September 14, 2021

PBM Trade Association Sues Over Transparency Rules

As the federal government continues rolling out new laws and regulations aimed at increasing price transparency in the health care industry, one group is fighting back: pharmacy benefit managers.

The Pharmaceutical Care Management Association, a trade association for PBMs, has sued the Department of Health and Human Services, Internal Revenue Service and Department of Labor, all of which were instrumental in rolling out transparency regulations in 2020, which took effect Jan. 1, 2021.

The rules specifically require health plans (including PBMs) and health insurers to disclose on their websites their in-network negotiated rates, billed charges and allowed amounts paid for out-of-network providers, and the negotiated rate and historical net price for prescription drugs.

PBMs were included in the transparency rules because numerous reports have found that some of them rely on opaque contracts with pharmacies and drug companies, and that they allegedly fail to pass on rebates and lower drug prices they negotiate to their enrollees.

The lawsuit comes as PBMs are feeling the heat over their practices. At least seven states and the District of Columbia are investigating them, mainly focusing on whether they fully disclose the details of their business and whether they receive overpayments under state contracts.

Also, attorneys general in four states have sued PBMs, mostly alleging that they misled state-run Medicare programs about pharmacy-related costs.

What the PBMs are saying

The PBMs allege in their lawsuit that the rule will not benefit consumers because their knowing what the contracted drug prices are won’t have an effect on them as there are no actions they can take knowing this information.

The trade association said: “The rule offers consumers no actionable information because net prescription drug prices are not charged to consumers and never appear on a bill.” Instead, the information will likely confuse consumers, it alleges.

The trade body in its court filing said PBMs maintain that their business model hinges on their ability to negotiate confidentially and keep the details of their manufacturer contracts as trade secrets that are not available to other drug manufacturers or otherwise disclosed to the public.

“Confidentiality, in turn, allows PBMs to bargain from a position of strength to reduce drug prices,” it wrote. “Government-enforced information sharing will raise costs by reducing PBMs’ ability to negotiate deeper discounts on drug prices.

“The regulation threatens to drive up the total drug price ultimately borne by health plans, taxpayers and consumers by advantaging drug manufacturers in negotiations over price concessions,” it added.

August 4, 2021

Rules Allowing Mid-Year Health Plan, FSA Changes Will Sunset

A temporary rule that allowed covered employees to make mid-year election changes to their health plans and revisit how much they set aside into their flexible spending accounts (FSAs) will sunset at the end of the year.

The rules gave employers the option to allow their employees to make changes to their health plans, including choosing a new offering, but it did not require that they allow them to make these changes.

The more relaxed rules were the result of provisions in the Consolidated Appropriations Act, 2021, which was signed into law in December 2020 by President Trump, and subsequent regulatory guidance by the IRS.

In response to the COVID-19 pandemic, the IRS liberalized the rules for cafeteria plan mid-year election changes for health plans and FSAs in the 2021 plan year. During 2021, employers may permit employees to make election changes without affecting their status. The rules that were relaxed:

  • Allow employees who had declined group health insurance for the 2021 plan year to sign up for coverage.
  • Allow employees who have enrolled in one health plan option under their group health plan to change to another plan (such as switching insurance carriers or opting for a silver plan instead of a bronze plan).
  • For health FSAs, allow participants to enroll mid-year, increase or decrease their annual contribution amount, or pull out of the plan altogether and stop contributing.
  • For plan years ending in 2020 and 2021, employers are permitted to modify their health FSAs to include a grace period of up to 12 months to spend unused funds from the prior policy year.
  • Allow for a higher carryover amount than the typical $500.

But, all plans that take effect on or after Jan. 1, 2022 will revert to the old rules that bar mid-year election changes and limit the grace period for spending unused FSA funds to just two and half months after the end of the prior policy year.

The takeaway

The rules coming to an end will only affect those employers who opted to allow their employees to make changes to their health plan choices and/or their FSAs. If you didn’t make this move, there is nothing you need to do.

If you did permit your staff to make these mid-year changes, you will need to communicate to them as soon as possible and before and during open enrollment that mid-year changes will not be possible in 2022.

When telling them about the rules change, make sure to inform them of the permanent rules and when they take effect again.

Also, if you extended the grace period and/or the carryover amount for FSAs, inform them that the carryover grace period will revert to two and half months and that the maximum carryover amount will revert to $500.

