terminate a provider for no reason or any erroneous reason. The ALJ Stayed the termination and Ordered Alliance to reverse the termination and continue to contract with Alpha.
Whew! We thought. Then, Alliance flat-out ignored the ALJ’s Order.
We brought a Motion for Contempt and/or Sanctions; however, we were instructed, at the time, that a Writ of Mandamus was the appropriate venue in Superior Court. This too was unsuccessful.
During our legal battle for Alpha, we were successful in obtaining injunctions for two other provider also terminated without cause.
Alpha did close. But the bright side of the story is what happened in the future. Those 3 injunctions, which were ignored by MCOs to the detriment of the three providers, were the last ones to be ignored. In the years that followed, OAH ALJs routinely held MCOs accountable for erroneous terminations and without cause terminations.
My team has witnessed successful injunctions across the country that protect providers from arbitrary and capricious terminations. We have litigated many of these successful injunctions.
Regulatory Fright: Audits Citing Harm, Abuse, Neglect, or Exploitation
There is little more daunting than the Division of Health Services Regulation (“DHSR”) – or whatever acronym is used in your State – slapping penalties on long term care facilities, nursing homes, and other residential facilities, such as residential homes housing handicapped recipients, mentally ill recipients, or substance abuse consumers. Many of these penalties are immediate and can easily put a facility out of business and a resident without a home. DHSR falls under the umbrella of DHHS, the “single State entity” that manages Medicaid in each respective State. DHSR may be a different acronym in your State, but the essence will be the same.
The primary difference between adult care homes and nursing homes is as follows:
“Adult Care Homes” provide care and assistance to people with problems carrying out activities of daily living and supervision to people with cognitive impairments whose decisions, if made independently, may jeopardize the safety or well-being of themselves or others and therefore require supervision. Medication in an adult care home may be administered by designated, trained staff. Smaller adult care homes that provide care to two to six unrelated residents are commonly called family care homes.
“Nursing Homes” are for people who need chronic or rehabilitative care, who, on admission are not acutely ill and who do not usually require special facilities such as an operating room, X-ray facilities, laboratory facilities, and obstetrical facilities. A “nursing home” provides care for people who have remedial ailments or other ailments, for which medical and nursing care are indicated; who, however, are not sick enough to require general hospital care. Nursing care is their primary need, but they will require continuing medical supervision.
Regarding Violations & Penalties in Adult Care Homes
Pursuant to G.S. 131-D-34 (a), the Department shall impose an administrative penalty in accordance with provisions of the Article on any facility which is found to be in violation of requirements of G.S. 131D-21 or applicable State and federal laws and regulations. Citations for violations shall be classified and penalties assessed according to the nature of the violation.
Type A1 and A2 Violations & Penalties: A monetary penalty fine may be imposed when a “Type A1” or “Type A2” violation has occurred.
- “Type A1 Violation” means a violation by a facility of applicable laws and regulations governing a facility which results in death or serious physical harm, abuse, neglect, or exploitation of a resident.
- “Type A2 Violation” means a violation by a facility of applicable laws and regulations governing the licensure of a facility which results in substantial risk that death or serious physical harm, abuse, neglect, or exploitation will occur.
- For family care homes (licensed for two to six beds), the penalty amount may range from $500.00 to $10,000 for each Type A violation.
- For adult care homes (licensed for seven beds or more), the penalty amount may range from $2000.00 to $20,000 for each Type A violation.
Examples of a Type A1 violation may include the following:
- The facility failed to provide supervision to a confused resident who exhibited wandering and exit seeking behaviors resulting in the resident leaving the facility unsupervised and without the knowledge of the facility’s staff. The resident was hit by a car and sustained multiple injuries causing death.
- The facility failed to administer an antibiotic medication for 7 days as ordered for a resident discharged from the hospital with diagnoses including pneumonia. The resident required a subsequent 11-day hospitalization for diagnoses including respiratory failure and an infection in the bloodstream.
