Patients will make the final decision about their care venue, but CMS says the initiative allows patients to stay at home with family without COVID-mandated visitation restrictions in hospitals.
"We're at a new level of crisis response with COVID-19," Centers for Medicare & Medicaid Services Administrator Seema Verma said.
"CMS is leveraging the latest innovations and technology to help healthcare systems that are facing significant challenges to increase their capacity to make sure patients get the care they need." she said.
Six health systems have been approved for the new waivers and include Brigham and Women's Hospital; Huntsman Cancer Institute; Massachusetts General Hospital; Mount Sinai Health System; Presbyterian Healthcare Services; and UnityPoint Health. CMS expects new applications to be submitted.
"With new areas across the country experiencing significant challenges to the capacity of their health care systems, our job is to make sure that CMS regulations are not standing in the way of patient care for COVID-19 and beyond," Verma said.
Patients will make the final decision about their care venue, but Verma said the initiative allows patients to stay at home with family without COVID-mandated visitation restrictions in hospitals.
The new allowances build on the March 2020 Hospitals Without Walls program that provides broad regulatory flexibility for hospitals to provide services in non-traditional care venues.
CMS identified more than 60 acute conditions, such as asthma, congestive heart failure, pneumonia, and chronic obstructive pulmonary disease, that can be treated and monitored safely in patients' homes.
Hospitals adopting the allowances must have screening protocols in place before care at home begins to assess both medical and non-medical factors, including working utilities, assessment of physical barriers and screenings for domestic violence concerns.
Medicare enrollees will only be admitted from emergency departments and inpatient hospital beds, and an in-person physician evaluation is required before starting home care.
In addition, a registered nurse must evaluate each patient once a day either in person or remotely, and two in-person visits must take place every day, by either registered nurses or paramedics, based on the patient's nursing plan and hospital policies.
ASC Flexibility
CMS is also updating its previously announced regulatory flexibility for ASCs during the Public Health Emergency, which will allow them to provide inpatient hospital care for longer periods than the 24-hour period normally allowed.
With the update, ASCs need only provide 24-hour nursing services when there is actually one or more patient receiving care onsite, which allows ASCs to "flex up" staffing as needed to provide a relief valve for overwhelmed hospitals while not mandating nurses be present when no patients are in the ASC.
The flexibility is available to any of the 5,732 ASCs in the United States and will be immediately effective for the 85 ASCs now participating in the Hospital Without Walls initiative.
CMS said the flexibility will allow ASCs enrolled as hospitals to serve as another access point for surgical capacity and other emergent non-COVID-19 procedures, such as cancer surgeries.
The rule finalizes changes to two technical aspects of the HHS-RADV program, the error rate calculation and the application of HHS-RADV results.
The Centers for Medicare & Medicaid Services this week issued a final rule to amend the methodology for the Department of Health and Human Services’ risk adjustment data validation (HHS-RADV) program.
After collecting stakeholder feedback, CMS says the final rule "will give states and insurers more stability and predictability, promote program integrity, and foster increased competition."
*These changes will also promote fairness by ensuring that insurers are not penalized in HHS-RADV when a difference in diagnosis for an enrollee has no effect on risk, as well as by ensuring that insurers that receive adjustments are receiving adjustments in proportion to the errors identified through HHS-RADV," CMS said.
The first change refines the HHS-RADV error rate calculation, which is based on the insurers' "failure rate," a metric that validates diagnoses and conditions associated with enrollees selected for audit.
The final rule will also:
* Modify grouping medical conditions in HHS-RADV within the same hierarchical condition category (HCC) coefficient estimation groups in risk adjustment to determine failure rates for those HCCs. The modification will better account for the difficulty in categorizing some conditions and to refine how the error rate calculation measures risk differences among condition groupings.
* Reduce the magnitude of risk score adjustments for insurers close to the threshold used to determine whether an issuer is an outlier. Now, insurers whose failure rates are not significantly different from insurers just inside the threshold may see significant changes to their risk scores and transfers, creating a "payment cliff" for insurers just outside the threshold.
* Modify the error rate calculation in cases where certain outlier insurers have a negative failure rate. A low failure rate is not always due to more accurate data submission. A low failure rate can also be due to not identifying conditions that should have been reported in risk adjustment.
The changes are based on lessons learned and stakeholder feedback from the initial years of HHS-RADV. It is part of a larger initiative to disincentivize insurers from cherry-picking, younger, healthier, low-risk enrollees.
Montgomery now is a Board Partner at venture capital firm Greycroft. In August, she resigned as CEO from home furnishings retailer Crate & Barrel, where she was credited with transitioning the company toward online sales.