June 29, 2021

Employer Medical Costs Expected to Rise 6.5% in 2022

As this year sees increased health care spending due to pent-up demand after many people delayed medical procedures in 2020, a new report by PricewaterhouseCoopers (PwC) predicts employer medical costs will rise 6.5% in 2022.

Last year was the first time that medical costs decreased, thanks to the COVID-19 pandemic keeping people from going to the doctor for many ailments and delaying necessary medical procedures. The annual cost of health care for a family of four was $26,078 in 2020, 4.2% lower than the year prior, according to a separate report by global insurer Milliman.

Some influencing trends that PwC predicts for 2022 include:

Drug spending — The report predicts that costly cell and gene therapies will only increase in number as the Food and Drug Administration continues approving new drugs. The use of so called “biosimilars,” which are cheaper versions of branded biologic medicines, has increased, which is expected to result in $104 billion in savings between 2020 and 2024.

The report notes that employers are covering more of the increased costs and insurance on average covers a larger share of prescription drug prices than it did 10 years ago. At the same time, enrollees’ shares have leveled off during that time.

Surprise billing — The No Surprises Act, which addresses surges in billing, takes effect on Jan. 1, 2022. One analysis predicts it will reduce premiums by up to 1% due to “smaller payments to providers.”

On the other hand, other analysts say the law will result in higher spending as costs shift from the consumer to the payer or employer. Specifically, the law bars out-of-network providers from billing patients for more than they would be charged by in-network providers (ground ambulance services are not covered under the law).

Continued spending on deferred treatments — The report describes a “COVID-19 hangover” in 2022 as people who deferred care during the pandemic return to get treatment.

“During the first six months of the pandemic, people with employer-based insurance most commonly deferred their annual preventive visits, and they were also likely to report delaying routine visits for chronic illnesses and laboratory tests or screenings,” the PwC report states. “As such, care deferred during the pandemic that comes back in 2022 may be higher acuity and cost than it would have been in 2020.” 

The report also notes that mental health, substance abuse and overall public health worsened during the pandemic.

Telehealth drives more utilization — The pandemic accelerated the health care sector’s investments in telehealth and virtual care, which had the effect of increasing patients’ access to care. It also introduced new tools to help patients, which has increased utilization of medical services.

Cost deflators

There are also some ongoing trends and factors that are counterbalancing some health care cost increases.

 More use of lower-cost care — Fewer people have been going to emergency rooms for ailments that do not require urgent care. Instead, they’ve been using telehealth services and going to retail clinics and alternative care sites for many run-of-the-mill ailments.

The report found that use of retail health clinics increased by 40% last year during the lockdowns in March and April, and urgent care center usage grew by 18%. During that same period, emergency room visits plunged 42%.

PwC estimates a 10% decrease in unnecessary emergency room visits could save employers nearly $900 million a year.

More health care for less —Health systems can reduce costs with new ways of operating; for instance, using remote work models, especially for administrative staff. They can also increase efficiency, reduce costs and boost revenue through process automation and cloud technology. 

In PwC’s 2021 survey, 31% of provider executives said that adopting automation and artificial intelligence for tasks previously performed by employees is a top priority.

 An increase in at-home testing — The report concludes that people are warming up to at-home, do-it-yourself testing. According to a survey but the Human Resources Institute, 88% of people with employer-sponsored health plans said they would be open to using an at-home COVID-19 test.

Hospitals get more efficient — Like many employers, the health care industry also sent many people to work remotely. Now many are making those arrangements permanent or introducing hybrid schedules for their staff, which can translate into reducing what hospitals pay for space.

UW Medicine in Seattle shrank its office space as a result of permanent shifts to working from home, and is saving $150,000 per month after it terminated leases on two office buildings used by its IT department.

June 15, 2021

Tackling the Group Health Employee Premium Burden

As the labor market tightens and businesses struggle to attract new talent, many companies are starting to boost their employee benefit offerings, particularly voluntary benefits.

But besides added benefit choices, what many employees want is relief from continually increasing health premiums as well as more options to choose from for their health insurance.

Group health insurance cost inflation has been averaging about 5% annually over the past few years and many employees have been put into plans that may have kept their share of premiums steady (like high-deductible health plans, or HDHPs), but which have instead increased their out-of-pocket costs. 

As we exit the ravages of the COVID-19 pandemic, more workers are looking to their employers to give them some relief from spiraling premiums and health care expenses. Here are a few things you can do.

