Here are six key ways Biden is promising to fight the coronavirus pandemic

By the time President-elect Joe Biden takes the oath of office on Wednesday, more than 400,000 Americans will have died of covid-19 — a dismal milestone in the deadly pandemic.

Yet the crucial task he faces  rapidly distributing coronavirus vaccines to the American public  is one that most experts one year ago didn’t think would even be an option by this point. Few expected multiple vaccines to be approved within a year — a record for vaccine development, by any measure. And although the rollout has been criticized, Israel and Great Britain are the only major nations the United States lags in vaccinations per capita and its daily rate of immunizations has more than doubled in the past two weeks.

“You have my word: We will manage the hell out of this operation,” Biden said in a speech on Friday, announcing his own vaccination plan. 

Regardless of whether one views the vaccine effort up to this point as a failure or success, this much is true: Biden and his new administration will face an enormous task, not only in getting the vaccines distributed but also in ramping up testing, convincing Americans to follow public health recommendations and responding to the economic fallout from the pandemic. 

Here are six key promises Biden is making about his pandemic response:

1. Administer 100 million doses of coronavirus vaccine during the first 100 days of his administration.

Biden previously cited this as a goal. He reiterated it Friday while rolling out a broader plan for coronavirus vaccinations

The plan would require a rate of 1 million immunizations per day — and the United States isn’t too far away from that goal right now. Nearly 800,000 Americans are getting shots every day on average. That’s a considerable improvement from two weeks ago, when the daily rate was closer to 350,000.

The 100-shot goal is “absolutely a doable thing,” Anthony S. Fauci, direct of the National Institute for Allergy and Infectious Disease, told NBC’s Chuck Todd yesterday.

“The feasibility of his goal is absolutely clear; there’s no doubt about it,” Fauci said. “That can be done.”

But top Biden advisers are also cautioning ramping up immunizations will be gradual and will require lots of coordination.

“The first days of that 100 days may be substantially slower than it will be towards the end,” Michael Osterholm, a member of Biden’s covid-19 task force, told Stat News. “It’s not going to occur quickly … you’re going to see the ramp-up occurring only when the resources really begin to flow.”

2. Set up mass vaccination clinics.

By the end of his first month in office, Biden has promised to open 100 federally managed clinics to administer shots. According to his vaccination plan, these sites would be set up by the Federal Emergency Management Agency. The federal government would reimburse states for sending National Guard members to help run them.

Biden says he also wants to deploy mobile units to rural and underserved areas, along with boosting the role already being played by pharmacies in distributing shots. 

This approach would diverge significantly from how things are being done now, with the Trump administration leaving it up to hospitals, doctors, pharmacies and state public health departments to administer the shots. Some cities and states have set up large vaccination sites, but many haven’t.

“Overall, the president-elect’s plan lays out a more muscular federal role than the Trump administration’s approach, which has relied heavily on each state to administer vaccines once the federal government ships them out,” Anne Gearan, Amy Goldstein and Laurie McGinley report.

“Many of the elements — such as seeking to expand the number of vaccination sites and setting up mobile vaccination clinics — were foreshadowed in a radio interview Biden gave last week and in an economic and health ‘relief plan’ he issued Thursday, which contains a $20 billion request of Congress to pay for a stepped-up campaign of mass vaccination,” our colleagues add.

3. Allow federally qualified health centers to directly access vaccines.

These community health centers — which receive higher government reimbursements but are required to accept all patients regardless of their ability to pay — are a core part of the nation’s safety net for low-income Americans.

Biden’s plan proposes a new program “to ensure [federally qualified health centers] can directly access vaccine supply where needed,” although here, too, it’s unclear exactly how that might work.

Under the Trump administration’s plan, these centers have been asked to enroll with state health departments as vaccine providers. States were then supposed to communicate to the federal government how many doses were needed and where they should go.

How well this is actually working is “all over the map,” said Amy Simmons Farber of the National Association of Community Health Centers. She said supplies vary from county to county and many health centers have received their supplies with little notice, making it challenging to prioritize and plan.

Farber declined to comment on the Biden plan, saying she doesn’t have a lot of details about it. But she’s “very encouraged by the recognition of the important role health centers have played in fighting the pandemic and the need to adequately resource them.”

4. Use the Defense Production Act to ensure plenty of vaccine supplies.

Several times over the course of the pandemic, President Trump has invoked the Defense Production Act, which allows the president to require companies to prioritize contracts deemed essential for national security.

Ventilator tubes are attached to a covid-19 patient at Providence Holy Cross Medical Center in Los Angeles. 

