CMS Moves to Strengthen Nursing Home Safety and Clarity of Consumer Info

Published in RINewsToday on January 23, 2023

To improve transparency of nursing home consumer information, the federal Department of Health and Human Services (HHS) through the Centers for Medicare & Medicaid Services (CMS), will now post Care Compare citations that are under dispute by nursing homes on its website.  CMS will also take steps to protect nursing home residents from being inappropriately diagnosed with schizophrenia which oftentimes leads to improper use of anti-psychotic medications to sedate and chemically restrain residents.

“We have made significant progress in decreasing the inappropriate use of antipsychotic medications in nursing homes, but more needs to be done,” said CMS Administrator Chiquita Brooks-LaSure, announcing the new guidance this week. “People in nursing homes deserve safe, high-quality care, and we are redoubling our oversight efforts to make sure that facilities are not prescribing unnecessary medications,” she says.

CMS’s actions advance President Biden’s goal of reinforcing safeguards against unnecessary medication use and treatments that was outlined in his State of the Union address to create an Action Plan for “Protecting Seniors by Improving Safety and Quality of Care in the Nation’s Nursing Homes.”

Tackling the inappropriate drugging of Nursing Home residents

Beginning this month, CMS will conduct targeted, off-site audits of nursing homes to determine whether facilities are accurately assessing and coding individuals with a schizophrenia diagnosis. Nursing home residents erroneously diagnosed with schizophrenia are at risk of receiving poor care and being prescribed inappropriate anti-psychotic medications. Anti-psychotic medications are especially dangerous to these residents due to their potential devastating side effects, including death.

According to the Washington, DC-based National Consumer Voice for Quality Long-Term Care, in 2008, CMS first introduced a quality measure in its Care Compare rating system that calculates the percentage of long-stay residents (over 100 days) that were receiving anti-psychotic medications. This quality measure was initially introduced to address the practice of some nursing homes of illegally using anti-psychotic medications to sedate residents with dementia or other increased patient care needs, rather than providing appropriate hands-on care interventions.

The measure, excluding residents with certain diagnoses, including schizophrenia, Huntington’s disease, and Tourette’s syndrome, resulted in some nursing homes improperly diagnosing residents with schizophrenia, observed the Consumer Voice, a national organization representing consumers in issues related to long-term care, helping to ensure consumers are empowered to advocate for themselves.      

CMS’s new guidance acknowledges that there has been a steady rise in schizophrenia diagnoses since the quality measure was first introduced, charges the Consumer Voice, noting that it comes on the heels of a report issued by the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) which found that from 2015-2019 there was a 194% increase in the number of residents diagnosed with schizophrenia who did not have that diagnosis prior to admission to the nursing home.

“It is important to note that it is extremely rare for schizophrenia to suddenly occur in older people,” says the Consumer Voice, stating that the onset of schizophrenia generally occurs in someone’s late teens through their twenties.

CMS announced that it will begin to conduct audits of nursing homes with high rates of schizophrenia diagnoses and “examine the facility’s evidence for appropriately documenting, assessing, and coding a diagnosis of schizophrenia.” Facilities that have “inaccuracies” will have their Five-Star Quality Measure Rating adjusted. CMS will downgrade the facility’s Quality Measure ratings to one star, which would drop their Overall Star Rating as well. CMS will monitor each facility’s data to determine whether they have addressed the identified issues. After that, CMS will decide whether any downgrades should be reversed.

While Consumer Voice has expressed significant concern with the accuracy of CMS’s Quality Measure, it supports these actions. The Quality Measure rating often inflates a facility’s overall 5-Star rating on Care Compare. This action will help incentivize compliance and make sure the public is aware of these illegal practices in nursing homes, says the consumer advocacy group.

Increased transparency

Separately, CMS announced it plans to take a new step to increase the transparency of nursing home information provided to consumers by publicly displaying survey citations that facilities are disputing. Currently, when a facility disputes a survey deficiency, that deficiency is not posted to Care Compare until the dispute process is complete. This process usually takes approximately 60 days; however, some cases can take longer. 

