The new final rules did not sit well with providers, who complained that the cuts are coming at a critical time for financially strapped hospitals.
Medicare on Wednesday unveiled long-anticipated final rules that will continue cuts to the 340B drug program, expand coverage for some procedures in ambulatory surgery centers, and gradually eliminate all 1,700 inpatient-only procedures under the Outpatient Prospective Payment System.
Eliminating the In-patient Only List
The Centers for Medicare & Medicaid Services said that eliminating the inpatient-only list -- starting with about 300 primarily musculoskeletal-related services, effective January 1, 2021 -- will give patients and physicians more freedom to choose an appropriate and potentially cost-saving care setting.
In the short term, CMS said, providing care in an outpatient setting during the public health emergency will also improve access to care for non-COVID-19 patients.
CMS Administrator Seema Verma said eliminating the in-patient only list will remove an incentive to send patients to hospitals for higher-priced procedures that could be done in lower-cost outpatient settings that will "level the playing field and boost competition at every turn."
"Today's rule is no different," Verma said Wednesday. "It allows doctors and patients to make decisions about the most appropriate site of care, based on what makes the most sense for the course of treatment and the patient without micromanagement from Washington."
The new final rule did not sit well with hospital stakeholders, who complained that the cuts are coming at a critical time for financially strapped providers.
"(The) Outpatient Prospective Payment System final rule takes critical resources away from hospitals as they strain under the heavy financial burden of COVID-19, and it threatens access to health are in underserved communities across the country now and after the public health crisis ends," said Beth Feldpush, SVP of policy and advocacy at America's Essential Hospitals.
"This rule would be bad policy at any time and is especially harmful now, as the public health emergency intensifies and front-line hospitals face unprecedented capacity and cost pressures," Feldpush said.
Tom Nickels, EVP at the American Hospital Association, said the elimination of inpatient-only list over three years has the potential to harm patients.
"The services on the inpatient-only list are often complex and complicated surgical procedures that require the close care and coordinated services provided in a hospital inpatient setting," he said.
340B Cuts Continue
The final rule also continues CMS's ongoing policy since 2018 of reducing payments for 340B drug, using a formula that pays the Average Sales Price plus 6% to an ASP minus 22.5%.
CMS said the policy lowers out-of-pocket drug costs for Medicare beneficiaries by letting them share in the discount that hospitals receive under 340B. Medicare beneficiaries have saved nearly $1 billion on drug costs, since the policy went into effect in 2018, and CMS expects to see an additional $300 million in savings for beneficiaries in 2021.
A federal appeals court in July overturned a district court ruling in a suit brought by hospital stakeholders. In upholding the policy, the appeals court said that CMS was acting within a "reasonable interpretation of the Medicare statute."
The AHA's Tom Nickels said that continuing the 340B cuts "undermines the effectiveness of the 340B program and exacerbates the strain placed on hospitals serving vulnerable communities."
"These cuts conflict with Congress' clear intent, perpetuate the Administration's inaccurate interpretation of the law, as well as its failure to protect the program from continued assaults by drug companies," Nickels said.
Feldpush said "there is no policy justification" for the 340B cuts, which she said "flout congressional intent for the 340B program and undermine the savings it was designed to create for hospitals that care for underserved people and communities."
She urged CMS to "reverse course on this damaging policy and restore support essential hospitals need to meet their safety-net mission."
ASC CPL Expands
The final rule also adds 11 procedures to the ambulatory surgery center covered procedures list, including total hip arthroplasty, and revises the criteria used to add surgical procedures to the ASC CPL.
"Using our revised criteria, we are adding an additional 267 surgical procedures to the ASC CPL beginning January 1, 2021," CMS said. "Finally, we are adopting a notification process for surgical procedures the public believes can be added to the ASC CPL under the criteria we are retaining."
The Iowa-based health system appointed CEOs for UnityPoint Health and its UnityPoint Clinic physician network.
UnityPoint Health has named veteran healthcare executive Clay Holderman as the West Des Moines, Iowa-based health system's new president and CEO.
Holderman, now COO and executive vice president at private, not-for-profit Presbyterian Healthcare Services in Albuquerque, New Mexico, will take over at UnityPoint in February 2021.
Holderman's strategic priorities upon his arrival next year are expected to focus on COVID-19-related workforce recovery efforts, UnityPoint said.
