HHS says "complexity of the issues raised by comments received on the proposed rule" pushed the date back to August 2021.
The much-anticipated final rule updating physician self-referral and anti-kickback laws has been pushed back for one year, the Department of Health and Human Services announced this week.
"We are still working through the complexity of the issues raised by comments received on the proposed rule," HHS Deputy Executive Secretary Wilma M. Robinson wrote in a public notice, "and therefore we are not able to meet the announced publication target date."
Instead, she said, the timeline has been pushed back to August 31, 2021.
The news was a disappointment for the American Hospital Association, which earlier this month had urged the Office of Management and Budget for an "expeditious review and release of the Physician Self-Referral and Anti-Kickback Statute final regulations" that the Centers For Medicare & Medicaid Services had submitted in July.
The AHA has long complained that the Stark Law prohibiting physician self-referrals is a major hindrance in the transition to value-based care, and that the proposed reforms would “provide space for the types of innovative arrangements among hospitals and physicians that can enhance care coordination, improve quality and reduce costs."
Those new exceptions would apply for Medicare and non-Medicare populations alike.
AHA General Counsel Melinda Hatton on Wednesday "strongly urged CMS to move more quickly to finalize these improvements."
"This is an extremely disappointing setback for hospital and health system efforts to continue to innovate coordinated care arrangements, which have great potential to benefit patients, lower costs and make care more accessible for everyone," she said.
The proposed rule was first unveiled in October 2019, as part of the Trump administration's "Patients Over Paperwork" initiative.
"We serve patients poorly when government regulations gather dust in the attic: they become ever more stale and liable to wreak havoc throughout the healthcare system," CMS Administrator Seema Verma said at the time.
For the sixth time in as many months, the federal government has changed reporting mandates for COVID-19, and hospitals are not happy about it.
Hospital stakeholders are calling on the federal government to toss out new "emergency regulations" for COVID-19 reporting issued this week.
The sixth reporting mandate change since the pandemic began was announced suddenly on Tuesday by the Centers for Medicare & Medicaid Services.
It requires hospitals and critical access hospitals participating in Medicare and Medicaid – under threat of "possible termination" – to include the number of confirmed or suspected COVID-19 positive patients, ICU beds occupied, and availability of essential supplies and equipment such as ventilators and PPE.
CMS says that while "many hospitals are voluntarily reporting this information now, not all are."
"These new rules represent a dramatic acceleration of our efforts to track and control the spread of COVID-19," CMS Administrator Seema Verma said in a media release.
"Reporting of test results and other data are vitally important tools for controlling the spread of the virus and give providers on the front lines what they need to fight it."
The interim rule skirted the normal comment period because of the COVID-19 Public Health Emergency, which runs through the end of October.
Rick Pollack, President and CEO of the American Hospital Association, said the rule was a "heavy-handed regulatory approach put forward by the Administration (that) threatens to expel hospitals from the Medicare program."
Pollack noted that since February CMS has made at least six changes to data reporting mandates, even as "94% (of hospitals) are reporting information, according to the federal government."
"It’s beyond perplexing why CMS would use a regulatory sledgehammer--threatening Medicare participation--to the very organizations that are on the frontlines in the fight against COVID-19," Pollack said.
"This disturbing move, announced in final form without consultation, or the opportunity to provide feedback through appropriate administrative procedures prior to it becoming effective, could jeopardize access to care and leave patients and communities without vital health services from their local hospital during a pandemic," he said.
That sentiment was shared by Chip Kahn, president of the Federation of American Hospitals, who complained in a Tweet that CMS "blindsides industry with mandatory reporting rules. Not only r rules not vetted but sudden change could jeopardize patient care. CMS action should be reversed."
The big question, however, is what will happen to telehealth when the coronavirus subsides.
The coronavirus pandemic has accelerated the use of telehealth and provided a stop gap for in-person physician visits, and large healthcare providers and distributors are positioned to benefit from this transition, Fitch Ratings said.
"For now, telehealth usage is partially offsetting service revenue that would have otherwise been lost during the pandemic," Fitch said. "Virtual care provides revenue continuity, with positive knock-on effects through the healthcare supply chain as doctors continue to prescribe medications."
The big question, however, is what will happen to telehealth when the coronavirus subsides.
