The proposed rule removes an Obama-era referral policy that the Trump administration says discriminates against religious providers.
The Department of Health and Human Services has unveiled a proposed rule that would remove a mandate that faith-based providers refer patients to other providers for services they won't offer for religious reasons.
"President Trump's administration is taking historic action to protect religious social service providers from discrimination in federal regulations," HHS Secretary Alex Azar said in a media release.
"Americans of faith play an essential role in providing healthcare and human services to so many vulnerable people and communities, and President Trump is dedicated to removing every unfair barrier that stands in the way of this important work," he said.
The proposed rule, released Thursday to coincide with Religious Freedom Day, removes what the Trump administration claims is a discriminatory Obama-era policy that requires religious providers of social services, but not other providers of social services, to make referrals.
HHS is one of nine federal departments, including the Department of Education and the Department of Justice, that were named in a Trump executive order to remove what it said were unfair barriers in federal policies that singled out faith-based groups.
The HHS proposed rule said the "burdens" imposed on faith-based organizations by the Obama administration were not required by law and were imposed only on religious social service providers.
"They are in tension with recent Supreme Court precedent regarding nondiscrimination against religious organizations," HHS said.
The proposed rule would also eliminate the requirement that religious organizations post notices of referral mandates, which is not required of secular organizations.
"By compelling religious organizations, but not secular organizations, to post special notices and make referrals, the alternative-provider requirements placed burdens unequally on religious organizations and cast unwarranted suspicion on them," HHS said.
The proposed rule also mandates that HHS will not discriminate against faith-based organizations when selecting award recipients.
An Urban Institute study found that 31 states saw a decline in premium costs for their lowest-price silver plan.
Premiums fell by an average of 3.5% for Affordable Care Act lowest-cost silver plans in 2020, signaling that the marketplace is stabilizing after uncertainty and price spikes in 2017 and 2018, according to a report from the Urban Institute.
Premium reductions were found in 31 states, according to the report, which looked at lowest-priced silver plans for a 40-year-old nonsmoker from 2017-2020.
The study found that premiums have stabilized in the past two years, and that more insurers are participating in the marketplaces. However, the study raised concerns about affordability for unsubsidized plans, especially in uncompetitive markets.
In 2018, the average silver plan premium increased by 30%, followed by a 0.4% decrease in 2019, as the ACA weathered challenges that included numerous legal challenges, funding cuts, and the elimination of the individual mandate penalty in 2017.
For 2020, lowest silver premiums saw an average 3.5% drop, with the average premium is $426, ranging from a low of $298 in Minnesota to a high of $871 in Wyoming.
Most low-cost silver premium states had more competition, often in the form of at least one Medicaid insurer, several non-Medicaid insurers, or a state reinsurance program. States with higher premiums frequently had little competition.
"The individual market has clearly stabilized since the disastrous premium spikes of 2018, but some markets remain uncompetitive, and affordability is a problem across the board for the unsubsidized." said Kathy Hempstead, senior policy adviser at the Robert Wood Johnson Foundation.
The study used lowest-cost silver plan because it is the entry-level price for standard coverage and qualifies for cost-sharing reductions. The lower-cost plans also have high enrollment.
In addition, CMS said 20 additional health insurance companies are participating in the Federal Health Insurance Exchange in 2020, bringing to 175 the total number of issuers, up from 132 in 2018.
The kickbacks took the form of free 'resupply services' for provider-customers who pushed their CPAP products.
ResMed Inc. has agreed to pay $39.5 million to settle whistleblower allegations that the San Diego-based medical equipment maker paid kickbacks to providers that sold its continuous positive airway pressure (CPAP) therapy machines, the Department of Justice announced Wednesday.
The settlement, the terms of which were first announced in July, 2019, stems from allegations made by five whistleblowers, including former sales reps for ResMed. The company will pay $37.46 million to the federal government and more than $2 million total to various states to settle five Medicaid-related cases. The whistleblowers will share more than $6.2 million.
The kickbacks took the form of free "resupply services" for provider-customers who pushed their product. ResMed charged service fees to those who sold competitors' CPAP machines.
Resupply services track patients' adherence to their CPAP therapy, identify replacement frequencies permitted by insurance, monitor patients' resupply cycles, and get patients permission to order new supplies.
“Improper kickbacks don’t always involve bags of cash or free trips to Hawaii,” said Stephen Hasegawa, a whistleblower attorney for former ResMed sales rep Thomas Baker.
"Services provided by vendors also can be kickbacks if they have some value to customers," Hasagawa said.
