Today, the Health Resources and Services Administration (HRSA) is releasing revised reporting requirements for recipients of Provider Relief Fund (PRF) payments. The updates include expanding the amount of time providers will have to report information, reducing burdens for smaller providers, and extending key deadlines for expending PRF payments for recipients who received payments after June 30, 2020. The revised reporting requirements will be applicable to providers who received one or more payments exceeding, in the aggregate, $10,000 during a single “payment received period” (the periods are outlined in the chart below) from the PRF General Distributions, Targeted Distributions, and/or the “Skilled Nursing Facility and Nursing Home Infection Control Distribution.”

HHS began issuing notices on post-payment reporting requirements in July 2020. On January 15, 2021, HHS issued updated requirements to increase reporting flexibilities for providers, as codified by the Coronavirus Response and Relief Supplemental Appropriations Act of 2021, and opened registration for the reporting portal. Since then, HHS has carefully weighed the rapidly evolving nature of the pandemic and its impact on health care providers and other stakeholders, which is reflected in the revised notice issued today.

The revised reporting requirements supplanting the January 15^th requirements can be found here.

In keeping with the Secretary’s commitment to greater transparency and proactive communication, please join HRSA Acting Administrator Diana Espinosa for a briefing about the updated reporting guidance on Monday, June 14, 2021. An invitation with the call-in information will be sent separately. 

Key Updates:

• The period of availability of funds is based on the date the payment is received (rather than requiring all payments be used by June 30, 2021, regardless of when they were received).
• Recipients are required to report for each Payment Received Period in which they received one or more payments exceeding, in the aggregate, $10,000 (rather than $10,000 cumulatively across all PRF payments).
• Recipients will have a 90-day period to complete reporting (rather than a 30-day reporting period).
• The reporting requirements are now applicable to recipients of the Skilled Nursing Facility and Nursing Home Infection Control Distributions in addition to General and other Targeted Distributions.
• The PRF Reporting Portal will open for providers to start submitting information on July 1, 2021.

Summary of Reporting Requirements

These reporting requirements do not apply to the Rural Health Clinic COVID-19 Testing Program or the two claims reimbursements programs: the HRSA COVID-19 Uninsured Program and the HRSA COVID-19 Coverage Assistance Fund. HRSA continues to encourage providers to establish their PRF Reporting Portal accounts now by registering here. Registration will also allow providers to receive updates closer to the official opening of the portal for their reporting submissions.

Additional information on the PRF reporting updates can be found on the PRF Reporting Webpage, PRF Reporting Portal User Guide, and Frequently Asked Questions. For more information, please call the Provider Support Line at (866) 569-3522; for TTY dial 711. Hours of operation are 7 a.m. to 10 p.m. Central Time, Monday through Friday. HHS also plans to provide technical assistance for providers and will communicate directly with them.

Overhauling reimbursement is one of several ways the administration is looking to secure the domestic pharmaceutical supply chain, according to a new White House report authored by HHS, FDA and the Assistant Secretary for Preparedness and Response.

HHS will set up a working group to review how current reimbursement models contribute to a lack of resilience for sterile injectables on the critical drug list as well as chemotherapeutics that have been in shortage in the past five years, according to the report, released Tuesday. The group might also include other sterile injectables at risk of shortage, such as sterile pediatric oncology drugs, in its review.

A key problem the White House hopes to tackle is generic drug makers’ reliance on low-cost foreign sites and suppliers due to the industry’s low profit margins.

“For lower cost drugs, profit margins from federal payers may play a role in ensuring that sterile injectables are at least risk of being in short supply. Accordingly, to reduce likelihood that these products will go into shortage due to low margins, the U.S. Government will review reimbursement models to determine updates that may improve supply chain resilience,” the report says.

The Biden administration also will investigate new financial incentives to spur investment as well as procurement guarantees.

The administration hopes to encourage new generic drug makers to enter the market and existing ones to upgrade their faculties by creating new incentives to invest in specialized equipment and processes. Among other things, the Biomedical Advanced Research and Development Authority will continue to help with manufacturing techniques.

But generic drug makers have said they also need a consistent demand for products to justify investment.

The administration will consider providing procurement guarantees, while also leveraging acquisition flexibilities, to show it is committed to buying products from domestic and small firms.

“These [procurement guarantees] will need to be established in a careful and nuanced manner to ensure that they service the needs of agencies, including DOD and the Department of Veterans Affairs (VA), and to ensure consistence with U.S. procurement laws and obligations,” the report warns.

The White House also says it’s important that the upfront investments are economically feasible. Regulators need to quantify the long-term benefits, which could include improved treatment when there are fewer drugs in shortage, reduced costs for purchasing alternative treatments, additional jobs and reduced dependence on strategic competitors, among others, the report says.

The report notes that in 2011, when drug shortages peaked, 56 percent of the shortages among sterile injectables were caused by quality-related manufacturing failures, which eventually led to patients needing to take alternative treatments. Product discontinuation accounted for 9% of sterile injectable shortages.

Some of these discontinuations might be related to lower reimbursement for older sterile injectables, as when drug companies reach manufacturing capacity, less profitable products might no longer be produced in favor of the more profitable ones.

The White House also wants to make sure its market-based reforms don’t advantage one group over another. “Several categories of stakeholders should be considered, including drug manufacturers, large and small, supply chain intermediaries such as GPOs, pharmacy benefit managers, and wholesalers; patients and health care providers such as hospitals and pharmacies; payers (both public and private); and workers at all levels of the supply chain,” the report says.

