The Alzheimer's Association called the CMS draft "a shocking discrimination against everyone with Alzheimer’s disease."
Medicare would pay for a limited class of pricey and controversial anti-amyloid drugs used to treat Alzheimer's disease, but only for seniors already enrolled in qualified clinical trials, under a proposed National Coverage Determination decision memorandum issued Tuesday by the Centers for Medicare and Medicaid Services.
The proposed NCD would cover only Food and Drug Administration-approved monoclonal antibodies -- such as Biogen's Aduhelm -- that target amyloid protein aggregates in early stage Alzheimer's patients with mild cognitive impairment.
Adulelm costs about $28,000-a-year per patient, and results so far have been mixed. While CMS and FDA do not take a drug's price into consideration when determining coverage, federal officials in November said the high cost of the drug was partially to blame for the $21-a-month increase in Medicare Part B premiums. However, Health and Human Services Secretary Xavier Becerra this week ordered Medicare to reassess the increase. CMS officials stressed that the proposal had no bearing on Becerra's comments.
CMS Administrator Chiquita Brooks-LaSure said the proposed NCD will give the public "a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients."
"CMS has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders," she said.
Public comments on the NCD will be accepted over the next 30 days, and a final decision is expected by April 11.
The pharmaceutical lobby and Alzheimer's patient advocates let their disapproval be known within minutes of CMS's announcement late Tuesday afternoon.
Biogen said the draft "denies nearly all Medicare beneficiaries" from accessing its product and future amyloid-targeting therapies.
"It is imperative to change this draft decision to be aligned with reimbursement for other therapies for progressive diseases, where patients have immediate and equal access to medicines approved by the FDA," Biogen said in a media release.
PhRMA spokesperson Nicole S. Longo called the draft "another setback for patients suffering from Alzheimer's disease and their caregivers."
"With this proposal, CMS is writing off an entire class of medicines before multiple products have even been reviewed by FDA, positioning itself and not FDA as the key arbiter of clinical evidence," she said
The Alzheimer's Association called the CMS draft "a shocking discrimination against everyone with Alzheimer’s disease, especially those who are already disproportionately impacted by this fatal disease, including women, Blacks and Hispanics."
"With this approach, access to treatment would now only be available to a privileged few, those with access to research institutions, exacerbating and creating further health inequities," the association said.
"Critically, this draft decision is not about one treatment but about this class of potential future treatments targeting amyloid for the treatment of Alzheimer's disease. This draft decision appears focused on an individual treatment rather than a class, which is not what CMS set out to do."
George Vradenburg, chairman and co-founder of UsAgainstAlzheimer's, called the proposal "absolutely unacceptable" and noted that CMS's limiting Medicare coverage for an FDA-approved drug shows that "HHS is clearly at war with itself."
"If this decision stands, for the first time in history, millions of Americans will be denied coverage not just to a drug, but to a whole class of drugs—not by the agency that regulates drugs but by the federal insurance bureaucracy," Vradenburg said.
"Why are treatments for Alzheimer's patients being held to a different standard than those treating cancer, HIV, and other illnesses," he said. "Is it because there are so many of us? Is it because we’re old? CMS should be ashamed of the way it is discriminating against this one group of patients."
At a media teleconference Monday afternoon, CMS CMO Lee Fleisher, MD, director of the Center for Clinical Standards, said the NCD is limited in scope because "our obligation is to ensure that we look at approved treatments that are shown that benefits and those benefits outweigh the harms."
"We are making sure that the patients in this clinical trial will reflect the population of patients who have Alzheimer's in the Medicare population."
The average size of the smaller hospital partner by annual revenue increased to $619 million from $388 million in 2020.
There were fewer hospital mergers and acquisitions in 2021, but the deals that went through involved bigger health systems generating almost twice as much revenue when compared with M&As in 2020, Kaufman Hall reports in a new analysis.
Of the 49 consolidations identified in the KH analysis in 2021, eight (16.3%) were classified as "mega mergers," with the smaller partner's average annual revenues surpassing $1 billion. This was nearly double the percentage from 2020 (8.9%) and the highest in six years, KH said.
Overall, the average size of the smaller hospital by annual revenue increased to $619 million in 2021 from $388 million in 2020, KH reports.
The analysis identified several factors limiting smaller mergers in 2021, including the fact that there are simply fewer smaller, independent, unaffiliated community hospitals looking for a partner, and that acquiring hospitals are getting choosier.
"Organizations are focused on partnerships with a strong strategic rationale and have become increasingly selective in identifying potential partners," KH said. "They seek partnerships that will have a transformative impact through the addition of new capabilities, enhanced intellectual capital, and access to new markets or services."
The analysis also noted that:
Smaller M&A partners with a credit rating of A- or better comprised more than 10% of transactions, which is consistent with 2020 transactions.