"Resupply is an important part of a CPAP equipment provider’s business," said Hasegawa, a partner at Phillips & Cohen LLP. "Customers who use resupply services tend to increase their resupply orders, so it benefits both the entities that sell to patients as well as those who manufacture sleep apnea equipment."
In a statement, ResMed said it had "not violated any laws" and that its "business practices are conducted in full accordance with U.S. laws and regulations."
"That said, we are pleased to put this matter behind us and avoid the expense, inconvenience, and distraction it would cause to gain the favorable outcome we deserve," the company said. "This settlement – the broad terms of which were disclosed in ResMed’s Q4FY19 earnings statement four months ago – is in the best interest of ResMed’s customers, investors, employees, and most important, millions of patients worldwide whose quality of life relies on the products and services ResMed provides."
"This settlement does not impact our ability to sell products in the United States, nor does it impact the reimbursement of our products by federal health programs. We have always acted in good faith with patients and our valued customers, and we do not expect this to impact our relationship with either."
The commitment includes a $200 million immunotherapy-focused partnership with the University of Pittsburgh.
UPMC Enterprises said Tuesday that it will "deploy" $1 billion to develop new drugs, diagnostics and medical devices over the next four years.
"The common link among our investments will be that each has a direct and powerful impact on how we care for patients, while generating a significant financial return," UPMC Enterprises Executive Vice President Jeanne Cunicelli said in amedia release.
"As important as the funding is the unparalleled scientific and medical expertise backing our ideas, thanks to resources provided by UPMC and our academic partner, the University of Pittsburgh," Cunicelli said.
Cunicelli said UPMC Enterprises will also look for partners globally that complement the scientific and commercial work already underway.
In the past two years, UPMC Enterprises has created five companies in the translational sciences sector and invested in external biotech company Werewolf Therapeutics, as well as more than 30 research projects internally.
The venture capital and commercialization arm of UPMC initially focused on immunotherapies for cancer, transplantation and diseases related to aging. However, their portfolio has expanded to include retinal and respiratory disease, autoimmune diseases, and neuroinflammation.
UPMC has invested more than $800 million to date, primarily in digital health solutions, which have returned more than $1.5 billion.
Companies formed under UPMC Enterprises include Generian,BlueSphere Bio, and Abound Bio.
AHA, AAMC seek preliminary and permanent injunctions to block $800 million in cuts.
Hospital stakeholders have filed suit in federal court to block the Centers for Medicare & Medicaid Services' plans to cut about $800 million from outpatient services at off-campus, hospital-based departments in 2020.
Arguing that the nation's hospitals would suffer "concrete and imminent" harm if the cuts are applied, the American Hospital Association, the Association of American Medical Colleges, and three hospitals called for a preliminary and permanent injunction against CMS.
"If the 2020 Final Rule is left in place, Plaintiff-Hospitals and Plaintiffs AHA’s and AAMC's members face the prospect of serious payment reductions for affected services, and may have to make difficult decisions about whether to reduce services in response to the lowered payment rate," the plaintiffs wrote in their 26-page complaint, filed with the U.S. District Court for the District of Columbia.
A federal judge in December ruled that CMS had exceeded its authority when it reduced 2019 off-campus outpatient services that were grandfathered in by Congress in 2015, but she stopped short of blocking the cuts for 2020.
The final rule completes the two-year phase-in of the site-neutral rate, which is 40% of the OPPS rate provided for grandfathered off-campus clinics in 2020.
CMS says the site-neutral policy will reduce cost-sharing by Medicare beneficiaries to $9, saving them about $14 for each off-campus clinic visit in 2020.
Medicaid expansion may have prevented up to 8,132 opioid overdose deaths in 2015 to 2017 in the 32 states that expanded Medicaid.
Expanding Medicaid coverage was linked to a 6% drop in opioid overdose deaths nationally, according to new research published in JAMA Network Open.
Researchers NYU Grossman School of Medicine and University of California, Davis, analyzed cause-of-death data from the National Vital Statistics System from 3,109 counties nationwide between 2001 and 2017.
They looked for changes in opioid overdose rates in counties that expanded Medicaid and compared those to changes that occurred in the same time period in counties within states that did not expand Medicaid.
The researchers found that:
Medicaid expansion may have prevented between 1,678 and 8,132 opioid overdose deaths in 2015 to 2017 in the 32 states that expanded Medicaid between 2014 and 2016.
Adoption of Medicaid expansion was associated with a 6% lower rate of total opioid overdose deaths, 11% lower rate of death involving heroin, and a 10% lower rate of death involving synthetic opioids such as fentanyl.
