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CMS to require positive COVID-19 test results for Medicare pay boost

https://www.beckershospitalreview.com/finance/cms-to-require-positive-covid-19-test-results-for-medicare-pay-boost.html?utm_medium=email

CMS to Pay For Hospital COVID-19 Care Furnished in Other Settings

CMS recently released guidance that includes a new requirement for hospitals to get a Medicare payment boost for caring for patients diagnosed with COVID-19. 

The Coronavirus Aid, Relief and Economic Security Act provided a 20 percent add-on payment to the inpatient prospective payment system diagnosis-related group rate for treating patients diagnosed with COVID-19. Until now, a physician’s documentation that a patient has COVID-19 was sufficient to receive the add-on payment. However, recent guidance from CMS adds the requirement to have a positive COVID-19 laboratory test documented in the patient’s medical record for the claim to be eligible for the add-on payment. The new requirement applies to admissions occurring on or after Sept. 1.

To receive the payment boost under the new guidance, the COVID-19 test must be taken within 14 days of the hospital admission. Only the results of viral testing that are consistent with CDC guidelines can be used. Tests performed by an entity other than the hospital, such as a local government-run testing center, can be manually entered into the patient’s medical record, CMS said.

Meeting the new requirement for the add-on payment could be difficult for hospitals, Ronald Hirsch, MD, vice president of the regulations and education group at R1 Physician Advisory Services, told Becker’s Hospital Review

“There is no way to indicate on a claim for a hospital patient that a test was positive or negative,” he said. “First, the hospital will manually need to go into every record for a patient with U07.1 as a diagnosis and look for a positive test in their own lab system. If one is not found, they will need to search the notes to see if the patient had a test in the 14 days prior to admission and if that test was positive. If there is a note the patient self-reported that they had a positive test, the hospital must decide if they must go through due diligence and attempt to get that actual test result for their records.”

In cases where there isn’t a positive test noted in the medical record, hospitals would need to notify the Medicare audit contractor that they are submitting a claim for a COVID-19 diagnosis that was made clinically, Dr. Hirsch said. The MAC would need to make the appropriate adjustment to ensure the 20 percent add-on payment is not made.

The “undue burden” that the new requirement will place on hospitals was one of the concerns the American Hospital Association highlighted in an Aug. 26 letter to CMS Administrator Seema Verma. The group is also concerned that requiring a positive COVID-19 test will lead to unnecessary additional testing.

“Basing the COVID-19 diagnosis code on clinical judgment alone — in line with coding rules — continues to be an important approach given that test accuracy may not be reliable, re-testing is unnecessarily onerous, and some communities face persistent testing shortages.” 

The AHA is urging CMS to drop the new requirement and allow provider documentation of a COVID-19 diagnosis to be sufficient for the add-on payment if the test result is unavailable. 

 

 

 

 

2020 Health Care Legislative Guide

https://unitedstatesofcare.org/resources/2020-health-care-legislative-guide/

Pennsylvania 2020 Health Care Legislative Guide - United States of Care

ABOUT THE UNITES STATES OF CARE

United States of Care is a nonpartisan nonprofit working to ensure every person in America has access to
quality, affordable health care regardless of health status, social need or income. USofCare works with elected
officials and other state partners across the country by connecting with our extensive health care expert
network and other state leaders; providing technical policy assistance; and providing strategic communications
and political support. Contact USofCare at help@usofcare.org

Health care remains one of the most important problems facing America.

Voters are concerned about access to and the cost for health care and insurance.

Health Care During the COVID Pandemic
The COVID-19 pandemic has illuminated the need for effective solutions that address both the immediate
challenges and the long-term gaps in our health care systems to ensure people can access quality health care
they can afford. Americans are feeling a mix of emotions related to the pandemic, and those emotions are
overwhelmingly negative.*

In addition, the pandemic has illuminated deficiencies of our health care system.

People feel that the U.S. was caught unprepared to handle the pandemic and our losses have
been greater than those of other countries.

People blame government for the inadequate pandemic response, not health care systems.

Health Care During the COVID Pandemic

The COVID-19 pandemic has illuminated the need for effective solutions that address both the immediate challenges and the long-term gaps in our health care systems to ensure people can access quality health care they can afford. In the wake of COVID, policymakers have a critical opportunity to enact solutions to meet their constituents’ short- and long-term health care needs. The 2020 Health Care Legislative Candidate Guide provides candidates with public opinion data, state-specific health care information, key messages and ideas for your health care platform.

Key Messages for Candidates:

  • Acknowledge the moment: “Our country is at a pivotal moment. The pandemic, economic recession, and national discussion on race have created a renewed call for action. They have also magnified the critical problems that exist in our health care system.”
  • Take an active stance: “It is long past time to examine our systems and address gaps that have existed for decades. We must find solutions and common ground to build a health care system that serves everyone.”
  • Commit to prioritizing people’s needs: “I will put people’s health care needs first and I’m already formalizing the ways I gather input and work with community and business leaders to put effective solutions in place.”
  • Commit to addressing disparities and finding common ground: “The health care system, as it’s currently structured, isn’t working for far too many. I will work to address the lack of fairness and shared needs to build a health care system that works for all of us.”

Click to access USC_Generic_CandidateEducationGuide.pdf

 

 

Promising State Policies to Respond to People’s Health Care Needs

In the wake of COVID, policymakers have a critical opportunity to enact solutions to meet their constituents’
short- and long-term health care needs. Shared needs and expectations are emerging in response to the
pandemic, including the desire for solutions that:

Ensure individuals are able to provide for themselves and their loved ones, especially those worried about
the financial impact of the pandemic.

• Protect against high out-of-pocket costs.
• Expand access to telehealth services for people who prefer it to improve access to care.
• Extend Medicaid coverage for new moms to remove financial barriers to care to support healthier moms
and babies.

Ensure a reliable health care system that is fully resourced to support essential workers and available when
it is needed, both now and after the pandemic.

