The 340B drug program is a topic that needs daily updates. It seems that something is happening constantly. Like a prime time soap opera or The Bachelor, the 340B program is all the talk at the water cooler. From lawsuits to legislation to executive orders – there is no way of knowing the outcome, so we all wait with bated breath to watch who will hold the final rose.
On Tuesday, July 17, 2018, the metaphoric guillotine fell on the American Hospital Association (AHA) and on hospitals across the country. The Court of Appeals (COA) dismissed AHA’s lawsuit.
On November 1, 2017, the US Department of Health and Human Services released a Final Rule implementing a payment reduction for most covered outpatient drugs billed to Medicare by 340B-participating hospitals from the current Average Sales Price (ASP) plus 6% rate to ASP minus 22.5%, which represents a payment cut of almost 30%.
Effective January 1, 2018, the 30% slash in reimbursement rates became reality, but only for locations physically connected to participating hospitals. CMS is expected to broaden the 30% reduction to all 340B-participating entities in the near future.
What is the 340B drug program? The easiest explanation for the 340B program is that government insurance, Medicare and Medicaid, do not want to pay full price for medicine. In an effort to reduce costs of drugs for the government payors, the government requires that all drug companies enter into a rebate agreement with the Secretary of the Department of Health and Human Services (HHS) as a precondition for coverage of their drugs by Medicaid and Medicare Part B. If a drug manufacturer wants its drug to be prescribed to Medicare and Medicaid patients, then it must pay rebates.
The American Hospital Association (“AHA”) filed for an injunction last year requesting that the US District Court enjoin CMS from implementing the 340B payment reduction. On the merits, AHA argues that the HHS’s near-30% rate reduction constitutes an improper exercise of its statutory rate-setting authority.
The US District Court did not reach an opinion on the merits; it dismissed the case, issued December 29, 2017, based on lack of subject matter jurisdiction. The District Court found that: Whenever a provider challenges HHS, there is only one potential source of subject matter jurisdiction—42 U.S.C. § 405(g). The Medicare Act places strict limits on the jurisdiction of federal courts to decide ‘any claims arising under’ the Act.
The Supreme Court has defined two elements that a plaintiff must establish in order to satisfy § 405(g). First, there is a non-waivable, jurisdictional requirement that a claim for benefits shall have been “presented” to the Secretary. Without presentment, there is no jurisdiction.
The second element is a waivable requirement to exhaust administrative remedies. I call this legal doctrine the Monopoly requirement. Do not pass go. Go directly to jail. Do not collect $200. Unlike the first element, however, a plaintiff may be excused from this obligation when, for example, exhaustion would be futile. Together, § 405(g)’s two elements serve the practical purpose of preventing premature interference with agency processes, so that the agency may function efficiently and so that it may have an opportunity to correct its own errors, to afford the parties and the courts the benefit of its experience and expertise, and to compile a record which is adequate for judicial review. However, there are ways around these obsolete legal doctrines in order to hold a state agency liable for adverse decisions.
Following the Dec. 29, 2017, order by the District Court, which dismissed the lawsuit on jurisdictional grounds, the plaintiffs (AHA) appealed to the U.S. Court of Appeals (COA), which promptly granted AHA’s request for an expedited appeal schedule.
In their brief, AHA contends that the District Court erred in dismissing their action as premature and that their continued actual damages following the Jan. 1 payment reduction’s effective date weighs heavily in favor of preliminary injunctive relief. More specifically, AHA argues that 30% reduction is causing irreparable injury to the plaintiffs “by jeopardizing essential programs and services provided to their communities and the vulnerable, poor and other underserved populations, such as oncology, dialysis, and immediate stroke treatment services.”
By contrast, the government’s brief rests primarily on jurisdictional arguments, specifically that: (1) the Medicare Act precludes judicial review of rate-setting activities by HHS; and (2) the District Court was correct that no jurisdiction exists.
Oral arguments in this appeal were May 4, 2018.
AHA posted in its newsletter that the COA seemed most interested in whether Medicare law precludes judicial review of CMS’ rule implementing the cuts. AHA says it hopes a ruling will be reached in the case sometime this summer.
In a completely different case, the DC District Court is contemplating a request to toll the time to file a Section 340B appeal.
AHA v. Azar, a case about RAC audits and the Medicare appeal backlog. During a March 22, 2018, hearing, the COA asked AHA to submit specific proposals that AHA wishes the COA to impose and why current procedures are insufficient. It was filed June 22, 2018.
In it proposal, AHA pointed out that HHS is needlessly causing hospitals to file thousands of protective appeals by refusing to toll the time for hospitals to file appeals arising out of the reduction in reimbursement that certain 340B hospitals. In order to avoid potential arguments from the government that 340B hospitals that do not administratively appeal the legality of a reduced rate will be time barred from seeking recovery if the court holds that the reduction in payments is unlawful, AHA proposed that the Secretary agree to toll the deadline for such appeals until resolution of the 340B litigation—an arrangement that would preserve the 340B hospitals’ right to full reimbursement in the event the 340B litigation is not successful. HHS has refused to toll the time, meaning that Section 340B hospitals will have to protect their interests in the interim by filing thousands upon thousands of additional claim appeals, which will add thousands upon thousands of more appeals to the current ALJ-level backlog.