Medicaid expansion states saw an 11% increase in methadone overdose mortality.
"At a broader level, the findings of this study suggest that providing expanded access to healthcare may be a key policy lever to address the opioid overdose crisis," said study senior author Magdalena Cerdá, director of the Center for Opioid Epidemiology and Policy in the Department of Population Health at NYU Langone Health.
Cerdá said Medicaid beneficiaries are more likely to receive prescriptions for methadone to treat pain, compared to the general population, which increases the risk of overdoses.
The researchers noted that their study's limitations include a reliance on misclassified coding of death certificate data. In addition, the study only looked at deaths among the whole population as opposed to just Medicaid beneficiaries and they did not examine how Medicaid expansion affects access to treatment for opioid use disorder.
The draft guidelines outline the agencies' analytical techniques, practices, and enforcement for vertical mergers.
The Federal Trade Commission and the Department of Justice's Antitrust Division have opened a 30-day window for public comment on draft 2020 Vertical Merger Guidelines.
The draft guidelines outline the agencies' analytical techniques, practices, and enforcement for vertical mergers, which combine two or more companies that operate at different levels in the same supply chain.
"While many vertical mergers are competitively beneficial or neutral, both the Department and the Federal Trade Commission have recognized for over 25 years that some vertical transactions can raise serious concern," Assistant Attorney General Makan Delrahim of DOJ's Antitrust Division.
"The revised draft guidelines are based on new economic understandings and the agencies’ experience over the past several decades and better reflect the agencies' actual practice in evaluating proposed vertical mergers," he said.
In a joint media release, FTC and DOJ said the draft guidelines adopt the principles and analytical frameworks in the agencies’ Horizontal Merger Guidelines. That includes defining a market, creating a framework for evaluating entry considerations, the treatment of the acquisition of a failing firm, and the acquisition of a partial ownership interest. .
Stakeholders say 'Pathways to Success' mandates have dampened ACO enthusiasm for the program.
Participation in the Medicare Shared Savings Program held steady for 2020, with 517 accountable care organizations participating in the value-based payment program, the Centers for Medicare & Medicaid Services reported.
The 2020 participation level is one fewer than the 518 ACOs that participated in 2019, and down from the high of 561 ACOs that participated in 2018.
Only 35 Shared Savings Program ACOs are entering their first contract with CMS, compared with an average of 107 new ACOs annually between 2012 and 2018. Last year, overall participation fell to 41 new ACOs.
However, 192 ACOs are taking on downside risk in 2020, more than double the 93 ACOs taking risk at the start of 2019.
In addition, CMS said 11.2 million Medicare beneficiaries–the largest number ever, and representing nearly 30% of Medicare fee-for-service beneficiaries–are being cared for by ACOs.
In an essay Friday in Health Affairs, CMS Administrator Seema Verma wrote that she was "excited to report continued strong interest and robust participation in the redesigned program."
"It’s been rewarding to see that low-revenue (physician-led) ACOs have found the new participation options appealing. As of January 1, there are 270 low-revenue ACOs participating in the program, up 27% from a year ago," she said.
Verma said the mandated downside risk is needed because ACOs aren't generating enough savings.
"Given all the best practices and learnings that emerged from over half a decade of experience, it was time to strengthen the incentives in the program and ensure real accountability while also providing more flexibility for ACOs to innovate," she wrote.
CMS reported in October that MSSP generated $1.7 billion in total savings in 2018. Of that, Medicare netted $739 million, after paying out shared savings bonuses, and collecting shared savings loss payments from ACOs.
However, ACOs that took on downside risk generated more savings than ACOs that did not, with an average $96 reduction in spending per enrollee, compared with $68 per enrollee in ACOs that did not take on risk.
ACO stakeholders had a decidedly different interpretation of the figures put forward Friday by CMS.
Clif Gaus, president and CEO of National Association of ACOs, said his association has predicted in 2018 "that changes CMS made under Pathways would throw off the careful balance of risk and reward for too many ACOs."
"Sadly, those fears may be coming true," he said. “To date, there have been few attractive alternative payment models besides ACOs, so harming participation in the Medicare Shared Savings Program hurts Medicare’s priority of changing how it pays for care."
A 2018 study commissioned by NAACOS found that MSSP ACOs generated estimated gross savings of $1.84 billion during performance years 2013 through 2015; nearly double the $954 million in estimated gross savings CMS had reported.
Gaus urged Congress to review the program "to ensure more damage isn't done."