He has used the DPA to speed the production of coronavirus tests and ventilators, and to keep meatpacking plants open. But he hasn’t invoked the authority to compel faster production of the supplies needed for packaging and administering the vaccine.

Biden says he will invoke DPA to ensure a steady stream of these supplies, which include glass vials, stoppers, syringes, needles and the capacity for companies to rapidly fill vaccine vials and finish packaging them.

5. Sign executive actions to combat the virus.

Biden has promised a raft of executive actions in his first ten days as president, laid out over the weekend in a memo from incoming White House Chief of Staff Ron Klain. They’ll include a number of pandemic-related orders.

On Inauguration Day, Biden intends to issue a mask mandate on federal property and for interstate travel, while encouraging all Americans to wear masks for what he’s calling a “100 Day Masking Challenge.”

The following day, Thursday, he’ll sign executive orders aimed at helping schools and businesses reopen safely, expanding testing, protecting workers and establishing clearer public health standards. And on Friday, Biden will direct his Cabinet secretaries to take immediate action to deliver economic relief to families.

“President-elect Biden will take action — not just to reverse the gravest damages of the Trump administration — but also to start moving our country forward,” Klain wrote.

6. Launch a vaccine education campaign.

The memo says Biden will run a “federally-run, locally-focused public education campaign.”

“The campaign will work to elevate trusted local voices and outline the historic efforts to deliver a safe and effective vaccine as part of a national strategy for beating covid-19,” it says.

But the transition team hasn’t detailed how the education campaign might differ from one launched by the Trump administration last month. 

The Department of Health and Human Services said it plans to spend $250 million on efforts to promote vaccine awareness. It kicked off the effort with a $150,000 buy on YouTube for ads that feature Fauci and Food and Drug Administration Commissioner Stephen Hahn. 

Vaccine reserve was exhausted when Trump administration vowed to release it, dashing hopes of expanded access

https://www.washingtonpost.com/health/2021/01/15/trump-vaccine-reserve-used-up/

Eric Feigl-Ding on Twitter: "BREAKING—We are out of vaccine reserves! Trump  HHS Sec Azar announced this week that the govt would begin releasing  #COVID19 vaccine doses held in reserve for 2nd shots—but

States were anticipating a windfall after federal officials said they would stop holding back second doses. But the approach had already changed, and no stockpile exists.

When Health and Human Services Secretary Alex Azar announced this week that the federal government would begin releasing coronavirus vaccine doses that had been held in reserve for second shots, no such reserve existed, according to state and federal officials briefed on distribution plans. The Trump administration had already begun shipping out what was available, starting at the end of December, taking second doses for the two-dose regimen directly off the manufacturing line.

Now, health officials across the country who had anticipated their extremely limited vaccine supply as much as doubling beginning next week are confronting the reality that their allocations will remain largely flat, dashing hopes of dramatically expanding access for millions of elderly people and those with high-risk medical conditions. Health officials in some cities and states were informed in recent days about the reality of the situation, while others were still in the dark Friday.

Because both of the vaccines authorized for emergency use in the United States are two-dose regimens, the Trump administration’s initial policy was to hold back second doses to protect against manufacturing disruptions. But that approach shifted in recent weeks, according to the officials, who spoke on the condition of anonymity because they were not authorized to discuss the matter.

Operation Warp Speed, which is overseeing vaccine distribution, stopped stockpiling second doses of the Pfizer-BioNTech vaccine at the end of last year, those officials were told. Shipping of the last reserve doses of Moderna’s supply, meanwhile, began over the weekend.

The shift, in both cases, had to do with increased confidence in the supply chain, so Operation Warp Speed leaders felt they could reliably anticipate the availability of doses for booster shots — required three weeks later in the case of the Pfizer-BioNTech product and four weeks later under Moderna’s protocol.

But it also meant there was no stockpile of second doses waiting to be shipped, as Trump administration officials suggested this week. Azar, at a briefing Tuesday, said, “Because we now have a consistent pace of production, we can now ship all of the doses that had been held in physical reserve.” He explained the decision as part of the “next phase” of the nation’s vaccination campaign.

Those in line for their second shots are still expected to get them on schedule because second doses are prioritized over first shots and states are still receiving regular vaccine shipments. But state and local officials say they are angry and bewildered by the shifting directions and changing explanations about supply. Their anxiety was deepened by projections that a highly contagious virus variant would spread rapidly throughout the United States and as daily covid-19 deaths averaged 3,320 this week.

The health director in Oregon, Patrick M. Allen, was so disturbed that he wrote Azar on Thursday demanding an explanation. In his letter, he recounted how Gustave F. Perna, the chief operating officer of Operation Warp Speed, had “informed us there is no reserve of doses, and we are already receiving the full allocation of vaccines.”