Government purchasing organizations could be on the hot seat. Contracting practices done by GPOs might have led to limits in the diversification of supply, the report says. GPOs might either contract with certain drug makers that will pay to become the sole supplier of a product or further link discounts to hospitals with sole supplier contractual arrangements.

A 2012 House Staff Report on drug shortages noted that GPO contracting can lead to only a few manufacturers producing certain generic injectable medicines, and both GPO contracts and the Medicare Modernization Act, which lowered reimbursement for injectable medications, have led to only around three companies producing a product. 

Two Republicans, Brian Fitzpatrick of Pennsylvania and Jenniffer González-Colón of Puerto Rico, supported the bill. 

Members had submitted a whopping 229 amendments to the sweeping legislation, which was threaded with provisions aimed at fighting climate change and supporting racial equity in the transportation system. Democrats hope the legislation will become a cornerstone of President Joe Biden’s $2 trillion-plus infrastructure package.

Committee Chairman Peter A. DeFazio, D-Ore., called the bill’s completion  “a really incredible effort,” saying the committee went through nearly 200 amendments before approving the bill.

“We don’t agree on a lot of stuff,” he said right around 5 a.m. when the committee gaveled out. “But heck, we got through it. It’s tomorrow… We won’t have to come back later today.”

Ranking Republican Sam Graves of Missouri, who voted against the bill, nonetheless applauded the committee for completing its work. 

“I’m just happy that once again we have produced a bill, a surface transportation reauthorization,” Graves said. “It’s not anything I would’ve done or anythingthat I can support but having said that we’re still doing the people’s work.”

Graves’ comments were a stark contrast from earlier in the debate, when members fought bitterly over issues that seemed unrelated to highway policy.

Police debate

The markup was briefly nearly derailed, for example, by a harsh debate over an amendment introduced by Rep. Troy Nehls, R-Texas, that would strip federal highway safety dollars from communities that defunded police. That debate devolved into a fight over the Jan. 6 mob attack on the Capitol, with Democrats accusing Republicans who did not back the Jan. 6 investigatory commission of not supporting the police. 

“You can talk a big game about supporting law enforcement, but if you voted no on [the Jan. 6 commission] then you don’t support law enforcement,” said Rep. Marilyn Strickland, D-Wash. 

Rep. Garret Graves, R-La., said Strickland’s comments “were completely absurd and completely out of line,” calling Jan. 6  “one myopic incident” that reflected a larger, looming division in the country. 

And Rep. Brian Mast, R-Fla., said Republicans opposed the commission because it was “totally political,” and pointed to the fact that Democrats had impeached President Donald Trump before working to craft the commission as evidence. 

“It’s like putting someone’s head in a guillotine and then trying to prove whether they’re guilty or innocent after their head’s laying in a basket,” Mast said. 

DeFazio and other Democrats argued that stripping NHTSA funding from communities that defunded the police would essentially keep communities from enforcing traffic safety laws at a time when traffic fatalities are at an all-time high. 

“I’m going to vote against your amendment,” Rep. Tom Malinowski, D-N.J., told Nehls, “because your amendment defunds the police.”

But Sam Graves, the ranking member of the committee, said the amendment aimed to discourage cities from defunding police, referencing the movement in some municipalities to shift some law enforcement funding to programs that aim to prevent violent incidents. 

“If you choose to defund the police, this amendment says you’re not going to get federal dollars to backfill your police budget,” he said. “You can’t get your cake and eat it too.”

The amendment failed, 31-37.

Child labor

Tempers also flared over an amendment by Rep. Pete Stauber, R-Minn., that would require the Secretary of Commerce to certify that no electric vehicle charging device paid for with federal dollars use minerals sourced or processed with child labor from overseas. 

The House Democrats’ bill would invest $4 billion in electric vehicle charging infrastructure aimed at advancing electric vehicle use in the country. DeFazio called Stauber’s amendment a “cynical attempt to protect carbon-polluting industries like oil and gas,” and argued it was designed to hinder the development of the electric vehicle industry. 

Stauber responded by saying he was “really offended” by DeFazio’s comments. “You cannot turn a blind eye to child labor,” he said.

But DeFazio was unmoved, accusing Stauber of using child labor as an excuse to source such minerals in Minnesota at the expense of the state’s environment. 

“Don’t give us a bunch of BS that we’re soft on China, don’t give us a bunch of of BS that we’re soft on child labor when what you’re trying to do here is cripple the EV industry or perhaps promote cobalt production in your own state,” DeFazio said. “One or the other is not in the national interest.”

The lengthy back-and-forth culminated in DeFazio introducing an amendment to Stauber’s amendment that would strip most provisions of the amendment with the exception of a commission to study electric vehicle battery sourcing and production issues in the United States. DeFazio’s amendment to the Stauber amendment was adopted, 38-30.

Both debates took up long stretches of time during a hearing aimed at marking up what Democrats hope will be a key part of Biden’s $2 trillion-plus infrastructure plan. Republicans from the start made it clear that they felt left out of the process and were disinclined to offer support. 

“The reality is you all have your mind made up, and you’re probably going to push this partisan bill through and push it out of the committee and vote it off the floor and send it off to the Senate, where hopefully something better will happen,” said Rep. Bruce Westerman, R-Ark.

While a $312.4 billion bill approved by the Senate Environment and Public Works Committee unanimously May 26, there was little hope that the House would repeat that moment of bipartisan cooperation with its bill.

The overall highway bill includes $343 billion for roads, bridges and safety; $109 billion for transit and $95 billion for freight and passenger rail.

It dedicates $8.3 billion for reducing carbon pollution, with an additional $6.2 billion for mitigation and resiliency improvements aimed at building infrastructure resistant to extreme weather events.