In a unanimous decision, three judges from the COA sided with HHS and ruled the hospitals’ suit was filed prematurely because hospitals had not formally filed claims with HHS because they were not yet experiencing cuts.
Basically, what the judges are saying is that you cannot ask for relief before the adverse action occurs. Even though the hospitals knew the 30% rate reduction would be implemented January 1, 2018, they had to wait until the pain was felt before they could ask for relief.
The lawsuit was not dismissed based on the doctrine of exhaustion of administrative remedies. The Decision noted that in some cases plaintiffs might be justified in seeking judicial review before they have exhausted their administrative remedies, but that wouldn’t be the solution here.
Hindsight is always 20-20. I read the 11 page decision. But I believe that AHA failed in two ways that may have changed the outcome: (1) Nowhere in the decision does it appear that the attorneys for AHA argued that the subject matter jurisdiction issue was collateral to the merits; and (2) The lawsuit was filed pre-January 1, 2018, but AHA could have amended its complaint after January 1, 2018, to show injury and argue that its comments were rejected (final decision) by the rule being implemented.
But, hey, we will never know.
CMS unveils new rural healthcare strategy via telehealth.
The Centers for Medicare & Medicaid Services (CMS) wants to reduce hospital readmissions and unnecessary ER visits with its newly unveiled Rural Health Strategy.
Currently, there are significant barriers to accessing telehealth. While physicians and providers have to answer to their respective healthcare boards within the states in which they are licensed, if you provide telemedicine, you are held accountable and ordered to follow the federal rules and regulations (of which there are many!) – and the rules and regulations of every state in which you provide services. For example, say Dr. Hyde resides in New York and provides medication management via telehealth. Patient Jekyll resides in New Jersey. Dr. Hyde must comply with all rules and regulations of the federal government, New York, and New Jersey.
Currently, 48 state medical boards, plus those of Washington, D.C., Puerto Rico, and the Virgin Islands, require that physicians engaging in telemedicine be licensed in the state in which a patient resides. Fifteen state boards issue a special purpose license, telemedicine license or certificate, or license to practice medicine across state lines to allow for the practice of telemedicine. There are 18 States that only allow Medicaid recipients to receive telemedicine services. One state requires only private insurance companies to reimburse for services provided through telemedicine. Twenty-eight states, plus D.C., require both private insurance companies and Medicaid to cover telemedicine services to the same extent as face-to-face consultations.
As you can see, telehealth can leave hospitals and providers wondering whether they took a left at Albuquerque.
Getting paid for telemedicine has been an issue for many hospitals and medical providers – not only in rural areas, but in all areas. However, according to CMS, rural hospitals and providers feel the pain more acutely. We certainly hope that the progress CMS initially achieves with rural providers and telehealth will percolate into cities and across the nation.
The absolute top barrier to providing and getting reimbursed for telehealth is the cross-state licensure issue, and according to CMS’s Rural Health Strategy, the agency is seeking to reduce the administrative and financial burdens.
Through interviews with providers and hospitals across the country and many informal forums, CMS has pinpointed eight methods to increase the use of telehealth:
- Improving reimbursement
- Adapting and improving quality measures and reporting
- Improving access to services and providers
- Improving service delivery and payment models
- Engaging consumers
- Recruiting, training, and retaining the workforce
- Leveraging partnerships/resources
- Improving affordability and accessibility of insurance options
What this new Rural Health Strategy tells me, as a healthcare attorney and avid “keeper of the watchtower” germane to all things Medicare and Medicaid, is that the current barriers to telehealth may come tumbling down. Obviously, CMS does not have the legal authority to change the Code of Federal Regulations, which now requires that telehealth physicians be licensed in the state in which a patient resides, but CMS has enough clout, when it comes to Medicare and Medicaid, to make Congress listen.
My crystal ball prediction? Easier and more telehealth is in everyone’s future.
*My blog was published on RACMonitor on June 7, 2018.
Last week, (May 22nd) the Center for Medicare and Medicaid Services (CMS) unveiled a new, streamlined appeal process aimed at decreasing the massive Medicare appeal backlog. CMS is hopeful that providers, like you, will choose to settle your Medicare appeal cases instead continuing the litigious dispute. Remember, currently, the backlog at the third level of Medicare appeals, the administrative law judge (ALJ) level, is approximately 5 – 8 years (I will use 8 years for the purpose of this blog). Recoupment can legally begin after level two, so many providers go out of business waiting to be heard at the third level. See blog.
The new “settlement conference facilitation” (SCF) process will allow CMS to make a settlement offer and providers have seven days to accept or proceed with the longer-lasting route. I have a strong sense that, if litigated, a judge would find forcing the decision between accepting a quick settlement versus enduring an 8-year waiting-period to present before an ALJ, coercion. But, for now, it is A choice other than the 8-year wait-period (as long as the provider met the eligibility requirements, see below).
To initiate said SCF process, a provider would have to submit a request in writing to CMS. CMS would then have 15 days to reply. If the agency chooses to take part, a settlement conference would occur within four weeks. Like that underlined part? I read the SCF process as saying, even if the provider qualifies for such process, CMS still has the authority to refuse to participate. Which begs the question, why have a process that does not have to be followed?