“If true, this is extremely disturbing, and puts our plans to expand eligibility at grave risk,” Allen wrote. “Those plans were made on the basis of reliance on your statement about ‘releasing the entire supply’ you have in reserve. If this information is accurate, we will be unable to begin vaccinating our vulnerable seniors on Jan. 23, as planned.”

HHS spokesman Michael Pratt confirmed in an email that the final reserve of second doses had recently been released to states but did not address Azar’s comments, saying only, “Operation Warp Speed has been monitoring manufacturing closely, and always intended to transition from holding second doses in reserve as manufacturing stabilizes and we gained confidence in the ability for a consistent flow of vaccines.”

But the explanations by the federal government were conflicting. The 13 million doses made available for states to order this week — for delivery next week — represented “millions more” than in previous weeks, Pratt said. He also said states have not requested the full amount they have been allocated.

Guidance circulated Friday among HHS officials acknowledged, however, that “the notion that there is a large bolus of second doses that will be released to jurisdictions is not accurate.” And state and municipal health officials said their allocations for next week had increased only marginally, if at all.

Chicago Public Health Commissioner Allison Arwady said her city’s share had gone from about 32,000 doses to 34,000 doses. “I have stopped paying a whole lot of attention to what is being said verbally at the federal level right now,” she said.

Nirav Shah, the director of Maine’s Center for Disease Control and Prevention, said he learned only Friday, by calling his state’s designated contact at Warp Speed, that the reserve no longer existed.

Maine still plans to broaden vaccination next week to those 70 and older. “Who is in line will not change,” Shah said. “The velocity of that line will change because this bolus of doses that we intuited was coming based on Azar’s comments is not coming.”

In an email that reached some state officials Friday morning, Christopher Sharpsten, an Operation Warp Speed director, called it a “false rumor” that “the federal government was holding back vaccine doses in warehouses to guarantee a second/booster dose.”

In fact, that information had come fromAzar, who said Tuesday that the “next phase” of the country’s vaccination campaign involved “releasing the entire supply we have for order by states, rather than holding second doses in physical reserve.”

Azar’s comments Tuesday followed a Jan. 8 announcement by President-elect Joe Biden’s transition team that his administration would move to release all available doses rather than holding half in reserve for booster shots. Biden’s advisers said the move would be a way to accelerate distribution of the vaccine, which is in short supply across the country.

Azar initially said the Biden plan was shortsighted and potentially unethical in putting people at risk of missing their booster shots. When he embraced the change four days later, however, he did not say that the original policy had already been phased out or that the stockpile had been exhausted. Trump administration officials and Biden’s team alike have sought to reassure the public that increasing the pace of immunizations would not endanger booster shots.

Azar also signaled to states that they would soon see expanded supply, urging them to begin vaccinating adults 65 and older and those under 64 with high-risk medical conditions. Officials in some states embraced that directive, while others said that suddenly putting hundreds of thousands of additional people at the front of the line would overwhelm their capacity.

In subsequent conversations with state and local authorities, federal officials sought to temper those instructions, said people who participated in the conversations. Perna, for instance, spoke directly to officials in at least two of the jurisdictions receiving vaccine supply, explaining that allocations would not increase and that they did not have to broaden eligibility as they had previously been told, according to a health official who was not authorized to discuss the matter.

The revised instructions led some state and local officials to hold off on changes. One state health official noted that the updated eligibility guidance announced Tuesday did not appear on the website of the CDC, even though it was stated as federal policy by Azar and by Robert R. Redfield, the CDC director, in their remarks. Under the original recommendations, adults 65 and older and front-line essential workers were to comprise the second priority group, known as Phase 1b, after medical workers and residents and staffers of long-term-care facilities.

There was additional confusion from another change Azar announced this week — making allocation of doses dependent on how quickly states administer them. He originally said that would not take effect for two weeks.

But Connecticut Gov. Ned Lamont (D) on Thursday tweeted that federal officials had notified him that the state would receive an additional 50,000 doses next week “as a reward for being among the fastest states” to get shots into arms. West Virginia, meanwhile, which is moving at the fastest clip, according to CDC data, did not get any additional doses, said Holli Nelson, a spokeswoman for the state’s National Guard.

In a sign that the incentive structure may not be long-lived, a senior Biden transition official, speaking on the condition of anonymity to address ongoing deliberations, said this week that the team did not look kindly on a system that “punishes states.”

