Draft legislation to update the landmark biomedical innovation law 21st Century Cures will likely come out in early June, lawmakers behind the bill said.
Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) indicated they want to pass their bill, known as Cures 2.0, by the end of the year, although they acknowledged the pandemic has set back their work.
The bill offers a chance for an increasingly divided Congress to pass legislation to remove hurdles to cutting-edge treatments when science is moving at a rapid pace.
The 2016 law has led to better screening for certain cancers, better understanding of the human brain, advances in regenerative medicine and more funding for Alzheimerâs research, a record number of drug approvals, and new opportunities for young scientists, DeGette said.
âThat effort has been really hailed as one of the most comprehensive pieces of health-care legislation,â DeGette said at the Alliance for Regenerative Medicineâs Cell & Gene Legislative Fly-In, the groupâs policy and advocacy event, Monday.
âBut what we realize is that weâre still not there, that there were still some things that werenât perfected under 21st Century Cures.â
The draft bill will focus more on the delivery of cutting edge treatments, whereas 21st Century Cures (Pub. L. 114-255) aimed to modernize the development of new therapies by focusing on the Food and Drug Administration and the National Institutes of Health. The legislation will include language to fold in the Advanced Research Projects Agency for Health, the new agency within the NIH for which President Joe Biden requested $6.5 billion in his initial budget proposal to build. The new agency would help translate discoveries into patient care, based on a program at the Pentagon and the Department of Energy that paved the way for the internet and GPS.
DeGette and Upton recently met with the Biden administration to discuss the ARPA-H proposal and have recently begun discussions with their Senate counterparts. The bill will include language on how to improve pandemic preparedness, and Sen. Patty Murray (D-Wash.) has also said sheâs working on bipartisan legislation to prepare for future pandemics. Murray is the chair of both the Senate health committee and the health spending panel on the Senate Appropriations Committee.
Lawmakers are also looking for recommendations on how to modernize the Centers for Medicare & Medicaid Services to help speed up their decision-making process, DeGette said. âIt doesnât do any good if you have drugs or devices that people canât afford.â
They indicated the draft bill is just a first step and they are looking for feedback to shape the next iteration of bills to speed the delivery of new drugs and devices. For example, there currently isnât language on value-based agreementsâwhich tie payment to how well the treatments actually workâbut DeGette indicated they are open to it.
âFred and I are not researchers; we are just lowly members of Congress,â she said to the regenerative medicine group. âIf we donât get those finer points that are specific to regenerative medicine, then we canât make as robust or effective of a bill.â
The lawmakers indicated they were open to tying Cures 2.0 to upcoming user fee legislation, as negotiations between industry and the FDA are ongoing with the current agreement expiring in September 2022. The FDA collects user fees from drug manufacturers, and in return, the agency commits to performance goals.
DeGette said itâs unlikely a bill that includes the ARPA-H proposal will be folded into the next user fee agreement. At the same time, she said, âWe just want to pass the bill. So whatever method we can do, we will do.â
The bill will include a provision for increasing diversity on clinical trials. There was some language in the 2016 21st Century Cures, but âweâre still not yet where we need to be, and as Fred says, weâve really realized during Covid that we need to get better data in all the clinical trials,â DeGette said.
Upton added thereâs a proposal to require the Department of Health and Human Services to submit a report to Congress regarding the current state of cell and gene therapies, particularly identifying any regulatory challenges for the FDA.
Employers that are having trouble explaining why their mental health coverage for employees differs from medical coverage arenât going to get sympathy from the Department of Labor.
The DOL began auditing employer-sponsored health plans in April for compliance with the Consolidated Appropriations Act enacted in December 2020, which requires the plans to analyze and document why they provide mental health benefits that differ from other medical benefits.
Employer attorneys and lobbyists say they are ill-equipped to provide the analysis. The information should come from the administrators, typically part of health insurance companies, that design and run the plans, they say.
