When the Centers for Medicare & Medicaid (CMS) released its final rule (CMS-3819-F) last year, it not only revised and modernized the conditions of participation (CoPs) that home health agencies must meet in order to participate in programs, it presented new conditions. One such condition is §484.65, Quality Assessment and Performance Improvement (QAPI).

The effective date of the final HHA CoP was January 13, 2018, but agencies have until July 13, 2018 to implement at least one performance improvement project (PIP), which is part of the new QAPI condition.

HHAs must develop, implement, evaluate and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA’s governing body must ensure the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and readmissions; and takes actions that address the HHA’s performance across the spectrum of care, including the prevention and reduction of medical errors.

CMS has not issued any standardized forms to meet this condition. Agencies are left to create their own forms and reporting tools. Many agencies are finding it difficult to know what to measure, how to measure, how to document their efforts and how to select a PIP. This article will help toward compliance.

QAPI is the merger of two complementary approaches to quality management, quality assurance (QA) and performance improvement (PI). QA is a reactive and retrospective while PI, is pro-active and continuous.

According to Shireesha Jevaji of the National Committee for Quality Assurance (NCQA), a key aspect of quality assurance is systematic measurement: monitoring processes, with a feedback loop for error prevention.

There are five standards in the QAPI requirements: 1) program scope, 2) program data, 3) program activities, 4) performance improvement projects (PIP), and 5) executive responsibility. The standards are not stand-alone or sequential. They flow together and cross over each other.

HHAs must also maintain and document an infection control program to prevent and control infections, along with communicable diseases. Infection prevention and control must be integrated into your QAPI policy.

1. Program Scope

§484.65(a)(1)The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety and quality of care.

To meet this standard: Utilize a model for improvement including the Plan-Study-Do-Act (PSDA) cycle to help identify a target area that is measurable and will improve outcomes, patient safety or quality of care. Target areas that meet this criterion are consistent across the industry and include patient falls, hospital readmissions, emergency department visits and patient infections, developing or worsening pressure ulcers and medication errors, to name a few.

Plan-Do-Study-Act Cycle

§484.65(a)(2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations.

To meet this standard:

Report and analyze potentially avoidable events, publicly reported outcomes, OASIS, Home Health Compare, HHCAHPs, triage/on-call logs, competency assessments, chart audits, adverse drug events, infections, falls, patient complaints, clinical or operational processes and other reports as indicated. Access all available reports to identify potential areas of concerns. Ensure the agency has an organized tracking system for these reports and the trending of data. Each area reviewed (or indicator) must be measurable with the ability to track the effectiveness in any change in procedures, policies or interventions.

The QAPI program must include procedures for and frequency of measurement and analysis of indicators.

2. Program Data

§484.65(b)(1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program.

§484.65(b)(2) The HHA must use the data collected to: §484.65(b)(2)(i) Monitor the effectiveness and safety of services and quality of care; and §484.65(b)(2)(ii) Identify opportunities for improvement.

§484.65(b)(3) The frequency and detail of the data collection must be approved by the HHA’s governing body.

To meet this standard: Utilize the data gathered and analyzed in the program scope standard. Identify opportunities for improvement. Focus on quality and safety issues. Measure and record quality indicators and areas that can stimulate performance improvement. Assign a focus group to review data and provide feedback. Establish benchmarks for comparisons. Prioritize and set goals. Remember: The governing body must be involved and ensure the agency systematically collects data to measure various aspects of quality of care; the frequency of data collection and how the data will be collected and analyzed (who, what, when and how often). Record these actions in the minutes of the governing body meetings. Keep a copy of the minutes in your QAPI binder.

3. Program Activities

§484.65(c)(1) The HHA’s performance improvement activities must:

§484.65(c)(1)(i) Focus on high risk, high volume or problem-prone areas; §484.65(c)(1)(ii) Consider incidence, prevalence and severity of problems in those areas; and §484.65(c)(1)(iii) Lead to an immediate correction of any identified problem that directly or potentially threatens the health and safety of patients.

§484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions.