Biden has said he wants to see 100 million shots administered within his first 100 days — an aim that will depend on quickly accelerating the pace of immunization. Together, Pfizer and Moderna have agreed to sell 200 million doses to the United States by the end of March, which is enough to fully vaccinate 100 million people.

Drugmakers sue HHS over 340B advisory opinion in feud over contract pharmacy access

Hospital associations sue HHS over 340B enforcement

Drug companies AstraZeneca, Eli Lilly and Sanofi filed separate lawsuits seeking to preserve their ability to restrict offering 340B-discounted drugs to contract pharmacies.

The lawsuits, filed Tuesday in different federal courts, seek to get rid of an advisory opinion filed by the Department of Health and Human Services’ (HHS’) general counsel that says drug companies must offer 340B drugs to contract pharmacies, which are third-party entities that dispense drugs on behalf of hospitals participating in the program.

The drug companies argue that the advisory opinion contracts the statute for the 340B program, which requires manufacturers to offer discounted products to safety net hospitals and other providers in exchange for participation in Medicare and Medicaid.

“The statute, on its face, does not require manufacturers to recognize any contract pharmacies, much less unlimited contract pharmacies,” the legal filing from AstraZeneca said.

AstraZeneca wants a federal court to declare the advisory opinion didn’t follow proper procedure and exceeded HHS’ statutory authority. The manufacturer also wants a court to declare that companies are not required to offer 340B discounts to contract pharmacies.

The lawsuits come less than a week after the American Hospital Association (AHA) and five other groups and three individual systems sent letters to the drug companies that have halted or restricted sales to contract pharmacies. They wanted the drugmakers to reinstate sending the discounted products to their pharmacies and reimburse facilities for any damages.

AHA and several groups sued HHS to get the agency to clamp down on the drug manufacturers’ moves.

AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi and United Therapeutics have taken a range of actions to clamp down on sales to contract pharmacies, which a majority of 340B-covered entities use.

The companies have argued that the discounts do not filter down to patients, but hospital and advocacy groups charge that the discounts are vital, especially as safety net providers operate on thin margins.

“Make no mistake: the boom in contract pharmacies has been fueled by the prospect of outsized profit margins on 340B discounted drugs,” AstraZeneca argued in its court filing.

The next wave of healthcare consolidation

https://mailchi.mp/a40e674b8d4a/the-weekly-gist-2021-special-edition?e=d1e747d2d8

Might health care consolidation be slowing and if so, why and what might it  mean? A perspective on where we are, how we got here and what is next. —  CASTLING PARTNERS

With many deals delayed by the pandemic, 2020 turned out to be slower than anticipated for hospital mergers and acquisitions. But we’d expect the pace of mergers to quicken this year as health systems emerge from the winter COVID surge. The calculus centers on both strategy and security.

Having weathered the pandemic better than expected, many larger systems approach the market as opportunists, looking expand their reach and capabilities. And systems of all sizes are seeking scale to enable better access to capital and greater risk mitigation—now viewed as essential should they once again face a pandemic-sized shock.

As systems contemplate new combinations, they would be wise to learn from the high-profile combinations that fell apart last year. In our experience, many mergers are felled by the “social” issues: board seat allocation, leadership structures, or cultural mismatches. These types of challenges appeared to be behind the stalling of Advocate Aurora Health’s merger with Beaumont Health (which faced pushback from doctors and community stakeholders) and the demise of the combination of Intermountain Healthcare and Sanford Health (called off amid leadership turnover). 

Any successful merger must not only present the financial rationale for partnership, but also make a clear case as to how a combined system will bring new capabilities that will improve care, access and experience for local consumers.

Expect scrutiny on deals to rise in the Biden administration with the likely confirmation of Department of Health and Human Services (HHS) Secretary nominee Xavier Becerra, who took a strict antitrust posture in reviewing hospital mergers and contracting during his tenure as California’s attorney general.

Duke Health, Geisinger sue HHS over Medicare payments

January Healthcare Industry Lawsuits and Settlements - Elite Learning

Five hospitals recently sued HHS over its calculation of Medicare Part A disproportionate share hospital payments for patients who were enrolled in Medicare Advantage plans under Part C of the Medicare Act.

The federal lawsuit was filed Dec. 21 by Duke Raleigh (N.C.) Hospital, Durham (N.C.) Regional Hospital, Geisinger Medical Center in Danville, Pa., Geisinger Wyoming Valley Medical Center in Wilkes-Barre, Pa., and The Washington (Pa.) Hospital. 

The hospitals’ lawsuit takes issue with a Medicare policy change, adopted in 2004, that included a new methodology for allocating Medicare Part C days in the disproportionate share hospital formula. The appeals court has ruled against HHS in three actions challenging its attempts to apply its Part C days policy to deny DSH payments to hospitals. However, the hospitals argue that HHS is disregarding those decisions and a decision by the U.S. Supreme Court. 