"If interest in ACOs dwindles, then doctors and hospitals will fall back into a fragmented, fee-for-service system, and any momentum to transform our health system will be lost," he said.
Last June, University of Michigan researchers issued a study which found that high-cost patients and high-cost doctors were much more likely to exit ACOs than low-cost patients and doctors, and that ACOs did not demonstrate improvement in spending or quality after selective dropping of clinicians and their patients from the program.
Healthcare created 399,000 new jobs in 2019, up from 350,000 jobs in 2018.
Nearly one-in-five jobs created in 2019 was in healthcare, which greatly outpaced nearly every other major sector of the economy for the year, federal data released Friday show.
For 2019, healthcare created 399,000 jobs—nearly 33,000 new jobs each month—up from 350,000 jobs in 2018. The 2019 figures include 269,000 new jobs in ambulatory services, up from 219,000 jobs in 2018, and 102,000 new hospital jobs, down from 107,000 new jobs in 2018.
More than 16.5 million people work in the healthcare sector at the end of 2019, which accounts for 11% of all jobs in the overall economy.
The new data is in line with BLS projections that healthcare sector employment will grow 18% from 2016 to 2026, "much faster than the average for all occupations, adding about 2.4 million new jobs."
On the downside, hospital spending will grow about 5.5% each year, from $1.3 trillion in 2018 to $1.8 trillion in 2026, driven largely by those same demographics.
In the overall economy, total nonfarm employment increased by 145,000 in December, lower than expectations, and 2.1 million in 2019, down from 2.7 million in 2018. The unemployment rate ended the year at 3.5%, compared with 3.9% at the end of 2018.
A further breakdown of employment in healthcare shows that the sector ended 2019 with 28,000 new jobs in December, including 23,000 jobs in ambulatory services and 9,000 jobs in hospitals.
At the end of 2019, more than 16.5 million people worked in the healthcare sector, which accounts for nearly 11% of all jobs in the overall economy, including 7.8 million in ambulatory services, and 5.3 million in hospitals.
It's the 10th straight year that DOJ's civil healthcare fraud settlements and judgments have exceeded $2 billion.
The federal government collected more than $3 billion from False Claims Act cases in 2019, and $2.6 billion of it came from the healthcare sector, the Department of Justice announced.
It's the tenth straight year that DOJ's civil healthcare fraud settlements and judgments have exceeded $2 billion, and the recoveries in 2019 came from drug and medical device makers, managed care providers, hospitals, pharmacies, hospice organizations, laboratories, and physicians.
The $2.6 billion reflect only federal losses, and do not include the additional millions of dollars recovered for state Medicaid programs.
Much of the recoveries were spurred by the 633 whistleblower lawsuits filed in 2019, which DOJ credited with helping in the recovery of $2.1 billion.
Among the larger FCA settlements of 2019:
Opioid maker Insys Therapeuticspaid $195 million to settle civil allegations that it paid kickbacks to clinicians to prescribe Subsys for their patients. The kickbacks allegedly took the form of sham speaker events, jobs for the prescribers' relatives and friends, and lavish meals and entertainment.
DOJ also alleged that Insys improperly encouraged physicians to prescribe Subsys for patients who did not have cancer and lied to insurers about patients' diagnoses to ensure payment by federal healthcare programs.
Opioid addiction treatment maker Reckitt Benckiser Group plcpaid a total of $1.4 billion to resolve criminal and civil liability related to the marketing of Suboxone, which is a formulation of the opioid buprenorphine.
Avanir Pharmaceuticalspaid more than $95 million to resolve allegations that it paid kickbacks and engaged in false marketing to induce long-term care facilities to prescribe the drug Neudexta for behaviors commonly associated with dementia patients, which is an unapproved use of the drug.
Pathology laboratory company Inform Diagnostics, formerly known as Miraca Life Sciences Inc., paid $63.5 million to resolve allegations that it paid kickbacks to referring physicians in the form of subsidies for electronic health records systems and free or discounted technology consulting services.
EHR vendor Greenway Health LLC, paid more than $57 million to resolve allegations that it misrepresented the capabilities of its EHR product "Prime Suite" and provided unlawful remuneration to users to induce them to recommend Prime Suite to prospective new customers.
Inpatient rehabilitation facilities operator Encompass Health Corporation(formerly known as HealthSouth Corp.), paid $48 million to resolve allegations that some of its IRFs provided inaccurate information to Medicare to maintain their status as an IRF and to earn a higher rate of reimbursement, and that some admissions to its IRFs were not medically necessary.