The Potentially Avoidable Event Report in Casper displays incidence rates for 12 untoward events. Each of the Potentially Avoidable Events should be investigated and actions taken to reduce incidence. To determine if one of these measures would be appropriate for a PIP, compare your current data with national data and to your prior time period. The incidence rates have been adjusted to account for variation in patient characteristics. Those events with higher incidence and/or those that have the most clinical relevance to the agency and patient safety should be considered for a PIP.

§484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained.

To meet this standard: Focus on high-risk, high-volume or problem-prone areas.

If a problem is identified which directly or potentially threatens the health and safety of a patient, correct the problem immediately.

Use Root Cause Analysis (RCA) to identify causative factors or root of the problem. Most of the accrediting bodies require homecare agencies to use the RCA process for investigating adverse or sentinel events. There are many free templates to guide an RCA.

Implement a corrective action plan focusing on the causative factors identified in your RCA. Continue to utilize the PSDA model.

• High risk: significant risk to the health or safety of patients
   
• High volume: frequently provided to a large patient population
   
• Problem-prone: potential for negative outcomes that are associated with a diagnosis or condition
   
• Adverse patient events: negative and unexpected impacting the plan of care and potential decline of the patient
   

4. Performance Improvement Projects

Beginning January 13, 2018, HHAs must conduct performance improvement projects.

§484.65(d)(1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity and past performance of the HHA’s services and operations.

§484.65(d)(2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects.

To meet this standard: The HHA should have one performance improvement project either in development, ongoing or completed each calendar year. By July 13, 2018 at least one PIP must be in place.

The HHA decides, based on the QAPI program activities and data, what projects are indicated and the priority of the projects. Projects should be selected based on areas identified to be problematic, poor outcomes, high-risk or high-volume, and they must be individualized to your agency.

Document progress toward the PIP goals in measurable terms. Present updates to the HHA governing body at least quarterly and obtain feedback for modification of the PIP. Identify resources needed to put the plans into action. Tools should be utilized to measure and track progress of action items. Obtain measurements and data at a regular and consistent interval to validate progress or decline in goals.

Below is an example of tracking the action items in a PIP.

Tracking PIP action items

5. Executive Responsibilities

The HHA’s governing body is responsible for ensuring the following:

§484.65(e)(1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; §484.65(e)(2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; §484.65(e)(3) That clear expectations for patient safety are established, implemented and maintained; and §484.65(e)(4) That any findings of fraud or waste are appropriately addressed. Interpretive Guidelines §484.65(e)

To meet this standard: The agency’s governing body must assume responsibility for your QAPI program and ensure documentary evidence of the program. Keep minutes from all QAPI meetings.

Educate staff at all levels on the QAPI program and each individual’s role in the success of your QAPI program.

An HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS.

In the event the HHA identifies a possibly illegal action by its employees, contractors or responsible/relevant physicians, it is the responsibility of the HHA to report the actions to the appropriate authorities according to the individual state laws and the nature of the action(s).

The QAPI program must be reviewed annually. The final rule (CMS-3819-F2) is available on the Federal Register website.

Competitive bidding has annihilated profitability for many HME/DME providers in the bedding and support surfaces category. The program does not take into account the cost of service and delivery for providers who put beds out as rentals, says Cynthia Counts, Graham-Field’s vice president of home care sales and marketing. The most recent Round 2 reimbursement rates continue to show a decrease in the fee schedule, much to the detriment of providers. Lower rates may force providers to choose a lower-cost bed or support surface as opposed to evaluating product quality and the comfort of the user, says Counts. Alternatively, some providers are looking at specialty areas not impacted by competitive bidding and even cash sales from the growing popularity of adjustable beds. “Medical providers, especially those in retail, have the opportunity to show end users the quality of the product,” says Counts. “If we can change the focus from price, price, price to quality, comfort, quality, there is an opportunity to sell more beds and remain profitable.” Graham-Field designs and manufactures products in the United States, including beds and support surfaces. Continued investment in high-capacity, high-technology manufacturing systems ensures quality and innovative products to enhance providers’ ability to compete in the changing health care environment, says Counts. An example of innovation is the Patriot LX Home Care Semi-Electric Bed, whose grid deck provides mattress support that will not sag over time like a spring deck. The head and footboards have no moving parts, which reduces the number of components that would require routine service. The design offers home care providers a bed that is easier to deliver, set up and maintain, making the bed’s lifetime cost-in-use among the lowest in the industry. Counts also sees opportunities to up-sell on mattress selection versus only selling the low-end basic support surfaces available. “Sleep is a critical and very important part of the day, and there are many products on the market today that sell extremely well due to their promise for comfort during sleep,” says Counts. Providers should make options of support surfaces available in their stores for users to touch and feel, Counts suggests, and they should know the differences available and allow users to choose. “When it comes to sleep, most likely, the end user will pay to have the most enhanced sleeping experience,” she says.