“The agency has continued to apply the Part C days policy adopted in the now-vacated 2004 rule in violation of these decisions, including in the payment determinations at issue for the plaintiff hospitals in this case, in a recently issued proposed rule seeking to re-adopt the same 2004 policy retroactively, and in a ruling that would leave undisturbed the payment determinations from which hospitals have appealed and, as construed by the agency’s administrative Board, not permit further administrative or judicial review of those determinations,” the complaint filed Dec. 21 states. 

The hospitals argue that HHS’ attempts to apply the policy should be rejected. The hospitals are asking the court to declare the final payment determinations reflecting the policy change invalid. 

Biden chooses Xavier Becerra to lead HHS

National

President-elect Joe Biden has chosen California Attorney General Xavier Becerra to be the secretary of the Department of Health and Human Services, the Biden transition team announced this morning and the New York Times first reported last night.

Why it matters: If confirmed, Becerra would be the first Latino to lead the department. He’s also been at the forefront of health care legal battles, most prominently over the future of the Affordable Care Act.

  • Becerra has led the effort by a group of 20 states and the District of Columbia in defending the ACA against a GOP lawsuit aiming to strike down the law. The case was argued in front of the Supreme Court last month.
  • Biden plans to announce several other top health care advisors, people familiar with the rollout told NYT.

Between the lines: Whoever leads HHS will immediately be in charge of addressing what will likely still be an out-of-control pandemic, including the government’s efforts to distribute coronavirus vaccines.

  • The virus has disproportionately affected people of color, and Becerra’s selection follows increasing pressure on Biden from the Latino community and the Congressional Hispanic Caucus to diversity his cabinet, per NYT.
  • On the other hand, Becerra has little experience managing a large bureaucracy or in public health, per Politico.

The big picture: If a global pandemic and the future of the ACA weren’t enough, the HHS secretary could end up in charge of executing most of Biden’s health agenda, particularly if the Senate remains in Republican hands.

  • Becerra’s legal background could prove useful in enacting a lawsuit-proof regulatory agenda.

BonusBiden has selected Rochelle Walensky, chief of infectious diseases at Massachusetts General Hospital and a professor at Harvard Medical School, to lead the Centers for Disease Control and Prevention, Politico reported last night.

Biden Closes In on Top Health Leaders as Pandemic Ravages U.S.

https://www.bloomberg.com/news/articles/2020-12-02/biden-closes-in-on-top-health-leaders-as-pandemic-ravages-u-s

President-elect Joe Biden’s front-runner for secretary of Health and Human Services is New Mexico Governor Michelle Lujan Grisham, and he may announce several of his administration’s health leaders as soon as next week, according to people familiar with the matter.

The position of HHS secretary is down to two possibilities, the people said, between Lujan Grisham and former Surgeon General Vivek Murthy, a co-chair of the coronavirus advisory board Biden appointed shortly after he was elected.

Biden’s health team will assume office with the U.S. still suffering from the pandemic, as virus cases and hospitalizations soared over the past month. His health secretary is expected to have input on filling other top health posts, such as FDA commissioner and the administrator of the Centers for Medicare and Medicaid Services, the people said, so those appointments may not be announced until later.

The Health and Human Services secretary will have the tough task of rebuilding Obamacare, which Biden has promised to expand. That will be a difficult undertaking with a Republican-led Senate.

Murthy or Jeff Zients, who led the Obama administration effort to repair healthcare.gov, the faulty Obamacare website, may be named to a leadership role on the pandemic, according to the people familiar with the matter — a “Covid-19 czar.”

Mandy Cohen, the North Carolina state health secretary, is a favorite for CMS, the people said. Biden’s choices to lead the Food and Drug Administration appear narrowed down to David Kessler, a former commissioner of the agency who is another co-chair of his coronavirus advisory board, and Joshua Sharfstein, a former FDA official who is a vice dean at Johns Hopkins University’s Bloomberg School of Public Health.

Biden announced his economic team on Tuesday, a group led by Treasury Secretary-designate Janet Yellen whose top priority will be restoring jobs eliminated by the pandemic. An announcement on some of his health team could come as soon as Monday, the people said.

The people familiar with the matter asked not to be identified because talks are still ongoing and no final decision has been made. It’s not clear how many people will be announced at once, or which positions would later be filled by the health secretary once the Biden administration is in place.

Biden’s transition team did not immediately respond to a request for comment.