The SCF process is directed toward sizable providers with older and more substantial, alleged overpayments. In order to play, you must meet the criteria to enter the game. Here are the eligibility requirements:
In fiscal year (FY) 2016, more than 1.2 billion Medicare fee-for-service claims were processed. Over 119 million claims (or 9.7%) were denied. Of the denied claims, 3.5 million (2.9% of all Medicare denied claims) were appealed. That seems surprisingly low to me. But many claims are denied to Medicare recipients, who would be less inclined to appeal. For example, my grandma would not hire an attorney to appeal a denied claim; it would be fiscally illogical. However, a hospital that is accused of $10 million in alleged overpayments will hire an attorney.
In recent years, the Office of Medicare Hearings and Appeals (OMHA) and the Council have received more appeals than they can process within the statutorily-defined time frames. From FY 2010 through FY 2015, OMHA experienced an overall 442% increase in the number of appeals received annually. As a result, as of the end of FY 2016, 658,307 appeals were waiting to be adjudicated by OMHA. Under current resource levels (and without any additional appeals), it would take eight years for OMHA and ten years for the Council to process their respective backlogs.
The SCF “Fix”
While I do not believe that the creation of the SCF process is a fix, it is a concerted step in the right direction. Being that it was just enacted, we do not have any trial results. So many things on paper look good, but when implemented in real life end so poorly. For example, the Titanic.
Considering that there is a court case that found Health and Human Services (HHS) in violation of federal regulations that require level three Medicare appeals to be adjudicated in 90 days, instead of 8 years and HHS failed to follow the Order, claiming impossibility, at least HHS is making baby steps. See blog. At some point, Congress is going to have to increase funding to hire additional ALJs. I can only assume that the Hospital Association and American Medical Association are lobbying to get this action, but you know what they say about assuming…
As broached above, I do not like the fact that – if you do not accept whatever amount CMS proposes as settlement – BOOM – negotiation is over and you suffer the 8-year backlog time, undergo recoupments (that may not be appropriate), and incur tens of thousands of attorneys’ fees to continue litigation. Literally, CMS has no incentive to settle and you have every reason to settle. The only incentive for CMS to settle that I can fathom is that CMS wants this SCF program to be a success for the jury of public opinion, therefore, will try to get a high rate of success. But do not fool yourself.
You are the beggar and CMS is the King.
The Centers for Medicare & Medicaid Services (CMS) posted its December 2017 list of health care services that the Recovery Audit Contractors (RACs) will be auditing. As usual, home health is on the chopping block. So are durable medical equipment providers. For whatever reason, it seems that home health, DME, behavioral health care, and dentists are on the top of the lists for audits, at least in my experience.
Number one RAC audit issue:
Home Health: Medical Necessity and Documentation Review
To be eligible for Medicare home health services, a beneficiary must have Medicare Part A and/or Part B per Section 1814 (a)(2)(C) and Section 1835 (a)(2)(A) of the Social Security Act:
- Be confined to the home;
- Need skilled services;
- Be under the care of a physician;
- Receive services under a plan of care established and reviewed by a physician; and
- Have had a face-to-face encounter with a physician or allowed Non-Physician Practitioner (NPP).
Medical necessity is the top audited issue in home health. Auditors also love to compare the service notes to the independent assessment. Watch it if you fail to do one activity of daily living (ADL). Watch it if you do too many ADLs out of the kindness of your heart. Deviations from the independent assessment is a no-no to auditors, even if you are going above and beyond to be sweet. And never use purple ink!
Number two RAC audit issue:
Annual Wellness Visits (AWV) billed within 12 months of the Initial Preventative Physical Examination (IPPE) or Annual Wellness Examination (AWV)
This is a simple mathematical calculation. Has exactly 12 months passed? To the day….yes, they are that technical. 365 days from a visit on January 7, 2018 (my birthday, as an example) would be January 7, 2019. Schedule any AWV January 8, 2019, or beyond.
Number three RAC audit issue:
Ventilators Subject to DWO requirements on or after January 1, 2016
This will be an assessment of whether ventilators are medically necessary. Seriously? Who gets a ventilator who does not need one? I was thinking the other day, “Self? I want a ventilator.”
Number four RAC audit issue:
This will be an assessment of whether cardiac pacemakers are medically necessary. Seriously? Who gets a pacemaker who does not need one? I was thinking the other day, “Self? I want a pacemaker.” Hospitals are not the only providers targets for this audit. Ambulatory surgical centers (ASCs) also will be a target. As patient care continues its transition to the outpatient setting, ASCs have quickly grown in popularity as a high-quality, cost-effective alternative to hospital-based outpatient care. In turn, the number and types of services offered in the ASC setting have significantly expanded, including pacemakers.
Number five RAC audit issue:
Evaluation and Management (E/M) Same Day as Dialysis
Except when reported with modifier 25, payment for certain evaluation and management services is bundled into the payment for dialysis services 90935, 90937, 90945, and 90947
It is important to remember that if you receive a notice of overpayment, you need to appeal immediately. The first level of appeal is redetermination, usually with the Medicare Administrative Contractor (MAC). Medicare will not begin overpayment collection of debts (or will cease collections that have started) when it receives notice that you requested a Medicare contractor redetermination (first level of appeal).
See blog for full explanation of Medicare provider appeals.