Although the number of actual deficiencies under dispute is relatively small, they can include severe instances of non-compliance such as Immediate Jeopardy (IJ) citations. This level of citation occurs when the health and safety of residents could be at risk for serious injury, serious harm, serious impairment, or death. Displaying this information while it is under dispute can help consumers make more informed choices when it comes to evaluating and choosing a facility. This new information will begin appearing on Care Compare on January 25th. While citations will be publicly displayed, they will not be included in the Five-Star Quality Rating calculation until the dispute is complete. 

“We support anything that CMS can reasonably do to improve the health and safety of seniors in long-term care, especially those with cognitive impairment. When it comes to the nursing home industry’s concerns about new CMS rules, we think it’s best to err on the side of transparency. Seniors and their families need as much information as possible to make informed decisions about long-term care,” says a spokesperson for the Washington, DC-based National Committee to Preserve Social Security and Medicare, an advocacy group whose mission is to protect Social Security and Medicare.

Local reaction:  “You cannot un-ring a bell”

RI Health Care Association

“We fully support improving nursing home transparency, safety and quality, and accountability regarding our members’ service to the residents and patients entrusted to their care,” says John E. Gage, President and CEO of Rhode Island’s Health Care Association, representing 64 of the 80 nursing facilities in the state. “Eliminating any inappropriate use of psychotropic medications and ensuring the highest quality of care is a shared focus of both CMS and RIHCA,” notes Gage.

“We strongly disagree with CMS’ decision to post of deficiencies that are in the process of being disputed through established CMS policies, regardless of their scope and severity, says Gage. “Posting deficiencies that, in many instances, are incorrect, inaccurately cited or cited at an inappropriate level of scope and severity, during an approved appeals process is unfair and could damage a facility’s reputation unfairly,” he adds.

According to Gage, doing this is akin to convicting someone before their full trial, (prosecution and defense alike) before the verdict is announced. “You cannot “un-ring a bell,” he says.

“As mentioned by CMS, we are just talking about a relatively small number of deficiencies,” states Gage. Rather than potentially posting erroneous deficiencies, he calls on CMS to speed up the process of conducting Informal Dispute Resolutions (IDRs) or Independent Dispute Resolutions (IIDRs) to no more than forty-five (45) days to ensure that accurate information is posted timely. IDRs and IIDRs are two different options from CMS that nursing homes can choose to appeal of cited deficiencies.

“As to the changes to the public reporting and the Five-Star Quality Rating System, we are disappointed that the Biden Administration and CMS have apparently made this determination administratively, without any comment period to allow for an opportunity for nursing homes and the public to provide feedback,” says Gage.

LeadingAge RI

“I appreciate CMS’s goal of increasing oversight of unnecessary antipsychotic medication use, although it should be noted that there has been a National Partnership to reduce the unnecessary use of antipsychotic drugs for years, so the industry has been very engaged in these efforts already,” notes James Nyberg, Executive Director of LeadingAge RI, a not-for-profit membership organization comprised of not-for-profit providers of aging services. 

Nyberg expresses concern about CMS posting deficiencies that are under dispute publicly. “That is taking a guilty before proven innocent approach, which is unfair and detrimental to providers. There is an existing process to resolve disputes over deficiencies, and this seems to short-circuit it, especially when deficiencies can be/and are overturned during the process.  One more blow to a beleaguered industry,” he says.

Long-Term Care Ombudsman

“The inappropriate use of antipsychotic medications in nursing homes has been an on ongoing issue for many years,” observes Kathleen Heren, Rhode Island’s Long-Term Care Ombudsman. “It takes a skilled practitioner who gives a battery of tests to diagnose someone with schizophrenia. This shouldn’t be determined by a hospital intern who spends 20 minutes with an agitated resident in a hospital emergency room,” she says.

According to Heren, schizophrenia has an early onset [about 4% of schizophrenia arise before the age of 15, and about 1% before the age of 10].  A 78-year -old resident does not become schizophrenic all of a sudden because he or she is agitated. “I can say that I have not seen many deficiencies given to Rhode Island nursing homes for overusing anti-psychotic medications,” she says, because of the efforts of  Health Care Centrics, Rhode Island’s Quality Assurance organization, that has provided in-depth staff training on the use of these drugs. The surveyors from the Rhode Island Department of Health (RIDoH) are very quick to cite facilities for not following guidelines in the inappropriate use of these drugs.

