Category Archives: Regulatory Audits
The Centers for Medicare & Medicaid Services (CMS) announced that they have modified the additional documentation request (ADR) limits for the Medicare Fee-for-Service Recovery Audit Contractor (RAC) program for suppliers. ADRs are the about of documents that a RAC auditor can demand from you. This is a win for DME providers.
Currently, the RAC’s methodology is based on a total claim number by NPI without consideration for the number of claims in a particular product category. This means that suppliers can receive large volumes of RAC audits for a product category in which they do minimal business.
These new limits will be set by CMS on a regular basis to establish the maximum number of medical records that may be requested by a RAC, per 45-day period. These changes will be effective beginning April 1, 2022.
Each limit will be based on a given supplier’s volume of Medicare claims paid within a previous 12-month period, in a particular HCPCS policy group (The policy groups are available on the PDAC website). Limits will be based on the supplier’s Tax Identification Number (TIN). Limits will be set at 10% of all paid claims, by policy group, paid within a previous 12-month period, divided into eight periods (45 days). If you get more than the allowed ADRs, call them out. These limits are created to lessen the burden on providers.
Although a RAC may go more than 45 days between record requests, in no case shall a RAC make requests more frequently than every 45 days. Limits are based on paid claims, irrespective of individual lines, although credit/replacement pairs shall be considered a single claim.
- Supplier A had 1,253 claims paid with HCPCS codes in the “surgical dressings” policy group, within a previous 12-month period. The supplier’s ADR limit would be (1,253 * 0.1) / 8 = 15.6625, or 16 ADRs, per 45 days, for claims with HCPCS codes in the “surgical dressings” policy group.
- Supplier B had 955 claims paid with HCPCS codes in the “glucose monitor” policy group, within a previous 12-month period. The supplier’s ADR limit would be (955 * 0.1) / 8 = 11.9375 or 12 ADRs, per 45 days, for claims with HCPCS codes in the “glucose monitor” policy group.
CMS reserves the right to give a RAC permission to exceed these ADR limits. But that would be in instances of potential fraud.
Hospitals across the nation are seeing lower profits, and it’s all because of a sudden, tsunami of Medicare and Medicaid provider audits. Whether it be RAC, MAC, UPIC, or Program Integrity, hospital audits are rampant. Billing errors, especially ‘supposed bundling,’ are causing a high rate of insurance claims denials, hurting the finances of hospitals and providers.
A recent report from American Hospital Association (AHA) found “Under an optimistic scenario, hospitals would lose $53 billion in revenue this year. Under a more pessimistic scenario, hospitals would lose $122 billion thanks to a $64 billion decline in outpatient revenue”*
The “Health Care Auditing and Revenue Integrity—2021 Benchmarking and Trends Report” is an insider’s look at billing and claims issues but reveals insights into health care costs trends and why administrative issues continue to play an outsize role in the nation’s high costs in this area. The data used covers 900+ facilities, 50,000 providers, 1500 coders, and 700 auditors – what could go wrong?
According to the report,
- 40% of COVID-19-related charges were denied and 40% of professional outpatient audits for COVID-19 and 20% of hospital inpatient audits failed.
- Undercoding poses a significant revenue risk, with audits indicating the average value of underpayment is $3,200 for a hospital claim and $64 for a professional claim.
- Overcoding remains problematic, with Medicare Advantage plans and payers under scrutiny for expensive inpatient medical necessity claims, drug charges, and clinical documentation to justify the final reimbursement.
- Missing modifiers resulted in an average denied amount of $900 for hospital outpatient claims, $690 for inpatient claims, and $170 for professional claims.
- 33% of charges submitted with hierarchical condition category (HCC) codes were initially denied by payers, highlighting increased scrutiny of complex inpatient stays and higher financial risk exposure to hospitals.
The top fields being audited were diagnoses, present on admission indicator, diagnosis position, CPT/HCPCS coding, units billed, and date of service. The average outcome from the audits was 70.5% satisfactory. So, as a whole, they got a ‘C’.