"Clay Holderman is a leader who believes in making a positive and lasting impact on the lives of those we are privileged to care for," said UnityPoint Board Chairman Randy Easton. "It was quickly evident Clay has that unique combination of a values-oriented mindset coupled with a transformative vision for the future."
Interim CEO Sue Thompson will lead UnityPoint until Holderman arrives.
UnityPoint Clinic
UnityPoint also named Sanjeeb Khatua, MD, president and CEO of UnityPoint Clinic, the health system's integrated physicians network, effective January 5, 2021.
Khatua, a board-certified family physician, now holds several leadership roles at Edward Elmhurst Health, a $1.5 billion integrated health system in Chicagoland.
"We are thrilled to welcome Dr. Khatua to our UnityPoint Health family," said Dave Williams, MD, CCO at UnityPoint Health. "As our organization continues to confront the ongoing COVID-19 crisis, we remain focused on delivering the best possible patient care to the patients and communities we serve."
UnityPoint Health is the nation’s 13th largest nonprofit health system with 21 hospitals, and more than 400 care venues in Iowa, western Illinois, and southern Wisconsin.
UnityPoint Clinic includes more than 1,100 clinicians at more than 400 clinics, providing primary and specialty care services across its three-state service area.
CMS Administrator Seema Verma said the extension of benefits is an acknowledgement of "the speed and effectiveness with which the American healthcare system has adapted to telehealth."
Medicare has made permanent nine telehealth services and will extend payments for another 59 services beyond the public health emergency in the ongoing effort to expand remote healthcare access in rural America, the Centers for Medicare & Medicaid Services said Tuesday.
In a media telephone conference Tuesday afternoon, CMS Administrator Seema Verma said the extension of benefits, limited by statutory authority to rural areas, is an acknowledgement of "the speed and effectiveness with which the American healthcare system has adapted to telehealth," which she called "astounding."
"Before the COVID public health emergency, only 15,000 beneficiaries each week receive Medicare telemedicine visits," Verma said. "But between and mid-March mid-October of 2020, early data shows that over 24 million Medicare beneficiaries used telehealth. This explosion represents nothing less than a seismic shift in healthcare delivery."
During the PHE, CMS added 144 services that Medicare will pay for. Now, nine of those services, including group psychotherapy and some visits for patients with cognitive imparities, will become permanent Medicare telehealth benefits.
Medicare payments for another 59 services, including emergency department visits, critical care, and physical and occupational therapy, will be extended beyond the PHE while CMS evaluates the effect on care quality and outcomes, Verma said.
"These additions allow beneficiaries in rural areas who are in a medical facility to continue to have access to a range of telehealth services that we know work for them," Verma said.
CMS has also commissioned a study to examine the efficacy of the remaining 76 telehealth services added during the PHE, Verma said.
"The study will evaluate telehealth as a whole," she said. "In particular, we will examine remote patient monitoring and virtual physician supervision to assess the impact of telehealth on quality, safety and cost as well as potential for fraud and abuse. This study should help inform future efforts the agency undertakes."
The extension of these telehealth services will be limited only to rural areas, Verma said, because "CMS does not have the statutory authority to permanently cover telehealth for beneficiaries living outside of rural areas, nor to generally allow beneficiaries to receive telehealth from their home unless there is congressional action."
"Without a change to statute, telehealth will revert to a rural benefit, albeit with a significantly expanded menu of services," Verma said. "Congress has the opportunity to make telehealth available to beneficiaries across the country and allow them to get telehealth services from the convenience of their home."
Stakeholders pledge to ensure that COVID-19 vaccines are evaluated and approved "through a rigorous scientific and regulatory process."
The nation's largest healthcare professional associations on Tuesday urged continued precautions to stem the spread of COVID-19 until vaccines for the virus make the public "broadly immunized."
In "an open letter to the American people," the American Medical Association, American Hospital Association, and American Nurses Association affirmed their commitment to ensure that COVID-19 vaccines are evaluated and approved "through a rigorous scientific and regulatory process."
"Vaccines have eradicated smallpox, nearly eliminated chickenpox and polio, and minimized the impact of countless other diseases," the letter said.
"To achieve a similar result from COVID-19 vaccines requires trust in the process to develop, distribute and administer a safe and effective vaccine and broad willingness to get vaccinated."
Until the U.S. reaches broad population immunization, the letter urged people to continue to practice three steps to prevent the spread of COVID-19: wear a face mask, maintain social distancing, and wash your hands."
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."