Reduce the employee’s share of premium

You could choose to pay for a higher percentage of the premium, which would reduce their monthly contributions. If that’s not feasible, one tactic that can end up saving you and your employees money is offering to either pay a certain portion of the premium if they choose a silver plan, or pay for the entire premium for employees who choose bronze plans.

The trade-off for the workers who choose the latter option is having no premiums, but more out-of-pocket expenses when they use health care services.

But if you are thinking about taking this route, please discuss it with us first as it’s best to crunch the numbers to see how cost-effective it would be for you. 

The majority of workers contribute a portion of the premium for their coverage. According to the Kaiser Family Foundation “2020 Employer Health Benefits Survey”:

  • The average U.S. worker contributes 17% of the group health plan premium for single coverage, and 27% of the premium for family coverage.
  • Workers in small firms contribute on average 35% for family coverage.
  • Workers in large firms contribute on average 24% for family coverage.
  • Workers in both small and large firms contribute on average 17% for single coverage.

The other option is to just offer to pay for a greater percentage of the premium across the board on the policies you do offer. Obviously, that comes with added expense. But it’s not a strictly financial decision, as a more generous benefits package can have the added advantage of helping you keep key talent and generate employee loyalty.

Offer different types of plans

This can be a win-win for everyone. Younger, healthy employees that do not use health care services often can opt for an HDHP, which features a lower up-front premium in return for the participant having to spend more out of pocket for services they access. But if someone doesn’t use medical services often, this type of plan may the right and most cost-effective option.

On the other hand, for older workers or those who see the doctor more often or have health issues, they may be more inclined to go with a preferred provider organization (PPO) to pay more for a higher premium in exchange for lower out-of-pocket costs over the year.

For the fifth year in a row, the percentage of companies that offer high-deductible plans as the sole option will decline in 2021, according to a survey of large employers by the National Business Group on Health. That may be a continuation of a trend, but the pandemic has also put an emphasis on improved employee benefits.

Here’s a breakdown of the kinds of small group plans across the country in 2020, according to Kaiser:

  • PPOs covered 47% of workers.
  • HDHPs covered 31%.
  • Health maintenance organizations (HMOs) covered 13%.
  • Point-of-sale plans covered 8%.
  • Conventional (indemnity) plans covered 1%.

Hire more employees

The more people you have in your group health plan, the more the risk is spread around, which can yield lower premiums. 

If you divide the risk amount of a small group of workers compared with a large pool, the law of averages dictates that the insurer will pay less in claims per worker in the larger pool.

In other words, the more employees you hire, the less risk for the insurance company, and the greater premium discount they can offer.

Talk to us

An experienced benefits consultant can help you analyze your spending, and a good broker can help you get the best rates thanks to their network and know-how.

We can provide the insights you need to make the best decision on which types of plans to offer your workers and the best plans for your and your employees’ money ― and we can negotiate the best rates possible on your behalf.

April 27, 2021

Put Money into an HSA instead of a 401(k) After Employer Matching: Report

One of the main recommendations for employees with 401(k) plans is that they should contribute at least enough to their plan every paycheck to ensure they receive the maximum they can in their employer’s matching contributions.

But a new study by Willis Towers Watson recommends that younger, healthier workers should divert savings to their health savings account from their 401(k) after capping out employer matching instead of continuing to put money into their retirement plan.

The report reasons that if they do this, they can get more bang for their buck when they use their HSAs to pay for future medical expenses.

That’s because HSAs can be kept for life and the money they’ve accumulated in them can be used to pay for medical expenses whenever they need them, including in retirement. And the moneys used in HSAs to pay for those expenses are not taxed when they are withdrawn, unlike 401(k)s, the funds of which are subject to federal income tax when withdrawn

The benefits of HSAs

With HSAs:

  • Pretax contributions, gains from investment, and withdrawals used for qualified medical expenses are exempt from federal and most state taxes.
  • Any unused balance is carried over to the next year.
  • Funds never expire.
  • Unused funds can be passed on to a beneficiary after death.
  • After turning 65, account holders can withdraw money for any purpose. However, if those funds are not use for a bona fide medical expense, they are taxed as income.

No other retirement savings vehicle has the same tax advantages as an HSA, so a dollar saved in an HSA can be worth significantly more than an unmatched dollar saved in a 401(k), according to Willis Towers Watson. Some employers will match a portion of workers’ HSA contributions or seed their accounts with money to encourage participation. 

That said, HSAs won’t outperform funds that are matched partly or fully by an employer, according to the report.