But Ali Khawar, the principal deputy assistant secretary for DOLâs Employee Benefits Security Administration, isnât buying it. The Mental Health Parity and Addiction Equity Act, which requires parity with medical coverage, was enacted in 2008, he said.
âThis isnât a new requirement,â he said in an interview. The agency has issued regulations and a significant amount of guidance on what companies should be doing to document their justification for any discrepancies between mental health and medical-surgical benefits, he said. âThe fact that now itâs a documented requirement, I donât really see that as changing all that much.â
Ensuring that health plans comply with the mental health parity laws is a top priority for the Biden administration, Khawar said. That may result in companies scrambling to get the analysis they need from the administrators that run their plans.
âI donât think I can understate the priority weâre putting on this issue,â Khawar said. âThis is really one of our highest enforcement priorities. And certainly in the health area, I would call this our highest enforcement priority.â
The mental health parity law âis intended to help people who are suffering or who have mental health conditions or substance abuse disorders and who need help,â Khawar said. âReally, it is well past time for us to start seeing that the promise of parity is being met.â
Most health plan sponsors are employers, many of which provide coverage for employees regulated by the federal government under the Employee Retirement Income Security Act (ERISA).
At issue is a document explaining the factors used to justify so-called non-quantitative treatment limitations (NQTLs) on mental health coverage that differ from limits imposed for medical and surgical benefits. Those limits differ from quantitative limits that can be more easily measured, such as limits on the number of visits covered for a particular treatment.
A common example of a non-quantitative treatment limit is requiring approval before covering a treatment or drug, known as prior authorization.
Khawar didnât have details on the number of health plans that have been queried to provide the documentation, saying it is early in the agencyâs efforts to check compliance. âWe are going to our existing inventory of cases and identifying where we think there may be an issue, and we are reaching out to those plans,â he said.
Plans that arenât in compliance may be required to notify their participants that they are not meeting the law.
The DOL also plans to educate the public about the requirements health plans must meet under the mental health parity law, Khawar said.
Further, he said, if companies believe that health insurers they work with arenât complying with the law, they should report that to the DOL. But, he added, âItâs pretty troubling to me that people in May of 2021 are saying that theyâre having trouble ensuring that their analysis is documented for a legal requirement thatâs been on the books for 10 years.â
Mental health parity rules require plans to look at why they imposed limits on mental health services, Kim Wilcoxon, a partner in the Cincinnati office of Thompson Hine LLP, said in an interview. âWe have to look at the strategies that we used to develop the limit; the factors that we considered; the evidence that we reviewed,â she said. Those factors shouldnât be more stringent than what is considered for medical and surgical coverage, she said.
The concept is âadmirable, but difficult for a lay employer to complete,â Wilcoxon said. âMuch of the thought process that goes into these limitations is actually done by an insurance company, a third-party administrator,â she said.
Plan administrators that pay claims typically design company health plans and have medical expertise to identify areas âto make sure weâre not paying for something thatâs not medically necessary,â Wilcoxon said.
âWe just have not yet seen analyses that would satisfy the requirements of the DOLâs requests,â Wilcoxon said.
The EBSA and other agencies issued guidance April 2 on complying with the requirements of the new law regarding the limits for mental health coverage.
Liability for plan administrators who fail to meet mental health parity requirements is unclear, according to many who work on the issue. However, a March 5 decision from the U.S. District Court for the Northern District of California in Jane Doe v. United Behavioral Health has gotten attention because it finds the plan administrator liable for not meeting the law instead of the company sponsoring the plan.
The court ruled that United Behavioral Health, which manages behavioral health services for insurer UnitedHealthcare, violated the mental health parity law by denying coverage for applied behavior analysis therapy for autism for a participant in a plan sponsored by technology company Wipro Ltd., which has offices throughout the U.S. and was not a party to the suit.
âWe are committed to ensuring our members have the mental health support they need, when they need it, as part of our broader commitment to accessible, quality care,â a company spokesman said in an email. Because the case is ongoing, the company has no additional comments, he said.