• Ensure safe workplaces for front-line health care workers and essential workers and increase the capacity to
maintain a quality health care workforce.
• Support hospitals and other health care providers, particularly those in rural or distressed areas.
• Expand mental health services and community workforce to meet increased need.

Ensure a health care system that cares for everyone, including people who are vulnerable and those who
were already struggling before the pandemic hit.

• Adopt an integrated approach to people’s overall health by coordinating people’s physical health, behavioral health
and social service needs.
• Establish coordinated data collection to quickly address needs and gaps in care, especially in vulnerable
communities.

Provide accurate information and clear recommendations on the virus and how to stay healthy and safe.
• Build and maintain capacity for detailed and effective testing and surveillance of the virus.
• Resource and implement contact tracing by utilizing existing programs in state health departments, pursuing
public-private partnerships, or app-based solutions while also ensuring strong privacy protections.

 

BY THE NUMBERS

The pandemic is showing different impacts for people across the country
that point to larger challenges individuals and families are grappling.

A disproportionate number of those infected by COVID-19 are Black, Indigenous, and people of color. According to recent CDC data, 31.4% of cases and 17% of deaths are among Latino residents and 19.9% of cases and 22.4% of deaths were among Black residents.ix They make up 18.5% and 13.4% of the total population, respectively.

Seniors are at greatest risk. According to a CDC estimate on August 1, 2020, 80% of COVID-19 deaths were among patients ages 65 and older. In 2018, only 16% of Americans were in this age range.

Access to health care in rural areas has only become more challenging during the pandemic and will likely have lasting impacts on rural communities.

The economic fallout of the pandemic has caused nearly 27 million Americans to lose their employer-based health insurance. An estimated 12.7 million would be eligible for Medicaid; 8.4 million could qualify for subsidies on exchanges; leaving 5.7 million who would need to cover the cost of health insurance policies (COBRA policies averaged $7,188 for a single person to $20,576 for a family of four) or remain uninsured.

 

History tells us trying to stop diseases like COVID-19 at the border is a failed strategy

https://theconversation.com/history-tells-us-trying-to-stop-diseases-like-covid-19-at-the-border-is-a-failed-strategy-145016?utm_medium=email&utm_campaign=Latest%20from%20The%20Conversation%20for%20August%2028%202020%20-%201715916573&utm_content=Latest%20from%20The%20Conversation%20for%20August%2028%202020%20-%201715916573+Version+A+CID_8719e3ecf842bc9762e48ce42f2ba6ad&utm_source=campaign_monitor_us&utm_term=History%20tells%20us%20trying%20to%20stop%20diseases%20like%20COVID-19%20at%20the%20border%20is%20a%20failed%20strategy

History tells us trying to stop diseases like COVID-19 at the border is a failed  strategy

To explain why the coronavirus pandemic is much worse in the U.S. than anywhere else in the world, commentators have blamed the federal government’s mismanaged response and the lack of leadership from the Trump White House.

Others have pointed to our culture of individualism, the decentralized nature of our public health, and our polarized politics.

All valid explanations, but there’s another reason, much older, for the failed response: our approach to fighting infectious disease, inherited from the 19th century, has become overly focused on keeping disease out of the country through border controls.

As a professor of medical sociology, I’ve studied the response to infectious disease and public health policy. In my new book, “Diseased States,” I examine how the early experience of outbreaks in Britain and the United States shaped their current disease control systems. I believe that America’s preoccupation with border controls has hurt our nation’s ability to manage the devastation produced by a domestically occurring outbreak of disease.

Germ theory and the military

Though outbreaks of yellow fever, smallpox, and cholera occurred throughout the 19th century, the federal government didn’t take the fight against infectious disease seriously until the yellow fever outbreak of 1878. During that same year, President Rutherford B. Hayes signed the National Quarantine Act, the first federal disease control legislation.

By the early 20th century, a distinctly American approach to disease control had evolved: “New Public Health.” It was markedly different from the older European concept of public health, which emphasized sanitation and social conditions. Instead, U.S. health officials were fascinated by the newly popular “germ theory,” which theorized that microorganisms, too small to be seen by the naked eye, caused disease. The U.S. became focused on isolating the infectious. The typhoid carrier Mary Mallon, known as “Typhoid Mary,” was isolated on New York’s Brother Island for 23 years of her life.

Originally, the military managed disease control. After the yellow fever outbreak, the U.S. Marine Hospital Service (MHS) was charged with operating maritime quarantine stations countrywide. In 1912, the MHS became the U.S. Public Health Service; to this day, that includes the Public Health Service Commissioned Corps led by the surgeon general. Even the Centers for Disease Control and Prevention started as a military organization during World War II, as the Malaria Control in War Areas program. Connecting the military to disease control promoted the notion that an attack of infectious disease was like an invasion of a foreign enemy.

Germ theory and military management put the U.S. system of disease control down a path in which it prioritized border controls and quarantine throughout the 20th century. During the 1918 influenza pandemicNew York City held all incoming ships at quarantine stations and forcibly removed sick passengers into isolation to a local hospital. Other states followed suit. In Minnesota, the city of Minneapolis isolated all flu patients in a special ward of the city hospital and then denied them visitors. During the 1980s, the Immigration and Naturalization Service denied HIV-positive persons from entering the country and tested over three million potential immigrants for HIV.

Defending the nation from the external threat of disease generally meant stopping the potentially infectious from ever entering the country and isolating those who were able to gain entry.

Our mistakes

This continues to be our predominant strategy in the 21st century. One of President Trump’s first coronavirus actions was to enforce a travel ban on China and then to limit travel from Europe.

His actions were nothing new. In 2014, during the Ebola outbreakCaliforniaNew York and New Jersey created laws to forcibly quarantine health care workers returning from west Africa. New Jersey put this into practice when it isolated U.S. nurse Kaci Hickox after she returned from Sierra Leone, where she was treating Ebola patients.

In 2007, responding to pandemic influenza, the Department of Homeland Security and the CDC developed a “do not board” list to stop potentially infected people from traveling to the U.S.