Since 2011, average smaller partner size by annual revenue has increased at a compound annual growth rate (CAGR) of approximately 8%.
Not-for-profit health systems' roles as both buyer and seller grew as a percentage of total transactions in 2021, representing 87% of announced transactions, compared with 81% in 2020.
Rural or urban/rural sellers grew to 31% of announced transactions from 24% in 2020. The number of financially distressed sellers remained flat at 16% of announced transactions from 2020 to 2021.
Other notable trends identified in the analysis include hospitals’ greater focus on core markets and assets, strengthening intellectual capital resources, and addressing societal issues and underserved populations.
KH says these trends are expected to continue into 2022.
Established in 1998, the SDP can be used by providers, suppliers, or other individuals or entities subject to Civil Monetary Penalties to voluntarily disclose self-discovered evidence of potential fraud.
Self-disclosure gives providers the opportunity to avoid the costs and disruptions associated with a government-directed investigation and civil or administrative litigation. The revision unveiled this week incorporates legal changes made since the last revision to the SDP in 2013.
What's changed?
Increased the minimum amounts required to settle under the SDP to match new statutory minimum penalty amounts.
Required SDP submissions to be made through the HHS-OIG website.
Added references to OIG's 2019 Grant and Contract SDPs.
Clarified that CIA Reportable Events can be disclosed under the SDP.
Clarified that DOJ sometimes settles SDP cases.
Clarified that disclosures must include damages to each affected federal healthcare program and the sum of all damages.
Made technical changes to statistics, terminology and background facts.
What hasn't changed?
Timelines and content requirements.
Methods for calculation of damages.
Timely settlement with a lower multiplier and an exclusion release.
The conversion factor per relative value unit under the 2022 fee schedule will be reduced to $33.59, down from $34.89 in 2021.
Physicians are staring at a nearly 9% cut in Medicare reimbursements in 2022, but telehealth payments will extend through at least 2023 under the 2022 Physician Fee Schedule made public late Tuesday by the Centers for Medicare & Medicaid Services.
CMS Administrator Chiquita Brooks-LaSure says the final rule will promote greater use of telehealth for behavioral healthcare, encourage growth in diabetes prevention and boost payments for vaccine administration.
"The COVID-19 pandemic has highlighted the gaps in our current healthcare system and the need for new solutions to bring treatments to patients, wherever they are," Brooks-LaSure said. "This is especially true for people who need behavioral health services, and the improvements we are enacting will give people greater access to telehealth and other care delivery options."
The final rule also adds quality metrics designed to incentivize clinicians to improve outcomes for Medicare beneficiaries.
Acting on legislation passed by Congress last year, CMS is eliminating geographic barriers and allowing patients to access telehealth services in their homes for diagnosis, evaluation, and treatment of mental health disorders.
For physicians, the conversion factor per relative value unit under the 2022 fee schedule will be reduced to $33.59, down from $34.89 in 2021, a drop of $1.31, which CMS said is the result of the anticipated sunset of a temporary 3.75% payment increase in 2022, a 0% conversion update, and adjustments mandated by budget neutrality.
The American College of Surgeons blasted the payment reductions and said the expected 3.75% payment sunset coupled with the mandated Medicare cuts mean that surgeons will see nearly a 9% reduction in reimbursements.
"Surgeons and their patients have already been significantly impacted by the pandemic," ACS Executive Director David B. Hoyt, MD, said. "These Medicare cuts will further exacerbate our pandemic-strained health care system and cause further delay in care to the patients who need it most."
CMS has also delayed by at least one year the penalties for Appropriate Use Criteria. The penalty phase was supposed to begin on Jan. 1, 2022, but it's been pushed back to either Jan. 1, 2023, or the Jan. 1 that follows the end of the COVID-19 public health emergency.
For the Quality Payment Program, CMS will implement seven optional Merit-based Incentive Payment System Value Pathways, starting in 2023. MVPs align the reporting requirements of the four MIPS performance categories around specific clinical specialties, medical conditions or episodes of care. CMS also will increase the MIPS performance threshold score clinicians and groups must exceed to receive positive payment adjustments beginning with CY 2024 payment.
After the violations were discovered, Geisinger Community Health Services told the United States Attorney's Office.
Geisinger Community Health Services will pay the federal government $18.5 million to resolve self-disclosed violations of Medicare billing rules for hospice and home-based care, the Department of Justice announced.
According to the voluntary disclosures, between January 2012 and December 2017, Danville, Pennsylvania-based GCHS affiliates submitted claims to Medicare for hospice and home health services that violated Medicare rules and regulations regarding physician certifications of terminal illness, patient elections of hospice care, and physician face-to-face encounters with home health patients, DOJ said.
After the violations were discovered, GCHS took corrective action and disclosed the matter to the United States Attorney’s Office.