Centers for Medicare & Medicaid Services (CMS) created a new page on its Recovery Audit Contractor (RAC) website entitled “Provider Resources.” CMS indicated that it will post on this page any new issues the RACs have proposed to audit and are being evaluated by CMS for approval. It is like a glimpse behind the curtain to see the Great Oz. This is a fantastic resource for providers. CMS posts a list of review topics that have been proposed, but not yet approved, for RACs to review. You can see the future!
Topics proposed for future audits:
- Inpatient Rehabilitation Facility (IRF) Stays: Meeting Requirements to be considered Reasonable and Necessary;
- Respiratory Assistive Devices: Meeting Requirements to be considered Reasonable and Necessary;
- Excessive or Insufficient Drugs and Biologicals Units Billed;
- E&M Codes billed within a Procedure Code with a “0” Day Global Period (Endoscopies or some minor surgical procedures);
- E&M Codes billed within a Procedure Code with a “10” Day Global Period (other minor procedures);
- E&M Codes billed within a Procedure Code with a “90” Day Global Period (major surgeries);
Over the next few weeks, intermittently (along with other blog posts), I will tackle these, and other, hot RAC audit topics.
IRFs are under fire in North Carolina, South Carolina, Virginia, and West Virginia!
Many patients with conditions like stroke or brain injury, who need an intensive medical rehabilitation program, are transferred to an inpatient rehabilitation facility.
Palmetto, one of Medicare’s MACs, conducted a prepayment review of IRFs in these four states. The results were bleak, indeed, and will, most likely, spur more audits of IRFs in the future. If you are a Medicare provider within Palmetto’s catchment area, then you know that Palmetto conducts a lot of targeted prepayment review. Here is a map of the MAC jurisdictions:
You can see that Palmetto manages Medicare for North Carolina, South Carolina, West Virginia, and Virginia. So Palmetto’s prepayment review covered its entire catchment area.
North Carolina Results A total of 28 claims were reviewed with 19 of the claims either completely or partially denied. The total dollars reviewed was $593,174.60 of which $416,483.42 was denied, resulting in a charge denial rate of 70.2 percent.
South Carolina Results A total of 24 claims were reviewed with 16 of the claims either completely or partially denied. The total dollars reviewed was $484,742.68 of which $325,266.43 was denied, resulting in a charge denial rate of 67.1 percent.
West Virginia Results
A total of two claims were reviewed with two of the claims either completely or partially denied. The total dollars reviewed was $32,506.21 of which $32,506.21 was denied, resulting in a charge denial rate of 100 percent.
A total of 39 claims were reviewed with 31 of the claims either completely or partially denied. The total dollars reviewed was $810,913.83 of which $629,118.08 was denied, resulting in a charge denial rate of 77.6 percent.
In all 4 states, the most cited denial code was “5J504,” which means that “need for service/item not medically and reasonably necessary.” Subjective, right? I mean, who is better at determining medical necessity: (1) the treating physician who actually performs services and conducts the physical; or (2) a utilization auditor without an MD and who as never rendered medical services on the particular consumer? I see it all the time…former dental hygienists review the medical records of dentists and determine that no medial necessity exists…
When it comes to IRF Stays, what is reasonable and necessary?
According to Medicare policy and CMS guidance, the documentation in the patient’s IRF
medical record must demonstrate a reasonable expectation that the following criteria were met at the time of admission to the IRF. The patient must:
- Require active and ongoing intervention of multiple therapy disciplines (Physical
Therapy [PT], Occupational Therapy [OT], Speech-Language Pathology [SLP], or
prosthetics/orthotics), at least one of which must be PT or OT;
- Require an intensive rehabilitation therapy program, generally consisting of:
◦ 3 hours of therapy per day at least 5 days per week; or
◦ In certain well-documented cases, at least 15 hours of intensive rehabilitation
therapy within a 7-consecutive day period, beginning with the date of admission;
- Reasonably be expected to actively participate in, and benefit significantly
from, the intensive rehabilitation therapy program (the patient’s condition and
functional status are such that the patient can reasonably be expected to make
measurable improvement, expected to be made within a prescribed period of time
and as a result of the intensive rehabilitation therapy program, that will be of practical value to improve the patient’s functional capacity or adaptation to impairments);
- Require physician supervision by a rehabilitation physician, with face-to-face
visits at least 3 days per week to assess the patient both medically and functionally
and to modify the course of treatment as needed; and
- Require an intensive and coordinated interdisciplinary team approach to the
delivery of rehabilitative care.
Did you notice how often the word “generally” or “reasonably” was used? Because the standard for an IRF stay is subjective. In fact, I would wager a bet that if I reviewed the same documentation as the Palmetto auditors did, that I could make a legal argument that the opposite conclusion should have been drawn. I do it all the time. This is the reason that so many audits are easily overturned…they are subjective!
Therefore, when you get an audit result, such as the ones referenced above:
APPEAL! APPEAL! APPEAL!
EHR Incentive Payments: If the Practice is Accepting Them, There Better Be a Legal Assignment Contract!