Heren says that there have been cases where RIDOH has rescinded a deficiency based on the input received by the survey team during the Informal Dispute Resolution process. “There are some facilities that are continually receiving deficiencies and that families should be able to see why a deficiency was given and a facilities response as to why it was considered unfair,” she says.

CMS Actions promote quality of care

RI Department of Health

“At the Rhode Island Department of Health (RIDoH), one of our major focus areas is monitoring and ensuring that nursing homes and other healthcare facilities provide the highest quality of care and services in a clean and safe environment, says Joseph Wendelken, RIDoH’s Public Information Officer. 

“We will continue to do everything we can to protect patients and residents, which includes following any new CMS protocols and partnering with CMS on new initiatives,” Wendelken says. 

Senior Agenda Coalition of RI

Adds Maureen Maigret, Policy Advisor for the Senior Agenda Coalition of RI, “Rhode Island nursing homes have generally provided good quality of care over the years,” acknowledging that improvements can always be made. “Both of these changes are intended to promote better quality care,” she says. “If people are erroneously coded as having schizophrenia, they may be subject to poorer care and harmed by being prescribed inappropriate medication. Posting inspection citations under dispute on Nursing Home Compare with a notation they are under dispute is important in that resolution of the dispute could take 60 days or longer and in the meantime the public remains unaware of what could be significant deficiencies which could impact their decisions,” states Maigret says.

The QSO memo — Updates to the Nursing Home Care Compare website and Five-Star Quality Rating System: Adjusting Quality Measure Ratings Based on Erroneous Schizophrenia Coding, and Posting Citations Under Dispute — is available here for review:

https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/policy-and-memos-states/updates-nursing-home-care-compare-website-and-five-star-quality-rating-system-adjusting-quality

Trustee Reports predict improved outlook for Social Security and Medicare

Published in RINewsToday on June 6, 2022

On June 2, 2022, following a meeting of the Social Security and Medicare Boards of Trustees, the Social Security Administration (SSA) – joined by the Departments of Health and Human Services and Labor, the Centers for Medicare & Medicaid Services, and the U.S. Department of Treasury — released a 275-page annual report giving us a snapshot of the financial health of the Social Security Trust Funds.

The Trustee reports findings

According to this year’s Trustee Reports, “Social Security and Medicare both face long-term financing shortfalls under currently scheduled benefits and financing. Costs of both programs will grow faster than gross domestic product (GDP) through the mid-2030s primarily due to the rapid aging of the U.S. population. Medicare costs will continue to grow faster than GDP through the late 2070s due to projected increases in the volume and intensity of services provided.”

The Social Security Trustees report that the combined asset reserves of the Old-Age and Survivors Insurance and Disability Insurance (OASI and DI) Trust Funds, paying benefits to 65 million retirees, disabled people as well as survivors of deceased workers, are projected to become depleted in 2035, one year later than projected last year, with 80 percent of benefits payable at that time. The DI Trust Fund asset reserves are not projected to become depleted during the 75-year projection period.

“It is important to strengthen Social Security for future generations. The Trustees recommend that lawmakers address the projected trust fund shortfalls in a timely way to phase in necessary changes gradually,” says Kilolo Kijakazi, Acting Commissioner of Social Security in a statement announcing the released report. “Social Security will continue to be a vital part of the lives of 66 million beneficiaries and 182 million workers and their families during 2022,” she adds.   

The Medicare Board of Trustees note in its 263 page report that the projected depletion date for Medicare’s trust fund for inpatient hospital care (Part A), covering around 64 million retirees and disabled persons, moved from last year’s forecast of 2026 to 2028. At this time Medicare will only be able to pay 90% of the scheduled benefits when the fund is depleted.

“We are committed to running a sustainable Medicare program that provides high quality, person-centered care to older Americans and people with disabilities,” said CMS Administrator Chiquita Brooks-LaSure. In a statement “Medicare trust fund solvency is an incredibly important, longstanding issue and we are committed to working with Congress to continue building a vibrant, equitable, and sustainable Medicare program,” she says.