While this report did not in it of itself lead to any alleged overpayments and recoupments, guess who else is reading this audit and salivating like Pavlov’s dogs? The RACs, MACs, UPICs, and all other alphabet soup auditors. The 900 facilities and 50,000 health care providers need to be prepared for audits with consequences. Get those legal defenses ready!!!!
Every time a regulation is revised, Medicare and Medicaid audits are altered…sometimes in the providers’ favor, most times not. Since COVID, payment parity has created a large discrepancy in reimbursement rates for Medicare across the country.
Payment parity is a State-specific, Governor decision depending on whether your State is red or blue.
Payment parity laws require that health care providers are reimbursed the same amount for telehealth visits as in-person visits. During the ongoing, pandemic, or PHE, many states implemented temporary payment parity through the end of the PHE. Now, many States are implementing payment parity on a permanent basis. As portrayed in the below picture. As of August 2021, 18 States have implemented policies requiring payment parity, 5 States have payment parity in place with caveats, and 27 States have no payment parity.
On the federal level, H.R. 4748: Helping Every American Link To Healthcare Act of 2021 was introduced July 28, 2021. HR 4748 allows providers to furnish telehealth services using any non-public facing audio or video communication product during the 7-year period beginning the last day of the public health emergency. Yay. But that doesn’t help parity payments.
For example, NY is one of the states that has passed no parity regulation, temporary or permanent. However, the Governor signed an Executive Order mandating parity between telehealth and physical services. Much to the chagrin of the providers, the managed long-term care organizations reduced the Medicare and Medicaid reimbursements for social adult day care centers drastically claiming that the overhead cost of rendering virtual services is so much lower., which is really not even accurate. You have to ensure that your consumers all have access to technology. About four-in-ten adults with lower incomes do not have home broadband services (43%) or a desktop or laptop computer (41%). And a majority of Americans with lower incomes are not tablet owners.
Amidst all this confusion on reimbursement rates, last week, HHS released $25.5 billion on provider relief funds and promised increased audits. Smaller providers will be reimbursed at a higher rate than larger ones, the department said. Which leads me tov think: and perhaps be audited disproportionately more.
The first deadline for providers to report how they used grants they have already received is coming up at the end of September, but HHS on Friday announced a two-month grace period. HHS has hired several firms to conduct audits on the program.
Remember on June 3, 2021, CMS announced that MACs could begin conducting post-payment reviews for dates of service on or after March 1, 2020. Essentially, auditors can review any DOS with or without PHE exceptions applicable, but the PHE exceptions (i.e., waivers and flexibilities) continue, as the PHE was extended another 90 days and likely will be again through the end of this year.
I’m currently defending an audit spanning a 4-month period of June 2020 – September 2020. Interestingly, even during the short, 4 month, period, some exceptions apply to half the claims. While other apply to all the claims. It can get tricky fast. Now imagine the auditors feebly trying to remain up to speed with the latest policy changes or COVID exceptions.
Here, in NC, there was a short period of time during which physician signatures may not even be required for many services.
In addition to the MAC and SMRC audits, the RAC has shown an increase in audit activities, as have the UPICs and most state Medicaid plans. Commercial plan audits have also been on the rise, though they were under no directive to cease or slow audit functions at any time during the PHE.
Lastly, audit contractors have increasingly hinted to the use of six-year, lookback audits as a means for providers that have received improper payments to refund overpayments due. This 6- year lookback is the maximum lookback period unless fraud is alleged. It is important to note that the recoupments are not allowed once you appeal, so appeal!
Today I want to discuss EHR – electronic health records and RAC audits. We all remember the government pushing providers into purchasing EHR. It’s known as the meaningful use (MU) program, which is now known as the Promoting Interoperability Programs. CMS initially provided 10 incentives to accelerate the adoption of EHRs to meet program requirements. Now, physicians who fail to participate in MU will receive a penalty in the form of reduced Medicare reimbursements, at a minimum. Multiple audits at a maximum. Physicians must use certified electronic health records technology (CEHRT) and demonstrate meaningful use through an attestation process at the end of each MU reporting period to avoid the penalty.