CVS Health Corporation on Monday announced that former Crate & Barrel CEO Neela Montgomery has been named president of CVS Pharmacy Retail, overseeing the company's more than 10,00 retail stores across the nation.
"I am thrilled to lead CVS Pharmacy with its 190,000 dedicated colleagues and join such an outstanding leadership team," said Montgomery, who starts on November 30.
"CVS Pharmacy plays a unique and important role in the health needs and lives of Americans. Increasingly these health care touch points will be digital, virtual and in-person," she said. "This is a fantastic opportunity to help accelerate the company's bold vision to deliver consumer health services in the community and ensure CVS Pharmacy plays an essential role in customers' health moments."
Montgomery now is a Board Partner at venture capital firm Greycroft. In August, she resigned as CEO from home furnishings retailer Crate & Barrel, where she was credited with transitioning the company toward online sales.
She brings with her more than 20 years of retail experience with her to CVS. Before Crate & Barrel, Montgomery served as Group Executive Board Member of the e-commerce retailers Otto Group.
"Neela is a seasoned retail industry leader with extensive digital and e-commerce experience," said Karen S. Lynch, who becomes president and CEO of CVS Health in February 2021.
"She brings deep consumer insights that will allow us to better anticipate consumers' changing needs and deliver even more value to our customers in local, personalized ways," Lynch said. "Neela is well-positioned to lead CVS Pharmacy today and into the future."
Before joining Otto, Montgomery served as UK General Merchandise Director at Tesco PLC, the British multinational retailer and a top 10 international retailer. She held a number of senior management positions with Tesco, including UK e-commerce director and chief merchant for Tesco Malaysia.
Montgomery will report directly to Lynch and become a member of the company's executive team. She earned a Bachelor of Arts degree in Literature and Language from Oxford University and holds an MBA from INSEAD in France and Singapore.
The administration will eliminate Medicare Part D drug rebates for "middlemen" and impose a Most Favored Nation pricing policy on some Part B drugs.
President Donald J. Trump on Friday unveiled two final rules; one that eliminate drug rebates to "middlemen" under Medicare Part D, and one that peg prices for some Part B drugs to the lowest price charged in other industrialized nations.
"The first action will save American seniors billions of dollars by preventing middlemen, famous middlemen they call them, from ripping off Medicare patients with high prescription prices," Trump said Friday afternoon at a media briefing.
"Currently, drug companies provide large discounts on the price of prescription medicines including nearly $40 billion in rebates to Medicare Part D plans last year alone," Trump said. "Yet often middlemen stop those discounts from going to the patients -- which is what we're interested in not the middlemen -- who need it the most."
Critics say eliminating the rebates does nothing for beneficiaries but provides a $100 billion bailout for drug makers.
President Donald J. Trump on Friday pushed forward two final rule to eliminate prescription drug rebates in Medicare Part D.
The Campaign for Sustainable Rx Pricing said eliminating the drug rebate does nothing to help Medicare beneficiaries, and could give drug makers billions in additional profits.
"The Big Pharma-backed Rebate Rule is a misguided proposal that the administration's own actuaries found would do nothing to lower drug prices while increasing premiums on Medicare Part D beneficiaries, costing taxpayers more than $200 billion and handing drug companies a more than $100 billion bailout," said CSRxP executive director Lauren Aronson.
"CSRxP looks forward to working with the next administration and lawmakers to halt and reverse implementation of this disastrous policy in order to focus drug pricing efforts instead on market-based solutions to increase transparency, boost competition and hold Big Pharma accountable," Aronson said.
Most Favored Nation
Trump said the Most Favored Nation Model, which will begin in January, will peg payments for some Medicare Part B drugs to the lowest price charged in other advanced nations, could save taxpayers $85 billion over the next five years.
Trump said Friday that Most Favored Nation "will transform the way the U.S. government pays for drugs to end global freeloading on the backs of Americans.
"Until now, Americans have often been charged more than twice as much for the exact same drug. as other medically advanced countries," he said. "In case after case our citizens pay massively higher prices than other nations pay for the same exact pill from the same factory, effectively subsidizing socialism abroad with skyrocketing prices at home," Trump said.
Health and Human Services Secretary Alex Azar said the MFN model is needed to stem the skyrocketing costs of Medicare Part B drugs, the cost of which have increased by 11.5 % over the past five years.
The 2020 Medicare Trustees report said Medicare Part B drugs have been a major contributor to overall Medicare Part B spending trends, accounting for 37% of the change in Medicare Fee-for-Service Part B benefit spending from 2015 to 2019.