Thoughts from senior advocacy groups

In a statement, AARP CEO Jo Ann Jenkins said that this year’s Social Security and Medicare Trustee report sends this clear message to Congress: “The Social Security and Medicare Trustees’ reports should send this “clear message” to Congress: “Despite the short-term improvement, you must act to protect the benefits people have earned and paid into both now and for the long-term. The stakes are too high for the millions of Americans who rely on Medicare and Social Security for their health and financial well-being.”

“These reports also underscore the urgent need for Congress to pass legislation allowing Medicare to negotiate for lower prescription drug prices, which would result in billions of dollars of savings for seniors, the Medicare program, and taxpayers,” says Jenkins.

Jenkins also calls on Congress to increase funding to fix serious long-time Social Security customer service problems, which currently impede or keep seniors and people with disabilities from getting their benefits in a timely manner.

Following the release of the Trustees Report, Executive Director Alex Lawson, of the Washington, DC-based Social Security Works, (SSW) a social welfare organization that lobbies for Social Security Reforms, also issued a statement: “Today’s report shows that our Social Security system remains strong. Protecting and expanding benefits is a question of values, not affordability. That this year’s projections are even stronger than last year’s proves once again that Social Security is built to withstand times of crisis, including pandemics.”

We don’t have a Social Security crisis, but we do have a retirement income crisis. With prices rising, seniors and people with disabilities are struggling to afford food and medicine. The solution is to expand Social Security,” says Lawson. 

According to SSW, the 2020 Social Security Trustee’s Report reported that Social Security has an accumulated surplus of about $2.85 trillion.  It projects that, even if Congress took no action whatsoever, Social Security not only can pay all benefits and associated administrative costs until 2035, it is 90 percent funded for the next quarter century, 84 percent for the next half century, and 81 percent for the next three quarters of a century.  

“At the end of the century, in 2095, Social Security is projected to cost just 5.86 percent of the gross domestic product (“GDP”), less than most other wealthy countries spend on their counterpart programs,” says SSW.

Max Richtman, President and CEO of the Washington, DC-based National Committee to Preserve Social Security and Medicare (NCPSSM), throws in his two cents about this year’s Trustee Report. “The takeaway from the latest Social Security Trustees report is this:  Congress must strengthen the program’s finances without delay. The Trustees project that the combined Social Security retirement and disability trust fund will become depleted by 2035, one year later than projected in their previous report. At that point, every Social Security beneficiary will suffer a 20% cut to their benefits.”

“Seniors struggling to meet rising living expenses need Social Security to be boosted and strengthened. The pandemic, runaway inflation and devastating stock market losses serve to remind us how vital a robust Social Security program is to workers, retirees, the disabled and their families. The clock is running down. The time for fair, just, and equitable action that safeguards Social Security’s financial stability is now,” adds Richtman.   

While acknowledging that the trust fund insolvency date may fluctuate from year to year, the urgent need to boost the program’s financing and benefits remains consistent, says Richtman. 

NCPSSM’s Richtman says, over the years, the GOP has opposed the expansion and strengthening of Social Security and has called for raising the retirement age, privatization, and more recently, ‘sunsetting’ Social Security and Medicare every five years.  He calls for passage of Rep. John Larson’s Social Security 2100: A Sacred Trust legislation that would extend trust fund solvency by requiring high wage earners to contribute their fair share through an adjustment in the payroll wage cap. 

A Washington Insider says that House Speaker’s Nancy Pelosi (D-CA) policy staff are concerned about the cost of Larson’s Social Security fix legislation and are seeking a CBO cost estimate. At press time this measure has more than 200 Democratic cosponsors in the House. The Congressional Asian Pacific American Caucus (CAPAC), Congressional Black Caucus (CBC), the Congressional Hispanic Caucus (CHC), the Task Force on Aging and Families, and the Congressional Progressive Caucus have all called on Pelosi to bring the bill to the House floor for a vote.

“Thanks to the American Rescue Plan, our economic recovery has strengthened both the Social Security and Medicare Hospital Insurance Trust Funds and improved financial projections for these vital programs. But to ensure that every American worker, senior, child, and person with disabilities receives the necessary and earned benefits provided by both Social Security and Medicare, we need to act. That’s why I am an original cosponsor of legislation like Social Security 2100: A Sacred Trust, to not only enhance benefits for seniors and some of our most vulnerable neighbors, but to also guarantee access to these programs for generations to come,” said Congressman David Cicilline, (D-RI).  

