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January 2025 |
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New HIPAA Rule Update Addresses CybersecurityThe message this month is about a new directive by HHS via HIPAA which involves steps to bolster security in the face of the rising number of attacks.
Essentially, the proposed rule would call for health plans, healthcare clearinghouses, and healthcare providers and their business associates, to strengthen their cybersecurity protections in an effort to better secure patients’ PHI.
What are the numbers? According to the Office of Civil Rights (OCR) which oversees HIPAA, there’s been a 102% rise in large breach reports since 2018, with an over 100% increase in patients being affected by breaches; in 2023 alone, it was over 167 million people.
The new rule, if adopted, would provide guidance (or rules) on how entities can better protect PHI. Comments on the proposed rule are being taken until March 7.
Click here for an HHS Fact Sheet.
(Security can’t be taken lightly which is why ADSRCM uses Equinix®, a SOC 1 and 2 certified global leader in cloud hosting services. To date, we’ve never experienced an intrusion, and we employ all the precautions and protections possible to ensure it never happens!)
What we’ll cover:
If you’re a clinical laboratory that bills for a molecular pathology procedure which has no specific code, say hello to your new friend, CPT 81479. Your friend’s nickname is Unlisted Molecular Pathology Procedure, but you can call him UMPP.
You probably have friends with idiosyncrasies. The problem with UMPP is that he has a high denial rate, hovering around 75% to 80%.
Including documentation with claims using CPT 81479 will make UMPP more compatible with payers. And BTW, keep in mind UMPP may need to be introduced in advance to payers in the form of getting a prior authorization before sashaying him into the party.
Documentation may include an overview of the test performed and medical records that have a bearing on the test performed.
One more item for UMPP: the specific gene being tested can’t be just willy-nilly anywhere on the claim. If it’s a Part A UB04 claim, put that gene in block 80. If it’s Part B, the gene goes into box 19 if paper or where appropriately relative on an electronic claim.
Click here for CMS details.
(ADSRCM and our team of laboratory billing experts, along with our automated prior authorizations option, will handle UMPP for you, helping to ensure you don’t get anywhere near the 75% to 80% denial rate mentioned above.)
The Food and Drug Administration (FDA) is being sued now that its Final Rule on Laboratory Developed Tests (LDTs) has been issued which requires laboratories to adhere to the same preapproval and post-marketing requirements of mass-produced tests.
The essence of the FDA’s Final Rule is that they (the FDA) have always had the discretion to enforce legal requirements concerning LDTs.
The crux of the whole thing is this: the FDA hadn’t exercised its authority under the Medical Device Amendments of 1976 because LTDs were initially manufactured by specialized personnel in smaller volumes for local patient populations However, over time, the reach of LDTs has become nationwide and has reached a wider range of patients and patient types. As such, because of the “popularity” of LTDs, the FDA now, by virtue of its Final Rule, may enforce “other applicable legal requirements.”
We said the FDA is being sued, but more specifically, they’re being sued twice. One suit was filed by the ACLA and the other by AMP, although both have been consolidated under ACLA. The basis of each is if laboratories are vulnerable to FDA regulations as per the Final Rule, it would be a tremendous setback for healthcare since laboratory innovation would be severely hindered. There would be billions of dollars in regulatory mandates, and millions of Americans would bear the brunt of this lack of ability for laboratories to produce LDTs.
Another element of the unified case is that the FDA has exceeded its authority, and that Congress hasn’t provided the FDA with the appropriate resources to implement their authority over thousands of testing services.
Besides everything else, the plaintiffs argue that LDTs have already been subject to regulatory requirements under the Clinical Laboratory Improvement Amendments (CLIA) and that even more regulation needed by the FDA would be stifling and to the detriment of US healthcare.
Who will prevail? That’s a TBD
This one involves kickback allegations which will cost the players involved a total of $1.4 million to settle.
Those players include two laboratory marketing people, three healthcare providers, an outpatient clinic, and some assorted others.
The allegations state that kickbacks were paid to the healthcare providers and a clinic for laboratory referrals. The laboratory player was ordered to pay $400,000. The marketing company that allegedly induced doctors into ordering tests by two specific laboratories will pay $140,000.
The three providers and the clinic will pay varying amounts from $63,000 to $228.000.
According to the US Attorney’s Office, these were paid to resolve allegations only, and there’s been no determination of liability yet.
Click here for the press release and all the details.
Here’s a disconcerting stat courtesy of Beckton Dickinson by way of a November Harris Poll: 72% of women in the US have delayed having an OB/GYN visit (more specifically, for cervical cancer screening) for one reason or another, including fear/discomfort and scheduling challenges.
It’s certainly unfortunate that patients are putting off important tests. In turn, it begs an obvious if/then premise: if they are (which really isn’t an “if”), then are laboratories seeing fewer of these types of samples to be tested?
If your laboratory is experiencing a drop in Pap smear testing, this is probably why.
Click here for the BD press release.
While the H5N1 how we made the numbers smaller?) risk is still insignificant for the general population, HHS has issued a risk assessment
More precisely, $185 million has been allocated so that the CDC can best monitor and advise on the local, state, and federal levels.
The idea is to only have “flew” associated with avians.
Click here for the HHS release.
While the H5N1 how we made the numbers smaller? risk is still insignificant for the general population, HHS Of course, your laboratory wants to provide the best and most accurate testing possible. You might also be exploring creative ways to provide new or updated testing. You want top-notch diagnostic equipment. You want the cream of the crop staffing. Essentially, you want it all.
But you also need something else without which none of the above means anything: you need to be paid. If you’re not paid, there’s nothing.
The problem is that getting paid today isn’t easy for laboratories even when they can be paid. Why? Are your claims being transmitted (a) for maximized value, or (b) just for the sake of transmitting them?
As we highlighted last month, the Final Medicare Physician Fee Schedule (MPFS) for 2025 reduces professional rates paid to pathologists by an average of 2.5%, while technical fees paid to pathology labs will fall by approximately 2.7%.
Essentially, you’ll want to ensure that every single claim your laboratory submits is done so for absolutely maximized reimbursement. That you’ll see your denials before they’re submitted so they can be edited first. That eligibility verification and prior authorizations, if needed, are processed in advance. That you get pre-testing out-of-network alerts.
You can waterproof, maximize your laboratory’s revenue, and even help consolidate your in-laboratory staffing, making that maximized revenue so much more significant, assuming you have the tools available for doing both.
(ADSRCM submits laboratory claims for optimized reimbursements. Clients have access to our AI-driven patient responsibility estimator, helping to control your patients’ A/R by avoiding unnecessary surprises on their part. All the other features mentioned are available, including our outsourced team of laboratory billing, EDI, work-flow, and analytics experts. Alternatively, MedicsPremier from ADS is available if an in-laboratory platform is preferred.)
Have questions? Simply click on the orange button to learn more about how you can drive maximized revenue and productivity for your laboratory with ADSRCM or about the MedicsPremier platform if in-laboratory automation is preferred!
"We strive to provide our newsletters with news of the current month, not the previous month. Feedback or comments on our newsletters/content are greatly appreciated. Please opine by emailing marc.klar@adsc.com or by calling me at 973-931-7516. We’d love to hear from you."
-- Marc E. Klar, Vice President, Marketing, ADSRCM
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