The bill also calls for investing $3 billion into a program aimed at tearing down or modifying bridges or overpasses that separated Black and Brown communities from their cities. That proposal would receive $20 billion over eight years in Biden’s plan and $500 million over five years in the Senate bill.

Regardless of Biden’s larger infrastructure plan, the highway bill is considered a must-pass; the current law, a one-year extension of the 2015 law expires at the end of September. 

In a letter to three Biden cabinet secretaries, the groups said the administration should set rules that provide consumers with clear protections from unexpected charges and create a framework for mediating bills that also doesn’t lead to higher costs for patients.

The letter, signed by such groups as the American Heart Association, Epilepsy Foundation and American Lung Association, also includes a request for an education campaign to inform consumers of their legal protections.

— Late last year, Congress included a ban on “surprise” medical bills in its year-end package, but left the Biden administration to hammer out many of the details on how to ensure patients aren’t stuck with an unpayable tab. Health groups are racing to sway the agencies tasked with making the law work. The first set of regulations is due out by July 1.

The measure sponsored by Sen. Chuck Grassley calls for small rural hospitals to shutter their in-patient operations, which often lose money, and revamp as standalone emerbency rooms with some outpatient services. Hospitals that seek and receive the new Rural Emergency Hospital designation receive increased funding.

“It gives a chance for these hospitals to exist,” said Spencer Perlman, director of healthcare research at Veda Partners. “It’s a choice between what you have now and nothing.”

But it means that patients who need to be admitted will have to travel even longer distances for care. Rural hospitals with fewer than 50 beds can apply for the new designation, which takes effect in 2023.

On Thursday, Grassley and Sen. Amy Klobuchar sent a letter to the Centers for Medicare & Medicaid Services asking the agency to prioritize implementation of the new Rural Emergency Hospital designation. “If nothing is done, more hospitals and rural Americans will continue losing access to essential medical services resulting in poorer outcomes and higher costs for patients and taxpayers,” the senators said in the letter.

The rules will apply to “hospitals, nursing homes, and assisted living facilities” DOL said, and include emergency responders and home health care workers, according to a summary of the rules. They will not apply to retail pharmacies and non-hospital ambulatory settings that bar people with suspected or confirmed Covid-19 from entering.

DOL also updated its optional Covid safety guidelines for all other workplaces, adding additional information for how employers should protect vaccinated and unvaccinated employees as well as recommendations for high- contact industries like meatpacking and grocery stores.

The guidance urges employers to provide masks to unvaccinated or at-risk workers and to allow for social distancing, but also noted that “most employers no longer need to take steps to protect their workers from COVID-19 exposure” if all of their employees are fully vaccinated.

The narrow scope of the long-awaited mandatory rules is a loss for unions, a strong source of grassroots support for Joe Biden’s presidential bid in 2020, galvanized by his promises to advance a “working class” agenda.

Other left-leaning groups also critized the rules.

“This decision represents a shameful failure of leadership by an administration that was elected on a platform of standing for the needs of all working people,” said Gina Cummings, of the anti-poverty group Oxfam America.

Democrats and worker safety advocates who wanted broad Covid safety measures to apply to all workplaces say that the administration’s decision to limit their scope to just health care abandons an essential piece of the Covid-19 response plan Biden campaigned on and will put vulnerable workers at risk.

“The Biden administration has missed a crucial opportunity to protect all workers,” said Jessica Martinez, co-executive director of the National Council for Occupational Safety and Health.

“This is a new insult on top of the injuries, illnesses and deaths suffered by frontline workers and their families,“ said Martinez. “Vaccines have not reached all workers and Covid-19 is not over.”

But Republicans and business groups expressed some relief, having opposed mandatory safety requirements throughout the pandemic that they argued would contradict state health rules in some places and impose unnecessary costs that would hold back the overall economic recovery.

“We appreciate the Department of Labor refuted the ridiculous claims from Democrats and their union allies that all American workers are presently in grave danger from the virus. Yet still, despite widespread vaccinations and COVID-19 cases at lows not seen since the beginning of the pandemic, OSHA caved to political pressure from special interests to adopt an emergency temporary standard (ETS) in the health care sector,” said Rep. Virginia Foxx (R-N.C.), the top Republican on the House Education and Labor Committee, in a statement.

“Placing new and burdensome regulation on this heroic industry at this stage of the pandemic is completely unnecessary. Further, we cannot endorse an inflexible, restrictive regulation that is unable to keep up with the ever-evolving science regarding COVID-19.”

The DOL’s decision to impose the rules for health care workers came after months of delay from the Biden administration, which was expected by both businesses and unions to issue stringent workplace masking and social distancing requirements.

Shortly after taking office, Biden asked DOL to decide by March 15 whether such emergency rules were necessary. OSHA only has the authority to issue an “emergency temporary safety standard” if it determines that workers are “in grave danger” due to exposure to something “determined to be toxic or physically harmful or to new hazards.”

However, DOL missed the deadline by several weeks after Walsh said he wanted the agency to continue reviewing the rules. After facing questions from Democrats and unions, the rules were sent to the White House budget office for review — the final step before it is released — at the end of April.

But while they were going through the final stages of review, the CDC issued new guidance in May clearing fully vaccinated people to remove masks in most settings, raising concerns that the rule would not be as stringent as originally thought.

“It’s been very tricky with guidance and the virus changing over the over the last couple of months,” Walsh said Thursday. “We know the administration’s vaccination efforts combined with OSHA’s workplace safety efforts, they’re definitely making a difference for workers and businesses across the country.”

