Exclusive Update on Medicare Coverage Determination for Special Stains and IHC Stains by Palmetto and WPS Effective July 14, 2024, two Medicare Administrative Contractors (MACs), Palmetto and WPS, have finalized their Local Coverage Determinations (LCDs) concerning medical necessity guidelines for special stains and immunohistochemical (IHC) stains. These determinations, LCD L36805 (WPS) and LCD L35922 (Palmetto), provide clear and stringent criteria under which Medicare will cover these stains. Key Points of the LCDs: *Conditions for Coverage: 1.Medical Necessity: The special stains and IHC stains must be medically necessary to ensure a complete and accurate diagnosis is reported to the treating physician. 2.Communication and Utilization: The results of the stains must be communicated to and used by the treating physician in the patient's treatment plan. 3.Documentation: The pathologist must document in the pathology report the rationale for performing the additional stains. *Prohibitions and Requirements: -A statement in the pathology report that merely says "IHC confirms the diagnosis" will not be considered sufficient for coverage. -The necessity of the stains must be justified with specific documentation within the surgical pathology report, detailing why the stains were performed and the results obtained. *Specifics of the LCD L36805 (WPS): -This policy emphasizes that reflex templates or pre-orders for special stains and IHC stains before reviewing the routine hematoxylin and eosin (H&E) stain by the pathologist are not considered reasonable and necessary. -Only the pathologist may determine the need for special stains after reviewing the routine H&E stain. -Exceptions include recognized standards of care in certain biopsies and the suspicion of infectious diseases. *Specifics of the LCD L35922 (Palmetto): -Like WPS, Palmetto’s policy requires detailed documentation of the medical necessity for special stains or IHC studies and their results in the pathology report. -The policy delineates scenarios where over-utilization or incorrect billing of these stains may occur, such as the use of pre-orders for special stains without prior review of the H&E stain. Implications for Pathologists and Healthcare Providers These determinations highlight the critical role of pathologists in ensuring that the use of special stains and IHC stains is both necessary and properly documented. Healthcare providers must ensure compliance with these guidelines to secure Medicare coverage for these diagnostic tests. Proper documentation and communication with treating physicians are paramount to adhere to these new standards. For further details, you can review the complete LCDs on the CMS website using the following LCD IDs: L36805 and L35922. #Medicare #Healthcare #Pathology #MedicalNecessity #IHCStains #SpecialStains #Palmetto #WPS
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Meet Victoria Heath, PharmD., BCACP - Clinical Pharmacist for SoNE Healthcare! Tell us about yourself: I attended Western New England University College of Pharmacy and graduated in 2016. I did a residency with WNEU and Walgreens right after graduation. I then became a pharmacy manager for Walgreens for a period of time, but I knew my passion was ambulatory care. I used a grant through the state that allowed me to transition from retail to in patient to then ambulatory care. I created an ambulatory care clinic at what was known as Riverbend- a primary care group -where I offered education and medication management on diabetes, hypertension, asthma and COPD. I helped create a collaborative practice agreement with the practice which still is in effect. With the pandemic, I transitioned from the grant and started working for SoNE Healthcare which broadened my patient practice but still allowed me to have my clinic at Riverbend, now Trinity Health of New England Medical Group. I currently have 3 clinic days where I prescribe and manage patient’s medications for the previously mentioned disease states. In my free time I love to bake, knit, go on walks with my dog and socialize with family and friends. Tell us about your practice setting: I currently work for SoNE Healthcare which is an ACO. We have 3 markets- Springfield, Hartford and Waterbury. I am the Springfield pharmacist. We are contracted with Trinity Health of New England both their hospitals and primary care groups as well as independent practices. My clinic site is in the Massachusetts market, but I do have some offices in Connecticut that I help manage their HEDIS and CMS measures. These include statin use in patients with diabetes and statin use in patients with cardiovascular disease. We also help