When such actions stop outbreaks from occurring, they are obviously sound public policy. But when a global outbreak is so large that it’s impossible to keep out, then border controls and quarantine are no longer useful.

This is what has happened with the coronavirus. With today’s globalization, international travel, and an increasing number of pandemics, attempting to keep infectious disease from ever entering the country looks more and more like a futile effort.

Moreover, the U.S. preoccupation with border controls means we did not invest as much as we should have in limiting the internal spread of COVID-19. Unlike countries that mounted an effective response, the U.S. has lagged behind in testingcontact tracing, and the development of a robust health care system able to handle a surge of infected patients. The longstanding focus on stopping an outbreak from ever occurring left us more vulnerable when it inevitably did.

For decades, the U.S. has been underfunding public health. When “swine flu” struck the country in 2009, the CDC said 159 million doses of flu shots were needed to cover “high risk” groups, particularly health care workers and pregnant women. We only produced 32 million doses. And in a pronouncement that now looks prescient, a Robert Wood Johnson Foundation report said if the swine flu outbreak had been any worse, U.S. health departments would have been overwhelmed. By the time Ebola appeared in 2014, the situation was no better. Once again, multiple government reports slammed our response to the outbreak.

Many causes exist for the U.S.‘s failed response to this crisis. But part of the problem lies with our past battles with disease. By emphasizing border controls and quarantine, the U.S. has disregarded more practical strategies of disease control. We can’t change the past, but by learning from it, we can develop more effective ways of dealing with future outbreaks.

 

 

 

 

Billions in Hospital Virus Aid Rested on Compliance With Private Vendor

Billions in Hospital Virus Aid Rested on Compliance With Private ...

The Department of Health and Human Services told hospitals in April that reporting to the vendor, TeleTracking Technologies, was a “prerequisite to payment.”

The Trump administration tied billions of dollars in badly needed coronavirus medical funding this spring to hospitals’ cooperation with a private vendor collecting data for a new Covid-19 database that bypassed the Centers for Disease Control and Prevention.

The highly unusual demand, aimed at hospitals in coronavirus hot spots using funds passed by Congress with no preconditions, alarmed some hospital administrators and even some federal health officials.

The office of the health secretary, Alex M. Azar II, laid out the requirement in an April 21 email obtained by The New York Times that instructed hospitals to make a one-time report of their Covid-19 admissions and intensive care unit beds to TeleTracking Technologies, a company in Pittsburgh whose $10.2 million, five-month government contract has drawn scrutiny on Capitol Hill.

“Please be aware that submitting this data will inform the decision-making on targeted Relief Fund payments and is a prerequisite to payment,” the message read.

The financial condition, which has not been previously reported, applied to money from a $100 billion “coronavirus provider relief fund” established by Congress as part of the $2.2 trillion Coronavirus Aid, Relief and Economic Security Act, or CARES Act, signed by President Trump on March 27. Two days later, the administration instructed hospitals to make daily reports to the C.D.C., only to change course.

“Another data reporting ask,” a regional official in the health department informed colleagues in an email exchange obtained by The Times, adding: “It comes with $$ incentive. We really need a consolidated message on the reporting/data requests, this is past ridiculous.”

A colleague replied, “Another wrinkle. What a mess.”

The disclosure of the demand in April is the most striking example to surface of the department’s efforts to expand the role of private companies in health data collection, a practice that critics say infringes on what has long been a central mission of the C.D.C. Last month, the federal health department moved beyond financial incentives and abruptly ordered hospitals to send daily coronavirus reports to TeleTracking, not the C.D.C., raising concerns about transparency and reliability of the data.

Officials at the Department of Health and Human Services say that the moves were necessary to improve and streamline data collection in a crisis, and that the one-time reports collected in April by TeleTracking were not available from any other source.

“The national health system has not been challenged in this way in any time in recent history,” Caitlin Oakley, a department spokeswoman, said in a statement, adding that TeleTracking offered a “standardized national hospital capacity tracking system which provided more real-time, better informed data to make decisions from.”

But critics remain alarmed.

“In the middle of a pandemic, the Trump administration is using funds meant to support hospitals as a tool to coerce them to use an unproven, untrusted and deeply flawed system that sidelines public health experts,” Senator Patty Murray of Washington, the ranking Democrat on the Senate Health Committee, said in a statement.

In a statement, TeleTracking said it has three decades of experience providing health care systems “with actionable data and unprecedented visibility to make better, faster decisions.”

Still, public health experts and hospital executives are puzzled as to why the health agency chose such a difficult time to employ an untested private vendor rather than improve the C.D.C.’s National Healthcare Safety Network, a decades-old disease tracking system that was deeply familiar to hospitals and state health departments.

The N.H.S.N., as it is known, had built up trust over decades of working with hospitals and state health departments. Administrators were reluctant to make the switch.

“People — especially in public health and clinical health — are very protective of their data, so that trust factor is certainly an issue,” said Patina Zarcone, the director of informatics for the Association of Public Health Laboratories. “The fear of having their data leaked or misused or used for a purpose that they weren’t aware of or agreed to — I think that’s the biggest rub.”

Ms. Oakley said the C.D.C.’s system was “not designed for use in a disaster response” and could not adapt quickly in a crisis. Allies of the C.D.C. say withholding taxpayer dollars from the CARES Act in lieu of cooperation was an inappropriate effort to push hospitals into a system they were reluctant to use.

“It’s an absolutely enormous lever,” said William Schaffner, an infectious disease expert at Vanderbilt University. “It’s a compulsion to oblige institutions to report to this TeleTracking system because they knew if it weren’t tied to money, it wouldn’t happen.”

The Pittsburgh company has no obvious ties to the Trump administration. Rather, the push appears to be part of a broader privatization. The Health and Human Services Department has also asked the Minnesota-based manufacturer 3M “to create, and continuously update, a nationwide clinical data set on Covid-19 treatment,” according to documents obtained by The Times.

The effort is separate from the TeleTracking data collection. Tim Post, a company spokesman, said that because 3M already operates hospital information systems, it is “uniquely positioned,” with the permission of its clients, to submit information to the health department to help officials study disease patterns and recommend treatment options.