Under the Medicare EHR incentive program, CMS makes incentive payments to individual providers, not to practices or groups. The same is true for Medicaid. According to CMS, the incentive payment is based on the provider’s meaningful use of the EHRs and does not constitute reimbursement for the expenses incurred in establishing EHRs. Prior to actual receipt of an incentive payment, a recipient may assign the payment to a third party, typically, the practice group of which the recipient is a member.
This is a question of equity. Legally, the incentive payments are made to physicians not practice groups. But if the facility bears the burden of the price tag of the computer software, which price tags are not nominal, shouldn’t the facility receive the incentive payments? CMS has made it clear that the incentive payments are not intended to subsidize the price of the software program and updates. Instead, the incentive payments are intended to reward the use of such computer software.
The facilities, generally, pay for the EHR incentive program software programs. Some programs can be as high as $50,000/month. And updated regulatory compliance is not guaranteed. See blog. Plus, the practice group can be held liable for non-compliance issues found in the EHR technology. If the facility is audited and any non-compliance is under-covered, most physicians will be indemnified by the facility for any alleged overpayment, and the facility will be on the hook for any alleged overpayment (depending on the employment relationship). This increased burden on the practice group is why many physicians assign their incentive payments to the facilities. But it has to be done in a legally compliant manner.
Recently, however, I have been contacted by multiple health care facilities which have accepted the EHR incentive payments on behalf of its employed physicians, but did not have adequate, legal assignment contracts to receive the EHR incentives on behalf of the providers. These facilities relied on old, outdated, generic, employment contracts as the basis for the facilities accepting these payments on behalf of the physicians. Not having appropriate assignment contracts with the physicians can make the facilities liable to the physicians for the money accepted on their behalf.
Generic employee contracts that simply state that the facility can bill for and receive reimbursements on behalf of the physicians do not constitute adequate legal authority to accept EHR incentive payments on behalf of physician-employees.
Facilities, in order to legally accept the incentive payments on behalf of their employee-physicians must (1) determine whether their physicians are eligible professionals; and (2) execute a legally binding assignment contract.
Eligible Professionals (“EPs”) must first determine whether they are exactly that – eligible professionals.
Eligible professionals under the Medicare EHR Incentive Program include:
- Doctor of medicine or osteopathy
- Doctor of dental surgery or dental medicine
- Doctor of podiatry
- Doctor of optometry
Who is an Eligible Professional under the Medicaid EHR Incentive Program?
Eligible professionals under the Medicaid EHR Incentive Program include:
- Physicians (primarily doctors of medicine and doctors of osteopathy)
- Nurse practitioner
- Certified nurse-midwife
- Physician assistant who furnishes services in a Federally Qualified Health Center or Rural Health Clinic that is led by a physician assistant.
To qualify for an incentive payment under the Medicaid EHR Incentive Program, an eligible professional must meet one of the following criteria:
- Have a minimum 30% Medicaid patient volume*
- Have a minimum 20% Medicaid patient volume, and is a pediatrician*
- Practice predominantly in a Federally Qualified Health Center or Rural Health Center and have a minimum 30% patient volume attributable to needy individuals
* Children’s Health Insurance Program (CHIP) patients do not count toward the Medicaid patient volume criteria.
Eligible for Both Programs?
Eligible professionals eligible for both the Medicare and Medicaid EHR Incentive Programs must choose which incentive program they wish to participate in when they register. Before 2015, an EP may switch programs only once after the first incentive payment is initiated. Most EPs will maximize their incentive payments by participating in the Medicaid EHR Incentive Program.
EPs can switch programs as often as they desire–until they receive their first payment. After receiving their first payment, they may only switch once between programs prior to 2015.
If you are part of a practice, each eligible professional may qualify for an incentive payment if each eligible professional successfully demonstrates meaningful use of certified EHR technology. Each eligible professional is only eligible for one incentive payment per year, regardless of how many practices or locations at which he or she provide services.
Hospital-based eligible professionals are not eligible for incentive payments. An eligible professional is considered hospital-based if 90% or more of his or her services are performed in a hospital inpatient (Place Of Service code 21) or emergency room (Place Of Service code 23) setting.
What language needs to be included in any assignment contracts?
A recent study by the American Hospital Association (AHA) found federal programs, including meaningful use, have cost health systems and post-acute care (PAC) providers nearly $39 billion a year. Small practices in particular have been hit hard by the added costs and administrative burden brought on by changing regulations. Studies have shown that small, specialty, non-hospital, facilities have carried the brunt of the financial burden for the EHR requirements.
Under the Medicaid incentive program, an EP may reassign incentive payments to “an entity promoting the adoption of certified EHR technology.” This term is defined as:
State-designated entities that are promoting the adoption of certified EHR technology by enabling oversight of the business, operational and legal issues involved in the adoption and implementation of certified EHR technology or by enabling the exchange and use of electronic clinical and administrative data between participating providers, in a secure manner, including maintaining the physical and organizational relationship integral to the adoption of certified EHR technology by eligible providers.
The Assignment Contract
At a minimum, the assignment language should address the following issues:
(1) Is the EP assigning all or a portion of the incentive payments to the facility? Be specific.
(2) Be clear on whether the facility or the EP must furnish the documentation necessary to establish meaningful use each year. In other words, denote who will be entering the data into the CMS or Medicaid website.
(3) Indicate whether the EP will consult with the facility in order to determine which incentive program will yield the higher possible payments – or – whether the decision rests with the facility.