Examples of a Type A2 violation may include the following:
- The facility failed to send a resident to the hospital for evaluation after the resident drank approximately 24 ounces of hand sanitizer on one occasion; drank approximately 8 ounces of body wash and ate an unknown amount of solid deodorant on a second occasion; and failed to notify the resident’s primary care provider of the resident drinking non-consumable substances on more than one occasion which placed the resident at substantial risk of serious physical harm and neglect.
- A resident was administered medications that belonged to another resident. The medications administered had the strong potential of adverse side effects. The resident required emergent evaluation and treatment in the emergency department of the local hospital which placed the resident at substantial risk of serious physical harm.
Unabated Violations and Penalties:
If a facility has failed to correct any violation within the specified date of correction (30 days for Type A violations; 45 days for Type B violations), these are “unabated violations.” Additional penalty fines may be imposed for unabated violations.
Unabated Type A1 and A2 Violations & Penalties:
When a facility has failed to correct a “Type A1” or “Type A2” violation within 30 days, a monetary penalty fine may be imposed in the amount of up to $1,000 for each day that the Type A1 or Type A2 violation continued to occur beyond the date specified for correction.
The Department has legal authority to impose a monetary fine for:
- The inspection in which the Type A1 or Type A2 violation was first identified and
- Additional monetary penalty fines as a result of each inspection in which the unabated Type A1 violation or unabated Type A2 violation continued to occur beyond the specified date of correction
Unabated Type B Violations & Penalties:
Another unabated violation that could result in the imposition of penalty fines is a “Type B” violation that has not been corrected by the facility within the specified correction date (45 days per regulatory authority), known as an Unabated B violation.
- A “Type B” violation means a violation by a facility of applicable laws and regulations governing a facility which is detrimental to the health, safety, or welfare of any resident, but which does not result in substantial risk that death or serious physical harm, abuse, neglect, or exploitation will occur.
- The range of the fine for an Unabated “Type B” violation that was not corrected is up to $400.00 for each day that the violation continues beyond the date specified for correction.
- Additional penalty fines may be imposed as a result of each inspection in which the unabated Type B violation continued to occur beyond the specified date of correction.
Examples of Unabated Type B violations may include the following:
- Several residents have orders to receive pain medications every evening but on one evening, staff forget to give the residents the ordered pain medications. One resident suffers from shoulder pain and could not sleep from the missed dose. Subsequent doses are given as ordered. The facility is cited a Type B violation for the non-compliance and on a follow-up visit, additional medication errors are noted; therefore, the facility is fined up to $400/day until compliance with medication administration is determined, which must be verified by another follow-up inspection.
- The facility’s pest management program is not effective, and roaches are noted in a couple of the residents’ rooms on one out of two halls in the facility. The facility is cited a Type B violation for the non-compliance and on a follow-up visit, additional roaches and insects are noted; therefore, the facility is fined up to $400/day until compliance with pest management is determined, which must be verified by another follow-up inspection.
The Department will determine whether each violation has been corrected.
Pursuant to Chapter 150B and N.C. Gen. Stat. § 131D-34(e), adult care homes have the legal right to appeal the imposition of a penalty fine by filing a petition for contested case within 30 days after the Department mails a notice of the penalty imposition decision to a Licensee.
Once a penalty has been imposed, payment is due within 60 days unless an appeal is timely filed at the at the Office of Administrative Hearings (OAH).
If a penalty is appealed, it will go to a hearing at the Office of Administrative Hearings (OAH). Alternatively, the Department and the Licensee may agree to resolve the penalty by executing a settlement agreement.
I emphasize, if you disagree with the sanction and/or the accusation, APPEAL. I have been successful in eliminating severe penalties that a residential home, nursing home, or adult care homes by arguing at the OAH. Just remember, DHSR can accuse anything of happening to constitute “abuse or neglect” of a consumer. But DHSR must prove it to a Judge!
NC Medicaid OVERHAULED!
NC Medicaid is getting a complete overhaul. Politically, everyone is lost and has no idea how this will work. Back in 2010-ish, when NC went to the MCO model, which we have now, hundreds of providers were not paid or had trouble getting paid until the “dust” settled, and the MCOs were familiar with their jobs. Providers continue to suffer nonpayment from MCOs.