Some experts say this kind of cooperation with the private sector is long overdue. But the push also appears to be driven at least in part by an intensifying rift between the C.D.C., based in Atlanta, and officials at the White House and Department of Health and Human Services, the parent agency of the disease control centers.

Dr. Deborah L. Birx, the White House coronavirus response coordinator, and Mark Meadows, the president’s chief of staff, have taken a dim view of the C.D.C. and believe its reporting systems were inadequate. In a recent interview, Michael Caputo, the spokesman for Mr. Azar, accused the C.D.C. of having “a tantrum.”

Accurate hospital data — including information about coronavirus caseloads, deaths, bed capacity and personal protective equipment — is essential to tracking the pandemic and guiding government decisions about how to distribute scarce resources, like ventilators and the drug remdesivir, the only approved treatment for hospitalized Covid-19 patients.

The health agency has set up a new database, H.H.S. Protect, to collect and analyze Covid-19 data from a range of sources. TeleTracking feeds hospital data to that system.

But the public rollout of H.H.S. Protect has been rocky. The nonpartisan Covid Tracking Project identified big disparities between hospital data reported by states and the federal government and deemed the federal data “unreliable.”

The tension dates to March, when the novel coronavirus was making its first surge in the United States

On March 29, Vice President Mike Pence, charged by Mr. Trump with overseeing the federal response, informed hospital administrators that the C.D.C. was setting up a “Covid-19 Module,” and asked them to file daily reports which, he said, were “necessary in monitoring the spread of severe Covid-19 illness and death as well as the impact to hospitals.”

But around that time, TeleTracking submitted a proposal for data collection to the Trump administration, through an initiative, ASPR Next, created to promote innovation. On April 10, TeleTracking was awarded its contract.

The health department’s spokeswoman said the intent was to complement the C.D.C., not compete with it. Like the C.D.C.’s network, TeleTracking’s system requires manual reporting on a daily basis. But in June, Ms. Murray demanded the administration provide more information about what she called a “multimillion-dollar contract” for a “duplicative health data system.”

Some hospital officials also objected to the change.

“We have been directing our hospitals to N.H.S.N.,” Jackie Gatz, a vice president of the Missouri Hospital Association, wrote to a regional health and human services official in an email obtained by The Times, “and now this email with a much greater carrot — CARES Act distributions — is routing them to TeleTracking.”

When the order was delivered, flaws had already emerged in the new system.

“H.H.S. has acknowledged long wait times for those calling for technical support, and indicated that TeleTracking recently added 100 staff to respond to call center requests,” the American Hospital Association wrote to its members in a “special bulletin” on April 23. “They also are directing hospitals to leave a message if they are unable to reach someone live.”

At the time, hospitals had the option of making their daily coronavirus reports to TeleTracking or the C.D.C. Few were using the new database.

In June, the administration again used a stick to demand that hospitals report to TeleTracking, this time in order to obtain remdesivir. By July, with Dr. Birx pushing to bolster hospital compliance, the administration instructed hospitals to stop filing daily reports to the C.D.C. and to send them to TeleTracking instead.

One official at a major academic hospital, who spoke on the condition of anonymity for fear of angering officials in Washington, said the switch left her “unable to sleep at night.”

“Ethically, it felt like they had taken a very trusted institution in the C.D.C. and all of that trust built up with many public health people,” she said, then “moved it onto a politically and financially motivated portion of this response.”

Health and human services officials say the government now has a much more complete picture of hospital bed capacity, with more than 90 percent of hospitals reporting. But Dr. Janis M. Orlowski, the chief health officer for the Association of American Medical Colleges, who worked with Dr. Birx and the administration to bolster hospital reporting, said that she was “stunned” by the switch and that the increase in reporting came because of efforts by her group and others, not the TeleTracking system.

Dr. Orlowski said the data and maps now published on the administration’s H.H.S. Protect data hub are “just not as sophisticated as the C.D.C.”

The switch also generated pushback inside the C.D.C., where officials have refused to analyze and publish TeleTracking data, saying they could not be assured of its quality and had continuing questions about its accuracy, according to a senior federal health official.

Administration officials say the C.D.C. is working with a little-known office in the executive branch — the United States Digital Service — to build a “modernized automation process” in which data will continue to flow directly to the Department of Health and Human Services. But the project is in its infancy, one senior federal health official said.

Critics say that if the department believed the C.D.C.’s health network had problems, those should have been fixed.

“We have a public health system that depends upon communication from hospitals to state health departments to the C.D.C.,” said Dr. Schaffner, the Vanderbilt University infectious disease expert. “It’s very well established. Can it be improved? Of course. But to cut out the public health infrastructure and report to a private firm essential public health data is misguided in the extreme.”

 

 

 

Drugmakers getting bolder in fight over 340B drug discounts

https://www.fiercehealthcare.com/hospitals/drug-makers-getting-bolder-fight-over-340b-drug-discounts?mkt_tok=eyJpIjoiTTJRMlkySTJZV1ZoWldGbSIsInQiOiJYVUFLbDJLQ2hkbzBrWjBpOVwvbm5YYUpVWExRZ21QRXBkWGJFWldLVGxCZXlFOENlazZBdUhpVm5RUTczOGFxZFVLSEszOTZra20zYzdOQllvMjVHVXNvOUFcL0J3Rk0reFwvV1VHRytoUTYwaDNxelgwcmw5RHhuSEZtNGtlcXZ6MCJ9&mrkid=959610

Drugmakers getting bolder in fight over 340B drug discounts ...

Drugmakers are getting bolder in their bid to restrict access to drugs discounted under the 340B program as legal experts say a lack of enforcement has created a regulatory void.

Hospitals are imploring the Department of Health and Human Services (HHS) to clamp down on several moves by drug companies, including Novartis and AstraZeneca, to limit distribution of certain 340B drugs. But experts say an administration-wide change in what agencies can enforce is likely behind drugmakers’ aggressive moves.