with pharmacy spend. In my clinic, I have a collaborative practice agreement for diabetes, hypertension, asthma and COPD, hyperlipidemia, heart failure and smoking cessation. Most of my patients are patients with diabetes. I will get referrals from primary care providers within the practice as well as reports SoNE obtains from insurance companies, and I will manage the patient’s disease state. Once the patient has met their goals, they will go back to their provider for future care- this may take on average 6-9 months. When prescribing medications, I always think about cost and is this regimen acceptable to the patient. My clinic is very patient centered- what do they want to get out of meeting/working with me. Why do you love being a pharmacist? I love being a pharmacist [because of] the connection you make with people to help them better understand what is happening in their bodies and create positive health outcomes. #careerdevelopment #opportunity #pharmacistsprovidecare
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CMS October 1 updates to the MDS include significant changes in the medication coding of high-risk drugs. A clear indication for these medications that correlates with a diagnosis must be documented during the 7 day look back period. Implications for SNFs: *Training for nurses *Evaluating and updating documentation practices *Auditing medical records to monitor for compliance Be proactive and prepare now! October 1 will be here before you know it! #Mitig8RiskReveal #Mitig8YourRisk #NursingHomeSafety #HealthcareCompliance #LegalNurseConsultants
The Centers for Medicare & Medicaid Services (CMS) has introduced significant changes regarding medication coding related to certain high-risk drugs that will go into effect on Oct. 1 with the updates to the Minimum Data Set. https://bit.ly/3K6q9Kt
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How to Look Up the Money Your Doctor Is Getting From Big Pharma When doctors instrumentality wealth oregon gifts from pharmaceutical companies those are required by instrumentality to beryllium reported to the U.S. government. But did you cognize there’s a website wherever you tin look up however overmuch wealth immoderate doc successful the U.S. has taken from healthcare companies? It’s wholly escaped and tally by Medicare. Evil’s Michael Emerson connected Working Opposite a Giant, Hairy, Five-Eyed Demon A caller survey from JAMA recovered that 26 of 28 physicians who had fixed endorsements to healthcare products connected the societal media level X had taken astatine slightest 1 outgo from the companies making those products, according to quality outlet STAT connected Thursday. However, astir fractional of the physicians had published nary probe related to the topics they were endorsing. But the website for looking up payments to American doctors isn’t conscionable astir endorsements. It covers payments involving research, speaking fees, and a big of different areas wherever doctors person outgo from companies wrong the healthcare sector. Providers are expected to study immoderate benignant of compensation fixed to doctors, adjacent if it’s conscionable a cupful of java portion the doc and a cause institution typical sermon the latest medications being released. The website is called Open Payments and is tally by the Centers For Medicare and Medicaid Services. And you tin benignant successful the sanction of immoderate doc successful the state to spot their latest data. For example, you tin plug successful immoderate personage doc and spot which companies mightiness beryllium giving them money. Screenshot: OpenPaymentsData.cms.gov Take Dr. Drew, a personage doc whose afloat sanction is Drew Pinsky, a antheral who utilized to beryllium connected mainstream TV each the clip with shows similar Celebrity Rehab With Dr. Drew and Dr. Drew connected Call. The astir caller information for Pinsky is from 2022 and shows that helium made a full of $60,000 successful 5 payments that twelvemonth from Metuchen Pharmaceuticals. Metuchen owns the rights to Stendra, an erectile dysfunction medication, which Pinsky started promoting successful a societal media-driven campaign, according to a property merchandise from 2022. As you tin spot from the screenshot below, the quality of the outgo is listed as, “Compensation for services different than consulting, including serving arsenic module oregon arsenic a talker astatine a venue different than a continuing acquisition program.” Pinsky didn’t instantly reply to a connection sent done his website connected Thursday. Screenshot: OpenPaymentsData.cms.gov To beryllium clear, it’s not needfully incorrect oregon shady erstwhile d...
