Home Health & Hospice Week

You’ll have to wade into the messy gray area of what’s unrelated.

The optional second part of Medicare’s new election statement process for hospice patients is poised to give hospices big trouble.

In a final rule published in the Aug. 6 Federal Register, the Centers for Medicare & Medicaid Services adopts mainly as proposed a new requirement that hospices furnish an election statement addendum to patients who request it, outlining what conditions, services, and items are considered unrelated to the patient’s terminal illness, and therefore not covered by the hospice (see specific requirements, p. 248).

Good news: When CMS proposed the addendum, it wanted hospices to furnish it within 48 hours at election or “immediately” during the course of treatment. In the final rule, it relaxes that timeframe to five days at election and 72 hours during the course of treatment.

“The 5 days on admission requirement matches the requirement for the completion of the comprehensive assessment,” points out Judi Lund Person with the National Hospice & Palliative Care Organization. “We believe that will help providers with compliance,” she cheers.

More good news: CMS also pushed back the implementation for a year, to Oct. 1, 2021. “We understand that making … an addendum to accompany the election statement will take time for hospices to create, educate staff, and incorporate into current admission processes. Likewise, we recognize that there are some additional logistical and operation considerations … that we will need to consider and communicate to the hospice industry to help ensure a more seamless implementation,” the rule says. “This additional year will allow hospices to make any current process and software changes to incorporate the addendum into their workflow.”

That delay is “useful,” judges attorney Brian Daucher with Sheppard Mullin in Costa Mesa, California.

In fact, it is “necessary,” says Catherine Dehlin, director of hospice and palliative services for Fazzi Associates in Northampton, Massachusetts. “This is a heavily burdened regulation which requires providers to develop new policies, procedures, forms, workflows, and processes in order to avoid the potential penalties a condition of payment requirement … can create if not implemented with care.”

In addition to the extensive staff education requirement, implementing this regulation would have been nearly impossible by the Oct. 1, 2020 start date, as first proposed, Dehlin says.

Serious Payment Risk Ahead

But aside from the time frame, CMS finalizes the addendum requirements mostly as-is over concerns, criticisms, and alternatives submitted by scores of commenters on the proposed rule.

Top misgivings commenters cited include:

• ‘Unrelated’ definition. Articulating to beneficiaries what is unrelated to the terminal diagnosis is incredibly complicated and difficult, commenters protested. There is a “lack of guidelines provided by CMS as to how determinations of relatedness are made, other than it is the responsi­bility of the hospice physician,” they complained, according to the final rule.

Other commenters said relatedness is “vague,” there is a lack of clarity around the term, and that hospices — and even physicians within hospices — hold a different view on the definition. They urged CMS to issue more specific guidance on the topic.

CMS insists that hospices really should have mastered this point already, given that “the hospice medical director must consider all health conditions, whether related or unrelated to the terminal condition, as well as current clinically relevant information supporting all diagnoses when making the decision to admit a patient into hospice;” the interdisciplinary group must establish an individualized plan of care; and the POC must meet the patient’s and family’s specific needs. The determinations the hospice uses for eligibility and POC purposes should go onto the new addendum, which should “spur conversations with the patient about these determinations and the impact on the patient,” CMS argues.

Plus: “We remind commenters that since the implementation of the Medicare hospice benefit, it has been our position that virtually all of the care needed by terminally ill individuals should be provided by the hospice,” CMS emphasizes. The agency repeats that “virtually all” language throughout the rule. “As such, there should not be a voluminous list of unrelated items, services, and drugs given the comprehensive nature of hospice services.”

Back in the FY 2015 rulemaking cycle, CMS “solicited comments on definitions of ‘terminal illness and related conditions,’” CMS adds. Most commenters opposed CMS proposing these definitions, saying “hospices were the experts at making such clinical determinations” and “the hospice should be the entity that establishes a process to make determinations as to what is related and unrelated … on a patient-by-patient basis.”

Due to this feedback, “we have not proposed definitions for ‘terminal illness or related conditions,’” CMS points out.

• Payment. CMS proposed that the addendum be a condition of payment, when the patient has requested the document.

Commenters vehemently opposed this idea. “Several commenters questioned how an addendum that is mandatory, but only upon request, could be appropriately used as a condition for payment,” the rule notes. The requirement should instead be part of the Conditions of Participation, commenters suggested.