The U.S. recorded 158,000 new coronavirus infections on Monday and a record 205,000 cases three days earlier. Biden will take office as distribution of coronavirus vaccines ramps up, and he has warned that any delay in the transition to his administration could slow or complicate that endeavor.

Lujan Grisham is seen as having an easier path to confirmation than Murthy, who has spoken out against gun violence as a public health threat and may draw strong opposition from Senate Republicans as a result, the people familiar with the matter said.

If he isn’t nominated to lead HHS, Murthy is under consideration as Covid-19 czar or another role, including a second stint as surgeon general, the people said. Murthy talks to Biden almost every day as co-chair of his advisory board and is seen as having influential supporters.

Murthy and Zients have also represented Biden’s transition team on calls with current HHS officials, two of the people said.

Biden’s team is still discussing what the White House coronavirus task force and Operation Warp Speed — the Trump administration’s effort to fast-track vaccines — will look like under the new administration.

If Biden announces his health team next week, he may be just days ahead of the first emergency FDA approval of a coronavirus vaccine. President Donald Trump is planning a vaccine summit next week at the White House, while an FDA advisory panel is scheduled to meet on Dec. 10 to discuss the shots.

Purdue Pharma pleads guilty to federal criminal charges related to nation’s opioid crisis

https://www.cnn.com/2020/11/24/us/purdue-pharma-oxycontin-guilty-plea/index.html?fbclid=IwAR2DM1jxDtKxFaCW1o-HJ45Tuh1-HOVw5DjNx_ncuhfajyjdkvP9wnMHUMg

Purdue Pharma, the maker of OxyContin, pleaded guilty Tuesday to three federal criminal charges related to the company’s role in creating the nation’s opioid crisis. Purdue Pharma board chairman Steve Miller pleaded guilty on behalf of the company during a virtual federal court hearing in front of US District Judge Madeline Cox Arleo.

The counts include one of dual-object conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetic Act, and two counts of conspiracy to violate the Federal Anti-Kickback Statute.

The plea deal announced in October includes the largest penalties ever levied against a pharmaceutical manufacturer, including a criminal fine of $3.544 billion and an additional $2 billion in criminal forfeiture, according to a Department of Justice press release.

The company, which declared bankruptcy last year, will be dissolved as a part of the plea agreement, and its assets will be used to create a new “public benefit company” controlled by a trust or similar entity designed for the benefit of the American public.

The Justice Department has said Purdue Pharma will function entirely in the public interest rather than to maximize profits. Its future earnings will go to paying the fines and penalties, which in turn will be used to combat the opioid crisis.

In pleading guilty to the criminal charges, the company is taking responsibility for past misconduct, Purdue Pharma said in a statement to CNN Tuesday.”Having our plea accepted in federal court, and taking responsibility for past misconduct, is an essential step to preserve billions of dollars of value for creditors and advance our goal of providing financial resources and lifesaving medicines to address the opioid crisis,” the statement said. “We continue to work tirelessly to build additional support for a proposed bankruptcy settlement, which would direct the overwhelming majority of the settlement funds to state, local and tribal governments for the purpose of abating the opioid crisis.”

According to the US Centers for Disease Control and Prevention, about 70,000 Americans died of drug overdoses in 2018, just one year of the opioid crisis, and about 70% of those deaths were caused by prescription or illicit opioids like OxyContin. In that year, an estimated 10.3 million Americans 12 and older misused opioids, including 9.9 million prescription pain reliever abusers and 808,000 heroin users, according to the US Department of Health and Human Services Substance Abuse and Mental Health Services Administration.

The Sackler family, and other current and former employees and owners of the company, still face the possibility that federal criminal charges will be filed against them. The court did not set a date for a sentencing hearing.

Appeals court sides with hospitals in latest challenge of DSH payment calculations

lady justice

A federal appeals court upheld a ruling that would allow hospitals to calculate their disproportionate share hospital (DSH) payments using Medicaid patients as well as patients eligible for treatment under experimental Medicaid “demonstration projects” approved by the Department of Health and Human Services (HHS).

The opinion, issued Friday, upheld the decision of a lower court that sided with 10 Florida hospitals seeking to include days of care funded by Florida’s Low Income Pool, an approved Medicaid demonstration project. Through the pool, the state and federal governments jointly reimbursed hospitals for care provided to uninsured and underinsured patients.

HHS argued against allowing the hospitals to include those patients in their Medicaid fraction on the ground that the patients were treated out of charity rather than as designated beneficiaries of a demonstration project.