How to Look Up the Money Your Doctor Is Getting From Big Pharma When doctors instrumentality wealth oregon gifts from pharmaceutical companies those are required by instrumentality to beryllium reported to the U.S. government. But did you cognize there’s a website wherever you tin look up however overmuch wealth immoderate doc successful the U.S. has taken from healthc...
marstopresources.com
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Dear David Cordani and Adam Kautzner, PharmD, On behalf of the Alliance for Aging Research, I am writing to ask you--as leaders of The Cigna Group and Express Scripts--whether your companies are targeting #Medicare providers with letters encouraging "non-medical switching" of a direct oral anticoagulant (DOAC) in older patients with nonvalvular atrial fibrillation (#AFib) and venous thromboembolism (#VTE). A letter we saw from RationalMed®/Cigna to a physician states: "Your older patient is receiving [X drug] based on claims records," and then cites only partial info on the drug from the latest American Geriatrics Society's (AGS) Beers Criteria before encouraging the doc to "make any changes in therapy that you believe are appropriate." As you know, the term "non-medical switching" comes from how this UM practice by payers interferes with clinical decision-making between doctors and patients. Unfortunately, the Centers for Medicare & Medicaid Services (CMS) does not prevent Part D/MA-PD plans from using it to save their already prosperous companies more money. If this is truly happening, the info being sent to providers is incomplete at best and misleading at worst, as well as potentially dangerous for certain beneficiaries. The AGS Beers criteria maintain that "DOACs are thus the preferred choice for anticoagulation for most people with these conditions." Importantly, the most recent American Heart Association/American College of Cardiology/Heart Rhythm Society clinical guidelines recommend DOACs as first-line therapy--although this info is NOT mentioned in the letter. Switching stable older patients off any oral anticoagulant therapy is alarming for those reliant on blood thinners to manage clot risk. A 2022 American Society of Preventive Cardiology survey of respondents taking anticoagulants who were non-medically switched by payers found that a reported 7% of patients had heart attacks, 4% had strokes, and 20% actually stopped taking their blood thinners. These are patients at high risk for deep vein thrombosis, pulmonary embolism, stroke, and heart attack. These insurance letters will also exacerbate health disparities. A 2022 JAMA, Journal of the American Medical Association study looking at 69,000+ patients in the Get With The Guidelines–Atrial Fibrillation registry, found that Black AFib patients experienced significantly higher rates of adverse outcomes than whites at 1 year after hospitalization, including stroke and mortality. I respectfully ask expert clinicians at the Association of Black Cardiologists, Inc. to weigh in here. We ask you to confirm whether or not these letters are being sent, and if they are being sent, to stop this practice immediately. Thank you. Sincerely, Sue Peschin Alliance for Aging Research #health #BeBetterThanThat
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I want to better understand potential impacts of the proposed retro trend adjustment (RTA) ahead of the RPA meeting later this week. “While nephrologists were comfortably aware of the use of the retroactive trend adjustment when entering into CKCC contracts, surprise arose over the magnitude of the reductions,” Keith A. Bellovich, DO, RPA president, told Healio. “These assumptions, using data from years when COVID skewed kidney care utilization, were completely unexpected and 2-3x larger than anticipated.” In the CMS contracting model, nephrology practices agree to take on a higher financial risk when providing patient care, with the hope that shared savings with Medicare after producing better patient outcomes will recoup that investment. [1] Here's an example (for illustrative purposes): • CMS gives a Nephrology Group their proposed benchmark of $10 million in 2022, which means CMS projects the nephrologists will spend $10 million providing care to their kidney patients. • In 2022 the Nephrology Group invests in more staff and services to provide