DOL officials said that the agency was working quickly to send the rules to the Federal Register for publishing, after which it will go into effect immediately.

Health care workplaces will also have two weeks to put the protections in place after the rule is published.

“Our group – comprised of 10 Senators, 5 from each party – has worked in good faith and reached a bipartisan agreement on a realistic, compromise framework to modernize our nation’s infrastructure and energy technologies,” the group led by Sens. Kyrsten Sinema (D-Ariz.) and Rob Portman (R-Ohio) said in a statement. “This investment would be fully paid for and not include tax increases.”

Sen. Mitt Romney (R-Utah), a member of a bipartisan negotiating group, said talks are “in the middle stages” but that he did not expect a deal before the Senate left Thursday. Sen. Jon Tester (D-Mont.) said the centrists don’t have an agreement but “we might,” listing remaining and long-held disagreements over spending numbers and how to pay for it.

“For some people it’s going to be plenty, for others it’s not going to be near enough. There’s going to be challenges for Republicans and Democrats,” Tester said. “The words [Republicans] use are: we have a general, total agreement.”

The negotiating crew of 10 believe they are nearing a framework they can present to Majority Leader Chuck Schumer and Minority Leader Mitch McConnell. Both leaders have kept track of recent talks.

The latest round of talks are perhaps the last chance for a bipartisan agreement before Democrats sideline Republicans and take a unilateral approach through budget reconciliation. Talks between Biden and Sen. Shelley Moore Capito (R-W.Va.) officially fell apart on Tuesday, though they’d been crumbling for weeks as Republicans and Biden remained hundreds of billions apart in spending and never agreed on a way to pay for it.

The senators in the group were mum on the details. Sources close to the negotiations said the number is $579 billion in new spending, though there’s not an agreement over how many years that money would encompass. Proposals to pay for the package include indexing the gas tax to inflation and using unused Covid money. Some Democrats, such as Banking Committee Chair Sherrod Brown (D-Ohio), have dismissed raising the gas tax when the GOP is resisting more progressive tax increases on the wealthy.

A source familiar with President Biden’s thinking told POLITICO that indexing the gas tax to inflation would violate Biden’s campaign pledge not to raise taxes on people earning less than $400,000 a year and that the White House is not willing to include it in an infrastructure package.

One source close to the negotiations described the group’s strategy as a “bottom-up approach” and that “the top line will come from that.” But the source did not set a specific deadline to reach a deal.

Sen. John Cornyn (R-Texas), a close McConnell adviser, said the talks “have promise but it’s a work in progress.” And Sen. Roy Blunt (R-Mo.), who participated in the most recent GOP negotiations with the Biden administration, expressed skepticism.

“The advantage of the other group Shelley [Moore Capito] was working with was that it had structure. You had committee staff, those ranking members could probably bring most of their members,” Blunt said, adding he’d “be pleased to be surprised” but that he expected negotiations would end with Democrats plowing forward without bipartisan support.

President Joe Biden has sought a minimum of $1 trillion in new spending in previous talks with Republicans and progressives have grown more vocal about keeping climate and spending priorities in the plans. Biden is overseas, complicating the consummation of a global agreement between Senate leaders, the rank-and-file and the White House.

Sen. Joe Manchin (D-W.Va.) said he believed “things are moving in the right direction” but declined to otherwise characterize the state of play. Nonetheless, he was beaming as he left the Senate chamber for midday votes.

The negotiations come as progressives are growing increasingly impatient with the infrastructure talks and are urging Democrats to go it alone, citing the dwindling days on the legislative calendar and the crush of other items on their agenda.

“It makes no sense,” Rep. Pramila Jayapal (D-Wash.), who leads the Congressional Progressive Caucus, said of the current state of bipartisan talks. “It’s not going to change what Republicans have been very clear about … stopping any progress by the Biden administration.”

A day earlier, Becerra told the House Ways & Means Committee that HHS would provide flexibility on the provider relief spending deadline, but he didn’t distinguish between already distributed funding and funding yet to be disbursed.

“[T]here’s a tranche of money that has not yet been allocated, and so, the deadline for spending of that has not yet been determined, but there is money that did go out; it does have a deadline,” Becerra told the Senate Appropriations subcommittee on HHS. “And what we’re trying to do is, over the next few weeks, make sure we provide some guidance so people understand how we can make sure that everyone fulfills their commitment to getting these dollars.”

He later added, “And so what we’ll try to do is understand that we can’t change the process that began before but what we can try to do is make sure we get the accountability while trying to provide some flexibility.”

The American Hospital Association, along with other medical organizations and a bipartisan group of 77 lawmakers, have been asking HHS for weeks to extend the provider relief spending deadline to the length of the public health emergency as providers say they have on-going COVID-19 costs.

Senate Appropriations subcommittee on HHS ranking Republican Roy Blunt (MO) told Becerra to be careful that new guidance doesn’t unintentionally restrict how providers can spend relief.

Stakeholders have complained over confusing and constantly changing guidelines. Congress even had to step in at one point to clarify how providers can calculate their lost revenue due to COVID-19.

“So I hope as you allocate this last group, this last amount of money or put out whatever guidance you need that it doesn’t suddenly restrict what they were earlier told they could do, but more importantly, it does let them know that you’re going to have guidelines out there that they can rely on if they spend the money that way that it meets the guidelines,” Blunt said.

Becerra also explained, at Blunt’s prompting, what past mistakes he wants to avoid with the next provider relief distribution.

There is an estimated $24 billion left in unallocated provider relief, though HHS has not said how much provider relief remains in each tranche. There hasn’t been a new provider relief distribution announced since October.