Audits for MU can equal tens of thousands of dollars. The monetary amount is not as high as other RAC audits for medical records. One of my clients is a pediatric facility in Georgia. His facility received an alleged overpayment of $34,000 for two of his physicians not meeting the meaningful use criteria 8 and 9. We were going to fight it, but the two physicians who were dinged had quit and would not testify positively on behalf of my client. Plus, attorneys’ fees would surpass the penalty. Criteria 8 and 9 constitute proving your consumer have email and actually open their emails to check their health care internet folders, which are ridiculous criteria.
On September 2, 2020, CMS published the Fiscal Year (FY) 2021 Medicare Hospital Inpatient Prospective Payment System (IPPS) for Acute Care Hospitals and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) Final Rule which included program requirements for calendar year (CY) 2021. In this final rule, CMS continued its advancement of EHR utilization, focusing on burden reduction, and improving interoperability, and patient access to health information.
Meaningful use’s not anticipated consequence is ramping up RAC audits. Many RAC auditors are using EHR to claim “copy and paste.” Obviously, the point of EHR is to morph all service notes into a certain standard-looking note. But standard-looking notes scream copy and paste to RAC auditors. Maybe RAC auditors haven’t digested meaningful use yet.
On August 2, 2021 CMS released the Fiscal Year (FY) 2022 Medicare Hospital Inpatient Prospective Payment System for Acute Care Hospitals and Long-term Care Hospital Prospective Payment System Final Rule. For more information on the proposed changes, visit the Federal Register.
COVID affected EHR audits too.
The deadline for eligible hospitals and critical access to submit a hardship exception application is September 1, 2021.
Today I am talking about a settlement agreement between CMS and the skilled nursing community, which, apparently, CMS conveniently forgot about – just recently. The Jimmo settlement agreement re-defines medical necessity for skilled nursing, especially for terminally, debilitating diseases, such as multiple sclerosis (“MS”). According to CMS/the MAC auditor, my client, who serves 100%, MS patients on Medicare owes over half a million dollars. The alleged overpayment and audit findings are in violation of the Jimmo Settlement and must cease.
My client received correspondence dated February 25, 2021, regarding CMS Inquiry #2349 that re-alleged an overpayment in the amount of $578,564.45, but the audit is in violation of the Jimmo Settlement with CMS. One basis for the claims denials is that “There is doc that the pt. has a dx of MS with no doc of recent exacerbation or change in function status.” After the first level of appeal, on June 8, 2021, the denial reason was as follows:
“The initial evaluation did not document there was an ACUTE exacerbation of this chronic condition that would support the need for skilled services.” This basis is in violation of the Jimmo Settlement. See below excerpt from the Jimmo Settlement.
In January 2013, the Centers for Medicare & Medicaid Services (“CMS”) settled a lawsuit, and the “Jimmo” Settlement Agreement was approved by the Court. Jimmo v. Sebelius, No. 5:11-CV17 (D. Vt., 1/24/2013). The Jimmo Settlement Agreement clarified that, provided all other coverage criteria are met, the Medicare program covers skilled nursing care and skilled therapy services under Medicare’s skilled nursing facility, home health, and outpatient therapy benefits when a beneficiary needs skilled care in order to maintain function or to prevent or slow decline or deterioration. Specifically, the Jimmo Settlement Agreement required Medicare Manual revisions to restate a “maintenance coverage standard” for both skilled nursing and therapy services under these benefits. The Jimmo Settlement Agreement dictates that:
“Specifically, in accordance with the settlement agreement, the manual revisions clarify that coverage of skilled nursing and skilled therapy services in the skilled nursing facility (SNF), home health (HH), and outpatient therapy (OPT) settings “…does not turn on the presence or absence of a beneficiary’s potential for improvement, but rather on the beneficiary’s need for skilled care.” Skilled care may be necessary to improve a patient’s current condition, to maintain the patient’s current condition, or to prevent or slow further deterioration of the patient’s condition.”