"Post-pandemic demand will depend on whether payers, including Medicare and private insurers, continue to cover telehealth visits and patients continue to see value in virtual care," Fitch said.
In-office visits will remain "the primary delivery channel" for healthcare in the United States after the pandemic, but telehealth services will continue to grow as it matures and becomes more nuanced, and as providers figure out how to bill for telehealth services.
The federal government provides funding for telehealth during the pandemic under the Coronavirus Aid, Relief, and Economic Security (CARES) Act and the Coronavirus Preparedness and Response Supplemental Appropriations Act.
Earlier this month, President Donald Trump signed an executive order proposing the Centers for Medicare and Medicaid Services make some telehealth provisions permanent.
Fitch notes that money is flowing into telehealth through M&A, venture capital and other investors who see the need for infrastructure to support virtual services.
"However, penetration post-pandemic could be limited by reimbursement uncertainty," Fitch said, "particularly as CMS seeks public input on which telehealth services to make permanent; access to high-speed internet services among seniors; and questions about the effectiveness of video versus in-person visits."
Teladoc Health, the largest telemedicine software provider in the US, reported 2.8 million virtual visits in the second quarter, more than triple the same period last year. The company said it expects gains to spill into 2021, Fitch said.
Increased demand for remote services during the quarter was confirmed by HCA Healthcare, Universal Health Services, Tenet Healthcare, and Community Health.
HCA recorded more than 500,000 virtual visits, Tenet had more than 190,000 virtual visits within its physician business and tens of thousands of hospital-to-hospital telehealth visits, and Community Health had more than 230,000 virtual visits, Fitch said.
"Healthcare providers are particularly challenged by depressed volumes of elective patient procedures during the health crisis," Fitch said. "HCA, Universal and Tenet have sufficient rating headroom to absorb the effects on volumes, assuming the sector experiences a strong recovery in elective patient volumes beginning in the second half of 2020 and into 2021."
"Volume declines are more detrimental to Community Health, however, due to its already stressed credit profile," Fitch said.
Telemedicine could also partially offset pandemic-related volume declines for pharmaceutical and medical distributers.
McKesson said telemedicine accounted for up to 15% of its oncology practice in the second quarter, and AmerisourceBergen said its community-based practices adapted to telehealth visits, Fitch said.
"Longer term, healthcare providers may be able to attract, service and retain more patients with virtual care, due to the convenience provided, and, depending on coverage levels, bill for calls that were previously uncompensated," Fitch said.
"Increased patient flow and greater operating efficiency could improve profitability and cash flow, as information collected during visits along with data from other technologies could help control healthcare costs."
Employers contracting with Aetna Whole Health – Cleveland Clinic could save as much as 10% in healthcare spending by choosing the new ACO's narrow network.
Cleveland Clinic and Aetna have formed aco-branded Accountable Care Organization that they say will reduce healthcare costs for employers in Northeast Ohio by as much as 10%.
"Given the current economic climate, employers are looking for a cost-effective, high quality insurance plan that also provides access for their employees to coordinated care and advanced medical expertise," said Cleveland Clinic CFO Steven C. Glass.
"Cleveland Clinic is committed to improving the health and wellbeing of Aetna members, and we look forward to working together to deliver value-based health care to an expanded patient population," Glass said.
Employers contracting with Aetna Whole Health – Cleveland Clinic ACO could save as much as 10% in healthcare spending by choosing the ACO's narrow network of Cleveland Clinic employed and affiliated providers over an existing Aetna broad network plan.
Employers in the 10-county region of Northeastern Ohio can enroll in Aetna Whole Health – Cleveland Clinic this fall, depending on segment and group size.
The new ACO will also provide CVS Health-owned Aetna commercial plan beneficiaries across the nation access to second opinions by Cleveland Clinic for some conditions and makes available Cleveland Clinic's Cardiac Center of Excellence program to Aetna plan sponsors. members.
Aetna care managers will work with beneficiaries to design personalized care plans.
Aetna's Angie Meoli, senior vice president, network strategy and provider experience, said the affiliation with Cleveland Clinic is "part of CVS Health's goal of becoming the most consumer-centric health company."
"We are facilitating access to high-quality health care where and when consumers need it," Meoli said. "Cleveland Clinic is renowned for delivering exceptional health care, and our new collaboration will enable our members to receive the personalized and coordinated care they need to get and stay healthy."