“I think most people will tell you, at least the comments that we’re receiving, are that there wasn’t enough transparency in the process, how the money was allocated,” Becerra said.

At the same time, Becerra added, HHS’ provider relief distribution formula was unfair to those catering to mostly Medicaid and low-income patients as relief payments were calculated from providers’ revenue. This meant providers accepting Medicare and private insurance typically received higher provider relief distributions.

“So we’re trying to provide that transparency, make sure we direct them to where it’s needed, and with the money that still left, we want to make sure that you all [Congress] look at this and say we get it,” Becerra said. — Dorothy Mills-Gregg (dmillsgregg@iwpnews.com)

The White House has asked HHS to lead a consortium comprising nearly a dozen federal agencies, the private sector and nonprofit entities charged with crafting a strategy to secure the pharmaceutical supply chain by boosting U.S. production, developing new manufacturing technologies, and increasing the resilience of U.S. and allied pharmaceutical production. The White House will kick off the effort with a high-level summit, according to a supply chain report released by the White House this week.

The new consortium will start by reviewing FDA’s Essential Medicines list and picking 50 to 100 drugs that it deems critical to always have available for U.S. patients. The group will then determine the potential volume needed of the drugs, using the COVID-19 pandemic as a gauge. Next, HHS will use the Defense Production Act to come up with financial incentives that could ensure the onshore or nearshore production needed for the global supply chain.

In the mid-term, HHS will set up a group of pharmaceutical supply chain experts to develop a resilience framework using the consortium’s recommendations. The department will then map out the specific supply chains for drugs on the critical list and identify those drugs for which onshoring or nearshoring might be advisable, the report says.

The next step will be determining whether there is a need to increase production or stockpile active pharmaceutical ingredients for those drugs on the critical list, and, if so, the amounts needed for the stockpile, the benefits and risks of a virtual stockpile and the ability to use platform technologies to provide surge production during a crisis.

HHS also will explore stockpiling strategies to reduce API supply risk, and it will investigate whether new reimbursement models could boost supplies without unduly increasing U.S. costs.

The main focus of the new initiative will be sterile injectables that are put on the critical drugs list as well as chemotherapeutics that have been in short supply over the past five years. But HHS will also evaluate whether to include other sterile injectables that are identified as being at significant risk of shortage, yet are not part of the critical list, such as sterile pediatric oncology drugs.

The new consortia will be responsible for advising private sector companies that are either interested in building domestic capacity or have the expertise to help facilitate production. Other agencies expected to participate in the cross-agency group include the Environmental Protection Agency, Department of Commerce (including the National Institute of Standards and Technology), Department of Labor, Department of Defense, Federal Trade Commission, Department of Justice and Small Business Administration.

The group will coordinate input from the federal agencies involved, provide sector-based training for American workers, and address how to mitigate the risk from climate change and limit the environmental impacts of manufacturing on any neighboring communities to plants.

The Biden administration’s strategy for securing the U.S. pharmaceutical chain also includes steps to bolster FDA’s authorities and foster stronger cooperation among the United States and its allied partners.

Boosting U.S. production will require investing in innovative generic drug manufacturing processes and production technologies. HHS plans to build off the novel platform technology development that took place as part of the pandemic response, including on-demand manufacturing capabilities for certain drugs that were created with DOD. Medicines produced like this can be purchased at one-tenth of the costs listed on the current federal supply schedule, the report suggests.

The National Institute for Innovation in Manufacturing Biopharmaceuticals is expected to launch an industry-scale effort in June to develop fully integrated, small footprint platforms to improve upon the technological capabilities for biomanufacturing APIs. HHS will also create a task force dedicated to increasing capacity for the development, evaluation, and implementation of novel manufacturing tech by forming partnerships with domestic drug companies and universities.

Another pillar of the administration’s strategy for toughening up the drug supply chain is increasing emergency capacity so that, in the event of unforeseen public health crises, there’s still no shortage of essential medicines. The administration recommends creating a virtual stockpile of APIs and other materials necessary for the manufacturing of essential medicines or expanding upon the existing National Strategic Stockpile. — Gabrielle Wanneh (gwanneh@iwpnews.com)

The first part of the highly anticipated rulemaking on the surprise billing legislation enacted late last year is now under review by the White House Office of Management and Budget (OMB), surprising some stakeholders who expected CMS might miss early deadlines. The interim final rule is expected to encompass provisions of the No Surprise Act — including the formula for the critical “qualified payment amount” and guidance on informed consent — that are statutorily required to be out by July 1 and the subject of heated stakeholder debate.

OMB received the rule, “Requirements Related to Surprise Billing; Part 1,” on June 8.

Loren Adler, associate director of USC-Brookings Schaeffer Initiative for Health Policy, says he’s impressed the rule is already moving, and says that even though it’s an interim final rule, the law doesn’t go into effect until Jan. 1 so he expects CMS will heavily weigh any comments and could make changes.

Under the No Surprises Act providers can no longer charge patients more than the in-network rates for services done in an out-of-network setting, or for treatment done by an out-of-network doctor in an in-network setting. For claims that payers and providers cannot agree on within 30 days, the law sets up an independent dispute resolution process that will go into effect on Jan. 1. Arbitrations will be baseball style, meaning that the arbitrator must choose either the amount sought by the provider or offered by the payer.

The law says arbitrators shall consider the qualified payment amount (QPA), which is generally the median in-network rate used by the payer for that service. But in a last-minute change, Congress added several other factors for consideration, including providers’ level of training, quality and patient outcomes, market share for providers and payers, patient acuity, teaching status and prior contracted rates.