Hospices also shared with CMS many worries about claims review, including that the lack of an addendum would lead to unfair denials and that the determinations used on the addendum would lead to denials.

“As commenters pointed out, the vast majority of hospices try to provide all care to all patients; and when hospice patients do get care outside of hospice, it is often without the hospice’s knowledge (on patient or patient representative initiative without consulting the hospice),” Daucher says.

“We asked CMS to provide specific assurance that this new [condition of payment] would not be used to claim back payment absent a showing that there was both an actual patient request as well as an actual loss to the Medicare program (meaning proof that in that case Medicare had to spend money on ‘unrelated’ care that was not disclosed,” Daucher tells Eli.

But CMS shot down the idea of moving the requirement to the CoP arena. Keeping the addendum as a payment condition “is necessary to ensure that hospices are diligent in providing this information to Medicare hospice beneficiaries on request,” CMS maintains. And it is “an important mechanism of accountability” for hospices, the rule adds.

Result: The new addendum requirement poses a “very significant audit risk,” Daucher warns. And don’t be surprised to see that risk realized. “If CMS were truly interested just in notice to patients, they could have started this out as merely a Condition of Participation, thus mitigating the audit risk,” Daucher continues.

The rule specifically mentions HHS Office of Inspector General reports finding that Medicare paid for drugs it shouldn’t have under Part D, when hospices should have covered them. With the OIG issuing a new report on that topic just a few weeks ago, expect the pressure to stay on for medical review in this area, experts caution.

CMS does try to allay commenters’ fears on the medical review front somewhat, however. “There is no current process for the MACs to make determi­nations of ‘relatedness’. We remind commenters that the regulations afford hospices this responsibility,” the rule says. “Therefore, the hospices’ determi­nation of those unrelated items, services, or drugs reported on the addendum could not be used solely to deny hospice claims.”

Even though that’s the case, CMS will take the extra step of “collaborat[ing] with the MACs to establish clear guidelines on the use of the addendum as a condition for payment,” with any requirements being included in future rulemaking, as necessary.

“We do not want hospices to perceive that the purpose of this addendum is punitive against hospices, nor that it is a mechanism to deny claims,” CMS stresses. “Rather we want hospices to understand that the intent of this addendum is to keep patients at the forefront of their decision-making equipped with adequate information to make care choices as they approach the end of life.”

Daucher believes that “providers can take some comfort from language that CMS wrote in the final rule,” and “can cite this language when auditors strike,” at least.

Do this: To protect against denials, hospices can develop a process to document that the patient did not request an addendum, CMS suggests.

• Burden. Commenters disagreed heartily over CMS’s estimate burden included in the proposed rule, and CMS has only further reduced the burden estimation in the final regulation. The proposed rule claimed it would take a nurse only 10 minutes to complete the addendum.

Completing the addendum “is not just a process of extrapolating the information, but … is often a process of information gathering as not all relevant information is readily available at the time of the initial assessment,” commenters told CMS.

Hospices should remember they won’t need to fill out the form for all of their patients, or even very many of them, CMS says. For many patients hospices will provide all the services, drugs, and items so no addendum is required; many patients won’t request an addendum; and the addendum is not required for patients who die within the time frame of five days at election or 72 hours during treatment. That is almost 28 percent of patients, CMS highlights.

CMS sticks with its 10 minutes of RN time per addendum figure and reduces the number of addenda expected to be required, thanks to the relaxed time frame. The result is a cost of $11.1 million per year for the new form, plus a one-time cost of about $200,000 to develop the form for initial use, the rule indicates.

Nonsense: “Any addendum must include a list of eight items, including ‘a written clinical explanation’ supporting a determination that certain care is unrelated — an explanation that will no doubt be scrutinized by auditors,” Daucher protests on his firm’s Hospice Law Blog. “Providers must somehow secure a patient signature on these addenda” as well. “Ten minutes to do all of this?” he asks skeptically.

Don’t hold your breath waiting for changes to the addendum in the 2021 rule, since CMS delayed the implementation date to next October. “We do not expect CMS to make any changes to the requirement in next year’s rulemaking,” Lund Person tells Eli.

Note: The rule is at www.govinfo.gov/content/pkg/FR-2019-08-06/pdf/2019-16583.pdf.