The new model consists of two, separate models: (1) the Standard Plan; and (2) the Tailored Plan models.
What’s the difference?
The Tailored Plan
Applies to:
- People who get Innovations Waiver services
- People who get Traumatic Brain Injury (TBI) Waiver services
- People who may have a mental health disorder,substance use disorder, intellectual /developmental disability (I/DD) or traumatic brain injury (TBI).
The Standard Plan
Applies to everyone else. It is normal, physical Medicaid.
December 1, 2022, is the “go-live” date for the Tailored Plans.
Unlike the MCO model, the Tailored Plan offers physical health, pharmacy, care management and behavioral health services. It is for members who may have significant mental health needs, severe substance use disorders, intellectual/developmental disabilities (I/DDs) or traumatic brain injuries (TBIs). Tailored Plans offer added services for members who qualify. DHHS is trying to distance itself from any Medicaid administration by hiring all these private companies to manage Medicaid for DHHS. DHHS has to get federal Waivers to do this.
The MCOs are taking on a new function. Starting December 1, 2022, the MCOs will be managing physical care, as well as mental health and substance abuse.
I see this HUGE change as good and bad (isn’t everything?). The good side effect of this transition is that Medicaid recipients who suffer mental health and/or substance abuse will have their physical health taken care of by the same MCO that manage their mental health and/or substance abuse services. Despite, this positive side effect, we all know that whenever NC Medicaid is OVERHAULED, consumers fall between cracks on a large scale. Let’s just hope that this transition will be easier than past transitions.
Dave Richard, Deputy Secretary NC Medicaid, NCDHHS, gave a presentation today for the NCSHCA. He said that the transition to MCOs was rocky. What does he think will happen when we transfer to the Tailored Plan?
I think I may ask him whether he thinks whether the MCOs are doing a good job, presently.
He’s a great presenter.
He said that the hospitals have come together in the last 4 weeks. He said that we will see something in the media on Monday.
He wants to expand Medicaid because his agency DHHS would be awarded $1.5 Billion over the course of 2 years. Of course, he wants to expand. He has no idea that the MCOs are “terminating at will” providers within the catchment areas in a disproportionate and discriminatory way.
We are close to expansion, he said. 80%, he guessed. “Expansion is really important.”
Not if there are not enough providers.
I did not ask him my question.
Today Mr. Richard had to get a bunch of data from the “new plans.” We are 2 1/2 months away, and he said they are not prepared yet, but hopes to be prepared by December 1, 2022. They still have the discretion to “pull the plug.” He’s worried about a lot of providers who have invested a lot of money to get compliant and ready for the transformation – that they won’t get paid.
“We have 5 really, strong Standard Plans,” he said. Most Medicaid recipients will choose the 5 Standard Plans,
Attorney from the audience: “We have to raise reimbursement rates.” There is a staffing crisis, the attorney, emphasized.
Mr. Richard stated that there will be a raise, but no indication of how much.
Finally, I did ask him his opinion as to whether he thinks the MCOs are doing better now than when the transformation happened (back in 2010-ish).
He said, that nothing is perfect. And that other Medicaid Deputy Secretaries think very highly of NC’s program. I wonder if he’ll run for office. He would win.
The guy next to me asked, “What is the future of the Tailored Plans when they go out of business in 4 years?”
Mr. Richards said that there needed to be competition for being the “big dogs.”
NC’s DHHS’ Secretary’s Handling of COVID-19: Yay or Nay?
I posted/wrote the below blog in 2017. I re-read my February 10, 2017, blog, which was entitled “NC DHHS’ New Secretary – Yay or Nay?” with the new perspective of COVID-19 being such a hot potato topic and sparking so much controversy. Interestingly, at least to me, I still stand by what I wrote. You have to remember that viruses are not political. Viruses spread despite your bank account, age, or location. Sure, variables matter. For example, I am statistically safer from COVID because I live on a small, horse farm in North Carolina rather than an apartment in Manhattan.