“It is an outrage that these actions are being taken at a time when hospitals are in the midst of their response to the COVID-19 public health emergency, which has further demonstrated the fractured, inadequate state of the prescription drug supply chain,” the American Hospital Association said in a release last week.

Hospitals and 340B advocates are furious that AstraZeneca announced last Friday that starting Oct. 1 it will not offer any discounted drugs to contract pharmacies, which are third-party entities that dispense drugs acquired under the program. 

It is the most aggressive move in a fight sparked last month between drug companies against contract pharmacies, which are a popular tool among 340B hospitals.

The back story

In exchange for participating in Medicaid, a drug manufacturer is required to offer discounts to safety-net hospitals that participate in 340B. But the program has been beset with controversy in recent years as drug companies claim the program has gotten too large and patients aren’t benefiting from the discounts.

Eli Lilly decided last month to restrict sales to contract pharmacies of certain formulations of erectile dysfunction drug Cialis. Merck and Novartis also said contract pharmacies would need to submit claims data to avoid duplicate discounts.

We’ve reached out to pharmaceutical companies for comment and will update when we hear back.

Industry advocacy organization Pharmaceutical Research and Manufacturers of America (PhRMA) has previously called for reforms to the 340B program, including to the ability for covered entities to contract with multiple outside pharmacies to dispense drugs that receive 340B discounts. Even though the number of Americans who are insured has risen, 340B is growing exponentially, they said. “Not all 340B hospitals are good stewards of the program,” PhRMA said.

Hospital groups and 340B allies charge that the moves blatantly violate a 2010 guidance released by the Health Resources and Services Administration (HRSA), which oversees the 340B program.

The guidance permits a hospital participating in 340B to voluntarily use a contract pharmacy and outlines the requirements to do so. The guidance also says a manufacturer must still sell a drug at a price not to exceed the statutory 340B price.

But an October 2019 executive order said federal agencies cannot enforce guidance documents unless they are part of a contract amid other exceptions.

HRSA has said that it doesn’t have the authority under the 340B statute to take enforcement action on “requirements that have been established under guidance,” said Emily Cook, a partner with law firm McDermott Will & Emery.

The agency’s current position is that it can only take enforcement actions on clear violations of the 340B statute, she added.

HRSA told Fierce Healthcare in a statement it is considering the issues raised by the manufacturers and “evaluating our next steps.”

What’s next

Hospitals are hoping HHS steps in and clears up the issue.

If not, then hospitals could either take drug companies to court or lobby Congress to give HRSA more authority over the program.

The advocacy group 340B Health said last week that if the administration refuses to step in then it will “pursue all legislative and legal avenues available to us to defend the safety net.”

Hospitals need to re-examine their 340B contract pharmacy deals to exclude AstraZeneca drugs, according to an article from Brenda Maloney Shafer and Richard Davis of law firm Quarles & Brady.

If they fail to do this, then the contract pharmacy could pay for dispensing and administrative fees for drugs that won’t get a 340B discount.

This is the latest spat over the controversial program. Hospitals took the administration to court after it tried to cut payments under the program by nearly 30%.

An appeals court recently ruled that HHS does have the authority to institute the cuts.

 

 

 

 

Trump Unveils Healthcare Agenda

https://www.medpagetoday.com/washington-watch/electioncoverage/88250?xid=nl_mpt_DHE_2020-08-26&eun=g885344d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%202020-08-26&utm_term=NL_Daily_DHE_dual-gmail-definition

What's in, and out, of Biden's health care plan

List of bullet points prompts debate over lack of detail, potential for actual achievement.

Health policy scholars critiqued the Trump campaign’s broad strokes healthcare agenda for his potential second term. While some found it overly vague, even dishonest, one suggested it was precisely what voters want.

Released Sunday night as a list of bullet points, the “Fighting for You” agenda will apparently serve as the Republican platform for the 2020 election. The GOP’s platform committee voted over the weekend to dispense with the customary detailed policy document for this cycle, in favor of simply backing President Trump’s agenda.

That agenda, which the Trump campaign promised would be fleshed out in future speeches and statements, included the following points relevant to healthcare:

Eradicate COVID-19

  • Develop a vaccine by the end of 2020
  • Return to normal in 2021
  • Make all critical medicines and supplies for healthcare workers
  • Refill stockpiles and prepare for future pandemics

Healthcare

  • Cut prescription drug prices
  • Put patients and doctors back in charge of our healthcare system
  • Lower healthcare insurance premiums
  • End surprise billing
  • Cover all pre-existing conditions
  • Protect Social Security and Medicare
  • Protect our veterans and provide world-class healthcare and services

Reliance on China

  • Allow 100% expensing deductions for essential industries like pharmaceuticals and robotics who bring back their manufacturing to the U.S.
  • No federal contracts for companies who outsource to China
  • Hold China fully accountable for allowing the virus to spread around the world

Joseph Antos, PhD, a resident scholar in healthcare and retirement policy at the American Enterprise Institute, characterized Trump’s strategy as “Don’t explain it. Just say what your goals are.”

He applauded the brevity of the document, 6 pages in total, covering 10 different policy areas from jobs to healthcare to immigration, as a “smart strategy.”

Voters don’t want to read lengthy policy briefs and gave the “Biden-Sanders Unity Task Force Recommendations” which were over 100 pages long and “unbelievably complicated stuff” as an example of how not to reach voters.

“I think [Trump] got it right. He’s not running a think tank…. He’s running for office. He does have a keen eye for what the average voter could stand to listen to.”

Gail Wilensky, PhD, an economist and senior fellow at Project Hope in Bethesda, Maryland, and CMS administrator under President George H.W. Bush, agreed that a platform packed with policy details doesn’t sway many voters.

This election, she said, is about one thing only: “Trump or not Trump.”

Whither the ACA?

Nevertheless, the Trump campaign’s goals merit attention, often for what they don’t include as well as what they do.