“The district court found the Secretary’s arguments to the contrary unpersuasive. The Secretary argued the text of the regulation allows hospitals to include days of care provided under a demonstration project only if the project entitles specific patients to specific benefit packages,” the judges said (PDF). “As the court noted, however, this is not what the regulation says. Rather, a patient must have been ‘eligible for inpatient services,’ meaning the demonstration project enabled the patient to receive inpatient services, regardless whether the project gave the patient a right to these services or allowed the patient to enroll in an insurance plan that provided the services.”

DSH payments have traditionally been calculated using the costs incurred to treat Medicaid and uninsured patients. However, the Centers for Medicare & Medicaid’s 2017 rule says costs incurred treating other patients are applicable. For example, a dually eligible patient who’s admitted to the hospital will likely have their stay paid for by Medicare, the agency said, as Medicaid is treated as the “payer of last resort.” As such, those costs would be eligible to be subtracted from DSH payouts.

In backing the hospitals on the DSH dispute, the judges pointed to a similar case considered by the Fifth Circuit last year in which the agency sought to exclude from the Medicaid fraction days of care funded through an “uncompensated care pool” created by a demonstration project. That pool reimbursed hospitals in Mississippi for services provided to uninsured patients affected by Hurricane Katrina but did not entitle specific patients to specific services.

In that case, the Fifth Circuit held “plain regulatory text demands that such days be included—period.”

“We see no flaw in Judge Collyer’s analysis and therefore embrace the district court’s opinion as the law of this circuit,” the judges said.

What healthcare executives can expect under Biden presidency

https://www.beckershospitalreview.com/hospital-management-administration/pwc-what-healthcare-executives-can-expect-under-biden-presidency.html?utm_medium=email

https://www.pwc.com/us/Biden2020healthagenda

President-elect Joe Biden’s healthcare agenda: building on the ACA, value-based care, and bringing down drug prices.

In many ways, Joe Biden is promising a return to the Obama administration’s approach to healthcare:

  • Building on the Affordable Care Act (ACA) through incremental expansions in government-subsidized coverage
  • Continuing CMS’ progress toward value-based care
  • Bringing down drug prices
  • Supporting modernization of the FDA

Bolder ideas, such as developing a public option, resolving “surprise billing,” allowing for negotiation of drug prices by Medicare, handing power to a third party to help set prices for some life sciences products, and raising the corporate tax rate, could be more challenging to achieve without overwhelming majorities in both the House and the Senate.

Biden is likely to mount an intensified federal response to the COVID-19 pandemic, enlisting the Defense Production Act to compel companies to produce large quantities of tests and personal protective equipment as well as supporting ongoing deregulation around telehealth. The Biden administration also will likely return to global partnerships and groups such as the World Health Organization, especially in the area of vaccine development, production and distribution.

What can health industry executives expect from Biden’s healthcare proposals?

Broadly, healthcare executives can expect an administration with an expansionary agenda, looking to patch gaps in coverage for Americans, scrutinize proposed healthcare mergers and acquisitions more aggressively and use more of the government’s power to address the pandemic. Executives also can expect, in the event the ACA is struck down, moves by the Biden administration and Democratic lawmakers to develop a replacement. Healthcare executives should scenario plan for this unlikely yet potentially highly disruptive event, and plan for an administration marked by more certainty and continuity with the Obama years.

All healthcare organizations should prepare for the possibility that millions more Americans could gain insurance under Biden. His proposals, if enacted, would mean coverage for 97% of Americans, according to his campaign website. This could mean millions of new ACA customers for payers selling plans on the exchanges, millions of new Medicaid beneficiaries for managed care organizations, millions of newly insured patients for providers, and millions of covered customers for pharmaceutical and life sciences companies. The surge in insured consumers could mirror the swift uptake in the years following the passage of the ACA.

Biden’s plan to address the COVID-19 pandemic

Biden is expected to draw on his experience from H1N1 and the Ebola outbreaks to address the COVID-19 pandemic with a more active role for the federal government, which many Americans support. These actions could shore up the nation’s response in which the federal government largely served in a support role to local, state and private efforts.

Three notable exceptions have been the substantial federal funding for development of vaccines against the SARS-CoV-2 virus, Congress’ aid packages and the rapid deregulatory actions taken by the FDA and CMS to clear a path for medical products to be enlisted for the pandemic and for providers, in particular, to be able to respond to it.

Implications of Biden’s 2020 health agenda on healthcare payers, providers and pharmaceutical and life sciences companies

The US health system has been slowly transforming for years into a New Health Economy that is more consumer-oriented, digital, virtual, open to new players from outside the industry and focused on wellness and prevention.  The COVID-19 pandemic has accelerated some of those trends.  Once the dust from the election settles, companies that have invested in capabilities for growth and are moving forcefully toward the New Health Economy stand to gain disproportionately.