Preventing Pressure Ulcers

Drive Medical offers both preventative and treatment pressure redistribution support surfaces to address pressure ulcers, according to Mitch Yoel, Drive Medical’s executive vice president of business development. Products include Group 1 surfaces (gel overlays, APPs and dry pressure mattresses), Group 2 surfaces with therapies such as True Low Air Loss, alternating pressure and non-powered self-adjusting technology and three full-line foam mattress series of Long Term Care preventative surfaces. Drive emphasizes its comprehensive and turn-key “Match the Product to the 
Patient” branding program. Product category reimbursement rates for DME providers were cut an average of 63 percent in Round 2 of competitive bidding and 47 percent in Round 1 Recompete. In response, Drive streamlined product feature offerings, but kept the clinically critical features to supply DME providers and their customers Group 2 surfaces that meet clinical needs while allowing providers to make a profit. The majority of patients who qualify for Medicare benefits for a semi-electric bed would most likely qualify for and benefit from a Group 1 support surface, says Yoel. Drive offers easy-to-read flowcharts and additional resources to assist DME providers in determining eligibility. Group 1 and Group 2 support surfaces fit hospital beds, but many can also be used on marital beds or even pull-out couches and lift chairs. Drive’s Masonair AS8800, a recommended go-to powered air mattress for HCPCS code E0277, is an affordable, combination alternating pressure and low-air-loss powered mattress (LAL/APM) replacement system. It is available in a standard hospital bed size, an 84-inch size to accommodate taller patients, and with raised side rails for enhanced safety and fall prevention. All three use the same pump, the AS8800 digital pump, whose microprocessing sensor technology means simpler operation (fewer phone calls to the DME) and better pressure redistribution. Sometimes the sickest homebound patients refuse to use a powered Group 2 support surface because they fear either a power failure or an increase to their electric bill. Drive now offers the Balanced Aire Non-Powered Self-Adjusting Group 2 (which fits HCPCS E0373—far less audited than E0277). The mattress offers comparable therapy and effectiveness of traditional LAL/APM mattress systems without relying on a pump, so it isn’t dependent on electricity and doesn’t increase a customer’s power bill. Yoel says DME providers sometimes follow Medicare rules and regulations related to support surfaces, even for payers that do not require it. He notes that when a non-Medicare insurance case manager is involved or a patient has a licensed clinician who will write a letter of medical necessity for them, support surfaces often get approved irrespective of Medicare guidelines. DME providers can sell support surfaces to help relieve or manage patients’ pain, too. Yoel says Drive’s support surfaces have been engineered to enhance patient comfort. For example, Drive’s LS9000’s powerful blower-based low air loss system also provides pulsation, which may help to control pain. Medicare does not cover support surfaces for pain, but other payers, and certainly hospices, cover support surfaces for pain relief, and many patients are willing to pay out-of-pocket for pain relief. Pain centers, head and neck physicians (neuro and orthopedic surgeons), physical and occupational therapists, hospice and palliative care agencies present potential opportunities to sell support surfaces beyond the usual support surface call points.

Assured Comfort offers customizable cash-sale beds, sometimes covered by private insurance.