As for the substance of the agenda, the key difference between the Trump administration’s proposed agenda and that of the Democratic nominee, former Vice President Joe Biden, is that the latter aims to expand access to health insurance using the Affordable Care Act’s (ACA) framework, said Wilensky.

While Trump’s 2016 healthcare agenda centered around repealing the ACA, his second-term agenda doesn’t mention the law by name.

Wilensky said she’s glad that Trump did not include ACA repeal among his goals, given that “there’s no historical precedence” for eliminating the core benefits of such far-reaching legislation, now on the books for 10 years and fully implemented for 6.

Kavita Patel, MD, a primary care physician and Brookings Institution scholar in Washington, D.C., who was an advisor on the Democrats’ platform, said, “This is all just posturing and politics and almost a continuation of things [Trump’s] been saying without any real details behind it.”

Many of these items — such as ending surprise billing, lowering health insurance premiums, and cutting prescription drug prices — would have Democrats’ support “but they would get there in a different way,” Patel said.

One thing she was surprised not to see in the agenda were references to abortion or other reproductive health issues, she noted.

Insurance Coverage Neglected

Rosemarie Day, founder and CEO of Day Health Strategies and author of Marching Toward Coverage: How Women can Lead the Fight for Universal Healthcare, was dumbfounded by the overall lack of substance in the agenda, and particularly by the absence of a plan to deal with rising rates of uninsurance related to the pandemic.

Day thought the Trump campaign could have at least included a plan for returning to the “baseline” on the number of uninsured. Another administration might have chosen to promote Medicaid coverage or encourage unemployed workers to enroll on the health insurance exchanges, but not this administration, she said.

“So, they’re really just leaving people out in the cold,” Day said.

Wilensky, too, suggested it would have been “useful” for the Trump campaign to have “talked about how they envision getting more people covered.”

Paul Ginsburg, PhD, director of the USC-Brookings Schaeffer Initiative for Health Policy, said much of the agenda is “just aspirations.”

“‘Put patients and doctors in charge of our healthcare system’? … I don’t know what the policy is, [but] who’s going to quarrel with that?”

Lowering healthcare premiums also sounds “nice” but how that would be achieved is unclear, he said.

One agenda item in the document that really really irked Day was the Trump administration’s pledge to protect people who have pre-existing conditions.

“I consider the ‘covering all pre-existing conditions’ an outright lie,” she said. “I find it incredibly upsetting that [Trump] continues to say that” because he spent his first term attacking the ACA, which does protect pre-existing condition coverage.

Day also noted that the administration has repeatedly promised an ACA replacement without ever delivering an actual proposal.

Responding to the Pandemic

The Trump campaign agenda lists “eradicate COVID-19” on its bullet list, but Patel said it’s “probably not an achievable goal.” A more realistic target is to control it better.

“We have deaths every year and hospitalizations from influenza, but we have a vaccine and we have … strategies to protect people like seniors and young children,” Patel said. “That’s exactly the kind of attitude we have to take” with regard to COVID-19.

For both Patel and Ginsburg, “return to normal” is another aspiration that’s beyond the government’s power to deliver.

“So much depends on a vaccine and its acceptance and how quickly it can be produced,” Ginsburg said.

As for making all critical medicines and supplies for healthcare workers in the United States, Ginsburg acknowledged that it’s theoretically doable, but still unrealistic because it would be “way too expensive.”

“Brand name drugs are routinely produced in other countries as well as the U.S.; I wouldn’t want to upset that supply chain, especially for drugs that are in shortage,” he said.

 

 

 

Drug payment cuts to 340B hospitals spur debate on best path forward

https://www.healthcarefinancenews.com/news/drug-payment-cuts-340b-hospitals-spur-debate-best-path-forward

340B hospitals breathing easier under Dem-controlled House

Hospitals say revenue from the 340B program is essential, while others contend the original law is being abused.

On August 3, an federal appeals court ruled that 340B hospitals will now be subject to Medicare cuts in outpatient drug payments by nearly 30%, reversing an earlier ruling calling those cuts illegal. The 2-1 decision by the U.S Court of Appeals for the District of Columbia Circuit essentially gives the Trump Administration and the Department of Health and Human Services the legal authority to reduce payment for Medicare Part B drugs to 340B hospitals.

HHS Secretary Alex Azar said the action means patients – particularly those who live in vulnerable areas – will pay less out-of-pocket for drugs in the Medicare Part B program. But providers, including the American Hospital Association, the Association of American Medical Colleges and America’s Essential Hospitals, said the 340B decision will hurt hospitals and patients in these vulnerable areas.

Hospitals that serve large numbers of Medicaid, Medicare and uninsured patients were getting the drugs for a discounted price, but, getting reimbursed at the higher price, HHS pays all hospitals for Medicare Part B drugs. The hospitals, many of which are in the red or operating on thin margins, were using the pay gap in the price difference to cover operational expenses. HHS deemed it inappropriate that these facilities would use Medicare to subsidize other activities and initiatives, and the appeals court agreed.

As per the original 340B legislation, discounts on drugs can range from 13% to 32% off the average retail price for participating providers, but Medicare Part D sets reimbursement in an entirely different way, leading to the significant reimbursement discrepancies – until the ruling, which furthered HHS’ push to narrow the spread between acquisition price and reimbursement.

THE DEBATE

“The opportunity to exploit this buy/sell differential probably has something to do with the explosive growth there’s been in the number of participating institutions in 340B,” said Michael Abrams, cofounder and managing partner of Numerof and Associates. “According to the data I came across, discounted 340B purchases grew 23% from 2018 to 2019, and currently make up about 8% of the total of the U.S. drug market. So from my perspective this looks like a loophole that’s been used by a small number of large institutions, who in many cases don’t serve that many disadvantaged patients, but nonetheless serve enough to qualify for the 340B program and to purchase the drugs they buy at the discounted rate.”

Groups representing U.S. hospitals would disagree with that assessment, and, in fact, when the appeals court handed its ruling, the AHA, AAMC and America’s Essential Hospitals said 340B hospitals and their patients would “suffer lasting consequences.”