âWith respect to employer-sponsored coverage that is self-funded, it is almost always the case that these plans are administered by the same companies that underwrite insurance,â Meiram Bendat, founder and president of Psych Appeal and the attorney who represented the plaintiff in the United Behavioral Health case, said in an interview.
âThe third-party administrators, or claims administrators, are really the de facto administrators of these plans, because they really do manage the day-to-day operations of these plans,â approving coverage, making decisions about reimbursements, and creating medical provider networks, Bendat said.
âMy sense is that employers really need to hammer down on the claims administrators to articulate the non-quantitative treatment limitations that are applied,â Bendat said. The administrators already do that with their fully insured health plans, he said.
At an April 15 hearing held by the House Education and Labor Committeeâs health subcommittee, Bendat called for enactment of the Parity Enforcement Act (H.R. 1364), introduced by Rep. Donald Norcross (D-N.J.), which would create new civil penalties for employer health plans or health insurers for violating the mental health parity law. Currently employers bear sole liability.
Many practices involving the limits arenât dependent on plan language, but instead rely on policies used by plan administrators, Bendat said.
Plan administrators may impose a variety of requirements for prior authorization, Bendat said. Administrators may impose utilization reviews more frequently or stringently for in-patient mental health treatments than for in-patient medical treatments, which makes it more difficult to get benefits approved, he said.
Plan documents typically just specify that some services require prior authorization âand leave it up to the claims administrators to do what they see fit,â Bendat said.
âEmployers donât design NQTLs,â James Gelfand, senior vice president for health policy for the ERISA Industry Committee (ERIC), which represents large employers on employee benefit policies, said in an interview.
âWe have behavioral health vendors who help us to design those in a way to ensure that they are in compliance with parity rules,â Gelfand said.
ERIC supported the provision of the Consolidated Appropriations Act requiring plan sponsors to document the limits, he said.
However, âin the last five months, there has been kind of a mad scramble from the employers to take possession of this information,â Gelfand said.
âWe assumed the vendors have always had this information, and now they just need to hand it over to us so that we have it for when the government or a patient comes knocking,â Gelfand said. âGetting information from any of the vendors has been a much longer and more complicated process than was initially imagined,â he said.
The DOLâs position âwas that employers essentially should already have had this data, which was news to us,â Gelfand said. âThey were of a mind that we should have already had it; if our vendors had it, then we should be able to get it from them immediately. They werenât sympathetic to this issue of it taking time and negotiations, etc.â
It will be important to see how the DOL treats the issue, Gelfand said. âIt may turn out that as the audits have actually started, that the vendors are going to pick up the case, and everything will be fine. But thatâs the best case scenario, and we get paid to worry about the worst case scenario.â
Democrats are beginning to lay the legislative groundwork for President Joe Bidenâs infrastructure priorities, flagging their must-haves as the final package is hashed out.
The bills Democrats have introduced in recent weeks would expand the low-income housing credit and streamline clean energy incentives. The proposals are seen as negotiating tools, as Biden and his administration work to fine tune his sweeping infrastructure proposal. What makes it into the final package will require careful maneuvering given competing priorities between Congress and the White House, and the narrow majority held by Democrats.
Former Congressman Charles Boustany (R-La.) said that when the president and the administration make a major push, members look to jump on board and act as âpolicy entrepreneursâ using work they have already done on a particular issue.
âIn some cases, theyâve worked on legislation for years, to no avail,â said Boustany, now with Capitol Counsel. At other times, they want to be part of a âlegislative victoryâ that they can talk about back home, he said.Bidenâs plan includes a 21% global minimum tax and a corporate rate of 28% as part of a $2.25 trillion effort to invest in roads and bridges. He has also offered a sweeping plan aimed at American families that would be funded in part by tax hikes on the wealthy. Some Democrats have already objected to the planâs lack of a fix for the $10,000 limit on federal deductions for state and local taxes paidâa sign that what the administration is seeking is far from final.