(4) The assignment language should state, accurately, whether the facility expects to be designated as an “entity promoting the adoption of certified EHR technology.”
(5) The contract should state, accurately, whether there is or will be a valid contractual arrangement allowing the facility to bill for the EP’s services. Basically, if there is already an employment contract in place, this assignment contract can act as an addendum or exhibit to the original employment contract.
(6) Define the term of assignment with a start date and an end date.
Only after the the facility determines that the physicians are eligible to receive the EHR incentive payments AND a valid assignment contract is executed, can the facility legally accept the incentive payments on behalf of its physicians. If the facility accepts the incentive payments and the physicians are not eligible, the facility will owe money to the government. If the facility accepts the incentive payments without an assignment contract, the physicians could demand the payments from the practice.
Interestingly, how OIG and who OIG targets for audits is much more transparent than one would think. OIG tells you in advance (if you know where to look).
Prior to June 2017, the Office of Inspector General’s (OIG) OIG updated its public-facing Work Plan to reflect those adjustments once or twice each year. In order to enhance transparency around OIG’s continuous work planning efforts, effective June 15, 2017, OIG began updating its Work Plan website monthly.
Why is this important? I will even take it a step further…why is this information crucial for health care providers, such as you?
These monthly reports provide you with notice as to whether the type of provider you are will be on the radar for Medicare and Medicaid audits. And the notice provided is substantial. For example, in October 2017, OIG announced that it will investigate and audit specialty drug coverage and reimbursement in Medicaid – watch out pharmacies!!! But the notice also states that these audits of pharmacies for speciality drug coverage will not begin until 2019. So, pharmacies, you have over a year to ensure compliance with your records. Now don’t get me wrong… you should constantly self audit and ensure regulatory compliance. Notwithstanding, pharmacies are given a significant warning that – come 2019 – your speciality drug coverage programs better be spic and span.
Another provider type that will be on the radar – bariatric surgeons. Medicare Parts A and B cover certain bariatric procedures if the beneficiary has (1) a body mass index of 35 or higher, (2) at least one comorbidity related to obesity, and (3) been previously unsuccessful with medical treatment for obesity. Treatments for obesity alone are not covered. Bariatric surgeons, however, get a bit less lead time. Audits for bariatric surgeons are scheduled to start in 2018. Considering that 2018 is little more than a month away, this information is less helpful. The OIG Work Plans do not specific enough to name a month in which the audits will begin…just sometime in 2018.
Where do you find such information? On the OIG Work Plan website. Click here. Once you are on the website, you will see the title at the top, “Work Plan.” Directly under the title are the “clickable” subjects: Recently Added | Active Work Plan Items | Work Plan Archive. Pick one and read.
You will see that CMS is not the only agency that OIG audits. It also audits the Food and Drug Administration and the Office of the Secretary, for example. But we are concerned with the audits of CMS.
Other targeted providers types coming up:
- Security of Certified Electronic Health Record Technology Under Meaningful Use
- States’ Collection of Rebates on Physician-Administered Drugs
- States’ Collection of Rebates for Drugs Dispensed to Medicaid MCO Enrollees
- Adult Day Health Care Services
- Oversight of States’ Medicaid Information Systems Security Controls
- States’ MCO Medicaid Drug Claims
- Incorrect Medical Assistance Days Claimed by Hospitals
- Selected Inpatient and Outpatient Billing Requirements
And the list goes on and on…
Do not think that if your health care provider type is not listed on the OIG website that you are safe from audits. As we all know, OIG is not the only entity that conducts regulatory audits. The States and its contracted vendors also audit, as well as the RACs, MICs, MACs, CERTs…
Never forget that whatever entity audits you, YOU HAVE APPEAL RIGHTS!
What is scarier than Pennywise, Annabelle, and Jigsaw combined? Getting sued for an EHR program mistake and getting audited for EHR eligibility when the money is already spent (most likely, on the EHR programs).
Without question, EHR programs have many amazing qualities. These programs save practices time and money and allow them to communicate instantly with insurers, hospitals, and referring physicians. Medical history has never been so easy to get, which can improve quality of care.
However, recently, there have been a few audits of EHR programs that have caused some bloodcurdling concerns and of which providers need to be aware of creepy cobwebs with the EHR programs and the incentive programs.
- According to multiple studies, EHR has been linked to patient injuries, which can result in medical malpractice issues; and
- In an audit by OIG, CMS was found to have inappropriately paid $729.4 million (12 percent of the total) in incentive payments to providers who did not meet meaningful use requirements, which means that CMS may be auditing providers who accepted the EHR incentive payments in the near future.
Since the implementation of the Health Information Technology for Economic and Clinical Health Act, which rewards providers with incentive payments to utilize electronic health record (EHR) computer programs, EHR use has skyrocketed. Providers who accept Medicare are even more incentivized to implement EHR programs because not using EHR programs lead to penalties.
I. Possible Liability Due to EHR Programs
A recent study by the The Doctors’ Company (TDC) found that the use of EHR has contributed to a number of patient injuries over the last 10 years. The study highlights why it is so important to have processes in place for back-up, cross-checking, and auditing the documentation in your EHRs.
