The Centers for Medicare & Medicaid Services (CMS) provides companies with the option of applying for a New Technology Add-on Payment, which can cover up to 50% of the cost of the new device or technology, or 50% of the overall incremental costs associated with the new technology costs in in-patient settings.
Full Answer
Is my medical device covered by Medicare?
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How are medical devices reimbursed?
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Is medical equipment covered by Medicare?
There is a variety of equipment covered by Medicare. Most medical equipment covered by Medicare can be described as Safety Devices, Therapy Equipment, or Mobility Devices. Household safety equipment can be covered under Durable Medical Equipment. Items include lift bars, shower chairs, bumpers for sharp edges, commode chairs, and guard rails.
What medical supplies are covered by Medicare?
The term DME is defined as equipment which:
- Can withstand repeated use; i.e., could normally be rented and used by successive patients;
- Is primarily and customarily used to serve a medical purpose;
- Generally is not useful to a person in the absence of illness or injury; and,
- Is appropriate for use in a patient’s home.
How do providers get reimbursed by Medicare?
Traditional Medicare reimbursements When an individual has traditional Medicare, they will generally never see a bill from a healthcare provider. Instead, the law states that providers must send the claim directly to Medicare. Medicare then reimburses the medical costs directly to the service provider.
Does Medicare offer reimbursement?
The Centers for Medicare & Medicaid Services (CMS) sets reimbursement rates for Medicare providers and generally pays them according to approved guidelines such as the CMS Physician Fee Schedule. There may be occasions when you need to pay for medical services at the time of service and file for reimbursement.
Which is a combination Medicare and Medicaid option that combines medical social?
What are dual health plans? Dual health plans are designed just for people who have both Medicaid and Medicare. They're a special type of Medicare Part C (Medicare Advantage) plan. Dual health plans combine hospital, medical and prescription drug coverage.
Does Medicare pay for used equipment?
It includes a variety of items, such as walkers, wheelchairs, and oxygen tanks. Medicare usually covers DME if the equipment: Is durable, meaning it is able to withstand repeated use.
How do reimbursements work in healthcare?
Healthcare reimbursement describes the payment that your hospital, healthcare provider, diagnostic facility, or other healthcare providers receive for giving you a medical service. Often, your health insurer or a government payer covers the cost of all or part of your healthcare.
What does Medicare reimbursement mean?
Medicare reimbursement is the process by which a doctor or health facility receives funds for providing medical services to a Medicare beneficiary. However, Medicare enrollees may also need to file claims for reimbursement if they receive care from a provider that does not accept assignment.
When a patient is covered through Medicare and Medicaid which coverage is primary?
Medicaid can provide secondary insurance: For services covered by Medicare and Medicaid (such as doctors' visits, hospital care, home care, and skilled nursing facility care), Medicare is the primary payer. Medicaid is the payer of last resort, meaning it always pays last.
Can you have Medicare and Medicaid at the same time?
Yes. A person can be eligible for both Medicaid and Medicare and receive benefits from both programs at the same time.
What plan provides both Medicare and Medicaid coverage to certain eligible beneficiaries?
Some people qualify for both Medicare and Medicaid and are called “dual eligibles.” If you have Medicare and full Medicaid coverage, most of your health care costs are likely covered. You can get your Medicare coverage through Original Medicare or a Medicare Advantage Plan.
What is Medicare DME?
DME is reusable medical equipment, like walkers, wheelchairs, or hospital beds. If I have Medicare, can I get DME? Anyone who has Medicare Part B (Medical Insurance) can get DME as long as the equipment is medically necessary.
Does Medicare pay for walkers and shower chairs?
Q: Will Medicare cover the cost of wheelchairs and walkers? A: Yes. Medicare Part B covers a portion of the cost for medically-necessary wheelchairs, walkers and other in-home medical equipment.
What is meant by durable medical equipment?
Equipment and supplies ordered by a health care provider for everyday or extended use. Coverage for DME may include: oxygen equipment, wheelchairs, crutches or blood testing strips for diabetics.
Understand applicable reimbursement codes for your medical device
Medical coding is a standardized, alphanumeric sequence used to describe medical devices and how they’re used by providers. While there are multiple types of coding systems the most essential kind you need to know for your reimbursement strategy is CPT codes.
Build strategic relationships with payers involved in reimbursement process
Even with the perfect product and deep comprehension of all applicable codes for your medical device, reimbursement can still fall outside your control. Once you reach the coverage and payment portions of reimbursement, things tend to hinge on the payer.
Execute your medical device reimbursement strategy and recoup your investment in record speed
Like any regulatory strategy, a reimbursement strategy requires a commitment to strong record-keeping and documentation of the proof required for reimbursement payout.