Senate Finance Chairman Ron Wyden (D-Ore.) built on Bidenâs energy plan with his own proposal that would replace a few dozen tax breaks with a technology-neutral tax incentive.
âIt would both put us on the path to achieving our emissions reductions goals and create good-paying jobs, and should be the linchpin of our clean energy efforts as we consider President Bidenâs jobs package,â Wyden said in a statement at the time.
Bidenâs plan would extend existing tax credits for wind and solar power and energy storage.
Wydenâs bill is an example of something Marc Gerson, a member at Miller & Chevalier Chartered, said is common when presidents offer policy proposals: A White House proposal is often very high-level, and members will either flesh it out or offer their own version.
Another piece of clean-energy legislation building out Bidenâs plan comes from Rep. Earl Blumenauer (D-Ore.). His bill would require companies to pay an excise tax for producing products that generate hazardous waste. It would restore taxes that expired in 1995.
The Biden administration wants to expand the low income housing tax credit because of a housing crunch that has become worse during the pandemic, calling on Congress to produce and preserve more than 1 million affordable, energy-efficient units. A bipartisan group of lawmakers have expanded on that idea.
A bill ( H.R. 2573, S.1136) from Rep. Suzan Delbene (D-Wash) and Sen. Todd Young (R-Ind.) would expand the credit. The measure would increase the credits to each state by 50% for the next two years and make permanent a temporary 12.5% increase in the credit.
âOur nationâs need for more affordable housing is at an all-time high because of the Covid-19 pandemic,â DelBene said while introducing the bill earlier this month. âCongress should leverage the proven success of the Housing Credit to build more affordable housing units.â
With Bidenâs tax hikes still up for debate in Congress, financing infrastructure with government debt may be an optionâan approach that was part of former President Barack Obamaâs stimulus package early in his presidency.
A bipartisan bill introduced this month by Sens. Michael Bennet (D-Colo.) and Roger Wicker (R-Miss.) would create American Infrastructure Bonds to pay for projects.
Interest on the bonds would be paid, in part, by the federal government. The Treasury Department would pay a percentage of the interest to the issuing entity, according to a news release from Wickerâs office.
Wyden has consistently pushed for debt financing to fund infrastructure, and the next few weeks could show how much force Democrats want to put behind the policy.
Democratic lawmakers waited for weeks to see how hard President Joe Biden would push for big health care changes in the next portion of the sweeping infrastructure package. The answer is leaving many frustrated.
The American Families Plan that Biden is set to roll out in a joint address to Congress Wednesday night contains just one big priority for Democrats and the health care industry: a permanent boost to subsidized health coverage in Obamacare markets. It’s devoid of other agenda items like drug price controls or expansions of Medicare and Medicaid that many of the party faithful saw as must-haves while Democrats maintain full control of Washington.
The White House will tout the ACA subsidies as a way to help 4 million uninsured people into private coverage and reduce the premiums of another 9 million by an average of $50 a month.
A senior administration official on a call Tuesday night called the extended subsidies âone of the most impactful investments we can make both in terms of reducing the cost of health insurance for those buyers, as well as making it more accessible and expanding coverage to those who have not previously had health insurance.â
Left unsaid was the administration’s desire to avoid a prolonged fight with entrenched health care interests as it tries to deliver what’s likely to be the last big tranche of pandemic relief. While the officials said Biden remains committed to lowering drug prices through direct government negotiations, they gave no details on how he’d accomplish that â or explain why proposals like a House drug price control plan, H.R. 3 (117), were left out of the infrastructure plan.
That’s leaving Democrats with few realistic options. They have little chance of advancing other ambitious health priorities as standalone legislation with their slim House and Senate majorities and a rapidly shrinking congressional calendar. And some lawmakers suggested they are already having trouble uniting around what policies to prioritize.