In the case of Jimmo v. Sebelius, which resulted in the Jimmo Settlement Agreement, the Center for Medicare Advocacy (“CMA”) alleged that Medicare claims involving skilled care were being inappropriately denied by contractors based on a rule-of-thumb-“Improvement Standard”— under which a claim would be summarily denied due to a beneficiary’s lack of restoration potential, even though the beneficiary did in fact require a covered level of skilled care in order to prevent or slow further deterioration in his or her clinical condition. In the Jimmo lawsuit, CMS denied establishing an improper rule-of-thumb “Improvement Standard.”
While an expectation of improvement would be a reasonable criterion to consider when evaluating, for example, a claim in which the goal of treatment is restoring a prior capability, Medicare policy has long recognized that there may also be specific instances where no improvement is expected but skilled care is, nevertheless, required in order to prevent or slow deterioration and maintain a beneficiary at the maximum practicable level of function. For example, in the federal regulations at 42 CFR 409.32(c), the level of care criteria for SNF coverage specify that the “. . . restoration potential of a patient is not the deciding factor in determining whether skilled services are needed. Even if full recovery or medical improvement is not possible, a patient may need skilled services to prevent further deterioration or preserve current capabilities.” The Medicare statute and regulations have never supported the imposition of an “Improvement Standard” rule-of-thumb in determining whether skilled care is required to prevent or slow deterioration in a patient’s condition.
A beneficiary’s lack of restoration potential cannot serve as the basis for denying coverage, without regard to an individualized assessment of the beneficiary’s medical condition and the reasonableness and necessity of the treatment, care, or services in question. Conversely, coverage in this context would not be available in a situation where the beneficiary’s care needs can be addressed safely and effectively through the use of nonskilled personnel. Thus, such coverage depends not on the beneficiary’s restoration potential, but on whether skilled care is required, along with the underlying reasonableness and necessity of the services themselves.
Any Medicare coverage or appeals decisions concerning skilled care coverage must reflect this basic principle. In this context, it is also essential and has always been required that claims for skilled care coverage include sufficient documentation to substantiate clearly that skilled care is required, that it is provided, and that the services themselves are reasonable and necessary, thereby facilitating accurate and appropriate claims adjudication.
The Jimmo Settlement Agreement includes language specifying that “Nothing in this Settlement Agreement modifies, contracts, or expands the existing eligibility requirements for receiving Medicare coverage. Id. The Jimmo Settlement Agreement clarifies that when skilled services are required in order to provide care that is reasonable and necessary to prevent or slow further deterioration, coverage cannot be denied based on the absence of potential for improvement or restoration.
100% of my client’s consumers suffer from MS. MS is a chronic condition that facilitates a consistent decline over a long period of time. 90% of those with MS do not suffer from acute exacerbations after approximately 5 years of their initial diagnosis. They move into a new phase of their disease called secondary progressive where there are no exacerbations but a slow, consistent decline is now the clinical presentation. According to the Jimmo Settlement, there is no requirement that a provider demonstrate recent exacerbation or change of function. This has been litigated and settled. My client’s Medicare audit is in violation of the Jimmo Settlement and must cease, yet the audit must still be defended.
My client’s documents clearly demonstrate that its consumers who all suffer from MS, qualify for skilled therapy based on the Jimmo Settlement Agreement and their physicians’ recommendations. The Jimmo Settlement clearly states that if the therapist determines that skilled nursing is necessary to stop further decline, then, under the Jimmo Settlement, skilled nursing is appropriate.
Now my client is having to defend itself against erroneous allegations that are clearly in violation of the Jimmo Settlement, which is adversely affecting the company financially. It’s amazing that in 2021, my client is defending a right given in a settlement agreement from 2013. Stay proactive!
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:
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.