Willis Towers Watson said that those tax-free dollars and withdrawals can help pay for health care when we are likely to use it most: in retirement.

Men who retire at 65 with an average life expectancy of 85 would spend about $140,000 out of pocket for medical costs, and woman who retires at the same age and lives to 87 would spend an average of $159,000, according to the research.

The HSA pitch

HSAs can only be used in conjunction with a high-deductible health plan. When HSAs were first introduced, they did not have investment options for the money in the accounts, but as they have grown in popularity over the years, many HSAs now have evolved to essentially have the same investment choices as a 401(k).

HSAs have rules about how much of the balance can be invested. They will typically require that the first $1,000 in the account to be held in cash, and anything above that can be invested to help the funds grow over time.

In 2021, workers can contribute a maximum of $3,600 to their individual HSA account and $7,200 to a family coverage account.

If you are offering your workers high-deductible health plans with matching HSAs, and if you also provide a 401(k) and match part of the contributions, you may want to consider sharing this information with them to help them make informed choices on where to park their money for future use.

April 13, 2021

HDHPs Do Not Slow Down Health Care Spending: Study

A new study has found that high-deductible health plans have only a limited effect on the growth of health care spending for people who sign on for these plans.

The National Bureau of Economic Research researched HDHPs over a period of four years and found they failed to control health spending any more than traditional preferred provider organization plans (PPOs) and health maintenance organizations (HMOs). The only statistically significant impact on lower growth by HDHPs was on more expensive pharmaceuticals.

The news comes as HDHPs continue growing in use and popularity among employers and some of their workers. They are often paired with a health savings account that allows participants to set aside a portion of their wages before taxes in special accounts used to pay for health-related expenses, including deductibles.

When HDHPs first came on the scene they were touted as a potential cost-saver. The logic went that when the worker has more skin in the game and has to pay more for their medical care and medications, they will shop around for the lowest-cost service or drug.

Here are the main findings of the report:

  • Covered workers who switched from low-deductible plans to high-deductible plans saw lower growth rates of spending, but for no more than a year.
  • HDHPs seem to discourage the use of less cost-effective drugs. The report surmised that’s because people with these plans will be more motivated to shop around for better prices, like from an online pharmacy.

Considerations

PPOs continue to be the most popular choice among employees and HDHPs continue growing as employers look to cut their and their employees’ premium expenditures, according to a recent report by Benefitfocus, a benefits technology company. HDHPs currently account for about 30% of group health plans in play.

Also, some employees prefer having an HDHP as they can save money up front on the premium.

Over the past few years, employers have noticed that younger and healthier workers will gravitate towards HDHPs when offered them, as they will usually not need much health care and they are willing to trade a lower up-front premium for the small likelihood that they will need a significant amount of medical care, which they would have to pay for out of pocket.

However, workers in their 40s and older are more apt to stick to their PPO or HMO plans, which have higher premiums but lower out-of-pocket maximums.

But the authors of the National Bureau of Economic Research report said that for some people with health problems, HDHPs “may have high adverse health consequences when patients delay, reduce, or forgo care to curb costs, even when costs are moderate compared to health benefits.”

The takeaway

There is no doubt that HDHPs will continue growing in use, but they are not for everyone. Employers that give their workers an option of choosing an HDHP or a traditional PPO plan will be able to better cater to the different needs of their workers.

This is important as the U.S. workforce becomes more diversified, and for employers with multi-generational employee pools.

March 23, 2021

HHS Proposes Higher Cost-Sharing Limits for 2022

The Department of Health and Human Services has proposed cost-sharing limits that would apply to all Affordable Care Act-compliant health insurance policies for the 2022 policy year.

The ACA imposes annual out-of-pocket maximums on the amount that an enrollee in a non-grandfathered health plan, including self-insured and group health plans, must pay for essential health benefits through cost-sharing.

This means that health plans are not allowed to require their enrollees to pay more than the maximum in a given year for health services. 

The proposed 2022 out-of-pocket maximums are $9,100 for self-only coverage and $18,200 for family coverage. This represents an approximate 6.4% increase over 2021 limits. For 2021, the out-of-pocket maximums are $8,550 and $17,100, respectively.