âWeâve got more work to do to get consensus around a broad health care package,â said Sen. Debbie Stabenow (D-Mich.). âI think we care so passionately about health care and we have a lot of different ideas. We just need to bring everybody together.â
While their priorities may differ, both moderate and progressive lawmakers are left facing a difficult midterm cycle where they had hoped to wield drug pricing reforms as a signature accomplishment.
“This is what elderly voters are going to be looking at in the fall of 2022,â Senate Finance Chair Ron Wyden (D-Ore.) told POLITICO. “Thereâs a real urgency about this and I conveyed that to the President and the Cabinet and key staff. And I said, ‘if you regard this as an emergency, you canât wait a single minute.'”
A fact sheet the White House circulated Tuesday night claimed Biden âhas a planâ to allow Medicare to negotiate prices, create a public insurance option, lower the Medicare eligibility age to 60 and enact a federal expansion of Medicaid in states that haven’t opted to enlarge their programs under Obamacare. But the administration intends to keep all of that separate from the infrastructure package.
Democrats in the House and Senate and outside advocacy groups have spent the last few weeks petitioning the White House to address precisely those issues this year.
In a wave of calls, letters and meetings with the White House, the lawmakers and activists warned the infrastructure package might be the last major bill Congress is able to pass this year, and a failure to keep the Medicare and drug pricing pledges Biden campaigned on would hurt Democratsâ efforts to defend their majorities in Congress.
Key lawmakers are insisting they still can go it alone. House Democrats led by Speaker Nancy Pelosi have reintroduced the sweeping drug price negotiation bill, with a hearing set for next week. Senate Budget Chair Bernie Sanders (I-Vt.) says heâll soon follow suit.
âCongress determines legislation,â he responded when asked about Biden leaving the measures out of his plan. âAnd Iâm going to do everything I can to make sure that we lower prescription drug costs in America for everybody and that we negotiate prescription drug prices for Medicare and that we use those savings to expand Medicare to include dental, hearing aids and eyeglasses.â
But even the most ardent advocates of these policies say the odds of accomplishing anything are daunting.
âPharma is ferocious and they wonât go quietly into the night,â Rep. Peter Welch (D-Vt.) told reporters on a call on Monday, adding that many Democrats are loath to take on the industry. âThe political situation now, with a razor-thin majority in the House and a 50-50 Senate, means that the effort to get the votes will be very, very tough. Weâve got to take seriously how hard this is.â
President Joe Biden wants to keep drug pricing separate from his new sweeping economic package. But some key Democratic lawmakers said they heard another message in his address to Congress on Wednesday night.
Senior Democratic leaders on health care are taking Bidenâs endorsement of government drug price negotiations as a green light to try to tack on pricing reforms to the administrationâs $1.8 trillion plan â stoking fresh jitters among some in the pharmaceutical industry.
âIn the speech, with respect to pharmaceuticals, he said, âLook, we’ve been talking about this for a long time. I’m going to give the Congress space to move,ââ said Senate Finance Chair Ron Wyden (D-Ore.), who told POLITICO heâs spoken with Democratic and Republican colleagues about adding drug price legislation to the newest Biden package, known as the American Families Plan. âWe’re going to look at every possible vehicle, starting today.â
House Democrats on Thursday announced plans to hold multiple hearings on their drug pricing negotiation bill, H.R. 3 (117), that they reintroduced ahead of Bidenâs speech. While Senate Democrats have been more cautious on drug pricing, the effort has united House progressives and moderates. Energy and Commerce Committee Chair Frank Pallone (D-N.J.) called H.R. 3 one of his âtop prioritiesâ as his committee begins translating Bidenâs policy outline into legislative text, and the 100-member Progressive Caucus has fully backed the measure.
But Democratic lawmakers have little time to forge consensus on a drug pricing overhaul that will draw fierce industry resistance, which could help explain why Biden kept it out of the new package bolstering the countryâs safety net. There is a wide gulf between the most prominent House and Senate drug pricing plans, which could make it difficult for Democratic leaders to win support from all of their members.