Medicare Part B drug spending of $30 billion in 2019 made up 14% of total Medicare FFS Part B spending, up from 11% in 2015.
By law, Medicare Part B must pay for most drugs administered by physicians at the average sales price in the United States, plus a percentage-based add-on payment.
Centers for Medicare & Medicaid Services Administrator Seema Verma says the current system "creates incentives for drug manufacturers to price Medicare Part B drugs as high as they can in the U.S. system because the program pays doctors more when they prescribe more expensive drugs, even when a lower cost, clinically-equivalent alternative is available."
"The Most Favored Nation Model will lead to lower drug prices for seniors," Verma said.
Unapproved Drugs Initiative
Also Friday, Trump announced that he is eliminating the Unapproved Drugs Initiative to stop price gouging by drug makers.
"In the past, drug companies have been allowed to identify certain very old, generic drugs that have been widely available for decades and exploit this misguided program" to gain market exclusivity, he said. "Then they jacked up the prices by as much as 1,000% to 5,000%. This program has also caused shortages of essential medicines."
It's not clear if the incoming Biden administration will keep the rules in place but Trump said he "hope(s) they have the courage to keep it because the powerful drug lobby, big PhRMA, is putting pressure on people like you wouldn't believe."
A new survey finds 60% of clinician respondents say telehealth has improved the health of their patients, and 68% said they’re motivated to increase telehealth use.
More than 75% of 1,594 physicians and other clinicians in a new national survey say telehealth has allowed them to provide quality care for a variety of specialties, from COVID-19-related care to behavioral health.
“The strong support shown for telehealth, as evidenced in these results, reinforces the knowledge that telehealth is critical to how we deliver healthcare today," said study co-author Steve Ommen, MD, medical director, Mayo Clinic Center for Connected Care.
"The use of telehealth during the COVID-19 pandemic highlights its importance in care delivery. Its continued use will be instrumental in connecting to patients everywhere, Ommen said.
The 48-question survey was conducted between July 13 and August 15. Most respondents (87%) were medical doctors and 13% were nurse practitioners, psychologists, physician assistants, and social workers.
Among the survey findings:
60% said telehealth has improved the health of their patients.
68% said they’re motivated to increase telehealth use in their practices.
11% said they were using remote patient monitoring technologies with patients in their homes, including smartphones, blood pressure cuffs, body weight scales, and pulse oximeters.
55% said that telehealth has improved the satisfaction of their work.
More than 80% said telehealth improved the timeliness of care for their patients. A similar percentage said their patients have reacted favorably to telehealth.
Barriers Remain
Despite the solid reviews for telehealth, the survey also identified ongoing barriers to adoption.
Specifically:
More than 64% said technology challenges for patients were a barrier, and included lack of access to technology and/or internet/broadband, and low digital literacy.
58% of physicians can't access their telehealth technology directly from their electronic health records.
73.3% said no or low reimbursement will be a major challenge post-COVID.
Susan R. Bailey, MD, president of the American Medical Association, said that, despite proving its worth during the pandemic, "how telehealth will be used after the pandemic is in the balance."
"No one wants to see new access to telehealth suddenly halted," she said. "The time is now for government officials, physicians, patients, and other stakeholders to work together on a solid plan to support telehealth services going forward."
The survey is part of the Telehealth Impact Study prepared by the coalition's Telehealth Work Group, comprised of the American Medical Association, American Telemedicine Association, Change Healthcare, Digital Medicine Society, Massachusetts Health Quality Partners, MassChallenge HealthTech, Mayo Clinic, and MITRE.
As coronavirus pandemic numbers reach new highs, public health officials and provider association ask the public to "celebrate responsibly."
With the coronavirus surging, the nation's leading healthcare associations on Thursday urged people to celebrate Thanksgiving "in a scaled-back fashion that limits the virus's spread, to help reduce the risk of infecting friends, family and others you love."
"In the strongest possible terms, we urge you to celebrate responsibly," the American Hospital Association, the American Nurses Association, and the American Medical Association wrote jointly in"an open letter to the American people."
"We are all weary and empathize with the desire to celebrate the holidays with family and friends, but given the serious risks, we underscore how important it is to wear masks, maintain physical distancing and wash your hands," the letter said.
The Johns Hopkins University Coronavirus Resource Center reported on Thursday that COVID-19 has claimed 251,000 lives across the United States, and that 11.5 million people have been infected by the coronavirus.