Hello! And beware the Ides of March, which is today! I am going to write today about the state of audits today. When I say Medicare and Medicaid audits, I mean, RACs, MACs, ZPICs, UPICs, CERTs, TPEs, and OIG investigations from credible allegations of fraud. Without question, the new Biden administration will be concentrating even more on fraud, waste, and abuse germane to Medicare and Medicaid. This means that auditing companies, like Public Consulting Group (“PCG”) and National Government Services (“NGS”) will be busy trying to line their pockets with Medicare dollars. As for the Ides, it is especially troubling in March, especially if you are Julius Caesar. “Et tu, Brute?”
One of the government’s most powerful tool is the federal government’s zealous use of 42 CFR 455.23, which states that “The State Medicaid agency must suspend all Medicaid payments to a provider after the agency determines there is a credible allegation of fraud for which an investigation is pending under the Medicaid program against an individual or entity unless the agency has good cause to not suspend payments or to suspend payment only in part.” (emphasis added). That word – “must” – was revised from “may” in 2011, part of the Affordable Care Act (“ACA”).
A “credible allegation” is defined as an indicia of reliability, which is a low bar. Very low.
Remember back in 2013 when Ed Roche and I were reporting on the New Mexico behavioral health care cluster? To remind you, the State of NM accused 15 BH health care providers, which constituted 87.5% of the BH providers in NM, of credible allegations of fraud after the assistant AG, at the time, Larry Heyeck, had just published a legal article re “Credible Allegations of Fraud.” See blog and blog. Unsurprisingly, the suicide rate and substance abuse skyrocketed. There was even a documentary “The Shake-Up” about the catastrophic events in NM set off by the findings of PCG.
I was the lawyer for the three, largest entities and litigated four administrative appeals. If you recall, for Teambuilders, PCG claimed it owed over $12 million. After litigation, an ALJ decided that Teambuilders owed $836.35. Hilariously, we appealed. While at the time, PCG’s accusations put the company out of business, it has re-opened its doors finally – 8 years later. This is how devastating a regulatory audit can be. But congratulations, Teambuilders, for re-opening.
Federal law mandates that during the appeal of a Medicare audit at the first two levels: the redetermination and reconsideration, that no recoupment occur. However, after the 2nd level and you appeal to the ALJ level, the third level, the government can and will recoup unless you present before a judge and obtain an injunction.
Always expect bumps along the road. I have two chiropractor clients in Indiana. They both received notices of alleged overpayments. They are running a parallel appeal. Whatever we do for one we have to do for the other. You would think that their attorneys’ fees would be similar. But for one company, NGS has preemptively tried to recoup THREE times. We have had to contact NGS’ attorney multiple times to stop the withholds. It’s a computer glitch supposedly. Or it’s the Ides of March!
Happy 55th Medicare! Pres. Biden’s health care policies differ starkly from former Pres. Trump’s. I will discuss some of the key differences. The newest $1.9 trillion COVID bill passed February 27th. President Biden is sending a clear message for health care providers: His agenda includes expanding government-run, health insurance and increase oversight on it. In 2021, Medicare is celebrating its 55th year of providing health insurance. The program was first signed into law in 1965 and began offering coverage in 1966. That first year, 19 million Americans enrolled in Medicare for their health care coverage. As of 2019, more than 61 million Americans were enrolled in the program.
Along with multiple Executive Orders, Pres. Biden is clearly broadening the Affordable Care Act (“ACA”), Medicaid and Medicare programs. Indicating an emphasis on oversight, President Biden chose former California Attorney General Xavier Becerra to lead HHS. Becerra was a prosecutor and plans to bring his prosecutorial efforts to the nation’s health care. President Biden used executive action to reopen enrollment in ACA marketplaces, a step in his broader agenda to bolster the Act with a new optional government health plan.
For example, one of my personal, favorite issues that Pres. Biden will address is parity for Medicare coverage for medically necessary, oral health care. In fact, Medicare coverage extends to the treatment of all microbial infections except for those originating from the teeth or periodontium. There is simply no medical justification for this exclusion, especially in light of the broad agreement among health care providers that such care is integral to the medical management of numerous diseases and medical conditions.