While the dispute resolution process isn’t set to go into effect until Jan. 1, 2022, several key regulatory decisions must be made first.

According to a Commonwealth Fund summary of the act, HHS, working with Labor and Treasury, needs to establish the methodology the health plan must use for a QPA in the individual, small group, and large group markets; the information that plans must share with providers when making a QPA determination; the geographic regions – taking into account services done in rural or underserved areas; and a process for receiving complaints about health plans relating to the QPA.

HHS is required to consult with the National Association of Insurance Commissioners to establish the regions, which must also be updated periodically.

On March 11, NAIC recommended HHS use individual and small market geographic rating areas for the rule but let states with surprise billing laws use their own regions if they choose. States should also be able to seek HHS approval to use alternative regions, NAIC says.

The rule landed at OMB one day after a group of 50 employers, patient advocates and other stakeholders urged the administration to ensure that arbitrators use the QPA as a primary factor in its decision-making, and the other five factors only in certain circumstances.

Other stakeholders, including a bipartisan group of senators, have asked the administration to ensure that all factors are given equal weight.

HHS is also required to craft guidance on the provision that allows out-of-network providers to balance bill a patient who has given consent to non-emergency care no later than 72 hours prior to the delivery of the services. The notice and consent must be written, and must clearly state that consent is optional, the providers is out of network, the patient can choose services from an in-network providers, and that an in-network provider could limit cost-sharing, and more.

The group of 50 stakeholders who wrote to the administration about the QPA also urged the administration to ensure the rule holds patients harmless from surprise bills as intended and leaves no loopholes for the practice to continue. The group says all services deemed medical necessary within 72 hours of delivery should be considered an emergency. “If treatment has started and a patient is incapacitated or in recovery, no level of notice or consent for out-of-network care is appropriate, and patients should have blanket protection from balance bills,” they add.

House Ways & Means Chair Richard Neal (D-MA) made similar comments to HHS Secretary Xavier Becerra in a Tuesday hearing. “Lawmakers did not design any intentional loopholes for, say, a patient to be handed a form when they’re unconscious and then subsequently get a bill that they supposedly agreed to pay,” he said.

On Wednesday, another 22 patient groups — including the American Heart Association, the American Kidney Fund, and the American Cancer Society Cancer Action Network — also urged the administration to focus on protecting patients and ensuring the arbitration process does not lead to higher costs.

“We worked alongside Congress to develop the bi-partisan, bi-cameral legislation to provide protections for patients from receiving unexpected medical bills,” the organizations’ letter states. “To truly ensure that patients are held harmless from surprise billing, however, it is critical that the regulations underpinning the law have robust safeguards for patients,” they wrote.

The groups also call for a comprehensive, well-funded campaign that will make sure consumers are aware of their rights under the law. — Amy Lotven (alotven@iwpnews.com)

The caucus’s proposal comes as President Joe Biden ended his negotiations with a group of Senate Republicans led by West Virginia’s Shelley Moore Capito. That Senate GOP group had offered a nearly $1 trillion infrastructure plan, roughly a third of which was new spending above the “baseline” amount the government would normally spend to sustain current infrastructure.

Biden initially proposed a more than $2 trillion plan, which Republicans said went far beyond their definition of core, physical infrastructure. In negotiations with Capito’s group, the president was willing to go as low as $1 trillion, but he wanted that to be all new spending — although Republicans said Biden told them the $1 trillion could include baseline spending before his staff walked that back.

The transit, passenger rail and electric vehicle funding is significantly higher than in the Capito group’s plan.

The Problem Solvers framework, however, includes less money for broadband internet access — $45 billion, compared to $65 billion in the last public offer Capito’s group made. It also includes less money for drinking and wastewater — $60 billion, compared to Capito’s $72 billion.

The caucus also proposes funding for several areas that weren’t part of the Senate Republican plan, including $25 billion for connecting green energy sources to the electric grid, $10 billion for nuclear energy, $5 billion for hydrogen hubs, $5 billion for carbon capture and storage, $5 billion for direct air capture and $10 billion for veterans’ housing.

Bipartisan urgency

The Problem Solvers Caucus, which has 29 Democrats and 29 Republicans, has been working for the past two months to reach agreement on the scope of a bipartisan infrastructure package. Its infrastructure working group, led by Reps. Conor Lamb, D-Pa., and John Katko, R-N.Y., put together the framework with input from the broader caucus.

“Developed with both Democratic and Republican lawmakers, this framework contains truly bipartisan policies that can form the basis for a comprehensive package to modernize our nation’s infrastructure systems,” Katko said in a statement.

Lamb emphasized the urgency of getting a bipartisan deal to ensure that infrastructure projects involving “bridges, locks, dams, power lines, and vehicle chargers will get started and finished no matter who is in power.”

The co-chairs of the full caucus, Reps. Josh Gottheimer, D-N.J., and Brian Fitzpatrick, R-Pa., have been separately engaged in talks with a bipartisan group of senators, including Sens. Bill Cassidy, R-La., Kyrsten Sinema, D-Ariz., Rob Portman, R-Ohio, and Joe Manchin III, D-W.Va.

That group of senators have not yet signed on to the Problem Solvers Caucus framework, but the bicameral group’s proposed spending numbers could end up being similar to the Problem Solvers framework, given Gottheimer and Fitzpatrick’s involvement. Pay-fors are being negotiated in the bicameral group. It’s unclear if the Problem Solvers would release any offsets separate from that.