The facts are the facts. Viruses and facts are not political.
I was surprised that more people did not react to my February 10, 2017, blog, which is re-posted below – exactly as it was first posted. For some reason (COVID-19), people are re-reading it.
___________________________________
Our newly appointed DHHS Secretary comes with a fancy and distinguished curriculum vitae. Dr. Mandy Cohen, DHHS’ newly appointed Secretary by Gov. Roy Cooper, is trained as an internal medicine physician. She is 38 (younger than I am) and has no known ties to North Carolina. She grew up in New York; her mother was a nurse practitioner. She is also a sharp contrast from our former, appointed, DHHS Secretary Aldona Wos. See blog.
Prior to the appointment as our DHHS Secretary, Dr. Cohen was the Chief Operating Officer (COO) and Chief of Staff at the Centers for Medicare and Medicaid Services (CMS). Prior to acting as the COO of CMS, she was Principal Deputy Director of the Center for Consumer Information and Insurance Oversight (CCIIO) at CMS where she oversaw the Health Insurance Marketplace and private insurance market regulation. Prior to her work at CCIIO, she served as a Senior Advisor to the Administrator coordinating Affordable Care Act implementation activities.
Did she ever practice medicine?
Prior to acting as Senior Advisor to the Administrator, Dr. Cohen was the Director of Stakeholder Engagement for the CMS Innovation Center, where she investigated new payment and care delivery models.
Dr. Cohen received her Bachelor’s degree in policy analysis and management from Cornell University, 2000. She obtained her Master’s degree in health administration from Harvard University School of Public Health, 2004, and her Medical degree from Yale University School of Medicine, 2005.
She started as a resident physician at Massachusetts General Hospital from 2005 through 2008, then was deputy director for comprehensive women’s health services at the Department of Veterans Affairs from July 2008 through July 2009. From 2009 through 2011, she was executive director of the Doctors for America, a group that promoted the idea that any federal health reform proposal ought to include a government-run “public option” health insurance program for the uninsured.
Again, I was perplexed. Did she ever practice medicine? Does she even have a current medical license?
This is what I found:
It appears that Dr. Cohen was issued a medical license in 2007, but allowed it to expire in 2012 – most likely, because she was no longer providing medical services and was climbing the regulatory and political ladder.
From what I could find, Dr. Cohen practiced medicine (with a fully-certified license) from June 20, 2007, through July 2009 (assuming that she practiced medicine while acting as the deputy director for comprehensive women’s health services at the Department of Veterans Affairs).
Let me be crystal clear: It is not my contention that Dr. Cohen is not qualified to act as our Secretary to DHHS because she seemingly only practiced medicine (fully-licensed) for two years. Her political and policy experience is impressive. I am only saying that, to the extent that Dr. Cohen is being touted as a perfect fit for our new Secretary because of her medical experience, let’s not make much ado of her practicing medicine for two years.
That said, regardless Dr. Cohen’s practical medical experience, anyone who has been the COO of CMS must have intricate knowledge of Medicare and Medicaid and the essential understanding of the relationship between NC DHHS and the federal government. In this regard, Cooper hit a homerun with this appointment.
Herein lies the conundrum with Dr. Cohen’s appointment as DHHS Secretary:
Is there a conflict of interest?
During Cooper’s first week in office, our new Governor sought permission, unilaterally, from the federal government to expand Medicaid as outlined in the Affordable Care Act. This was on January 6, 2017.
To which agency does Gov. Cooper’s request to expand Medicaid go? Answer: CMS. Who was the COO of CMS on January 6, 2017? Answer: Cohen. When did Cohen resign from CMS? January 12, 2017.
On January 14, 2017, a federal judge stayed any action to expand Medicaid pending a determination of Cooper’s legal authority to do so. But Gov. Cooper had already announced his appointment of Dr. Cohen as Secretary of DHHS, who is and has been a strong proponent of the ACA. You can read one of Dr. Cohen’s statements on the ACA here.