Penalties to rise

Applicable large employers (ALEs) — employers with 50 or more full-time or full-time-equivalent workers who are required to offer their employees health insurance under the ACA — can face large penalties known as “shared responsibility” assessments if they have at least one full-time employee who enrolls in public marketplace coverage and receives a premium tax credit. There are two types of infractions with different penalty amounts:

The “play or pay” penalty — This can be levied when an ALE fails to offer minimum essential coverage to at least 95% of its full-time employees and their dependent children during a month, and at least one of its full-time employees receives a premium tax credit through a public marketplace.

The per-employee penalty will rise to $2,880 in 2022 from the current $2,700.

The “play and pay” penalty — An ALE can be hit by this penalty if it offers minimum essential coverage to at least 95% of its full-time employees but a full-time employee receives a premium tax credit because: (1) the employer-offered coverage is unaffordable or fails to provide minimum value, or (2) the employee was not offered employer-sponsored coverage.

For 2022, the maximum annual assessment for each full-time employee receiving a premium tax credit will be an estimated $4,320, up from the current $4,060.

March 17, 2021

IRS Lets Employers Give Workers a Break on FSA Contributions, Health Plan Rules

New guidance from the Internal Revenue Service allows employers to temporarily give their employees extra benefits leeway in making changes to their flexible spending accounts (FSAs) and health savings accounts (HSAs).

The guidance, in response to the COVID-19 pandemic, also allows employees to make changes to their health plans outside of the traditional open enrollment period.

The COVID relief bill signed into law at the end of 2020 changed the tax law. The law ordinarily requires employees to make irrevocable plan choices before the first day of the plan year; later changes are normally permitted only under certain circumstances, such as a change in employee status.

However, 2020 was an abnormal year. For example, stay-at-home orders left employees with unused money in their dependent care FSAs because they unexpectedly did not have to pay for child daycare.

The temporary changes

Recognizing the current extraordinary situation, the new guidance makes several temporary changes:

  • Employers can permit employees to carry over unused funds from their 2020 FSAs to 2021, and from 2021 to 2022. Ordinarily, these accounts have a “use it or lose it” rule under which the employee forfeits unused funds at the end of the year.
    If an employee contributed $5,000 to a dependent care FSA in 2020 but used only $3,000 because he or she worked from home, they can now carry the remaining $2,000 forward for use in 2021.
  • Alternatively, employers can extend the grace period for employees to spend unused FSA funds. Normally, employees have two and a half months from the end of the plan year to spend the money on qualifying expenses. The temporary rules permit employers to give them up to 12 months to do it.
  • Employers can allow certain employees to use dependent care FSA funds for care of children up to age 14. The normal cut-off age is 13.
  • Employers may allow employees to change their future contributions to 2021 FSAs mid-year, something that is ordinarily prohibited.
  • Employers may also permit employees to make mid-year health plan changes. Employees who did not enroll in the employer’s health plan during open enrollment will be able to do so.
    Employees can change available plans, or they can drop coverage entirely if they can show that they have replacement coverage such as through a spouse’s employer.
  • If an employee changes from a high-deductible health plan to one with copayments or lower deductibles (or vice versa), employers can also permit them to switch mid-year between contributing to an HSA or an FSA. By law, an HSA must be coupled with an HDHP.
  • Lastly, they can allow employees who stop contributing to a health care FSA mid-year to receive reimbursements through the end of the plan year.

It is important to know that:

  • The law does not require employers to make these changes.
  • The changes expire for plan years starting in 2022 and later.

The pandemic has been difficult for employers and employees alike. These temporary changes will make it a little easier for both to cope.

March 10, 2021

The Top Five Health Conditions Driving Insurance Costs

A new study has identified the top five health conditions that are driving the overall cost of group health plan outlays, and without which spending would actually be falling.

The report is enlightening, and employers can use the findings to offer programs aimed at education and prevention to help control their employees’ health care costs and cut into health insurance premiums paid by both employers and workers.

Inspecting its study data for trends, the Health Action Council (HAC) determined that 63% of its covered lives had at least one of five conditions that were driving health care costs. Most of these top five conditions are preventable or treatable with lifestyle modifications that employers can encourage. 

Here’s a look at the five conditions and the burden they put on your employees and your company:

Asthma

Average costs paid per member of the HAC for asthma treatment are increasing on average 6.4% a year. This is one of the most prevalent health conditions in the country. Three important stats:

  • The incidence of asthma was 31% higher among women than men.
  • The incidence of asthma among African American covered lives was 20% more prevalent than among other races.
  • The average age of HAC members with asthma was 31.9, two years younger than the overall membership average age of 33.9.