“It’s critically important that we get a robust infrastructure package signed into law, and that we do it with strong bipartisan support,” Gottheimer said in a statement. “The Problem Solvers Caucus framework — Building Bridges — does exactly that and tackles everything from electric vehicles to clean water to fixing our crumbling bridges, tunnels, roads, and rail.”

Fitzpatrick added: “The time is now for Congress and the Administration to reach across the aisle, unite, and boost investments in our surface transportation network that will move our transportation systems into the 21st century.”

How the Biden administration interprets the No Surprises Act, passed as part of appropriations legislation (H.R. 133) late in 2020, will likely be crucial to controlling costs of medical bills that can reach into the tens of thousands of dollars for both health insurers and employers who pay health-care bills for employees. The law takes effect in 2022.

The OMB must review the interim final rule before it can be issued by the Department of Health and Human Services, which sent it to OMB Tuesday. The regulations are due to be issued by July 1.

The No Surprises Act limits bills to patients for emergency treatment and for treatment by out-of-network doctors at facilities covered by health insurance networks, such as by anesthesiologists used during surgery. Bills in those situations can’t exceed what patients would be billed for in-network care. 

The law allows for billing disputes to be handled through arbitration, which under state surprise billing laws has led to high charges being passed on to insurers and employers.

Arbiters are prohibited from considering rates for government programs such as Medicare or Medicaid, which providers say are often below their costs. Nor can arbiters consider so-called “billed charges” by providers, which are typically well above what insurers pay for in-network treatment.

Allowing billed charges to be used by arbitrators under state laws, such as a surprise billing law enacted by New York state, has resulted in “very high out-of-network reimbursement,” according to a 2019 report by the USC-Brookings Schaeffer Initiative for Health Policy. That in turn leads to higher premiums and costs borne by employers.

Arbiters can consider factors such as the median contracted rate, the provider’s market share, provider training and qualifications, and the severity of the patient’s condition in deciding between the competing offers submitted by the provider and insurance plan.

Payment Rate Calculations

The interim final rule is likely to define how to calculate the qualified payment rate that will be used to help determine what providers should be paid, James Gelfand, senior vice president of the ERISA Industry Committee, said in an interview. The ERISA Industry Committee represents large employers that provide health and retirement benefits to employees.

The qualified payment amount generally is the median in-network rate, Gelfand said. The median in-network rate is one of the factors used to determine how much insurers and employers pay, and it also affects coinsurance payments that patients will have to pay. Coinsurance payments are a percentage of fees.

“How exactly is this going to be calculated? What is the methodology that is to be used?” are questions that need to addressed to determine the qualified payment amount, Gelfand said.

It will likely take longer to issue rules on how the independent dispute resolution, or arbitration process, will work and what entities can run that process, Gelfand said.

Various groups representing hospitals, doctors, insurers, employers, and consumers are lobbying the HHS to influence how billing disputes will be resolved.

The ERISA Industry Committee is part of a coalition of 49 organizations that sent the HHS a letter Tuesday calling for the agency to draft regulations “that make the qualifying payment amount (QPA), on which patient cost-sharing is based, the primary factor in resolving payment disputes.”

The American Medical Association, in a May 21 letter to the department, said contracted rates used to calculate median rates should be limited by factors such as what is paid to providers in the same specialty. It also said the contracted rates “should be as specific as possible as to the type of item or service.”

Twenty-two patient and consumer organizations representing millions of people with chronic conditions sent the HHS a letter Wednesday saying “the law must be implemented in a way that ensures the independent dispute resolution (IDR) process does not lead to higher costs for patients.”

Balancing the Arbitration Process

At a House Ways and Means Committee hearing Tuesday, the panel’s ranking Republican, Rep. Kevin Brady (R-Texas), told HHS Secretary Xavier Becerra that the department should carefully balance the arbitration process to avoid favoring health-care providers or insurers.

“The integrity of that arbitration process should be protected in as many ways as possible, including through robust transparency,” Brady said.

Ways and Means Committee Chairman Richard Neal (D-Mass.) said lawmakers will be examining the coming regulations to ensure providers can’t sidestep the rules. “Lawmakers did not design any intentional loopholes,” he said.

A bipartisan group of House moderates on Wednesday unveiled an eight-year, $1.25 trillion infrastructure plan designed to help break the months-long impasse over President Biden’s top domestic legislative priority.

The framework offered by the 58-member Problem Solvers Caucus calls for more than $959 billion for traditional infrastructure, including highways, bridges, rail, airports and waterways; $25 billion of that money would be set aside for electric vehicle infrastructure, including electric buses.

The plan also calls for $74 billion for drinking water and wastewater systems; $71 billion for the electric grid and clean-energy programs; $45 billion for broadband; and $10 billion for veterans’ housing.https://bdc721f79bd56543f5447d228d5a7b86.safeframe.googlesyndication.com/safeframe/1-0-38/html/container.html

In the coming days, the group — 29 Democrats and 29 Republicans — will offer proposals for how to pay for the package but it is not backing tax increases that Biden and progressives want, sources said. About $762 billion of the package represents new spending. 

“It’s critically important that we get a robust infrastructure package signed into law, and that we do it with strong bipartisan support,” Rep. Josh Gottheimer (D-N.J.), co-chair of the Problem Solvers Caucus, said in a statement. “This is the model for how we should govern in Washington: Democrats and Republicans working together to find common ground.”

“The time is now for Congress and the Administration to reach across the aisle, unite, and boost investments in our surface transportation network that will move our transportation systems into the 21st century,” added Rep. Brian Fitzpatrick (R-Pa.), the other co-chair. “Infrastructure investment can and will deliver real benefits to every American and additionally, has the unique power to unite us as a nation.”

