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.
When natural disasters strike, Medicare and Medicaid audits become less important, and human safety becomes most important. During Hurricane Ian, 16 hospitals were evacuated in Florida alone. Hospitals and long-term care facilities were without water.
Approximately, 8,000 patients were evacuated from 47 nursing homes and 115 assisted living facilities. Seventy-eight nursing homes lost power and all had to implement emergency plans involving generator power. Did the providers continue to bill during this time? If so, could regulations be followed in the midst of a pandemic.
These natural disasters impact future Medicare and Medicaid audits. Obviously, during natural disasters a hospital may not be able to maintain the two-midnight rule or determine whether a patient is in observation status or in-patient. You may be surprised to hear that there are no automatic audit exceptions during a disaster.
The general rule, which has exceptions, is a 30-day extension for records requests. Broadly speaking, Medicare fee-for-service has three sets of potential temporary adjustments that can be made to address an emergency or disaster situation. These include:
- Applying flexibilities that are already available under normal business rules. This is on an individual basis;
- Waiver or modification of policy or procedural norms by CMS; and
- Waiver or modification of certain Medicare requirements pursuant to waiver authority under § 1135 of the Social Security Act. This waiver authority can be invoked by the Secretary of the DHHS in certain circumstances.
These waivers are not automatic.
Section 1135 of the Social Security Act authorizes the Secretary DHHS to waive or modify certain Medicare, Medicaid, CHIP, and HIPAA requirements. Two prerequisites must be met before the Secretary may invoke the § 1135 waiver authority. First, the President must have declared an emergency or disaster, and the Secretary must have declared a Public Health Emergency (PHE).
Waivers authorized by the statute apply to Medicare in the context of the following requirements:
- conditions of participation or other certification requirements applicable to providers;
- licensure requirements applicable to physicians and other health professionals;
- sanctions for violations of certain emergency medical standards under the Emergency Medical Treatment and Labor Act (EMTALA)
- sanctions relating to physician self-referral limitations (Stark)
- performance deadlines and timetables (modifiable only; not waivable); and
- certain payment limitations under the Medicare Advantage program.
Following a disaster, such as Ian, there is no standing authority for CMS to provide special emergency/disaster relief funding following an emergency or disaster in order to compensate providers for lost reimbursement. Congress may appropriate disaster-specific special funding for such; but absent such special appropriation, Medicare does not provide funding for financial losses.
In the context of Medicare audits, providers can obtain extensions to audit requests. Audits will only be suspended on a case-by-case basis, which means it is a subjective standard. Natural disasters are awful, and we probably need more comprehensive audit exceptions.
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.”