In fact, regardless your political stance on Medicaid expansion, Gov. Cooper’s unilateral request to expand Medicaid without the General Assembly is a violation of NC S.L. 2013-5, which states:
SECTION 3. The State will not expand the State’s Medicaid eligibility under the Medicaid expansion provided in the Affordable Care Act, P.L. 111-148, as amended, for which the enforcement was ruled unconstitutional by the U.S. Supreme Court in National Federation of Independent Business, et al. v. Sebelius, Secretary of Health and Human Services, et al., 132 S. Ct. 2566 (2012). No department, agency, or institution of this State shall attempt to expand the Medicaid eligibility standards provided in S.L. 2011-145, as amended, or elsewhere in State law, unless directed to do so by the General Assembly.
Obviously, if Gov. Cooper’s tactic were to somehow circumvent S.L. 2013-5 and reach CMS before January 20, 2017, when the Trump administration took over, the federal judge blockaded that from happening with its stay on January 14, 2017.
But is it a bit sticky that Gov. Cooper appointed the COO of CMS, while she was still COO of CMS, to act as our Secretary of DHHS, and requested CMS for Medicaid expansion (in violation of NC law) while Cohen was acting COO?
You tell me.
I did find an uplifting quotation from Dr. Cohen from a 2009 interview with a National Journal reporter:
“There’s a lot of uncompensated work going on, so there has to be a component that goes beyond just fee-for service… But you don’t want a situation where doctors have to be the one to take on all the risk of taking care of a patient. Asking someone to take on financial risk in a small practice is very concerning.” -Dr. Mandy Cohen
Why Auditors Can’t be Unbiased
Last week on Monitor Mondays, Knicole Emanuel, Esq. reported on the case of Commonwealth v. Pediatric Specialist, PLLC, wherein the Recovery Audit Contractors’ (RACs’) experts were prohibited from testifying because they were paid on contingency. This means that the auditor (or the company for which they work) is paid some percentage of the overpayment findings it reports.
In this case, as in most nowadays, the overpayment estimate was based upon extrapolation, which means that the auditor extended the overpayment amount found in the sample to that of all claims within the universe from which the sample was drawn. I have written about this process before, but basically, it can turn a $1,500 overpayment on the sample into a $1.5 million overpayment demand.
The key to an effective extrapolation is that the statistical process is appropriate, proper, and accurate. In many audits, this is not the case, and so what happens is, if the provider believes that the extrapolation is not appropriate, they may choose to challenge the results in their appeal. Many times, this is when they will hire a statistician, like me, to review the statistical sampling and overpayment estimate (SSOE), including data and documentation to assist with the appeal. I have worked on hundreds of these post-audit extrapolation mitigation appeals over the years, and even though I am employed by the provider, I maintain a position as an independent fact-finder. My reports are based on facts and figures, and my opinion is based on those findings. Period.
So, what is it that allows me to remain independent? To perform my job without undue influence or bias? Is it my incredibly high ethical standards? Check! My commitment to upholding the standards of my industry? Check! Maybe my good looks? Well, not check! It is the fact that my fees are fixed, and are not contingent on the outcome. I mean, it would be great if I could do what the RACs do and cash in on the outcomes of a case, but alas, no such luck.
In one large class-action case in which I was the statistical expert, the defendant settled for $122 million. The law firm got something like a quarter or a third of that, and the class members all received some remuneration as well. Me? I got my hourly rate, and after the case was done, a bottle of Maker’s Mark whiskey as a thank you. And I’m not even sure that was appropriate, so I sent it back. I would love to be paid a percentage of what I am able to save a client in this type of appeal. I worked on a case a couple of years ago for which we were able to get the extrapolation thrown out, which reduced the payment demand from $5.9 million to $3,300. Imagine if I got paid even 2 percent of that; it would be nearly $120,000. But that can’t happen, because the moment my work product is tied to the results, I am no longer independent, nor unbiased. I don’t care how honest or ethical you are, contingency deals change the landscape – and that is as true for me, as an expert, as it is for the auditor.