Diabetes

Average costs paid per member of the HAC for diabetic treatment are also increasing 6.4% a year. Three important stats:

  • Diabetes was 20% more common in men than women among the HAC’s enrollees.
  • The average age of HAC plan enrollees with diabetes was 52.
  • Although Asian covered lives amounted to only 3% of the HAC enrollees, they had the highest incidence of diabetes of all racial groups.

Hypertension

Average costs paid per member of the HAC for hypertension treatment are increasing 6.3% a year. Three important stats:

  • Hypertension was 23% more common in men than women.
  • The average age among HAC enrollees with hypertension was 53.1.
  • The risk of African Americans developing hypertension was 63% more than for other races.

Back disorders

Average costs paid per member of the HAC for back treatment are increasing 3.4% a year. Three important stats:

  • Back disorders were 27% more common in women than men.
  • The average age among HAC enrollees with back disorders was 43.3.
  • Caucasian HAC members had 14% higher back disorder prevalence than other races.

Mental health, substance abuse

Average costs paid per member of the HAC for mental health and substance abuse treatment are increasing 2.7% a year. Three important stats:

  • Mental health and substance abuse problems were 39% more common in women than men.
  • The average age among HAC enrollees with mental health and substance abuse issues was 32.8.
  • Caucasian HAC members had 20% higher mental health and substance abuse issues than other races.

The takeaway

To help workers with these conditions, the report recommends:

  • Creating and implementing simple education and targeted wellness programs to address common conditions among your employees.
  • Instituting an exercise, stretch or meditation program at the beginning of a work shift to improve safety and decrease injuries. These types of practices are preventative and may decrease the severity of an injury if one occurs.
  • Evaluating benefit plan design for opportunities to implement continuum-of-care protocols. For example, employers can make chiropractic care or physical therapy mandatory for back disorders before moving to more aggressive treatments.
  • Covering medications for specific common chronic conditions as preventative care. Another option is to promote the use of patient assistance programs for medicines that may be excluded in your plan’s drug formulary.
  • Promoting virtual care for specific conditions; for example, mental health support if you have staff in rural areas.
  • Working with your health insurer or medical expert(s) to identify opportunities for provider outreach and education to your workers.
February 23, 2021

CMS Approves Medicare Coverage of ‘Breakthrough’ Medical Devices

The Centers for Medicare and Medicaid Services has issued new rules that require Medicare to cover medical devices that the Food and Drug Administration designates as “breakthrough” technology. 

The rule paves the way for giving Medicare recipients access to the latest technologies four years after they receive market approval by the FDA. The move should greatly speed up the time by which these new devices are covered by Medicare, the approval process of which can be extremely slow.

Under the final rule, the CMS will use the data for these devices during the four years after the FDA approves them, to evaluate them based on clinical and real-world experiences. If the data shows they are effective, the CMS could move to approve them for coverage under Medicare. 

The CMS said the rule was necessary because the current process hinders innovative technologies from getting to Medicare beneficiaries. Companies that make the breakthrough devices currently have to receive approval from the FDA and then receive approval for Medicare coverage, which costs them both time and funds.

Examples of breakthrough devices that were approved in 2020 include:

  • Innovative stents
  • Heart valve replacements
  • Advanced lab tests
  • Automatic defibrillator machines.

To further reduce the time it takes for Medicare to approve a device after FDA approval, the CMS has created a special “breakthrough” approval timeline that the FDA can use to approve innovative devices and potentially life-saving equipment.

Along with the expedited pathway to FDA approval, Medicare may automatically cover FDA-approved products for up to four years. After four years or the given timeframe for coverage, the CMS can reassess whether it will continue covering the device based on patient outcomes.

Qualifying requirements

Covered devices would have to fit Medicare statutory definitions of “reasonable and necessary” for treating patients. To that end, the final rule refines these definitions. Among the requirements, devices would have to be considered:

  • Safe and effective.
  • Not experimental or investigational.
  • Appropriate for Medicare patients, including the duration and frequency that is considered appropriate and whether it is covered by commercial insurers.

The new rule aims to nationalize what some state Medicare systems are already doing and avoid the possibility that a revolutionary new product may receive Medicare coverage in one state, but not another.

Making coverage of breakthrough products national also prevents the product manufacturers from having to approach individual Medicare administrative contractors for local coverage determinations, the CMS said in a press release.

The rule takes effect March 15 and is retroactive for two years before the effective date.