better care to their kidney patients. They improve outcomes for those patients and save money. In the end, the Nephrology Group only spends $9 million on better care for their patients in 2022. • In November 2023, CMS told the Nephrology Group they predicted their 2022 spend incorrectly and they will be applying the retrospective trend adjustment which makes the new benchmark $8 million for 2022. This means that 11 months after the performance year ended the Nephrology Group goes from saving $1 million to increasing costs for patients by $1 million. This impacts their bottom line since they only capture savings after CMS gets its guaranteed taxpayer savings. [2] -- Now, recall the Biden administration's stated goal of bringing all 34 million beneficiaries in traditional Medicare into value-based arrangements by 2030. "Driving accountable care" was one of five strategic objectives laid out in CMMI’s vision-defining white paper in 2021. The Affordable Care Act (ACA) authorized CMMI to launch 54 value-based programs over the past ten years, which now include more than 18 million patients and 200,000 providers. [3] *** My hope is that RPA, ASN and other forums will give the kidney community a place to have these discussions, voice concerns, understand implications, and chart a path forward that's best for patients and the long-term health of value-based kidney care. What do you think? What else should we know, hear, or learn to better understand what's at stake here? #health #innovation #valuebasedcare #vbc -- Sources: [1] https://lnkd.in/ez5wQVVB [2] https://lnkd.in/eKknP6tr [3] https://lnkd.in/esPcVf-w
ASN, RPA: Nephrologists may leave Kidney Care Choices model if CMS issues payment cuts
healio.com
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Medicare Severity DRG (MS-DRG) system The Medicare Severity DRG (MS-DRG) system is a classification system that assigns a diagnosis-related group (DRG) to each patient based on their diagnosis, treatment, and other factors. This system is used by Medicare to determine the reimbursement for inpatient hospital services. MSDRGs are based on the severity of the patient's condition, the complexity of their treatment, and the resources required to provide care. The MSDRG system has several advantages. Firstly, it helps to ensure that Medicare reimbursement is fair and consistent across different hospitals and regions. By categorizing patients into specific groups, it prevents hospitals from being reimbursed at higher rates for treating less severe cases or at lower rates for treating complex cases. This promotes equity and prevents any potential discrepancies in payments. Secondly, the MSDRG system promotes efficiency and quality of care. Hospitals are incentivized to deliver high-quality care in a cost-effective manner since they receive a predetermined amount for each MSDRG. This encourages hospitals to streamline their operations, reduce unnecessary procedures or tests, and focus on evidence-based practices to optimize patient outcomes. Furthermore, the MSDRG system allows for better data analysis and research. By categorizing patients into groups based on their conditions and treatments, researchers and policymakers can study trends, outcomes, and resource utilization patterns. This information is invaluable for identifying areas of improvement, making informed policy decisions, and promoting evidence-based medicine. The classification used to determine the presence and impact of complications and comorbidities on a patient's health condition are in three levels. It is also used in the MS-DRG system to determine the appropriate reimbursement for hospitals and healthcare providers. The three levels are: 1. Major complication and comorbidity (MCC): This level represents patients with severe complications or comorbidities that significantly impact their health condition and require extensive medical intervention. 2. Complication and comorbidity (CC): This level includes patients with less severe complications or comorbidities, which still require medical intervention but not as extensive as those in the MCC category. 3. No complication and comorbidity (without CC/MCC): This level includes patients without any significant complications or comorbidities that require minimal medical intervention and have a lower impact on their overall health condition.