Congress can step in to financially strengthen the Social Security and Medicare programs. A message from the Social Security and Medicare Boards of Trustees suggest Congress pass legislation to reduce or eliminate the long-term financing shortfalls in both the Social Security and Medicare. “Taking action sooner rather than later will allow consideration of a broader range of solutions and provide more time to phase in changes so that the public has adequate time to prepare,” say the Trustees.

Congress should look for “medium-term solvency” fixes to ensure that Social Security program can pay full benefits for several decades rather than for the full 75-year projection period, suggests Paul N. Van De Water, Senior Fellow at the Washington, DC-based Center for Budget and Policy Priorities, a nonprofit nonpartisan research organization and policy institute that conducts research on government policies and programs. “But shoring up the program’s financing for a substantial period of time is important for assuring both current and future beneficiaries that Social Security will be there for them in the years to come,” he says.

At a crossroad

NCPSSM’s Richtman believes Social Security’s future is now at a crossroads. “We can either cut benefits or expand benefits and pay for it by requiring the wealthiest to pay their fair share,” he says, calling on Congress to hold an up or down votes on Larson’s Social Security legislation.

Polling shows that voters support fixing Social Security and Medicare. Seniors may well go to the polls, sending a message with their vote that strengthening and expanding Social Security is important to them.   

For a copy of the 2022 Social Security Trustee Report, go to https://www.ssa.gov/OACT/TR/2022/tr2022.pdf. For a copy of the 2022 Medicare Trustee Report, go to https://www.cms.gov/files/document/2022-medicare-trustees-report.pdf

Controversial move by CMS limits coverage for new Alzheimer’s drug, Aduhelm 

Published in RINewsToday on April 25, 2022

Earlier this month, amid the pleas of the Alzheimer’s Association, the National Committee to Protect Social Security and Medicare, and other aging advocacy groups, the Centers for Medicare & Medicaid Services (CMS) made its final decision to limit their Medicare coverage of the controversial Alzheimer’s drug, ADUHELM® , for only those Medicare recipients participating in clinical studies overseen by the National Institutes of Health (NIH) or in other approved clinical trials.

When releasing its decision on April 7, CMS noted from the onset, the federal agency “ran a transparent, evidence-based process that incorporated more than 10,000 stakeholder comments and more than 250 peer-reviewed documents into the determination” to make its decision.

Calls for More Rigorous Studies

According to CMS, over 6 million older Americans are believed to have Alzheimer’s, and this prevalence is expected to rise to 14 million by 2060, barring effective interventions. CMS stated that effective treatments are needed, and because of the early, but promising, evidence and the immense burden of this devastating disease on the Medicare population, the agency is finalizing Medicare coverage, calling for rigorous studies approved by the U.S. Federal Drug Administration (FDA) and NIH to help answer whether this class of drugs improves health outcomes for patients.

“Science, evidence, and stakeholder input led our team of career civil servants and clinicians through this national coverage determination process. There is potential for promise with this treatment; however, there is not currently enough evidence of demonstrating improving health outcomes to say that it is reasonable and necessary for people with Medicare, which is key consideration for CMS when making national coverage determination, said Dr. Lee Fleisher, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality, in a statement announcing CMS’s regulatory payment decision.

“In arriving at this final decision, we looked at the unique circumstances around this class of treatments and made a decision that weighed the potential for patient benefit against the significance of serious unknown factors that could lead to harm,” added Fleisher. “If a drug in this class shows evidence of clinical benefit through the traditional FDA approval process, then CMS will provide broad access and ensure the results from the rigorous trials are generalizable for people with Medicare participating in a CMS-approved study, such as a registry,” she said, noting that this decision was made to provide CMS flexibility to respond quickly to providing coverage for any new drugs in this class showing a clinical benefit. 

Biogen, a biotechnology company that manufacturers ADUHELM®m , was quick to give its opinion about CMS’s final decision about coverage of this drug. The Cambridge, Massachusetts based company charged that “this unprecedented decision effectively denies all Medicare beneficiaries access to ADUHELM®m , the first and only FDA approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class. These coverage restrictions, including the distinction between accelerated approval and traditional approval, have never been applied to FDA-approved medicines for other disease areas.”