The impact of the Problem Solvers plan remains to be seen. The group had played a major role in breaking the partisan impasse that had stalled a huge coronavirus relief package in December, leading to the adoption of $900 billion in new COVID-19 spending. 

The focus of the current infrastructure debate, however, has been in the Senate, where President Biden has sought Republican buy-in for at least a significant part of the $2.25 trillion public works plan he proposed earlier in the year. 

Those talks have been stymied by partisan disagreements over the size, scope and offset provisions Biden is seeking, including a proposal to cover much of the new spending by raising taxes on corporations and wealthy individuals — a non-starter for Senate Republicans. 

Biden this week ended talks with Sen. Shelley Moore Capito (W.Va.), senior Republican on the Environment and Public Works Committee, and shifted his focus to working with a bipartisan group of 20 senators working on their own plan. That group includes Democratic Sens. Joe Manchin (W.Va.) and Kyrsten Sinema (Ariz.); and Republican Sens. Mitt Romney (Utah) and Bill Cassidy (La.). 

Problem Solvers leaders have been working with the new Senate group, which also appears ready to reject Biden’s call to roll back the Republicans’ 2017 tax cuts to help pay for the package.

“Bottom line, this is probably the hardest part from my perspective, is how you get it paid for,” moderate Sen. Jon Tester (D-Mont.), another member of the group, told reporters in the Capitol on Wednesday.

The new framework arrived the same day the House Transportation and Infrastructure Committee, headed by Rep. Peter DeFazio (D-Ore.), began a marathon markup of a $547 million package to fund infrastructure projects over the next five years. 

That proposal, focused largely on surface transportation projects, is one Democrats are hoping will ultimately be incorporated into whatever package emerges from the talks between Biden and the Senate. 

Complicating the debate for the White House, liberal Democrats have already run out of patience with the GOP negotiators, contending that Republicans are merely trying to drag out the talks to keep other Democratic priorities from being considered. The progressives are pressing Biden to abandon the bipartisan talks in favor of a massive infrastructure bill, which could avoid a Senate filibuster if Democrats tap a procedure known as reconciliation. 

“In case it wasn’t clear already, it certainly is now: Republicans are not going to do what needs to be done for working families,” Rep. Pramila Jayapal (D-Wash.), head of the Progressive Caucus, said Tuesday. 

The Labor Department will limit long-awaited emergency Covid-19 workplace safety rules to the health care sector, Labor Secretary Marty Walsh said Wednesday, a decision that disappointed unions pushing for more expansive rules but that will likely be a relief to businesses worried about new costs.

The rules, which have been under White House review since late April and are set to be released Thursday, were expected by both unions and businesses to apply broadly to all workplaces and require workers to wear masks on the job.

But the administration has decided it will instead update its optional guidance for general industry and has “tailored” the mandatory safety requirements to apply only to health care settings, Walsh said.

“OSHA has tailored a rule that focuses on health care, that science tells us that health care workers, particularly those who have come into regular contact with people either suspected of having or being treated for Covid-19 are most at risk,” he said during a House Education and Labor Committee hearing Wednesday. “We also expect to release some updated guidance for general industry which also reflects the CDC’s latest guidance and tells employers how to protect workers who have not yet been vaccinated.”

The change in direction from the administration on the workplace safety requirements is a letdown for unions and Democrats who argue precautions like masking and social distancing are necessary to protect unvaccinated workers in all workplaces, who may not be getting the shot for a variety of reasons.

“We’re still hearing from many food workers that their jobs are not safe. . . We’re still seeing big percentages of essential worker populations for various reasons not able to access the vaccination that we know is so critical,” said Sonia Singh co-director of the Food Chain Workers Alliance, a coalition of organizations that advocate for higher wages and better working conditions in that industry.

“So vaccination is important, but we still need strong emergency standards for all workers,” she added.

Advocates are also worried that workers will be left exposed to Covid-19 in high-risk industries like meat processing and farming, jobs typically filled by minority and immigrant workers who are seeing low rates of vaccination.

“We know that workers in many industries outside of health care faced elevated risks of COVID, especially in low wage industries like meat processing that is [made up of] disproportionately Black and brown workers,” said Debbie Berkowitz, director of safety and health at The National Employment Law Project, a worker advocacy group, “and we need to make sure these workers are still protected with mitigation measures such as ventilation and filtration to control airborne exposures, masks and social distancing — and OSHA must enforce these.”

The National Nurses United union said that while it applauds the administration’s move to issue mandatory Covid-19 safety rules for healthcare workers, it will be closely reviewing the standard to see if it requires respiratory protections “to prevent workers from becoming infected through aerosol transmission of the virus.”

NNU President Zenei Triunfo-Cortez also said the union supports “stronger workplace pandemic safety measures for all workers, all patients, and all communities.”

President Joe Biden directed the Labor Department to decide by March whether mandatory workplace safety rules that required businesses to take steps to protect their workers from Covid-19 were necessary. After weeks of delay, the administration sent the emergency rules to the White House for review at the end of April.

Unions and other advocates grew concerned about how strong the safety rules would be following the Centers for Disease Control’s surprise update to its guidance in May that cleared fully vaccinated people to remove masks in most settings.

But business groups and conservatives argue that issuing stringent safety requirements this late into the pandemic would create confusion and undermine the economic recovery just as businesses are trying to get back to normalcy.

Ed Egee, vice president of government relations and workforce development at National Retail Federation, said that while he needs to review the final text once the rule is published, “the decision to address this issue in an industry-specific way is consistent with sound science and CDC guidelines.”