Durable Medical Equipment (DME) proposed rule would reduce administrative burden for new innovative technologies

On October 27, CMS proposed new changes to Medicare Durable Medical Equipment, Prosthetics, Orthotic Devices, and Supplies (DMEPOS) coverage and payment policies. This rule would provide more choices for beneficiaries with diabetes, while streamlining the process for innovators in getting their technologies approved for coverage, payment, and coding by Medicare.

The proposed rule would expand the interpretation regarding when external infusion pumps are appropriate for use in the home and can be covered as DME under Medicare Part B, increasing access to drug infusion therapy services in the home. The proposed rule also drastically reduces administrative burdens – such as complicated government coverage, payment, and coding processes – that block innovators from getting their products to Medicare beneficiaries in a timely manner. This action aligns with President Trump’s Executive Order on Protecting and Improving Medicare for Our Nation’s Seniors.

“With the policies outlined in this proposed rule, innovators have a much more predictable path to understanding the kinds of products that Medicare will pay for,” said CMS Administrator Seema Verma. “For manufacturers, bringing a new product to market will mean they can get a Medicare payment amount and billing code right off the bat, resulting in quicker access for Medicare beneficiaries to the latest technological advances and the most, cutting-edge devices available. It’s clearly a win-win for patients and innovators alike.”

Due to administrative constraints, the process for making Medicare benefit classifications, pricing determinations, and creating billing codes for DMEPOS used to routinely take up to 18 months to complete. Last year, CMS changed this process through sub-regulatory guidance to reduce that timeframe to six months in many cases, and is now proposing to establish a streamlined process for coding, coverage, and payment in regulation. Under this accelerated process, benefit classification and pricing decisions could happen on the same day the billing codes used for payment of new items take effect, which would facilitate seamless coverage and payment for new DMEPOS and services. If finalized, this proposed rule would allow innovators to bring their products to Medicare beneficiaries quicker giving them more choices and increased access to the latest, cutting-edge devices.

If finalized, this proposed rule will also expand Medicare coverage and payment for Continuous Glucose Monitors (CGMs) that provide critical information on blood glucose levels to help patients with diabetes manage their disease. Currently, CMS only covers therapeutic CGMs or those approved by the FDA for use in making diabetes treatment decisions, such as changing one’s diet or insulin dosage based solely on the readings of the CGM.

CMS is proposing to classify all CGMs (not just limited to therapeutic CGMs) as DME and establish payment amounts for these items and related supplies and accessories. CGMs that are not approved for use in making diabetes treatment decisions can be used to alert beneficiaries about potentially dangerous glucose levels while they sleep and that they should further test their glucose levels using a blood glucose monitor. With one in every three Medicare beneficiaries having diabetes, this proposal would give Medicare beneficiaries and their physicians a wider range of technology and devices to choose from in managing diabetes. This proposal will improve access to these medical technologies and empower patients to make the best health care decisions for themselves.

In addition, the proposed rule would expand classification of external infusion pumps under the DME benefit making home infusion of more drugs possible for beneficiaries. An external infusion pump is a medical device used to deliver fluids such as nutrients or medications into a patient’s body in a controlled manner. The proposal would expand classification of external infusion pumps as DME in cases where assistance from a skilled home infusion therapy supplier is necessary for safe infusion in the home, allowing beneficiaries more choices to get therapies at home instead of traveling to a health care facility.

Lastly, in the proposed rule, CMS proposes to continue to pay higher amounts to suppliers for DMEPOS items and services furnished in rural and non-contiguous areas to encourage suppliers to provide access and choices for beneficiaries living in those areas. CMS is making this proposal based on previous stakeholder feedback that indicate unique challenges and higher costs for providing for DMEPOS items for beneficiaries in rural and remote areas.

For More Information:

• Proposed Rule
• Fact Sheet

The Centers for Medicare & Medicaid Services (CMS) has a new rural health care listserv dedicated to sharing information about programs, policies and resources to help ensure rural populations have access to quality health care.

To subscribe to the new topic, click here and enter your email! Look for Outreach and Education, then Rural Health.

Our goal at CMS is to develop programs and policies that ensure rural Americans have access to high quality care, support rural providers and not disadvantage them, address the unique economics of providing health care in rural America, and reduce unnecessary burdens in a stretched system to advance our commitment to improving health outcomes for Americans living in rural areas. Rethinking Rural Health is a vital part of CMS’s push to transform the health care delivery system to a model that delivers high quality, affordable, and accessible health care for every American.