Wyden and many other Democrats had spent weeks fruitlessly lobbying Biden to include drug price reform in the package. But on health care,Bidenâs plan only called for immediately making permanent the subsidies for private Obamacare plans Congress temporarily approved in Marchâs Covid relief package.
Still, numerous pharmaceutical industry sources said Bidenâs speech was more forceful on drug pricing than they had expected. His reference to the higher costs Americans pay for drugs compared to people in other countries was reminiscent of former President Donald Trumpâs rhetoric attacking drugmakers. Biden also suggested that Medicare-negotiated prices be extended to commercial health plans, reviving support for a policy he endorsed in a âunityâ document his campaign wrote with progressives last year.
âThe president endorsed, in a prime-time address to Congress, a policy proposal we and many others have long opposed because it could lead to less patient access and fewer new cures and treatments,â said PhRMA spokesperson Brian Newell.
Democratic leaders in Congress offered few hints on their strategy, and thereâs still some disagreement within the party about how to invest the huge savings that drug pricing legislation would generate.
House Speaker Nancy Pelosi, whose top health care priority was the extension of Obamacare subsidies, demurred Thursday when asked if she would push for drug price negotiation to be added to the American Families Plan.
âWhat is in one bill or another is not really important,” she said. âThere is big interest in our caucus, and in the committees of jurisdiction, as well among the leadership that we want to see a path to that.â
Senate Majority Leader Chuck Schumer has yet to weigh in. And Senate HELP Committee Chair Patty Murray (D-Wash.) said she hasnât spoken with other leaders about adding drug price reform to the new package, though sheâs âexploring every avenueâ to do so.
Wyden is pushing Democrats to consider the House drug pricing bill, as well as his own bipartisan legislation that would penalize drugmakers who raise prices faster than inflation and also make them pick up a portion of some seniorsâ pharmaceutical costs. Wydenâs bill is seen as a possible compromise, though progressives argue it doesnât go far enough and some moderates arenât sold on the idea. Still, it has the appeal of providing about $100 billion in savings that could offset spending elsewhere in the bill â or provide another revenue source if Democrats want to dial back tax increases.
Sen. Bob Menendez (D-N.J.), seen as a potential pharma ally given that his state is a major base for the industry, stressed on Thursday that drug companies shouldnât be used to fund other priorities.
The proposal is also unlikely to gain muchRepublican support. The top Republican on the Senate Finance Committee, Mike Crapo of Idaho, voted against the Wyden bill in the previous Congress, and told POLITICO on Thursday he would continue to oppose it.
âI’ve never supported government price fixing in any industry and I don’t think that the government price fixing will work here either,â Crapo said. âI think it’ll be a failed solution.â
Many Democrats see the infrastructure package as their last chance to push through their boldest legislative ideas this year. A failure to fulfill campaign promises to lower health care costs could hurt the partyâs efforts to keep their slim House and Senate majorities in the 2022 midterms, Wyden and other Democrats have warned.
But if drug pricing canât hitch a ride on infrastructure, Democrats are likely to keep pushing the issue. Biden on Wednesday called for getting health care changes done âthis year,â though the timeline remains uncertain with a tight legislative calendar and several competing priorities.
âItâs not a done deal that it doesnât get attached to infrastructure at the end of the day, but if they donât, theyâll want to take another shot,â said Joe Grogan, a top Trump administration policy aide who tried and failed to negotiate a drug pricing compromise with Pelosi in the last Congress. âI donât think itâs over by the summer â I think it continues to bubble through the end of the year.â
JERSEY CITY, NJ â U.S. Senator Bob Menendez (D-N.J.) and Congressman Bill Pascrell, Jr. (N.J.-09), senior members of the Senate Finance and House Ways and Means Committees that respectively oversee national health policy, today announced that they have secured key provisions in the final FY2022 Centers for Medicare and Medicaid Servicesâ (CMS) proposed rulemaking that will pump at least $133 million more annually in federal funding into New Jersey hospitals, help them attract the best talent and provide high quality care, and address the national doctor shortage by adding more medical school residency slots.