In the pediatric case referenced above, the RAC that performed the audit is paid on a contingency, although I like to refer to it as a “bounty.” As such, the judge ruled, as Ms. Emanuel reported, that their experts could not testify on behalf of the RAC. Why not? Because the judge, unlike the RAC, is an independent arbiter, and having no skin in the game, is unbiased in their adjudication. But you can’t say that about the RAC. If they are being paid a “bounty” (something like 10 percent), then how in the world could they be considered independent and unbiased?
The short answer is, they can’t. And this isn’t just based on standards of statistical practice; it is steeped in common sense. Look at the appeal statistics; some 50 percent of all RAC findings are eventually reversed in favor of the provider. If that isn’t evidence of an overzealous, biased, bounty-hunting process, I don’t know what is. Basically, as Knicole reported, having their experts prohibited from testifying, the RAC was unable to contest the provider’s arguments, and the judge ruled in favor of the provider.
But, in my opinion, it should not stop here. This is one of those cases that exemplifies the “fruit of the poisonous tree” defense, meaning that if this case passes muster, then every other case for which the RAC did testify and the extrapolation held should be challenged and overturned. Heck, I wouldn’t be surprised if there was a class-action lawsuit filed on behalf of all of those affected by RAC extrapolated audits. And if there is one, I would love to be the statistical expert – but for a flat fee, of course, and not contingent upon the outcome.
And that’s the world according to Frank.
Frank Cohen is a frequent panelist with me on RACMonitor. I love his perspective on expert statistician witnesses. He drafted based off a Monitor Monday report of mine. Do not miss both Frank and me on RACMonitor, every Monday.
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.
Another NCTracks Debacle? Enter NC HealthConnex – A Whole New Computer System To Potentially Screw Up
North Carolina is mandating that health care providers link with all other health care providers. HIPAA be damned! Just another hoop to jump through in order to get paid by Medicaid – as if it isn’t hard enough!
If you do not comply and link your health care practice to NC HealthConnex by June 1, 2019, you could lose your Medicaid contract.
“As North Carolina moves into data-driven, value-based health care, the NC HIEA is working to modernize the state-designated health information exchange, now called NC HealthConnex.” About NC HealthConnex website.
NC HIEA = NC Health Information Exchange Authority (NC HIEA) and created by N.C. Gen. Stat. § 90-414.7. “North Carolina Health Information Exchange Authority.”
North Carolina state law mandates that all health care providers who receive any State funds, which would include Medicaid, HealthChoice and the State Health Plan, must connect and submit patient demographic and clinical data to NC HealthConnex by June 1, 2019. The process could take 12 to 18 months. So you better get going. Move it or lose it, literally. If you do not comply, you can lose your license to participate in state-funded programs, including Medicaid.
If you go to the NC Health Information Exchange Authority (NC HIEA) website article, entitled, “NC HealthConnex Participant Base Continues to Grow,” you will see the following:
I highlighted the Session Law that, according to the above, requires that health care providers who receive state funds must connect to NC HealthConnex. See above. However, when you actually read Session Law 2017-57, it is untrue that Session Law 2017-57 mandates that health care providers who receive state funds must connect to NC HealthConnex.
If you follow the citation by NC HIEA (above), you will see that buried in Session Law 2017-57, the 2017 Appropriations Bill, is a clause that states:
“SECTION 11A.8.(e) Of the funds appropriated in this act to the Department of Health and Human Services, Division of Central Management and Support, Office of Rural Health, for the Community Health Grant Program, the sum of up to one hundred fifty thousand dollars ($150,000) in recurring funds for each fiscal year of the 2017‑2019 fiscal biennium shall be used to match federal funds to provide to safety net providers eligible to participate in the Community Health Grant Program, through the Rural Health Technology Team, ongoing training and technical assistance with respect to health information technology, the adoption of electronic health records, and the establishment of connectivity to the State’s health information exchange network known as NC HealthConnex.”