Subscribe to the rural health care listserv to receive the latest information and resources on:

• CMS Rural Health Strategy
• Maternal health care
• Payment and billing
• Policies and regulation
• Resources for partners

In order to find more information on rural health activities at CMS, please visit go.cms.gov/ruralhealth or contact RuralHealth@cms.hhs.gov.

Where It Hurts Podcast Series, Chapter 5

Sixty-five-year-old Karen Endicott-Coyan is living with a blood cancer.  Her chemotherapy takes less than 30 minutes. Before the hospital closed, it was just a short drive into the small town of Fort Scott, Kansas, for her to get treatment.

But these days getting to chemo means a trek on rural roads and narrow highways, driving help from her sister-in-law and some Ritz crackers tucked into her purse to steady her stomach on the way home. The whole trip should take less than three hours. Endicott-Coyan puts on her makeup, her diamond earrings and powers through.

“If I can help it, I’m not going to go over there looking like a sick person,” Endicott-Coyan said. “I don’t like looking like a sick person. That’s just me.”

Endicott-Coyan had a long career in hospital administration, and she uses that expertise to try to smooth out her newly fractured health care. But during every minute of the trip, a nagging worry at home steals her energy and attention. In this chapter of the podcast, host-reporter Sarah Jane Tribble goes along for the ride and is witness to the stress and frustration.

The journey illuminates one reason people in rural America are more likely to die from cancer than patients in metro areas.

Click here to read the episode transcript.

Pennsylvania Department of Human Services (DHS) Secretary Teresa Miller reminded Pennsylvanians that safety-net programs like the Supplemental Nutrition Assistance Program (SNAP) and Medicaid are available to individuals and families who are struggling to afford food or access health care.

“So many people are coping with the stress and anxiety of these challenging times by simply putting one foot in front of the other, one day at a time. I want to remind Pennsylvanians that they are not alone. There is help available, and it always OK to reach out for help when you need it,” Sec. Miller said. “I encourage Pennsylvanians who are struggling to apply for these programs online at www.compass.state.pa.us. You do not need to know your own eligibility in order to apply. We’ll take care of that part.”

Enrollment statewide for Medicaid has increased by 244,603 people since February, for a total enrollment of 3,076,166 in September – an 8.6 percent increase. Secretary Miller also reported that because Governor Wolf expanded Medicaid eligibility in 2015 through the Affordable Care Act approximately 160,000 Pennsylvanians are getting through this pandemic with their access to health care intact.

Around this time last year, about 680,000 Pennsylvanians had health care coverage because of Medicaid expansion. That number is now up to more than 840,000 as of the end of September. If the Affordable Care Act is repealed or struck down, Medicaid expansion would be among the expanded health care options and critical consumer protections that would no longer exist.

“Medicaid expansion has provided a lifeline when people need it most. If you aren’t healthy and taking care of medical needs, you can’t think about getting a job or moving forward. And yet, the Affordable Care Act is under attack,” Sec. Miller said. “If we lose the Affordable Care Act, the nearly 1.3 million people in Pennsylvania who have health insurance because of the ACA could lose that coverage. But the ripple effect will not stop there. Consumer protections like coverage on a parent’s policy up to age 26, no lifetime limits, essential health benefits, and coverage regardless of pre-existing conditions will end – leaving millions of people vulnerable.”

DHS has found that more than half of Pennsylvania’s Medicaid expansion population is working a job that does not offer health benefits. In fact, a new report reveals that workers with incomes of less than $30,000 a year are offered employer-sponsored insurance (ESI) less than 30 percent of the time.

When people leave Medicaid coverage, many are doing so because their income is increasing. Research suggests that Medicaid expansion has had a positive effect on keeping workers employed and helping the unemployed get a new job.

Enrollment for SNAP statewide has increased by 129,155 people since February, for a total enrollment of about 1,866,614 in September — a 7.4 percent increase.

SNAP helps nearly 1.9 million Pennsylvanians expand purchasing power by providing money each month to spend on groceries, helping households have resources to purchase enough food to avoid going hungry. Inadequate food and chronic nutrient deficiencies have profound effects on a person’s life and health, including increased risks for chronic diseases, higher chances of hospitalization, poorer overall health, and increased health care costs. As the nation faces the COVID-19 pandemic, access to essential needs like food is more important than ever to help keep vulnerable populations healthy and mitigate co-occurring health risks.