Plaintiffs say the final award is expected to reach $13 million with attorneys' fees and interest. Centene said it will appeal.
A federal jury in Arkansas this week handed up a $9.4 million breach of-contract award to a Tennessee-based emergency physician group after finding that subsidiaries of Centene Corporation violated their contracts by systematically underpaying the physicians.
Attorneys for Knoxville-based Southeastern Emergency Physicians, LLC, a subsidiary of TeamHealth Inc., said the final award could hit $13 million with legal fees and interest.
"They treated commercial insurance claims like Medicare payments, they tried to hide which company owed the money, they paid late. Their cavalier attitude toward these essential workers was abominable," Zavitsanos said.
In an email to HealthLeaders, NovaSys Health, a Little Rock-based subsidiary of Centene, said: "We disagree that NovaSys breached the contract, and we plan to appeal. All of the health insurance claims at issue have already been paid at the appropriate rate for ACA claims."
According to the plaintiffs' attorneys, Centene-controlled NovaSys agreed in a 2011 contract to pay the ER doctors 75% of the regular commercial insurance billing rates. Instead, the doctors were paid only 10% of the billing, and slowly.
The plaintiffs also alleged that Centene tried to hide their ownership of the entities responsible for paying the doctors.
"Today's ruling is a win for frontline providers heroically risking their lives treating patients during the deadly COVID-19 pandemic. Centene's actions are all too common on the part of payors," TeamHealth CEO Leif Murphy said.
"Large and profitable health insurance companies are using their market power to systematically underpay doctors, cancel contracts, and further boost their record profits," he said.
The consolidated California v. Azar and Texas v. Azar will be heard one week after the presidential election, but a ruling is not expected until June.
The U.S. Supreme Court has scheduled oral arguments for November 10 in a multistate lawsuit that will determine the future of the Affordable Care Act.
The nation's highest court scheduled one hour of oral arguments in the consolidated California v. Azar and Texas v. Azar lawsuits, but a ruling is not expected until next June at the earliest.
The plaintiffs in both cases are asking the justices to rule on the constitutionality of the individual mandate without a tax mandate, and whether the mandate is severable, and the rest of the law can remain in place.
In December, the Fifth Circuit Court of Appeals ruled that the ACA's individual mandate was unconstitutional but remanded the case to a district court that had ruled the entire law was unconstitutional.
The 18 states hoping to have the ACA tossed are led by Texas Republican Attorney General Ken Paxton.
California Democratic Attorney General Xavier Becerra, lead plaintiff among 20 states and the District of Columbia that hope to save the ACA, had asked the high court for an expedited hearing.
Becerra said Wednesday "it makes no sense" that "President (Donald) Trump and 18 states have decided to go all the way to the Supreme Court to rip away the Affordable Care Act at a time when our nation is suffering the worst pandemic we've seen in more than a century."
"We will be at the Supreme Court to lead the argument to save affordable healthcare, and with it, the lives of countless loved ones," Becerra said.
ACA backers say the program protects 133 million people with pre-existing conditions and provides health insurance for 20 million people.
Nearly 60% of 3,513 respondents in The Physician Foundation biennial survey believe COVID-19 will reduce the number of independent physician practices in their communities.
More than 8-in-10 physicians (86%) believe the COVID-19 pandemic won't be under control until at least next year, and 72% believe the accompanying delays in routine care will adversely affect patient health.
That's according to The Physicians Foundation biennial Survey of America's Physicians, which also found that 49% of physicians don’t believe the coronavirus will be controlled until after June 2021.
"The data reveals a near-consensus among America's physicians about COVID-19's immediate and lasting impact on our health care system," said The Physicians Foundation President Gary Price, MD.
"We are living through a historical shift in the way we practice and how we deliver care to patients. Our healthcare landscape is constantly changing right now, and we expect it will be radically different for both physicians and our patients long after the pandemic passes," Price said.
The online survey was conducted for The Physicians Foundation by physician recruiters Merritt Hawkins. The poll, taken from July 15 to July 26, was received by more than 500,000 physicians nationwide, and 3,513 physicians responded, giving the survey a margin of error of +/- 1.86%.
In addition to routine care delays, 75% of physicians say patients will feel "indirect effects" of the pandemic through job losses that may disrupt health insurance coverage.