Reimbursement Landscape in the USA
The purpose of this step is to understand the current reimbursement environment in the USA, relevant for your medical device, and develop an initial reimbursement strategy. To do so, we will:
Reimbursement Planning for US Decision Makers
According to the conclusions in the Reimbursement Landscape, we devise the plan for developing the required evidence for US decision makers, such as the Centers for Medicare & Medicaid Services (CMS), the American Medical Association (AMA) or health technology assessment (HTA) entities such as the Blue Cross and Blue Shield Association's Technology Evaluation Center (TEC).
Implementation
Depending upon the existence, or the lack of, applicable reimbursement mechanisms (as identified in the Reimbursement Landscape step), we will conduct the following activities:
How often is Medicare's reimbursement rate updated?
Like its billing guidelines, Medicare’s reimbursement rates are updated each year in the annual final rule release. (Fun fact: The final rule is officially called the Physician Fee Schedule, as it determines the fees Medicare will pay providers for certain services.)
How often does Medicare update its billing policies?
Medicare updates its billing policies each year following the release of the annual final rule. The final rule often introduces and explains coding and billing changes (e.g., when to use the KX modifier or the new X modifiers) and reporting programs (e.g., the implementation of the Merit-Based Incentive Payment System (MIPS) and the death of functional limitation reporting (FLR) ). There are many billing rules that participating Medicare providers must adhere to—and I can’t cover them all here. However, some of the most prominent and often-talked about documentation and/or billing policies are:
How are Medicare and Medicaid similar?
Medicare and Medicaid do share one monumentally important similarity: both programs are rapidly shifting toward value-based payment models. In other words, CMS wants to encourage providers (and other payers) to focus on quality of care over quantity of care the only way they know how: by fiddling with reimbursement rates. In 2017, for instance, CMS kicked off the Part B-exclusive Merit-Based Incentive Payment System (MIPS), and it has consistently encouraged—and required—more and more providers to participate in MIPS each year. Additionally, in April 2019, CMS and the HHS announced new Medicare payment programs called Primary Care First (PCF) and Direct Contracting (DC). These programs are intended to improve healthcare quality—and they’re “specifically designed to encourage state Medicaid programs and commercial payers to adopt similar approaches,” said HHS Secretary Alex Azar.
What are the different Medicare plans?
The Medicare program is split into four different coverage plans: parts A, B, C, and D. According to the Department of Health and Human Services (HHS), Part A covers “inpatient care in a hospital or skilled nursing facility (following a hospital stay), some home health care and hospice care.” Medicare Part B covers other medically necessary costs that aren’t covered by Part A, like outpatient physician and physical therapy services as well as other supplies and medical care. Part C, often referred to as Medicare Advantage, is provided by private companies that have partnered up with Medicare to offer all-in-one inpatient and outpatient coverage—sometimes with prescription plans bundled in. And finally, Part D is a prescription drug plan that’s provided by private companies.
How many people use medicaid?
In 2019, 75.8 million Americans rely on this program.
When was Medicare established?
Medicare. Established in 1965 —and now overseen by the Centers for Medicare and Medicaid Services (CMS)—the Medicare program was designed to help our country’s elderly population pay their inpatient and outpatient medical bills.
What forms do you need to file a claim in Mississippi?
Part C billing form requirements vary based on payer and state: Mississippi, for instance, requires the use of a specific, state-mandated form.
How to buy equipment for Medicare Part B?
Here are the steps you need to take to purchase equipment: Go to an in-person doctor visit, where your doctor will write an order for the DME. Take the order to a Medicare-approved DME supplier.
How long does Medicare pay for rental equipment?
A Medicare-approved supplier will know if you can buy an item. Original Medicare pays 80 percent of the monthly costs for 13 months of rental. If you still need the equipment after this time, depending on the type of product, you may be allowed to own it.
What is a Medigap plan?
Medigap. Medigap is supplemental insurance you can buy to help pay coinsurance and copayment costs not covered by original Medicare. Since Medicare Part B pays 80 percent of covered DME costs, a Medigap plan may be a good option to help pay some, or all, of the balance of your DME products.
What is DME covered by Medicare?
Eligible DME costs are covered under Medicare Part B from an approved provider who accepts assignment. Regardless of whether you rent or buy equipment, Medicare pays 80 percent of costs after you meet your deductible. You then pay 20 percent coinsurance and your monthly premium costs.
How long does Medicare pay for oxygen?
Medicare pays 80 percent of the rental fees for the oxygen and any supplies for 36 months. You must still pay the 20 percent coinsurance each month.
What does Medicare Part A cover?
Part A. Medicare Part A covers hospital stays, hospice care, and limited home health and skilled nursing facility care. If DME supplies are required during your stay at any of these facilities, Medicare expects the provider to pay for these costs based on your Part A benefits.
What is DME in Medicare?
Millions of Medicare beneficiaries rely on durable medical equipment (DME) every day. This includes canes, nebulizers, blood sugar monitors, and other medically necessary supplies to improve quality of life and maintain independence at home.