Applications for SNAP and other public assistance programs can be submitted online at www.compass.state.pa.us. Those who prefer to submit paper documentation can print from the website or request an application by phone at 1-800-692-7462 and mail it to their local County Assistance Office (CAO) or place it in a CAO’s secure drop box, if available. While CAOs remain closed, work processing applications, determining eligibility, and issuing benefits continues. Clients should use COMPASS or the MyCOMPASS PA mobile app to submit necessary updates to their case files while CAOs are closed.

For more information about food assistance resources for people around Pennsylvania impacted by COVID-19 and the accompanying economic insecurity, visit the Department of Agriculture’s food security guide.

At Lerew’s Orchard in York Springs, Pennsylvania Agriculture Secretary Russell Redding and his wife, Nina, joined a volunteer gleaning operation through Project SHARE of Carlisle.

Gleaning is a centuries-old concept where growers would leave excess food in their fields for the poor to pick up to feed their families for free for the labor of harvesting the produce. In today’s times, groups like Project SHARE organize volunteer opportunities to collect excess, unsaleable, but still perfectly good field crops, market leftovers, and the last planting that farmers do not pick or cannot sell. Whether it’s tomatoes or corn on the cob – or in today’s case, Granny Smith apples – the produce is donated to the charitable food system to be enjoyed by those who wouldn’t otherwise have the opportunity.

“If there’s anything worse than fresh food and hard work rotting away in farmers fields, it’s the fact there are more than two million Pennsylvanians facing hunger every day,” said Redding. “Today, Nina and I were humbled to spend time harvesting apples that will go directly to local families in need.

“You’ve probably heard me say it before, but you can’t have a charitable food system without a food system that’s charitable. Farmers like the Lerews are making a difference every day,” added Redding. “And every Pennsylvanian has a variety of opportunities to make a difference, too.”

So far this year, Project SHARE has gleaned more than 134,000 pounds of local food from farmers. Previous years have averaged around 90,000 pounds, making 2020 a record year for Project SHARE. All of the produce is free for the work of the labor to harvest. The donated produce is available at the Project SHARE farm stand in downtown Carlisle. Along with the gleaned produce, the farm stand distributes additional perishable products and bread. The farm stand serves as a substitute to regular food distributions of Project SHARE, so community members have access to fresh, nutritious food as needed.

Pennsylvanians interested in volunteering to support their community and Pennsylvania’s charitable food system have a variety of options:

• Volunteer your time or donate food or financial resources to a local food bank or local food pantry.
• Contact your local school district to learn about opportunities to assist with school food pantries or support out-of-school time feeding programs.
• Donate a harvested deer through Hunters Sharing the Harvest.

Pennsylvanians in need of assistance are encouraged to start with PA 211 by either searching their online resource database or texting their ZIP code to 898-211 to communicate with a live specialist. Pennsylvanians negatively affected by COVID-19 are eligible to receive state and federally sourced foods from Pennsylvania’s food banks and pantries.

For more information about food security and resources for Pennsylvanians in need, visit agriculture.pa.gov/foodsecurity.

The Centers for Medicare & Medicaid Services (CMS) announced that starting today consumers can preview 2021 healthcare plans and prices on HealthCare.gov. This is an opportunity for consumers to compare coverage options ahead of Open Enrollment for the Federal Health Insurance Exchange, which officially kicks-off on November 1. As in previous years, window shopping allows consumers and those assisting consumers, such as licensed brokers and Navigators, to browse plans without logging in, creating an account, or filling out the official application.

As we get ready for Open Enrollment, CMS has updated and improved the HealthCare.gov experience by incorporating integrated help and enhanced resources. These updates provide content that guides consumers and enables enrollees to easily access and understand information they may need to make informed choices about coverage. HealthCare.gov also added a new planning resource for consumers to estimate their yearly income. CMS will continue to enhance the application, enrollment, and educational support based on consumer feedback.

Starting November 1, consumers can log in to HealthCare.gov and CuidadodeSalud.gov or call 1-800-318-2596 to fill out an application and enroll in a 2021 Exchange health plan. The Federal Health Insurance Exchange 2021 Open Enrollment Period is November 1, 2020 to December 15, 2020, with coverage beginning on January 1, 2021.

• To view the press release, visit: Press Release
• To view the 2021 Fact Sheet for more information, visit: Fact Sheet
• To view the 2021 Plan Landscape Data, visit: Plan Landscape Data
• To view the 2021 Health Insurance Exchange Premium Landscape Issue Brief, visit:   Issue Brief
• To see the 2021 Health Insurance Exchange Public Use Files, visit: Health Insurance Exchange Public Use Files
• To see the Plan Year 2021 Quality Rating System Public Use Files, visit:  Quality Rating System Public Use Files