“The decision conflicts with Congress’ clear intent and defers to the government’s inaccurate interpretation of the law, a point that was articulated by the judge who dissented from the opinion,” the groups wrote in a statement. “For more than 25 years, the 340B program has helped hospitals stretch scarce federal resources to reach more patients and provide more comprehensive services. Hospitals that rely on the savings from the 340B drug pricing program are also on the front-lines of the COVID-19 pandemic, and today’s decision will result in the continued loss of resources at the worst possible time.”

President and CEO of 340B Health Maureen Testoni also lamented the appeals court’s decision, calling the cuts “discriminatory.”

“These cuts of nearly 30% have caused real and lasting pain to safety-net hospitals and the patients they serve,” she said earlier this month. “Keeping these cuts in place will only deepen the damage of forced cutbacks in patient services and cancellations of planned care expansions. These effects will be especially detrimental during a global pandemic.

Abrams contends that much of the confusion and legal wrangling can be attributed to the vagueness of the original 340B legislation, the stated goal of which was to “enable participating institutions to stretch scarce financial dollars.” With little else to go on in terms of the language, those on each side of the issue were able to interpret it in their own way, with participating institutions saying it’s within the bounds of the law to use that revenue stream to enhance their mission – another phrase that’s open to wide interpretation.

“There’s no question this is being put to uses that were never intended,” said Abrams, adding that the profits generated by the buy/sell differential often disappear into balance sheets with little to no accountability.

Hospitals, for their part, feel they’re under siege by HHS at a critical time for the healthcare system’s financial viability. Even before the COVID-19 pandemic, hospitals saw the migration of lucrative inpatient procedures, such as hip and knee replacements, to freestanding outpatient facilities, which in some cases are not owned by the hospital. That represents a significant loss of revenue. Factor in the lost revenue from cancelled or delayed elective procedures due to the coronavirus, as well as patients who are too cautious to enter the healthcare system, and hospitals are hurting. AHA President and CEO Rick Pollack said in July that half of all U.S. hospitals will likely be in the red by the end of the year.

A COMPLICATED PICTURE

Actions by the pharmaceutical industry are also adding to the complication. A recent statement from America’s Essential Hospitals alleges that recent actions by pharmaceutical manufacturers “hinder access to affordable medications for millions of people who face financial hardships and defy clear statutory requirements that they provide drugs to 340B Drug Pricing Program covered entities.”

The manufacturers have threatened punitive actions – including withholding 340B drugs to contract pharmacies – for failing to comply with reporting requirements that Essential Hospitals call “arbitrary.”

“These data requests have no clear link to program integrity,” the group said. “Rather, they seem to be little more than a fishing expedition.”

A concrete example can be found in AstraZeneca’s decision to refuse 340B pricing to hospitals with on-site pharmacies for any drugs that will be dispensed through contract pharmacies. In a statement this week, Testoni of 340B called this action an “attack” on the 340B program that will hurt healthcare institutions as well as low-income and rural Americans.

“We believe that refusing to offer discounts that the 340B statute requires is a violation of federal law,” said Testoni. “We are calling on Health and Human Services Secretary (Alex) Azar to exercise his authority to stop these overcharges before they cause permanent damage to the healthcare safety net.”

Abrams sides more with the appeals court decision, saying that requiring the pharmaceutical industry to sell drugs at a discount comes with significant regulation to ensure they do so – a stark contrast to the lack of regulation around the resulting revenue. Though another appeal certainly isn’t out of the question, Abrams expects participation in the program to shrink back to a level reflecting the size of the target populations.

“This is about helping disadvantaged patients get their drugs, and that should be the driving activity of the program,” he said. “I’m fine with HHS taking this problem on, because it was an abuse that was never intended in the original legislation. It just seems to me that HHS really wants the healthcare sector to deliver care that is more accountable both for efficient use of resources and outcomes.”

One person who disagrees is Circuit Judge Cornelia Pillard, who wrote the dissenting opinion in the appeals court decision.

“The challenged rules took a major bite out of 340B hospitals’ funding,” she said. “Often operating at substantial losses, 340B hospitals rely on the revenue that Medicare Part B provides in the form of standard drug-reimbursement payments that exceed those hospitals’ acquisition costs. 340B hospitals have used the additional resources to provide critical healthcare services to communities with underserved populations that could not otherwise afford these services.”

 

 

 

 

Supreme Court to hear ACA arguments after November election

https://www.healthcaredive.com/news/supreme-court-will-hear-aca-case-after-november-election/583804/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202020-08-20%20Healthcare%20Dive%20%5Bissue:29204%5D&utm_term=Healthcare%20Dive

Dive Brief:

  • The Supreme Court will hear oral arguments in the Republican-led case seeking to overturn the Affordable Care Act on November 10, exactly one week after the presidential election, according to the court’s online docket on Wednesday.
  • A hearing post-election was the likeliest choice from the outset. The justices’ October schedule did not include the highly anticipated case, leaving just one day for arguments to potentially be heard before the election.
  • Still, Wednesday’s news does not mean the Supreme Court will make a ruling on the case in 2020. Legal experts say a final ruling is still expected next year.

 

Dive Insight:

The ACA court case has loomed large as the nation has been ravaged by the novel coronavirus pandemic that has sickened millions, killed thousands and severed millions of people from their employer-sponsored health insurance coverage. 

Alternative coverage options introduced or strengthened by the ACA, such as expanded Medicaid coverage or marketplace plans, have served as an important safety net for those who have lost coverage as a result of the pandemic. 

Onlookers have long been waiting for the court to set a date for final arguments in the case against the ACA. Wednesday’s updated docket means the country is one step closer to knowing whether the ACA and its popular provisions, such as protections for pre-existing conditions, will remain the law of the land. 

Waiting to schedule oral arguments until after the election may have been intentional, legal experts say.

The highly unusual decision by the Trump administration’s DOJ to refuse to defend the law is likely to change with the election result, if former Vice President Joe Biden, the Democratic presidential nominee and a staunch ACA backer, wins the White House.