As you can plainly read, this clause only allots funds to provide training and assistance to providers eligible to participate in the Community Health Grant Program. The above clause certainly does not mandate that Healthcare providers who receive state funds connect to NC HealthConnex.
Session Law 2017-57, only mandates $150,000 for training and assistance for HealthConnex.
So what is the legal statute that mandates health care providers who receive state funds must connect to NC HealthConnex?
Ok, bear with me. Here’s where it gets complex.
A law was passed in 2015, which created the North Carolina Health Information Exchange Authority (NC HIEA). NC HIEA is a sub agency of the North Carolina Department of Information Technology (NC DIT) Government Data Analytic Center. NC HIEA operates the NC HealthConnex. The State CIO maintains the responsibility if the NC HealthConnex.
Supposedly, that 2015 law mandates that health care providers who receive state funds must connect to NC HealthConnex…
I read it. You can click on the link here. This subsection is the only section that I would deem apropos to health care providers accepting State funding:
“In consultation with the Advisory Board, develop a strategic plan for achieving statewide participation in the HIE Network by all hospitals and health care providers licensed in this State.”
What part of the above clause states that health care providers are MANDATED to participate? So, please, if any of my readers actually know which law mandates provider participation, please forward to me. Because my question is – Is participation REALLY mandated? Will providers seriously lose their reimbursement rights for services rendered for failing to participate in NC HealthConnex?? Because I see multiple violations of federal law with this requirement, including HIPAA and due process.
HealthConnex can link your practice to it if you use the following EHR programs:
- Ace Health Solutions
- Allscripts
- Amazing Charts/Harris Healthcare Company
- Aprima
- Athena Health
- AYM Technologies
- Casehandler
- Centricity
- Cerner
- CureMD
- DAS Health/Aprima
- eClinicalWorks
- eMD
- eMed Solutions, LLC
- EPIC
- Evident- Thrive
- Greenway
- ICANotes Behavioral Health EHR
- ICAN Solutions, Inc
- Integrity/Checkpoint
- Kaleidacare
- Lauris Online
- McKesson Practice Partners
- Medical Transcription Billing Corporation
- Medinformatix
- Meditab Software, Inc.
- Meditech
- Mediware-Alphaflex
- MTBC
- MicroMD
- Netsmart
- NextGen
- Office Ally
- Office Practicum
- Oncelogix Sharenote
- Patagonia Health
- Physician’s Computer Company (PCC)
- PIMSY
- Practice Fusion Cloud
- Praxis
- PrognoCIS
- PsyTech Solutions, Inc.
- Qualifacts – Carelogic
- Radysans
- Reli Med Solutions
- SET-Works
- SRS
- The Echo Group
- Therap
- Trimed Tech
- Valant
- Waiting Room Solutions
The law also requires:
- Hospitals as defined by G.S. 131E-176(13), physicians licensed to practice under Article 1 of Chapter 90 of the General Statutes, physician assistants as defined in 21 NCAC 32S .0201, and nurse practitioners as defined in 21 NCAC 36 .0801 who provide Medicaid services and who have an electronic health record system shall connect by June 1, 2018.
- All other providers of Medicaid and state-funded services shall connect by June 1, 2019. See changes in 2018 Session Law below.
- Prepaid Health Plans (PHPs), as defined in S.L. 2015-245, will be required to connect to the HIE per their contracts with the NC Division of Health Benefits (DHB). Clarifies that PHPs are required to submit encounter and claims data by the commencement of the contract with NC DHB.
- Clarifies that Local Management Entities/Managed Care Organizations (LMEs/MCOs) are required to submit encounter and claims data by June 1, 2020.
New from the 2018 Legislative Short Session, NCSL 2018-41:
- Dentists and ambulatory surgical centers are required to submit clinical and demographic data by June 1, 2021.
- Pharmacies are required to submit claims data pertaining to State services once per day by June 1, 2021, using pharmacy industry standardized formats.