"The $18 million payment in this matter reflects the priority healthcare providers should place on making sure they closely follow all Medicare rules and regulations," Bruce D. Brandler, acting U.S. Attorney for the Middle District of Pennsylvania, said in a media release.
"Healthcare fraud remains a focus of the Department of Justice and the Affirmative Civil Enforcement Unit of the United States Attorney's Office. I commend GCHS for taking this seriously, voluntarily disclosing these issues to our office and working to address the problems that led to these violations," he said.
GCHS responds
GCHS issued the following statement:
"As part of a routine self-audit, Geisinger uncovered billing deficiencies related to home health and hospice services from 2012 to 2017. We promptly took corrective action, notified the federal government and cooperated fully with the government leading up to this settlement. Since uncovering these deficiencies, we have conducted follow-up audits that have shown 100 percent compliance, and we do not anticipate any further billing deficiencies related to these services."
The state executives were told that frail patients have come to rely on remote access with their specialist providers, many of whom reside out of state.
More than 230 telehealth stakeholders sent a letter to the nation's 50 governors urging them to keep in place licensure flexibilities enacted at the start of the pandemic for the duration of the federal public health emergency.
"Over the last few months, many states have allowed COVID-19 emergency declarations to expire and the licensure flexibilities to expire with it, despite the ongoing pandemic and surge in cases due to the Delta variant," said the letter, coordinated by the Alliance for Connected Care, the ALS Association, and the National Organization for Rare Disorders.
"This has been extremely detrimental and disruptive to necessary and ongoing patient care," the letter said. "Healthcare providers have had to scramble to notify thousands of out-of-state patients that their telehealth appointments were no longer possible, and that they would have to drive across state borders to keep their appointments."
Among the flexibilities in the March 2020 1135 waiver put forward by the Centers for Medicare & Medicaid Services, states were allowed to waive licensing requirements so that remote providers could offer patient care across state lines. In addition, eligible payments for telehealth services were expanded to include hospital, physician office, and patient home visits, and a range of providers were allowed to bill for telehealth, including nurse practitioners, clinical psychologists, and licensed clinical social workers. Providers were also given the flexibility to reduce or waive cost-sharing for telehealth visits paid for by federal healthcare programs.
The stakeholders told the governors that many patients have come to rely on telehealth access to see specialists in another state, "made possible by licensure flexibilities enacted at the start of the pandemic, so as not to risk exposure to the virus and to maintain continuity of care through virtual options."
"These patients are now faced with canceling these vital appointments or risking an in-person visit and thus exposure to COVID-19," the letter said.
Krista Drobac, executive director of the Alliance for Connected Care, said government and stakeholdders "must build on the lessons learned from the pandemic and ensure patients can access care from their providers regardless of where they live, especially as the pandemic continues."
"Patients and their families seek care across state lines for many reasons," she said, "and the licensure flexibilities put in place throughout the pandemic have been critical for expanding patient access to care, improving care coordination and continuity of care, and addressing workforce shortages. State governors must act to ensure these flexibilities continue and consider solutions to address the ongoing needs of patients both during the pandemic and in the future."
In October, telehealth stakeholders asked the Biden Administration to provide guidance on the anticipated end of the PHE while also calling for the extension of the PHE and its telehealth provisions through the end of 2022.
In a letter to Health and Human Services Secretary Xavier Becerra, American Telemedicine Association CEO Ann Mond Johnson said the PHE created "flexibilities that have allowed clinicians across the country to provide all Americans high-quality virtual care at a time of great need."
USDA also invests $50 million to improve access to telemedicine, distance learning for 7.6 million rural Americans.
The U.S. Department of Agriculture says it will begin accepting applications for up to $1.15 billion and loans and grants to expand broadband in rural areas.
To be eligible for the ReConnect Program – part of President Joe Biden's Build Back Better Agenda -- the USDA said applicant must serve an area without broadband service at speeds of 100 megabits per second and 20 Mbps, and commit to building facilities capable of providing broadband service at speeds of 100 Mbps to every location in its proposed service area.
"For too long, the 'digital divide' has left too many people living in rural communities behind: unable to compete in the global economy and unable to access the services and resources that all Americans need," USDA Secretary Tom Vilsack said in a media release.
"Rural people, businesses and communities must have affordable, reliable, high-speed internet so they can fully participate in modern society and the modern economy, Vilsack said.
"As we build back better than we were before, the actions… will go a long way toward ensuring that people who live or work in rural areas are able to tap into the benefits of broadband, including access to specialized health care, educational opportunities and the global marketplace."
Funding awards will priorititize projects that serve low-density rural areas with locations lacking internet access services at speeds of at least 25 Mbps and 3 Mbps.
USDA will also consider the economic needs of the community; affordable service options; commitments to strong labor standards; and whether a project is serving tribal lands or is submitted by a local government, Tribal Government, non-profit or cooperative.
