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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.
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.
Post-COVID Medicare/caid Rules Matter!
How many times have we panelists talked about COVID and COVID exceptions to the regulatory rules? How many times have we warned providers that the exceptions will expire at the end of public health emergency (“PHE”)? Well, it’s coming. The COVID PHE is still in effect for America, but some States have lifted their PHE status. NC’s state of emergency expired August 15, 2022. In Montana, the state of emergency ended June 30, 2021.
What does that mean? When America’s PHE expires, so does also all the exceptions. When your particular State’s PHE ends, so do the PHE exceptions your particular State allowed. This is imperative to ALL Medicare and Medicaid audits by whatever alphabet soup is knocking on your door. As well you know, auditors don’t always get it right. Add in confusion due to COVID exceptions…which apply in which State and which expired?
Last week, CMS released fact sheets summarizing the current status of Medicare and Medicaid COVID waivers and exceptions by provider type. The fact sheets include information about which waivers and flexibilities have already been terminated, have been made permanent or will end at the end of the COVID-19 public health emergency. Unless specifically stated, all exceptions expire at the end of PHE, which is in the process of winding down.
I decided to review a fact sheet to determine how useful it was. I chose for provider type – hospitals. The fact sheet is entitled, “Hospitals and CAH (including swing beds, DPUs), ASCs and CMHCs.” It is 28 pages. The fact sheets are must reads for all providers. When you play chess the rules matter. When you accept Medicare and/or Medicaid, the rules matter. And these fact sheets are the rules.
The fact sheets cover telehealth and reimbursement rates. The hospital fact sheet covers hospitals without walls, off-site patient screening, paperwork requirements, physical environment requirements, which waivers will or will not expire at the end of PHE, and much more. I would say these fact sheets, for whichever type of provider you are – are mandatory reads. The fact sheets may not be absolutely encompassing, but they are summaries for you, all in one spot, organized for ease of reading. Thank you, CMS, for gathering this info and putting it all in one spot.
PHE Is an Enigma for Most Providers
As of now, the public health emergency (PHE) for the COVID-19 pandemic will expire July 24, 2020, unless it is renewed. Fellow contributor David Glaser and I have both reported on the potential end date of the PHE. Recent intel from Dr. Ronald Hirsh is that the Centers for Medicare & Medicaid Services (CMS) may renew the PHE period. Each time the PHE period is renewed, it is effective for another 90 days. Recent news about the uptick in COVID cases may have already alerted you that the PHE period will probably be prolonged.
CMS has given guidance that the exceptions that it has granted during this period of the PHE may be extended to Dec. 1, 2020. There is no indication of the Recovery Audit Contractor (RAC) and Medicare Administrative Contractor (MAC) audits being suspended until December 2020. In fact, we expect the audits to begin again any day. There will be confusion when audits resume and COVID exceptions are revoked on a rolling basis.
I witnessed some interesting developments as a health care attorney during this ongoing pandemic. Three of my physician clients were erroneously placed on the Medicare exclusion lists. One would think that during the pandemic, CMS would move mountains to allow a Harvard-trained ER doctor to work in an ER. Because of the lack of staff, it was actually difficult to achieve an easy fix. This doctor was suspended from Medicare based on an accidental and inadvertent omission of a substance abuse issue more than 10 years ago. He disclosed everything except an 11-year-old misdemeanor. He did not omit the misdemeanor purposely. Instead, this ER physician relies on other hospital staff to submit his Medicare re-credentialing every year, as he should. It just happened that this year, the year of COVID, this doctor got caught up in a mistake that in normal times would have been a phone call away from fixing. We cleared up his issue, but not until he was unable to work for over two months, during the midst of the PHE.
At the time of the announcement of the public health emergency, another company, a home health provider, was placed on prepayment review. I am not sure how many of you are familiar with prepayment review, but this is a Draconian measure that all States and the federal government may wield against health care providers. When you are on prepayment review, you cannot get paid until another independent contracted entity reviews your claims “objectively.” I say objectively in quotes because I have yet to meet a prepayment review audit with which I agreed.
Mostly because of COVID, we were forced to argue for a preliminary injunction, allowing this home heath provider to continue to provide services and get paid for services rendered during the PHE. We were successful. That was our first lawsuit during COVID. I believe we went to trial in April 2020. We had another trial in May 2020, for which we have not received the result, although we have high hopes. I may be able to let you know the outcome eventually. But for now, because of COVID, with a shortage of court reporters willing to work, we will not receive the transcript from the trial until over four weeks after the trial.
Tomorrow, Tuesday, we begin our third COVID trial. For the first time since COVID, it will not be virtual. This is the guidance that conveys to me that RAC and MAC audits will begin again soon. If a civil judge is ordering the parties to appear in person, then the COVID stay-at-home orders must be decreasing. I cannot say I am happy about this most recent development (although audits may be easier if they are conducted virtually).
The upshot is that no one really knows how the next few months will unfold in the healthcare industry. Some hospitals and healthcare systems are going under due to COVID. Big and small hospital systems are in financial despair. A RAC or MAC audit hitting in the wake of the COVID pandemic could cripple most providers. In the rearranged words of Roosevelt, “speak loudly, and carry a big stick.”