Products for Low- to 
High-Risk Patients

Referral sources for therapeutic support services are the same as those for other sectors of the HME/DME business—wheelchairs, beds, oxygen, etc. In addition, referrals also come from home health agencies and wound care facilities, according to Cali Thomson, business manager, therapeutic support surfaces, Invacare. Invacare offers a broad range of products for low to high risk patients for treatment and prevention of pressure ulcers, which are a serious health problem and a major financial burden to hospitals, nursing homes, Medicare, Medicaid and third-party payers. Cost estimates to treat one pressure ulcer can be quite high, says Thomson. Not only is there a financial cost, but pressure ulcers cause pain and suffering and can even lead to death. Avoiding pressure ulcer problems begins with prevention. Invacare’s microAIR MA55 mattress has alternating pressure plus on-demand low-air loss and includes a power outage safety feature. The mattress remains inflated as long as the air hose remains connected to the compressor, and it also has a 2-inch safety mat as an added feature to prevent patients from bottoming out. The product also has constant pressure monitoring. Sensor technology adjusts the pressure to regulate the air inside the mattress and maintain the pressure at or below 32mm/HG to avoid capillary occlusion.

The Rules Have Changed

Blue Chip Medical Products manufactures dynamic therapeutic support surfaces, and can custom-make products in their Suffern, N.Y., factory to any size and specification, whether it’s a gel overlay, a non-powered systems or custom foam products. Not all support surfaces use hospital beds, and Blue Chip Medical can customize surfaces to fit any size bed or a mattress that is powered on one side and not on the other side. Blue Chip Medical’s Airus A210 is a Group 3 air fluidized therapy bed for the home health care market. Air fluidized therapy redistributes pressure over the body contact area, significantly reducing tissue interface pressure and the forces of friction and shear. Air fluidized therapy is created by using a high flow of air, which diffuses microsphere beads to create a fluidized support surface allowing for proper immersion and an effective microclimate for the healing of pressure ulcers. The bed is applicable to the skin graft and wound care markets and has not been impacted by competitive bidding. Ron Resnick, president of Blue Chip Medical Products, says low Medicare reimbursements make it critical that providers look to expand their market and be more efficient, whether by embracing a specialized market, becoming a rental specialist, or looking for new referral or payer sources. “The rules have changed but the customer is still there,” says Resnick. “Dealers can succeed by learning a different set of marketing tools. We have helped dealers all over the country to navigate these shark-infested markets. We give you both patient care and profitability and act as your clinical liaison.” The daily or monthly rental model in the acute care or long-term care market can be an attractive alternative route for providers, Resnick says. Training and education can help providers become expert in specialized equipment, such as air fluidization, and distance themselves from a dependence on Medicare, he says.

New Sales Opportunities

Star Cushion Products offers pressure relief with its StarMat overlay, which consists of four large sections that fit together to go on an existing mattress. The non-powered system enables each section to be pumped up individually by hand, and an adjustable valve ensures the ideals level of immersion for various body sections. Multi-cell technology enables more exact adjustment of pressure compared to using larger air pockets, says Brandon Fraser, COO of Star Cushion. The StarMat replacement system is similar, but comes with a foam mattress and a cutout so that the mat does not add height to the bedding. The system is reimbursable using Code 0373 (Group 2). Star Cushion also provides customized products using the same technology in various sizes. “A lot of caregivers are familiar with this type of technology,” says Fraser.

Blue Chip Medical’s Airus air fluidized therapy bed is applicable to wound care markets not affected by competitive bidding.