When additional data from this new class of treatments become available, Biogen urged CMS to reconsider its final decision for all FDA-approved amyloid-beta targeting therapies. The company says that it is carefully considering its options and will provide updates as the company further evaluates the business impact of this decision.

Creating Unnecessary Barriers to Care 

Calling the CMS decision wrong, the Chicago-based Alzheimer’s Association expressed deep disappointment, charging that it has essentially ignored the needs of people living with Alzheimer’s disease. “CMS has created unnecessary barriers for individuals with Alzheimer’s disease. Patients with Alzheimer’s, a fatal disease, should have FDA approved treatments covered by Medicare just as those facing other diseases do,” said Harry Johns, Alzheimer’s Association chief executive officer. 

Notably, CMS has said in its decision the only way for patients to access the first approved FDA treatment targeting amyloid in those living with Alzheimer’s is to enroll in a clinical trial. While we note CMS has expanded where those clinical trials may take place, in reality this remains an unnecessary and never before imposed barrier to access an FDA-approved treatment, says Johns.

“People living with MCI, Alzheimer’s disease and other dementia deserve the same access to therapies given to those living with other conditions like cancer, heart disease and HIV/AIDS. They deserve the opportunity to assess if an FDA-approved treatment is right for them,” said Joanne Pike, Dr.P.H., Alzheimer’s Association president. “Drugs that treat people in the early stages of Alzheimer’s could mean more time for individuals to actively participate in daily life, have sustained independence and hold on to memories longer,” she said.

According to the Alzheimer’s Association, CMS has incorporated one of its recommendations into the final rule. “Importantly, CMS has decided to utilize a registry for future treatments granted full FDA approval. The Alzheimer’s Association registry will play an important role in collecting and analyzing real-world data. This registry will monitor and report clinical and safety endpoints for patients treated with FDA-approved AD therapies, including accompanying diagnostics, to track the long-term outcomes associated with these therapies in real-world settings. Similar successful registries in heart disease and cancer have enabled researchers, clinicians, health systems and payers to track the long-term performance of therapies using a large, real-world evidence dataset,” the advocacy group says. 

The Alzheimer’s Association also expressed strong concern about the immediate impact CMS’s decision will have on Alzheimer’s and dementia research and innovation. “The agency’s decision to essentially reject the Accelerated Approval Pathway for monoclonal antibodies targeting amyloid for the treatment of Alzheimer’s disease is broad overreach. Accelerated approval is a pathway created by Congress and utilized by FDA to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need. Alzheimer’s is a deadly disease with no survivors,” stated the advocacy group.

“The decision by CMS is a step backward for families facing Alzheimer’s disease,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer. “Years of increased research funding has led to more progress and innovation than ever before, but today’s decision may halt this progress as developers question if there is a pathway forward to coverage,” she said.

Calls for Reducing Cost of Medicare Part B Premiums

Max Richtman, President and CEO of the National Committee to Preserve Social Security and Medicare, calls on CMS to “swiftly reduce the hefty 2022 Medicare Part B premium increase ($21.60 per month), now that the agency has made its final decision to limit coverage of the controversial Alzheimer’s drug, ADUHELM®m, to patients in clinical trials.” 

“The spike in Medicare Part B premiums was partly based on the drug’s exorbitant cost (originally priced at $56,000 per year) and the potential expense of wider coverage,” says Richtman, noting that the agency is still “reviewing” Part B premiums, under previous direction from HHS Secretary Xavier Becerra. “Medicare beneficiaries struggling to pay their bills need relief from this year’s premium increase as soon as possible, warns Richtman. .

“The Aduhelm controversy highlights the urgent need for Medicare to be able to negotiate drug prices with Big Pharma. If the price of Aduhelm had been negotiated, it is unlikely that it would have impacted Medicare premiums so dramatically in the first place,”  adds Richtman, 

For a fact sheet on Medicare coverage policy for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease, visit https://www.cms.gov/newsroom/fact-sheets/medicare-coverage-policy-monoclonal-antibodies-directed-against-amyloid-treatment-alzheimers-disease.

To read the final NCD CED decision memorandum, visit https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305.