In addition, 67% of physicians said patients' reluctance to seek care during the pandemic poses a threat to their health, and 65% said the closure of physician offices also will adversely affect patients.
Nearly 60% of physicians said the national reopening, even as the pandemic rages in many parts of the nation, poses a bigger risk to patients than continuing social distancing policies.
The survey also found that:
59% believe COVID-19 will reduce the number of independent physician practices in their communities.
8% have already closed their practices as a result of COVID-19, a number totaling approximately 16,000 practices nationally.
43% have reduced staff due to COVID-19.
96% will not leave medicine because of pandemic-related health risks.
75% said they received sufficient federal funding to remain open from the Paycheck Protection Program.
50% believe hospitals will have a stronger influence over care organization and delivery because of the pandemic.
37% saw volume decreases of 25% or less, and 41% saw volume decreases of 26% or more.
:
12% – representing about 100,000 physicians nationally – have switched to a primarily telemedicine practice as a result of COVID-19, up 1,577% from only 6,000 in 2018.
52% plan to increase the use of telemedicine in their practice in the next 12 months.
4% said they plan to switch to a primarily telemedicine practice.
"This survey emphasizes how the pre-existing issues within our healthcare system, such as physician shortages and lack of patient access to health care, will continue to worsen unless we empower and support physicians as they continue to work tirelessly through a global pandemic ," said Robert Seligson, CEO of The Physicians Foundation.
Many of the more than 4,000 people surveyed by the Commonwealth Fund said their care costs are a significant and in some cases insurmountable burden.
Nearly half (43%) of working-age adults had spotty health insurance coverage in the first half of 2020, and many more faced dauntingly high deductibles and out-of-pocket costs, and hard choices on paying the rent, buying food, or seeking healthcare, according to a new survey released today by the Commonwealth Fund.
"The survey shows a persistent vulnerability among U.S. working-age adults in their ability to afford coverage and healthcare," said study lead author Sara R. Collins, Commonwealth Fund Vice President for Healthcare Coverage, Access, and Tracking.
"That vulnerability could worsen if the COVID-19 pandemic and related economic downturn continue," Collins said. "Coverage inadequacy is compromising people's ability to get the care they need and leaving many with medical debt at a moment of widespread health and financial insecurity, and an uncertain future."
The Biennial Health Insurance Survey, which the Commonwealth Fund has conducted since 2001, randomly interviewed 4,272 adults via cellular and landline telephone in Spanish and English from January through June.
Among the findings:
People of color, small business workers, people with low incomes, and young adults had the highest uninsured rates. More than one-third of Latino adults, small business workers, and adults with low incomes were either uninsured or spent some time uninsured in the past year.
The growth in the underinsured since 2010 has been driven by employer health plans with inadequate coverage. One-quarter of adults with employer plans were underinsured.
One-quarter of working-age adults with adequate coverage for the full year reported medical bill problems or debt in the past year.
Half of adults who spent any time uninsured or underinsured reported problems paying medical bills or that they were paying off medical debt over time.
African Americans were significantly more likely than whites to report problems with medical bills (45% vs. 35%).
Among adults who reported any medical bill or debt problem 37% said they had used up all their savings to pay their bills, 40% had received a lower credit rating as a result of their medical debt, and 26% were unable to pay for basic necessities such as food, heat, or their rent.
The survey also noted that Americans are shouldering a heavying increase in premiums, out-of-pocket costs and copays over the past decade that is leaving them financially stressed and vulnerable to lapses in coverage.
In 2010, for example, 7% of people in either employer or individual private plans had deductibles that amounted to 5% or more of income, an indicator of underinsurance. By 2016, the share had more than doubled to 15%.
In addition, between 2010 and 2020, the share of privately insured adults with deductibles of $1,000 or more doubled — from 22% to 46%, the survey found.
"Even before the pandemic, people were struggling with inadequate health coverage and mounting medical debt," said Commonwealth Fund President David Blumenthal, MD. "It has never been more important to ensure that all U.S. residents have affordable, comprehensive coverage to survive this pandemic and beyond."
To alleviate the problem, the Commonwealth Fund is calling for expanding Medicaid in the 12 states that have yet to do so, enhancing Affordable Care Act marketplace subsidies, increasing outreach and enrollment efforts, and banning non-ACA compliant short-term policies that expose people to catastrophic healthcare costs.