The provider associations' plea came shortly after the Centers for Disease Control and Protection issued a similar plea and suggested that "the safest way to celebrate Thanksgiving is to celebrate at home with the people you live with."
"Travel may increase your chance of getting and spreading COVID-19. Postponing travel and staying home is the best way to protect yourself and others this year," the CDC said.
The associations and the CDC note that COVID-19 cases spiked after Memorial Day, July 4th, Labor Day, and are hitting new highs two weeks after Halloween.
"The record-shattering surge underway is resulting in uncontrolled community spread and infection that has already overburdened health systems in some areas and will ultimately consume capacity of our health care system and may reduce the availability of care in many places in our country," the provider associations said.
"Following these science-based, commonsense measures is the best way to prevent our health care systems and dedicated health care professionals from being overwhelmed by critically ill patients," they wrote. "We must protect the doctors, nurses and other caregivers who have tirelessly battled this virus for months. You can do your part to ensure they can continue to care for you and your loved ones."
AMA President Susan R. Bailey, MD, said the "guardrails" for the public option were adopted by the AMA's House of Delegates as part of a broader effort to get more people covered.
The American Medical Association has offered caveat-laden support for some version of a public option health plan that is expected to be brought forward in the coming months when President-elect Joe Biden takes office.
AMA President Susan R. Bailey, MD, said the "guardrails" for the public option were adopted by the AMA's House of Delegates as part of a broader effort to get more people covered.
Specifically, Bailey said, the public option should be available to patients who fall into the "coverage gap" in states that have not expanded their Medicaid rolls under the Affordable Care Act; people who make too much money to qualify for Medicaid, but not enough to afford commercial coverage.
"A public option should not be seen as a panacea to cover the uninsured. It should not be used to replace private insurance; rather it can be used to maximize competition," Bailey said. "With appropriate guardrails, the AMA will examine proposals that would provide additional coverage options to our patients."
The AMA would also support providing financial assistance to buy private or public-option coverage on the ACA Marketplace for people who have access only to otherwise unaffordable employer-sponsored coverage.
The AMA guidelines also call for:
Public-option plans to compete "on an even playing field" with commercial plans.
Payment rates that are "similar" to those of private plans, established through "meaningful negotiations and contracts."
No mandates on physician participation.
Prohibiting federal subsidies for public option plans, which must be "financially self-sustaining."
The AMA's House of Delegates also backed auto-enrollment in Medicaid and CHIP, and in zero-premium ACA marketplace plans for the uninsured who have coverage options available to them at no cost after subsidies are included.
"The AMA believes that now is the time to build upon the ACA to cover more of the uninsured," Bailey said. "We look forward to being at the table to represent physicians and our patients to ensure that our patients are able to secure affordable and meaningful coverage, and access the care that they need."
Whether or not a Biden administration passes a public-option depends largely upon which party controls the Senate in 2021. Republicans oppose the initiative, and if they have the Senate majority, the public option likely won't even be heard in committee.
Assistant Attorney General Jeffrey Bossert Clark of DOJ's Civil Division said the practice of up-coding "undermines the integrity of the program."
"The United States relies on Medicare Advantage Organizations to submit accurate diagnosis data to Medicare to ensure that the compensation they receive is appropriate," he said.
The settlement resolves allegations that the MA plan, formerly known as Group Health Cooperative, brought forward in a whistleblower suit by former employee Teresa Ross, who will get $1.5 million of the recovery money.
Kaiser Responds
Kris Greco Thompson, vice president of public relations, communictions, and brand mamagement, at Kaiser Permanente, said the alleged violations occurred, in 2011 and 2012, before it acquired Group Health Cooperative.
"Kaiser Permanente, which acquired Group Health in 2017 after this investigation was launched and conducted, has a history of commitment to compliance in this area," Greco Thompson said.
"We've fully cooperated with the Department of Justice throughout this entire process and have agreed to a settlement to resolve the outstanding civil claims, as we believe Group Health submitted its data in good faith and in reliance on recommendations by its contracted risk adjustment vendor, which purported to be an expert in this area. Under the settlement, Kaiser Foundation Health Plan of Washington has made no admission of liability and denies the allegations," she said.
Federal regulators say the consolidated health system would reduce competition in the region and raise healthcare costs for consumers.
The Federal Trade Commission is asking a federal court to block Methodist Le Bonheur Healthcare's $350 million acquisition of two Memphis-area hospitals owned by rival Tenet Healthcare Corporation.