Republicans for years have been trying to dismantle President Barack Obama’s landmark health law, including by eliminating the financial penalty for not holding insurance.

The central argument in the case, brought primarily by a group of red states, is whether the entire law is invalid because it no longer contains the so-called individual mandate. The red states have argued that because Congress lowered the penalty to zero that the individual mandate can no longer be considered a tax and therefore renders the entire law unconstitutional.

Lower courts have ruled in favor of the red state plaintiffs, though the appeals court did not weigh in on whether the rest of the law could be severed from the mandate.

 

 

 

 

Medicaid Is Essential for Workers

Medicaid Is Essential for Workers as COVID-19 Spreads

Earlier this year, when public schools in Kansas City, Missouri, shut down in-person instruction because of the COVID-19 pandemic, Nika Cotton quit her job in social work to start her own business. She has two young children — ages 8 and 10 — and no one to watch them if she were to continue working a traditional job.

It was a big decision, made weightier by the loss of her employer-sponsored health insurance. But on August 5, Cotton awoke to the news that Missouri voters had narrowly approved the expansion of the state’s Medicaid program via ballot initiative, making it the second politically right-leaning state to do so during the pandemic. The expansion opens Medicaid eligibility to individuals and families with incomes up to 138% of the federal poverty guidelines, which are $12,760 for an individual and $21,720 for a family of three, allowing Cotton’s family of three to qualify.

“It takes a lot of stress off of my shoulders with having to think about how I’m going to take care of myself, how I’m going to be able to go and see a doctor and get the health care I need while I’m starting my business,” she told Alex Smith of KCUR, the NPR affiliate in Kansas City.

Nearly 1,264,000 voters weighed in on the measure, with 53% voting for it and 47% against it. Missouri’s Republican governor Mike Parson opposed it, arguing that the state could not afford the coverage expansion — even though the federal government pays 90% of the costs and a fiscal analysis (PDF) by the Center for Health Economics and Policy at Washington University estimated that the state would save $39 million if it implemented Medicaid expansion in 2020.

The ballot measure requires the state to expand Medicaid by July 2021, and an estimated 230,000 residents with low incomes will become eligible for affordable health coverage.

Voters Signal Support

In late June, Oklahoma voters also approved Medicaid expansion by ballot measure, eking out a victory by less than one percentage point.

“It is difficult to ignore that these ballot initiatives passed in right-leaning states in the middle of the coronavirus pandemic, when millions of Americans have lost their jobs and, with them, their employer-sponsored health insurance,” Dylan Scott wrote in Vox. “This is partly a coincidence — the signatures were collected to put the Medicaid expansion questions on the ballot long before COVID-19 ever arrived in the US — but the relatively narrow margins made me wonder if the pandemic and its economic and medical consequences proved decisive.”

Earlier this year, Scott spoke to Cynthia Cox, MPH, director of the Peterson-Kaiser Health System Tracker, about the potential impact of the pandemic on health care politics. “Many of the biggest coverage expansions both in the US and in similar countries happened in the context of wars and social upheavals, as well as financial crises,” Cox said. “One theory is that those circumstances redefine social solidarity, thus expanding views of the role of government.”

Between February and May, Missouri’s Medicaid program saw enrollment rise nearly 9%, one of the largest increases nationwide during the pandemic, Rachel Roubein reported in Politico. During that same period, Oklahoma’s Medicaid program saw enrollment increase by about 6%.

States that implemented Medicaid expansion are better positioned to respond to COVID-19, according to a report by the Center on Budget and Policy Priorities (CBPP). These states entered the health crisis and resulting economic downturn with lower uninsured rates, which is important for public health “because people who are uninsured may forgo testing or treatment for COVID-19 due to concerns that they cannot afford it, endangering their health while slowing detection of the virus’ spread,” the authors wrote.

CBPP and KFF estimate that 3.6 to 4.4 million uninsured adults would become eligible for Medicaid coverage if the 12 states that have not yet expanded the program did so. Those states are Alabama, Florida, Georgia, Kansas, Mississippi, North Carolina, South Carolina, South Dakota, Tennessee, Texas, Wisconsin, and Wyoming.

Coverage for Frontline Essential Workers

Medicaid is particularly important for frontline essential workers — such as those working in grocery stores, meat processing plants, and nursing homes — during the pandemic. Their jobs require them to report in person, increasing their risk of getting sick with the coronavirus as they interact with coworkers and, in many cases, with customers and patients. Essential workers are often paid low wages and not offered employer-sponsored health insurance or can’t afford the premiums for it.

About 5 million essential workers nationwide get health coverage through Medicaid, “including nearly 1.8 million people working in frontline health care services and 1.6 million in other frontline essential services including transportation, waste management, and child care,” Matt Broaddus, senior research analyst at CBPP, wrote on the center’s blog.

In California, over 950,000 essential workers are enrolled in Medi-Cal, the state’s Medicaid program. People of color are overrepresented in many categories of essential jobs. According to a UC Berkeley Labor Center analysis of the 15 largest frontline essential occupations, Latinx workers are overrepresented in agriculture, construction, and food preparation, among other occupations. Asian workers are overrepresented among registered nurses and personal care aides; and Black workers are overrepresented among personal care aides, laborers and material movers, and office clerks.

In addition to low-wage workers, Medi-Cal continues to bridge the coverage gap for other key populations amid the COVID-19 crisis, which is magnifying historical health inequities. (Medi-Cal covers nearly 40% of the state’s children, half of Californians with disabilities, and over one million seniors. For a refresher on the program, see CHCF’s Medi-Cal Explained series.)

Medicaid Saves Lives

Research has shown time and time again the varied benefits of Medicaid expansion: lower mortality rates among older adults with low incomes, declines in infant mortality, reductions in racial disparities in the care of cancer patients, and fewer personal bankruptcies, just to name a few.

Even though Missouri’s Medicaid expansion won’t take effect for another year, Nika Cotton remains excited. “It’s better late than never,” she said. “The fact that it’s coming is better than nothing” — perhaps a takeaway for the remaining 12 states.