Also Monday, CMS announced that it would resume inspections of provider facilities.
Hospitals treating Medicare beneficiaries admitted with COVID-19 will see a 20% payment increase on September 1 that acknowledges the additional cost of treating the virus, the Centers for Medicare & Medicaid Services announced Monday.
"To safeguard taxpayer dollars spent on this increased payment, CMS will now require that a positive COVID-19 laboratory test result is documented in the patient's medical record," CMS said.
Only the results of viral testing (i.e., molecular or antigen) that are consistent with Centers for Disease Control and Prevention guidelines can be used.
The test must be taken within two weeks of admission, either at the hospital or before admission. It can be manually entered into the patient's medical record.
"For example, a copy of a positive COVID-19 test result that was obtained a week before the admission from a local government-run testing center can be added to the patient’s medical record," CMS said.
"In the rare circumstance where a viral test was performed more than 14 days prior to the hospital admission, CMS will consider whether there are complex medical factors in addition to that test result for purposes of this documentation requirement."
CMS said it will conduct post-payment medical audits to confirm the presence of a positive COVID-19 (viral) laboratory test result.
"If the positive test result is not found in the medical record, the increased payment will be recouped by CMS as an overpayment," CMS said.
CMS Resumes Provider Inspections
Also Monday, CMS announced that it will resume routine inspections of all Medicare and Medicaid certified providers and suppliers.
The inspections had been suspended this spring in response to the coronavirus pandemic, CMS said, so that it could "prioritize infection control and immediate jeopardy situations and to give healthcare providers and suppliers time needed to respond to the spread of COVID-19."
"CMS has worked closely with states to complete focused infection control surveys of virtually all nursing homes in the country in just a few months," CMS Administrator Seema Verma said.
"These surveys fortified healthcare facilities around the country to prepare for and implement actions to prevent transmission of the virus and provided indispensable insight into the situation on the ground.”
In the guidance released Monday, CMS directed the resumption of onsite revisit surveys, non-immediate jeopardy complaint surveys and annual recertification surveys as soon as resources are available.
In addition, CMS is providing guidance on resolving enforcement cases that were previously on hold because of survey prioritization changes.
The ACP warns that delivery delays at the USPS could harm millions of people who rely on the mail for prescription medications.
The ongoing disarray at the U.S. Postal Service have raised concerns among the nation's primary care doctors.
The American College of Physicians on Monday warned that "recent reports of changes" at USPS could worsen delivery delays with the potential to harm millions of people who rely on the mail for prescription medications.
"Any prescription medication can only be as effective as a patient’s ability to access it," ACP President Jacqueline W. Fincher, MD, said in a media release.
"A delay in receiving a necessary prescription could be life-threatening," Fincher said. "My patients who rely on their insulin, or their inhalers, or any other type of medication can’t wait weeks to see whether or not their prescription will be delivered."
"The new organization will align functions based on core business operations and will provide more clarity and focus on what the Postal Service does best; collect, process, move and deliver mail and packages," USPS said.
However, the initiative has raised concerns among Democrats that the Trump administration is attempting to "kneecap" the post office ahead of the November elections, which will rely heavily upon mail-in ballots.
House Democrats have earmarked $25 billion for the USPS in their latest coronavirus relief package, but Senate Republicans and President Donald Trump oppose the funding.
In an interview with Fox Business News last week, President Trump admitted that he was opposed to additional funding for the USPS as a means of limiting mail-in voting.
The president's comments prompted House Speaker Nancy Pelosi (D-CA) to call the House back into session from summer recess to address the issue.
ACP President Fincher said she's hearing reports that the Department of Veterans Affairs, which fills 80% of its prescriptions by mail, has already experienced "significant delays" in mail-order prescription drugs to veterans.
"Mail-order prescriptions can be particularly important in rural areas where the local pharmacy may be a long distance away," Fincher said. "We also know that increasingly insurance plans are moving patients to mail-order services."
The problem is exacerbated of late, Fincher said, by the COVID-19 pandemic, which has pushed more Americans to transition to mail delivery of their prescription drugs.
"This may be most important for those with chronic conditions, who are more likely to need a prescription and are also more at risk from a COVID-19 infection," she said.