Shortages of clinicians and foreign medical students may continue to be an issue for a while

The Trump administration made limiting the flow of immigrants to the US a priority. The associated policy changes have the potential to exacerbate shortages of physicians, nurses and other healthcare workers, including medical students. These consequences have been aggravated by the pandemic, which dramatically curtailed travel into the US.

  • Healthcare organizations, especially rural ones heavily dependent on foreign-born employees, may find themselves competing fiercely for workers, paying higher salaries and having to rethink the structure of their workforces.
  • Providers should consider reengineering primary care teams to reflect the patients’ health status and preferences, along with the realities of the workforce on the ground and new opportunities in remote care.

Focus on modernizing the supply chain

Biden and lawmakers from both parties have been raising questions about life sciences’ supply chains. This focus has only intensified because of the pandemic and resulting shortages of personal protective equipment (PPE), pharmaceuticals, diagnostic tests and other medical products.

  • Investment in advanced analytics and cybersecurity could allow manufacturers to avoid disruptive stockouts and shortages, and deliver on the promise of the right treatment to the right patient at the right time in the right place.

Drug pricing needs a long-term strategy

Presidents and lawmakers have been talking about drug prices for decades; few truly meaningful actions have been implemented. Biden has made drug pricing reform a priority.

  • Drug manufacturers may need to start looking past the next quarter to create a new pricing strategy that maximizes access in local markets through the use of data and analytics to engage in more value-based pricing arrangements.
  • New financing models may help patients get access to drugs, such as subscription models that provide unlimited access to a therapy at a flat rate.
  • Companies that prepare now to establish performance metrics and data analytics tools to track patient outcomes will be well prepared to offer payers more sustainable payment models, such as mortgage or payment over time contracts, avoiding the sticker shock that comes with these treatments and improving uptake at launch.
  • Pharmaceutical and life sciences companies will likely have to continue to offer tools for consumers like co-pay calculators and use the contracting process where possible to minimize out-of-pocket costs, which can improve adherence rates and health outcomes.

View interoperability as an opportunity to embrace, not a threat to avoid or ignore

While the pandemic delayed many of the federal interoperability rule deadlines, payers and providers should use the extra time to plan strategically for an interoperable future.

  • Payers should review business partnerships in this new regulatory environment.
  • Digital health companies and new entrants may help organizations take advantage of the opportunities that achieving interoperability may present.
  • Companies should consider the legal risks and take steps to protect their reputations and relationships with customers by thinking through issues of consent and data privacy.

Health organizations should review their policies and consider whether they offer protections for customers under the new processes and what data security risks may emerge. They should also consider whether business associate agreements are due in more situations.

Plan for revitalized ACA exchanges and a booming Medicare Advantage market

The pandemic has thrown millions out of work, generating many new customers for ACA plans just as the incoming Biden administration plans to enrich subsidies, making more generous plans within reach of more Americans.

  • Payers in this market should consider how and where to expand their membership and appeal to those newly eligible for Medicare. Payers not in this market should consider partnerships or acquisitions as a quick way to enter the market, with the creation of a new Medicare Advantage plan as a slower but possibly less capital-intensive entry into this market.
  • Payers and health systems should use this opportunity to design more tailored plan options and consumer experiences to enhance margins and improve health outcomes.
  • Payers with cash from deferred care and low utilization due to the pandemic could turn to vertical integration with providers as a means of investing that cash in a manner that helps struggling providers in the short term while positioning payers to improve care and reduce its cost in the long term.
  • Under the Trump administration, the FDA has approved historic numbers of generic drugs, with the aim of making more affordable pharmaceuticals available to consumers. Despite increased FDA generics approvals, generics dispensed remain high but flat, according to HRI analysis of FDA data.
  • Pharmaceutical company stocks, on average, have climbed under the Trump administration, with a few notable dips due to presidential speeches criticizing the industry and the pandemic.
  • Providers have faced some revenue cuts, particularly in the 340B program, and many entered the pandemic in a relatively weak liquidity position.  The pandemic has led to layoffs, pay cuts and even closures. HRI expects consolidation as the pandemic continues to curb the flow of patients seeking care in emergency departments, orthopedic surgeons’ offices, dermatology suites and more.

Lawmakers and politicians often use bold language, and propose bold solutions to problems, but the government and the industry itself resists sudden, dramatic change, even in the face of sudden, dramatic events such as a global pandemic. One notable exception to this would be a decision by the US Supreme Court to strike down the ACA, an event that would generate a great deal of uncertainty and disruption for Americans, the US health industry and employers.