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🌟 New Medicare Billing Codes for PEMGARDA™: Empowering COVID-19 Pre-Exposure Prophylaxis 🌟 Exciting news for healthcare providers! As of March 22, 2024, Centers for Medicare & Medicaid Services (CMS) has introduced two new HCPCS Level II codes for PEMGARDA™, an investigational monoclonal antibody product aimed at COVID-19 pre-exposure prophylaxis. Billing Breakdown: Product Code (Q0224): Injection of pemivibart for pre-exposure prophylaxis in certain adults and adolescents (12 years and older, weighing ≥ 40 kg) with no known SARS-CoV-2 exposure, and moderate-to-severe immune compromise, priced at $6,583.50. Administration Code (M0224): Intravenous infusion of pemivibart for pre-exposure prophylaxis in eligible individuals, including infusion and post-administration monitoring, set at $450 (subject to geographic adjustments). PEMGARDA Details: Comes in a convenient single-dose vial (500 mg/4 mL, 125 mg/mL). Administered as a single intravenous infusion, with potential for repeat dosing every three months. Continued Coverage Post-Public Health Emergency: Despite the conclusion of the public health emergency for COVID-19 in May 11, 2023, Medicare will continue to cover PEMGARDA and its administration under the Part B vaccine benefit for pre-exposure prophylaxis. Importantly, there is no cost-sharing for Medicare beneficiaries receiving PEMGARDA or its administration. Indications for Use: PEMGARDA is authorized for emergency use by the FDA for individuals aged 12 and above, weighing at least 88 pounds, who are not infected with COVID-19, have no recent exposure to the virus, and have moderate to severe immune compromise due to medical conditions or treatments. Prescription Protocol: PEMGARDA may only be prescribed by licensed physicians, advanced practice registered nurses, or physician assistants for individual patients. These new billing codes signify a significant step forward in enhancing access to innovative COVID-19 prevention strategies for vulnerable populations. Stay informed and empowered in your medical coding endeavors!
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This week we’re scheduled to get some clarity on FDA’s Elevidys Accelerated Approval. There are three main categories that the FDA is due to weigh in on – each precedent-setting in its own way: The first is whether the current narrow Elevidys label will be expanded beyond 4- and 5-year-old Duchenne patients. Recall, the EMBARK Confirmatory trial enrolled patients ages 4-7. Sarepta’s sBLA submitted in December ‘23 also included some early subset data from ENVISION (and older supporting data from ENDEAVOR) that could potentially support age expansion. Sarepta has treated patients as old as 25 years old with Elevidys in the context of clinical trials. Sarepta believes their Elevidys label should be age agnostic. The second is whether Elevidys will remain on market with Accelerated Approval or be converted to a full approval, at least for the 4-5 year olds. Recall, whether granted access to the market via accelerated approval or full approval, the price is likely to remain $3.2M. Sarepta does not appear to be discounting or offering outcomes-based agreements or warranties so $3.2M is probably the actual price tag (with Sarepta making minor pricing concessions to distribution channels). Finally, because the sBLA included supporting subset data from ENDEAVOR and ENVISION, Sarepta is asking for removal of the ambulatory requirement that is currently in the Elevidys Accelerated Approval label. Alas, analysts see the evidence for efficacy in non-ambulatory patients as too limited and preliminary to warrant approval. But time will tell. Since back in the Garabedian days, I’ve learned to never bet against Sarepta. If Sarepta gets all that it has asked FDA for, after this week, Elevidys’ will have full approval with a label open to all age Duchenne patients, regardless of ambulatory status. But that scenario is unlikely; the FDA response will probably be more mixed than binary. However, any expansion of label has implications for payers, as more patients from the prevalent Duchenne population would have access immediately. And at $3.2M per patients, insurers, reinsurers and self-insured employers will be watching because...$3.2M here and $3.2M there and pretty soon you’re talking real money. Sarepta has assured the investment and patient community that it is ready to meet product demand, regardless of how the FDA chips fall. So there you have it. We should know by week's end. #sarepta #elevidys #cgt #atmp #acceleratedapproval #reinsurance #duchenne