In an administrative complaintfiled this weekin the U.S. District Court for the Western District of Tennessee,the FTC alleges that the acquisition of the 519-bed Saint Francis Hospital – Memphis, and 196-bed Saint Francis Hospital – Bartlett "would substantially lessen competition in the Memphis area for a broad range of inpatient medical and surgical diagnostic and treatment services that require an overnight hospital stay, known as inpatient general acute care services, sold to commercial insurers and their insured members."
Four hospital systems now provide acute care services in the Memphis area and the Tenet sale would reduce that number to three and the combined health system would control 60% of the Memphis-area market for general acute care services.
The FTC said that only rival Baptist Memorial Health Care would "meaningfully constrain the combined health system" because the region's fourth system,Regional One Health, is smaller and focuses on a specialized patient mix.
If the acquisition goes through, the FTC said, "healthcare costs will rise, and the incentive to expand service offerings, invest in technology, improve access to care, and focus on quality of health care provided in the Memphis area will diminish."
"Competition between hospitals helps keep prices down and quality high, and that’s as true in Memphis as it is elsewhere," said Daniel Francis, deputy director of the FTC’s Bureau of Competition.
"It's clear that patients in the Memphis area have benefitted from the competitive pressure that Saint Francis brings to bear on Methodist, through lower rates, more options for insurers and patients, and quality improvements. This transaction would take that competition away, and patients will pay the price," he said.
The FTC says the acquisition would eliminate direct competition between Methodist and Tenet, while boosting Methodist's leverage with insurers to negotiate higher reimbursements. Those increased costs, the FTC said, would be passed on to consumers and employer-based health plans.
On a 5-0 vote Friday, the FTC authorize staff to seek a temporary restraining order and preliminary injunction. An administrative trial is scheduled to begin on May 18, 2021.
Tenet and Methodist Le Bonheur Respond
Sally Hurt-Deitch, CEO, of Saint Francis Healthcare, and Michael Ugwueke, president and CEO of Methodist Le Bonheur, issued this joint statement:
"Our joint commitment has always been to improve healthcare delivery for the residents of Memphis, Bartlett and the surrounding communities, including enhancing access to care, cutting-edge medical technology and the highest quality physicians and staff. Our two organizations promote a culture of compassion backed by strong core values, which together, we believe will have an even greater impact on care delivered in these communities."
"We are reviewing this recent action by the FTC and actively considering next steps. We are surprised by the FTC action given the strong support for the transaction by local stakeholders, including leading local health plans, physicians, employers, and community leaders and the evidence that the transaction will lead to lower prices, improved quality, and enhanced access to care for Memphis-area patients."
Medicare will not pay for the monoclonal antibody products that providers receive for free but will reimburse providers for the infusion costs.
Starting immediately, Medicare beneficiaries can get coverage of monoclonal antibodies to treat COVID-19 with no cost-sharing during the public health emergency, the Centers for Medicare and Medicaid Services announced Wednesday.
"Today, CMS is announcing a historic, first-of-its kind policy that drastically expands access to COVID-19 monoclonal antibodies to beneficiaries without cost sharing," CMS Administrator Seema Verma said.
"Our timely approach means beneficiaries can receive these potentially life-saving therapies in a range of settings – such as in a doctor's office, nursing home, infusion centers, as long as safety precautions can be met. This aggressive action and innovative approach will undoubtedly save lives," she said.
CMS said the monoclonal antibody likely will be given to providers at no charge, at least at first.
Medicare will not pay for the monoclonal antibody products that providers receive for free but will reimburse providers for the infusion costs.
When providers start buying the monoclonal antibodies, CMS said it will likely set the payment rate in the same way it set the payment rates for COVID-19 vaccines, such as based on 95% of the average wholesale price for COVID-19 vaccines in many provider settings.
Billing and coding instructions for providers will be issued in the coming days, CMS said.
Verma said today's initiative will allow a range of providers and suppliers to administer the antibody treatment and bill Medicare, including freestanding and hospital-based infusion centers, home health agencies, and nursing homes.
Medicaid
Under section 6008 of the Families First Coronavirus Response Act, state Medicaid programs may receive a temporary 6.2 percentage point increase in the Federal Medical Assistance Percentage through the end of the quarter in which the COVID-19 public health emergency ends.
"A condition for receipt of this enhanced federal match is that a state or territory must cover COVID-19 testing services and treatments, including vaccines and their administration, specialized equipment, and therapies for Medicaid enrollees without cost sharing," CMS said.
"This means that this monoclonal antibody infusion is expected to be covered when furnished to Medicaid beneficiaries, in accordance with the EUA, during this period, with limited exceptions."