To meet the state’s mandate, a Medicaid provider is “connected” when its clinical and demographic information pertaining to services paid for by Medicaid and other State-funded health care funds are being sent to NC HealthConnex, at least twice daily—either through a direct connection or via a hub (i.e., a larger system with which it participates, another regional HIE with which it participates or an EHR vendor). Participation agreements signed with the designated entity would need to list all affiliate connections.
Let’s just wait and see how this computer system turns out. Hopefully we don’t have a second rendition of NCTracks. We all know how well that turned out. See blog and blog.
Medicaid participation continues to get more and more complicated. Remember the day when you could write a service note with a pen? That was so much cheaper than investing in computers and software. When did it get so expensive to provide health care to the most needy?
Medicaid Incidents: To Report or Not To Report?
The answer resides in the injury, not the quality of the care.
A consumer trips and falls at your long term care facility. It is during her personal care services (PCS). Dorothy, a longtime LPN and one of your most trusted employees, is on duty. According to Dorothy, she was aiding Ms. Brown (the consumer who fell) from the restroom when Ms. Brown sneezed multiple times resulting in a need for a tissue. Dorothy goes to the restroom (only a few feet away) when Ms. Brown’s fourth sneeze sends her reeling backward and falling on her hip.
To report or not to report? That is the question.
What is your answer?
Is Ms. Brown’s fall a Level I, Level II, or a Level III incident? What are your reporting duties?
- If you answered Level II and no requirement to report – you would be correct.
- If you answered Level III and that you must report the incident within 24 hours, you would be correct.
Wait, what? How could both answers be correct? Which is it? A Level II and no reporting it or a Level III and a report due within 24 hours?
It depends on Ms. Brown’s injuries, which is what I find fascinating and a little… how should I put it… wrong?! Think about it…the level of incident and the reporting requirement is not based on whether Dorothy properly provided services to Ms.Brown. No…the answer resides in Ms. Brown’s injuries. Whether Dorothy acted appropriately or not appropriately or rendered sub-par services has no bearing on the level of incident or reporting standards.
According to the Department of Health and Human Services’ (DHHS) Incident Response and Reporting Manual, Ms. Brown’s fall would fall (no pun intended) within a Level II of response if Ms. Brown’s injuries were not a permanent or psychological impairment. She bruised her hip, but there was no major injury.
However, if Ms. Brown’s fall led to a broken hip, surgery, and a replacement of her hip, then her fall would fall within a Level III response that needs to be reported within 24 hours. Furthermore, even at a Level III response, no reporting would be required except that, in my hypothetical, the fall occurred while Dorothy was rendering PCS, which is a billable Medicaid service. Assuming that Ms. Brown is on Medicaid and Medicare (and qualifies for PCS), Dorothy’s employer can be reimbursed for PCS; therefore, the reporting requirement within 24 hours is activated.
In each scenario, Dorothy’s actions remain the same. It is the extent of Ms. Brown’s injury that changes.
See the below tables for further explanation:
INCIDENT RESPONSE AND REPORTING MANUAL
These tables are not exhaustive, so please click on the link above to review the entire Incident Response and Reporting Manual.
Other important points:
- Use the federal Occupational Safety and Health Administration’s (OSHA) guidelines to distinguish between injuries requiring first aid and those requiring treatment by a health professional.
- A visit to an emergency room (in and of itself) is not considered an incident.
- Level I incidents of suspected or alleged cases of abuse, neglect or
exploitation of a child (age 17 or under) or disabled adult must still be reported
pursuant to G.S. 108A Article 6, G.S. 7B Article 3 and 10A NCAC 27G .0610.
Providing residential services to anyone is, inevitably, more highly regulated than providing outpatient services. The chance of injury, no matter the cause, is exponentially greater if the consumer is in your care 24-hours a day. That’s life. But if you do provide residential services, know your reporting mandates or you could suffer penalties, fines, and possible closure.
Lastly, understand that these penalties for not reporting can be subjective, not objective. If Ms. Brown’s fall led to a broken hip that repaired without surgery or without replacement of the hip, is that hip injury considered “permanent?”
In cases of reporting guidelines, it is prudent to keep your attorney on speed dial.