The Biden administration has taken steps to roll back a controversial Trump-era rule that requires Medicaid beneficiaries to work in order to receive coverage. Two weeks ago, CMS sent letters to several states that received approval for a Section 1115 waiver – for Medicaid. CMS said it was beginning a process to determine whether to withdraw the approval. States that received a letter include Arizona, Arkansas, Georgia, Indiana, Nebraska, Ohio, South Carolina, Utah, and Wisconsin. The work requirement waivers that HHS approved at the end of the previous administration’s term may not survive the new presidency.
Post Payment Reviews—Recovery Audit Contractor (“RAC”) audits will increase during the Biden administration. The RAC program was created by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. As we all know, the RACs are responsible for identifying Medicare overpayments and underpayments and for highlighting common billing errors, trends, and other Medicare payment issues. In addition to collecting overpayments, the data generated from RAC audits allows CMS to make changes to prevent improper payments in the future. The RACs are paid on a contingency fee basis and, therefore, only receive payment when recovery is made. This creates overzealous auditors and, many times, inaccurate findings. In 2010, the Obama administration directed federal agencies to increase the use of auditing programs such as the RACs to help protect the integrity of the Medicare program. The RAC program is relatively low cost and high value for CMS. It is likely that the health care industry will see growth in this area under the Biden administration. To that end, the expansion of audits will not only be RAC auditors, but will include increased oversight by MACs, CERTs, UPICs, etc.
Telehealth audits will be a focus for Pres. Biden. With increased use of telehealth due to COVID, comes increased telehealth fraud, allegedly. On September 30, 2020, the inter-agency National Health Care Take Down Initiative announced that it charged hundreds of defendants ostensibly responsible for—among other things—$4.5 billion in false and fraudulent claims relating to telehealth advertisements and services. Unfortunately for telehealth, bad actors are prevalent and will spur on more and more oversight.
Both government-initiated litigation and qui tam suits appear set for continued growth in 2021. Health care fraud and abuse dominated 2020 federal False Claims Act (“FCA”) recoveries, with almost 85 percent of FCA proceeds derived from HHS. The increase of health care enforcement payouts reflects how important government paid health insurance is in America. Becerra’s incoming team is, in any case, expected to generally ramp up law enforcement activities—both to punish health care fraud and abuse and as an exercise of HHS’s policy-making authorities.
With more than $1 billion of FCA payouts in 2020 derived from federal Anti-Kickback Statute (“AKS”) settlements alone, HHS’s heavy reliance on the FCA because it is a strong statute with “big teeth,” i.e., penalties are harsh. For these same reasons, prosecutors and qui tam relators will likely continue to focus their efforts on AKS enforcement in the Biden administration, despite the recent regulatory carveouts from the AKS and an emerging legal challenge from drug manufacturers.
The individual mandate is back in. The last administration got rid of the individual mandate when former Pres. Trump signed the GOP tax bill into law in 2017. Pres. Biden will bring back the penalty for not being covered under health insurance under his plan. Since the individual mandate currently is not federal law, a Biden campaign official said that he would use a combination of Executive Orders to undo the changes.
In an effort to lower the skyrocketing costs of prescription drugs, Pres. Biden’s plan would repeal existing law that currently bans Medicare from negotiating lower prices with drug manufacturers. He would also limit price increases for all brand, biotech and generic drugs and launch prices for drugs that do not have competition.
Consumers would also be able to buy cheaper priced prescription drugs from other countries, which could help mobilize competition. And Biden would terminate their advertising tax break in an effort to also help lower costs.
In all, the Biden administration is expected to expand health care, medical, oral, and telehealth, while simultaneously policing health care providers for aberrant billing practices. My advice for providers: Be cognizant of your billing practices. You have an opportunity with this administration to increase revenue from government-paid services but do so compliantly.