Without question, the federal government pushed for physicians and hospitals to implement EHR programs quickly. Now 80% of physician practices use EHR programs. 90% of hospitals use EHR programs. But the federal government did not create EHR standards when it mandated the use of the programs. This resulted in vastly inconsistent EHR programs. These programs, for the most part, were not created by health care workers. The people who know whether the EHR programs work in real life – the providers – haven’t transformed the EHR programs into better programs based on reality. The programs are “take it or leave it” models created in a vacuum. This only makes sense because providers don’t write computer code, and the EHR technology is extremely esoteric. A revision to an EHR program probably takes an act of wizardry. Revitalizing the current EHR programs to be better suited to real life could take years.
There are always unanticipated consequences when new technology is implemented – didn’t we all learn this from the NCTracks implementation debacle? Now that was gruesome!
TDC study found that EHR programs may place more liability on the provider-users than pre-electronic databases.
The study states the following:
“In our study of 66 EHR-related claims from July 2014 through December 2016, we found that 50 percent of these claims were caused by system factors such as failure of drug or clinical decision support alerts and 58 percent of claims were caused by user factors such as copying and pasting progress notes.
This study was an update to our first analysis of EHR-related claims, a review of 97 claims that closed from January 2007 through June 2014.”
Another study published by the Journal of Patient Health studied more than 300,000 cases. Although it found that less than 1% of the total (248 cases) involved technology mistakes, more than 80% of those suits alleged harms of medium to intense severity. The researchers stressed that the 248 claims represented the “tip of an iceberg” because the vast majority of EHR-related cases, even those involving serious harm, never generate lawsuits.
Of those 248 claims that may have been the result of EHR-related mistakes, 31% were medication errors. For example, a transcription error in entering the data from a handwritten note. Diagnostic errors contributed to 28% of the claims. Inability to access records in an emergency setting accounted for another 31%. But systems aren’t entirely to blame. User error — such as data entry and copy-and-paste mistakes and alert fatigue — is also a big problem, showing up in 58% of the claims reviewed. Boo!
- Avoid copying and pasting; beware of templates.
- Do not just assume the EHR technology is correct. Cross check.
- Self audit
II. Possible Audit Exposure for Accepting EHR Incentive Payments
Not only do providers need to be careful in using the EHR technology, but if you did attest to Medicare or Medicaid EHR incentive programs, you may be audited.
In June 2017, the Office of Inspector General (OIG) audited CMS and its EHR incentive program. OIG found that “CMS did not always make EHR incentive payments to EPs [eligible professionals] in accordance with Federal requirements. On the basis of [OIG’s] sample results, [OIG] estimated that CMS inappropriately paid $729.4 million (12 percent of the total) in incentive payments to EPs who did not meet meaningful use requirements. These errors occurred because sampled EPs did not maintain support for their attestations. Furthermore, CMS conducted minimal documentation reviews, leaving the self-attestations of the EHR program vulnerable to abuse and misuse of Federal funds.”
OIG also found that CMS made EHR incentive payments totaling $2.3 million that were not in accordance with the program-year payment requirements when EPs switched between Medicare and Medicaid incentive programs.
OIG recommended that CMS review provider incentive payments to determine which providers did not meet meaningful use requirements and recover the estimated $729,424,395.
What this means for you (if you attested to EHR incentive payments) –
Be prepared for an audit.
If you are a physician practice, make sure that you have the legally adequate assignment contracts allowing you to collect incentive payments on behalf of your physicians. A general employment contract will , generally, not suffice.
Double check that your EHR program was deemed certified. Do not just take the salesperson’s word for it. You can check whether your EHR program is certified here.
If you accepted Medicaid EHR incentive payments be sure that you met all eligibility requirements and that you have the documentation to prove it. Same with Medicare. These two programs had different eligibility qualifications.
Following these tips can save you from a spine-tingling trick from Pennywise!
The Center for Medicare and Medicaid Services (CMS) announced the expansion of Targeted Probe and Educate (TPE) audits. At first glance, this appears to be fantastic news coming on the heels of so much craziness at Health and Human Services (HHS). We have former-HHS Secretary Price flying our tax dollars all over. Dr. Don Wright stepping up as our new Secretary. The Medicare appeal backlog fiasco. The repeal and replace Obamacare bomb. Amidst all this tomfoolery, health care providers are still serving Medicare and Medicaid patients, reimbursement rates are in the toilet, which drives down quality and incentivizes providers to not accept Medicare or Medicaid (especially Caid), and providers are undergoing “Audit Alphabet Soup.” I actually had a client tell me that he receives audit letters requesting documents and money every single week from a plethora of different organizations.
So when CMS announced that it was broadening its TPE audits, it was a sigh of relief for many providers. But will TPE audits be the benign beasts they are purporting to be?
What is a TPE audit? (And – Can We Have Anymore Acronyms…PLEASE!)
CMS says that TPE audits are benevolent. CMS’ rhetoric indicates that these audits should not cause the toner to run out from overuse. CMS states that TPE audits will involve “the review of 20-40 claims per provider, per item or service, per round, for a total of up to three rounds of review.” See CMS Announcement. The idea behind the TPE audits (supposedly) is education, not recoupments. CMS states that “After each round, providers are offered individualized education based on the results of their reviews. This program began as a pilot in one MAC jurisdiction in June 2016 and was expanded to three additional MAC jurisdictions in July 2017. As a result of the successes demonstrated during the pilot, including an increase in the acceptance of provider education as well as a decrease in appealed claims decisions, CMS has decided to expand to all MAC jurisdictions later in 2017.” – And “later in 2017” has arrived. These TPE audits are currently being conducted nationwide.