USDA said it has simplified the application process and expanded the program, offering 100% grants for certain projects on tribal lands and in socially vulnerable communities.
American Telemedicine Association CEO Ann Mond Johnson says the PHE created "flexibilities that have allowed clinicians across the country to provide all Americans high-quality virtual care at a time of great need."
Telehealth stakeholders are asking the Biden Administration to provide guidance on the anticipated end of the COVID-19 Public Health Emergency while also calling for the extension of the PHE and its telehealth provisions through the end of 2022.
In a letter to Health and Human Services Secretary Xavier Becerra, American Telemedicine Association CEO Ann Mond Johnson said the PHE created "flexibilities that have allowed clinicians across the country to provide all Americans high-quality virtual care at a time of great need."
"Patients and providers know the 'telehealth cliff' is coming with the end of the PHE should Congress fail to act in time," Mond Johnson said. "However, a significant amount of uncertainty surrounds the question of when the PHE will actually expire,"
"We recognize there are many unknowns related to the trajectory of the COVID-19 pandemic over the next 12 to 24 months. However, we implore Secretary Becerra to provide as much predictability and certainty as possible to ensure adequate warning before patients are pushed over this looming cliff," she said.
Becerra this month extended by 90 days the PHE, effective October 18 through January 16, 2022.
Mond Johnson noted that in January 2021 the Biden administration promised governors across the nation that it would provide predictability and stability during the PHE.
"This was a simple action but proved to be hugely beneficial to state and local leaders, federal policymakers, providers, and patients who all relied on a sense of certainty that PHE policies—including those for telehealth—would not be taken away without warning," Mond Johnson said.
The consumer-focused genealogy researcher says the acquisition will advance its "vision of individualized primary care that empowers consumers to live healthier lives."
Under the deal, the purchase price is $400 million, of which 25% will be paid in cash and 75% in shares of 23andMe Class A Common Stock. The acquisition is expected to close by December.
Paul Johnson, CEO and co-Founder of Lemonaid Health, will be the general manager of the 23andMe consumer business and will continue to run Lemonaid Health.
"23andMe's mission-driven focus on empowering and transforming the healthcare experience is perfectly aligned with Lemonaid Health's founding principle to improve access to quality healthcare," Johnson said.
Ian Van Every, managing director, U.K. and co-founder of Lemonaid Health, will manage operations in the U.K.
Anne Wojcicki, CEO and co-founder of 23andMe, said that, with the addition of Lemonaid Health's clinical and pharmacy services offerings to her company's consumer business, "we are taking an important step in transforming the traditional primary care experience and making personalized healthcare a reality."
"By starting with genetics as the foundation, we will give patients and healthcare providers better information about health risks and treatments, opening up the door to prevent as well as better manage disease," Wojcicki said. "Lemonaid Health's focus on the patient and its philosophy of delivering individualized care fits perfectly with our mission of empowering people to take control of their health."
The program launches in January 2022 and will be available to all Cigna customers enrolled in employer-sponsored plans.
Cigna Health Plan's Evernorth subsidiary announced Tuesday that it will leverage its recently acquired MDLIVE telehealth platform to expand virtual care to "millions of customers."
The clinical services offered will include digital-first primary, dermatology, behavioral and urgent care. In addition, MDLIVE physicians will join Cigna's other clinicians, with access to patient health records, to coordinate the care, the company said.
The program launches in January 2022 and will be available to all Cigna customers enrolled in employer-sponsored plans.
"With MDLIVE now part of Evernorth, we've fast-tracked our ability to offer a broader suite of differentiated, future-state care solutions that make the patient experience easier and more convenient," Evernorth President Eric Palmer said in a media release.
"Today's announcement represents a significant step forward for millions of health plan customers who will gain on-demand access to a wider range of highly-specialized, in-network health care professionals."
Heather Dlugolenski, senior vice president, solutions, Cigna said the expansion builds on last year's launch with MDLIVE of a virtual wellness visit program and extends primary care access to the more than 75% of Cigna customers in 2020 who used MDLIVE but did not have a regular primary care doctor.
"Not only will this give more people an additional entry point to the healthcare system, but patients will be able to build lasting relationships with their preferred MDLIVE provider just as they would in a traditional office setting," Dlugolenski said.
For some employers, Cigna is also offering virtual-first health plans that include $0 copays with MDLIVE primary care providers, chronic disease management and care navigation, with no referrals needed for in-person visits with in-network health care providers.
The Cigna announcement comes one week after UnitedHealthcare unveiled a collaborative with Optum to roll out a "virtual-first health plan" in nine markets across the nation. Minnetonka, Minnesota-based United is touting NavigateNOW as "a simpler, more convenient experience at approximately 15% less premium cost than traditional benefit plans."