SleepSafe Beds create a safe sleeping environment for children, eliminating all areas of entrapment identified by the FDA and virtually eliminating pinch points and burrowing. The beds also offer an appealing design that avoids the hospital-room look, according to Al Flora, sales manager of SleepSafe and Assured Comfort beds. For pediatric patients, the beds provide parents and caregivers peace of mind that their children are safe. The beds may be covered by public or private insurance. A new extension now increases the safety rail height to 53 inches. The beds continue to evolve with new enhancements to adapt to the changing pediatric market. The company also offers Assured Comfort beds, which are similar except there are no sides or safety rails; the beds will adjust to a variety of home health care needs. Each Assured Comfort bed is customized—the customer chooses the head board and footboard (if desired), made of wood from Virginia forests, and among different types of mattresses. They can also choose whatever controls they need, including high-low control to make transfers easy and to enable the bed level to be raised to a convenient height for caregivers. Welded, aluminum and bolted bed frames—in a fixed foundation or with manual or electric adjustments—adapt to any mattress suitable for an adjustable bed, including memory foam and cooling gel-infused choices. Assured Comfort beds are cash-sale items, although they can sometimes be covered by workman’s comp, private insurance or disabled veterans groups.

Selling Adjustable Beds for Cash

Flex-A-Bed was one of the first adjustable beds in the United States in 1969. Each Flex-A-Bed is built by hand in the LaFayette, Ga., factory. In addition to head and food adjustments and massage options, Flex-A-Bed also offers high-low functionality that is especially attractive to HME clientele. Offering the same functionality as a hospital bed, the bed has a luxury appearance and can be lowered down to 19 inches from the floor, making wheelchair transfer easier. Raising the bed can provide a better working height for the caregiver. Flex-A-Bed is embracing changing market demands and just added a memory foam mattress infused with gel particles to help air circulation and provide a cooler surface. Consumer-oriented enhancements include a USB port to charge a smart phone or tablet, and new LED lights illuminating the underside of the bed make it easier for someone to get up at night. Flexible beds are desirable in post-surgery situations, offering luxury beyond an uncomfortable hospital-type bed but with similar functionality. The beds are also being embraced for lifestyle advantages in various markets. They are a cash sale opportunity for HME/DME providers looking for alternatives to low Medicare reimbursements. There is also untapped potential for sales among workman’s comp insurance companies, says Groce. Ben Groce, CFO of Flex-A-Bed says many people who come into DME stores looking for mobility or other products may not have considered an adjustable bed. The best, most successful dealers provide a floor model and a couple of different mattresses to choose from. The big players have spent millions paying for commercials to explain what an adjustable bed is, so there is already a lot of awareness of the product, Groce says. “Educate your staff on what the options and benefits are,” says Groce. “Adjustable beds are not just for the senior citizen crowd.” They can be for teens wanting to play video games or for someone who just came out of the hospital. Baby boomers who enter a DME store because of the needs of their aging parents might themselves be good customers for an adjustable bed.

Embracing Stealth Therapy

Transfer Master has been making adjustable bed solutions for 20 years, including twin, full and queen sizes with two to five functions, in standard and bariatric weight capacities and low-bed options. The one-stop custom manufacturer ships beds across the country, offering a home-style appearance rather than an institutional or medical look. The company sells beds for hospital postpartum wards and sleep labs, as well as through the HME/DME channel. Transfer Master’s new Supernal adjustable bed, going on the market in March 2014, looks like expensive furniture. All modular from the mattress to the bed frame, the Supernal provides stealth therapy. The mattress can be a therapeutic core covered with high-end wool and bamboo fabrics. Existing beds can be upgraded over time as an end user’s medical needs change—guard rails could be added or a vapor barrier to deal with incontinence. Anyone coming into a bedroom would not know it’s a medical bed. Fully loaded, the beds can sell for around $3,000 and be an attractive cash sale to any customer of lift chairs, for example. Given their medical market knowledge, HME/DMEs are well positioned to sell the new beds, which otherwise might be sold by high-end furniture stores, says Aaron Goldsmith, president of Transfer Master. “We’ve been to Medtrade 17 times, and this is the first time (in Orlando) that we were one of the busiest booths,” says Goldsmith. “We were jammed for two days with people seeing how comfortable and easy to operate the beds are. It shows how HMEs are starting to think about cash products.” Transfer Master offers catalogs, PDFs and a new kiosk system to help HMEs sell adjustable beds. “Many people sell lift chairs and don’t understand how much they can make on adjustable beds,” says Goldsmith. “We make it easy for a dealer to have minimal knowledge and still become a specialized supplier of customized beds.”