Below is CMS’ vision for a TPE audit:
Clear? As mud?
The chart does not indicate how long the provider will have to submit records or how quickly the TPE auditors will review the documents for compliance. But it appears to me that getting through Round 3 could take a year (this is a guess based on allowing the provider 30 days to gather the records and allowing the TPE auditor 30 days to review).
Although the audit is purportedly benign and less burdensome, a TPE audit could take a whole year or more. Whether the audit reviews one claim or 20, having to undergo an audit of any size for a year is burdensome on a provider. In fact, I have seen many companies having to hire staff dedicated to responding to audits. And here is the problem with that – there aren’t many people who understand Medicare/caid medical billing. Providers beware – if you rely on an independent biller or an electronic medical records program, they better be accurate. Otherwise the buck stops with your NPI number.
Going back to CMS’ chart (above), notice where all the “yeses” go. As in, if the provider is found compliant , during any round, all the yeses point to “Discontinue for at least 12 months.” I am sure that CMS thought it was doing providers a favor, but what that tells me is the TPE audit will return after 12 months! If the provider is found compliant, the audit is not concluded. In fact, according to the chart, the only end results are (1) a referral to CMS for possible further action; or (2) continued TPE audits after 12 months. “Further action” could include 100% prepayment review, extrapolation, referral to a Recovery Auditor, or other action. Where is the outcome that the provider receives an A+ and is left alone??
CMS states that “Providers/suppliers may be removed from the review process after any of the three rounds of probe review, if they demonstrate low error rates or sufficient improvement in error rates, as determined by CMS.”
I just feel as though that word “may” should be “will.” It’s amazing how one word could change the entire process.
Durable Medical Equipment (DME) providers across the country are walking around with large, red and white bullseyes on their backs. Starting back in March 2017, the RAC audits began targeting DME and home health and hospice. DME providers also have to undergo audits by the Comprehensive Error Rate Testing Program (CERT).
The RAC for Jurisdiction 5, Performant Recovery, is a national company contracted to perform Recovery Audit Contractor (RAC) audits of durable medical equipment, prosthetic, orthotic and supplies (DMEPOS) claims as well as home health and hospice claims. Medicare Part B covers medically necessary DME. The following are the RAC regions:
Region 1 – Performant Recovery, Inc.
Region 2 – Cotiviti, LLC
Region 3 – Cotiviti, LLC
Region 4 – HMS Federal Solutions
Region 5 – Performant Recovery, Inc.
As you can see from the above map, we are in Region 3. The country is broken up into four regions. But, wait, you say, you said that Performant Recovery is performing RAC audits in region 5 – where is region 5?
Region 5 is the whole country.
The Centers for Medicare and Medicaid (CMS) has contracted with Performant Recovery to audit DME and home health and hospice across the whole country.
DME and home health and hospice providers – There is nowhere to hide. If you provide equipment or services within the blue area, region 5, you are a target for a RAC audit.
What are some common findings in a RAC audit for DME?
Without question, the most common finding in a RAC or CERT audit is “insufficient documentation.” The problem is that “insufficient documentation” is nebulous, at best, and absolutely incorrect, at worst. This error is by auditors if they cannot conclude that the billed services were actually provided, were provided at the level billed, and/or were medically necessary. An infuriating discovery was when I was defending a DME RAC audit and learned that the “real” reason for the denial of a claim was that no one went to the consumers door, knocked on it, and verified that a wheelchair had, in fact, been delivered. In-person verification of delivery is not a requirement, nor should it be. Such a burdensome requirement would unduly prejudice DME companies. Yes, you need to be able to show a signed and dated delivery slip, but you do not have to go to the consumer’s house and snap a selfie with the consumer and the piece of equipment.
Another common target for RAC audits is oxygen tubing, oxygen stands/racks, portable liquid oxygen systems, and oxygen concentrators. RAC auditors mainly look for medical necessity for oxygen equipment. Hospital beds/accessories are also a frequent find in a RAC audit. A high use of hospital beds/accessories codes can enlarge the target on your back.
Another recurrent issue that the RAC auditors cite is billing for bundled services separately. Medicare does not make separate payment for DME provider when a beneficiary is in a covered inpatient stay. RAC auditors check whether suppliers are inappropriately receiving separate DME payment when the beneficiary is in a covered inpatient stay. Suppliers can’t bill for DME items used by the patient prior to the patient’s discharge from the hospital. Medicare doesn’t allow separate billing for surgical dressings, urological supplies, or ostomy supplies provided in the hospital because reimbursement for them is wrapped into the Part A payment. This prohibition applies even if the item is worn home by the patient when leaving the hospital.
As always, documentation of the face to face encounter and the prescription are also important.
You can find the federal regulation for DME documentation at 42 CFR 410.38 – “Durable medical equipment: Scope and conditions.”
Once you receive an alleged overpayment, know your rights! Appeal, appeal, appeal!! The Medicare appeal process can be found here.