What is included in a demand letter for Medicare?
The demand letter also includes information on administrative appeal rights. For demands issued directly to beneficiaries, Medicare will take the beneficiary’s reasonable procurement costs (e.g., attorney fees and expenses) into consideration when determining its demand amount.
What is Medicare beneficiary?
The Medicare beneficiary when the beneficiary has obtained a settlement, judgment, award or other payment. The liability insurer (including a self-insured entity), no-fault insurer, or workers’ compensation (WC) entity when that insurer or WC entity has ongoing responsibility for medicals (ORM). For ORM, there may be multiple recoveries ...
Who has the right to appeal a demand letter?
This means that if the demand letter is directed to the beneficiary, the beneficiary has the right to appeal. If the demand letter is directed to the liability insurer, no-fault insurer or WC entity, that entity has the right to appeal.
Can CMS issue more than one demand letter?
For ORM, there may be multiple recoveries to account for the period of ORM, which means that CMS may issue more than one demand letter. When Medicare is notified of a settlement, judgment, award, or other payment, including ORM, the recovery contractor will perform a search of Medicare paid claims history.
What is the ACA? What are the new payment models?
The Affordable Care Act (or ACA) enacted in 2010, which aims at a shift from fee-for-service to value-based models, has led to the emergence of some new payment models such as pay for performance, shared savings, and bundled payments. Medical device companies find it more difficult to market their products due to increased scrutiny, increased coverage by public payers, and CMS taking into account cost perspective while evaluating medical devices for coverage. Additionally, an excise tax of 2.3% on sales of all medical devices has also impacted the profitability and the research and development (or R&D) spending of medical device companies.
What is the US healthcare system?
US healthcare payment systems are based on a fee-for-service model and consist of public payers such as Medicare and Medicaid as well as private third-party payers such as insurance companies. To find out more about the insurance industry, read An investor’s guide to the insurance business.
What is the first step a medical device company must take as it seeks market access for procedures using its technology?
The first step a medical device company must take as it seeks market access for procedures using its technology is to secure some type of coding mechanism , whether it be a Current Procedural Terminology (CPT) code, a level II Healthcare Common Procedure Coding System (HCPCS) code or utilizing an existing procedure code.
Why is coding important?
Coding is vital to ensure that physicians and other providers, certified coders, and payers all receive uniform information about the procedure. In order to justify investing millions of dollars in new equipment, hospitals want to see the potential for a device to be used to perform procedures at scale.
Does Medicare benefit seniors?
While Medicare reimbursement directly benefits seniors across the country , its impact is far-reaching beyond this population.
What is IDE in Medicare?
Instructions: Medicare Coverage Related to Investigational Device Exemption (IDE) Studies. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) allowed Medicare payment of the routine costs of care furnished to Medicare beneficiaries in certain categories of Investigational Device Exemption (IDE) studies.
How long does it take CMS to review a study?
CMS will review each complete submission within approximately thirty days. Study sponsors that have been disapproved may submit revised protocols. Upon request, CMS can meet with study sponsors/applicants for coverage and provide feedback about favorable study protocol adjustments to help improve the likelihood of approval upon resubmission.
Do study sponsors have to submit protocol to CMS?
Study sponsors do not have to submit the protocol to CMS if the participating study investigator sites have already received approval from their MAC. Study sponsors should continue to follow the process established by the MAC for any site additions or protocol changes. Click on this link to find a list of MACs: ...
Coding
- Coding is the link between coverage and payment. Codes are based on a standard alphanumeric language that describes services provided to patients. This “language of insurers” permits automated claims processing and review. Coding provides a standard mechanism for payers an…
Coverage
- Coeverage refers to a payors decision to provide program benefits for a specific product or service. This coverage is usually condition on FDA clearance, the product not deemed experimental or investigational, the use of the product is medical necessary, and the use of the product is appropriate for the patient in the treatment setting. Medicare and private payers instit…
Payment
- Payment is the transfer of money from payer to provider for the provision of health care services. Payment amounts for procedures or medical devices does not often depend on a manufacturer’s price for a product reflect its perceived clinical value. Importantly, payment mechanisms will vary by setting (e.g. hospital, ambulatory surgery setting, physician office) and may be paid separatel…
The Importance of Knowing Who The Payor Is
- Patient demographics and clinical indication for the device can affect which payors may have a great influence on a technologies reimbursement strategy (e.g. devices with use primarily for elderly patients would be influenced to a greater degree by Medicare policy decisions). Understanding which payors represent what percentage of the patient groups your p…
Next Steps
- Understanding how each of the above payors make coverage decisions and use existing coding systems to pay providers is essential towards determining how to approach a reimbursement strategy for a new medical technology. These are topics which will be explored in this continuing series of blog posts.