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Diagnosis-Related Groups (DRGs) are a way to classify hospital cases into groups that are expected to have similar hospital resource use. Developed originally by researchers at Yale University in the 1970s, DRGs are used to standardize the payments to hospitals for similar medical and surgical procedures, ensuring consistency and fairness in hospital compensation across the healthcare system. How DRGs are Defined: DRGs are defined by considering a mix of factors such as: - The primary (and sometimes secondary) diagnosis - Surgical procedures performed - Patient comorbidities and complications - Patient age and sex - Discharge status Each case assigned to a DRG is expected to consume similar levels of hospital resources. Therefore, each DRG has a payment weight assigned to it based on the average resources used to treat patients in that group. How DRGs are Implemented: DRGs are implemented in the hospital billing and insurance reimbursement process through several steps: 1. Patient Classification: When a patient is discharged from the hospital, their diagnoses and procedures performed are coded by medical coders according to the ICD (International Classification of Diseases) codes. 2. DRG Assignment: These codes are then used to assign the case to a DRG. Software applications typically handle this assignment based on the coding and the DRG system rules. 3. Payment Calculation: Each DRG has a predetermined payment weight associated with it, reflecting the expected costliness of care. The base payment rate, specific to the hospital's geographic location or other factors, is multiplied by this weight to determine the total reimbursement amount the hospital will receive from Medicare or other insurers. 4. Quality Adjustments: In some healthcare systems, like in the U.S. under Medicare, payments may be adjusted for factors such as hospital-acquired conditions, readmission rates, and other quality indicators. DRGs encourage hospitals to be more efficient as they receive a fixed amount per case. If a hospital treats a patient for less than the DRG payment, it profits, but if treatment costs exceed the DRG payment, the hospital absorbs the extra costs. This system aims to standardize care and control costs, promoting efficiency and discouraging unnecessary services while maintaining care quality. For further details on the creation and use of DRGs, here are two helpful resources: [MedPAC](https://lnkd.in/eapJKfQ6) provides an overview of hospital acute inpatient services payment system which is closely tied to DRGs, and [CMS](https://lnkd.in/e6yX7HX2) offers insights into the specifics of how these groups are used in Medicare payments.
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Monitoring for adverse medication reactions is a critical aspect of healthcare, ensuring the safety and well-being of patients. It can lead to unnecessary suffering, complications, and even life-threatening situations. This negligence not only jeopardizes patient well-being but also poses potential legal liabilities for healthcare providers and institutions. It's imperative to remember that every medication has the potential to cause adverse effects. Consider this scenario: a patient is prescribed the anticoagulant medication warfarin (coumadin). Warfarin is a blood thinner that prevents and treats clots. It is a high-risk medication that requires close monitoring due to its narrow therapeutic window and potential for severe bleeding complications. If healthcare providers fail to regularly check the patient's international normalized ratio (INR) levels and adjust the warfarin dosage accordingly, the patient could experience a life-threatening bleeding event or a stroke. Furthermore, in the described scenario, instances of nosebleeds and bleeding gums following teeth brushing were noticed in the patient. These are signs of concern for one that is taking a blood thinner. Regrettably, these signs were not recognized by the licensed nursing staff as warranting monitoring, further evaluation, a potential adverse reaction, or side effects related to warfarin. Antipsychotic medications are prescribed to manage several conditions. Among them are dementia, agitation, delirium, and schizophrenia. Some potential side effects of antipsychotic medications are dizziness, sedation, inability to hold still, and blood pressure dropping when one stands or sits up quickly. It was reported in “Evidence and Practice”, that 85% of older patients seen in the emergency room who had fallen had been prescribed an antipsychotic medication. The adverse reactions noted as potential side effects of antipsychotic medications can increase the risk of falls. Oversights of failing to monitor the therapeutic drug levels and failure to monitor for signs of adverse reaction to drugs can prove to be detrimental to the patient's well-being. Failure to monitor for adverse medication reactions are a deviation from the standards of care! In addition to safe administration of medication, it is the duty of the health professional to be aware of the purpose, desired effects, and potential side effects of the medications being administered. By adhering to the standard of practice for monitoring adverse medication reactions, healthcare providers can ensure the safety and well-being of their patients, reduce the risk of harm, and promote optimal health outcomes. #MedicationSafety #PatientSafety #Pharmacovigilance #EthelWills #EWillsLegalNurseConsultants
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