âAt a time when New Jerseyâs hospitals, doctors and nurses have been on the frontlines of the COVID-19 pandemic, they need all the help they can get to continue to deliver the high quality care their patients expect and deserve,â said Sen. Menendez. âThese moves by CMS to implement policies I have long fought for will inject millions of dollars in annual federal funding into New Jerseyâs hospitals, help them attract the best talent and pay providers, and begin to meaningfully address the doctor shortage by creating new residency slots and supporting our local teaching hospitals.â
âPerhaps no state in our union was hit harder by COVID-19 than New Jersey. Our doctors and nurses on the frontlines are heroes of this pandemic and they must have the support they need to protect our communities,â said Rep. Pascrell. âSenator Menendez and I have repeatedly called on CMS to make these moves and I am gratified they are injecting millions of fresh dollars into the arms of New Jersey hospitals. This federal support will benefit patients by allowing our top-notch hospitals to retain and hire the best and the brightest.â
CMS will move to make permanent the so-called imputed rural floor, which would generate millions more annually in Medicare reimbursements for New Jerseyâs hospitals.
Sen. Menendez authored and successfully fought to include a provision in the American Rescue Plan before it passed the Senate that permanently restores the so-called imputed rural floor policy that was eliminated by the Trump Administration, costing New Jersey hospitals millions of dollars annually. As a result, hospitals in New Jersey have been left at a competitive disadvantage due to depressed Medicare wage payments.
CMS first established the imputed rural floor in FY2005 in order to ensure equitable payment policies for rural hospitals located in states designated as âall-urbanâ by CMS. New Jersey is currently one of only three states, along with Delaware and Rhode Island, designated by CMS as âall-urbanâ based upon geographic size and statewide population, but that designation ignores the realities that there are rural areas within those densely populated states and hospitals operating in those communities that face the same challenges as rural hospitals located in other states. Permanently restoring the imputed rural floor allows New Jerseyâs hospitals to effectively compete for the highest quality health care talent available by providing parity with neighboring states.
Sen. Menendez and Rep. Pascrell have, for years, successfully led efforts to extend the so-called imputed rural floor policy. It was last extended in 2017, but the Trump Administration allowed it to lapse at the end of FY2018, putting New Jersey hospitals at a competitive disadvantage due to depressed Medicare wage payments and costing them millions annually.
CMS will raise the imputed rural floor in FY2022 above expectation, delivering even more resources for New Jerseyâs hospitals.
By raising the imputed rural floor in FY2022, the New Jersey Hospital Association (NJHA) estimates New Jersey hospitals will potentially receive an additional $133 million in Medicare reimbursements.
CMS will delay for at least one year the creation of a separate Medicare Area Wage Index in Central Jersey that would cost area hospitals an estimated $100 million.
Sen. Menendez and Rep. Pascrell led the delegationâs objection to a Trump-era rule that would create a new Medicare Area Wage Index in Central Jersey by removing three countiesâMiddlesex, Monmouth, and Oceanâfrom the New York-Newark-Jersey City core-based statistical area (CBSA). The one-year delay in its implementation gives them additional time as they continue to fight to reverse the rule, which would cut Medicare reimbursements by 17% for providers operating in those three counties, costing them approximately $100 million, according to NJHA estimates. It also puts these hospitals at a competitive disadvantage in attracting the best talent when nearby hospitals in northern New Jersey or New York City are reimbursed by Medicare at a higher rate.
CMS will begin to phase-in 1,000 additional physician residency slots, at 200 slots a year over the next five years beginning in FY2022, to address a national doctor shortage.
In December, Sen. Menendez secured the first increase in Medicare-funded graduate medical education (GME) slots in nearly a quarter century to help address the national doctor shortage. Language included in the FY2021 spending package adding 1,000 new physician residency slots was based on the senatorâs bipartisan Resident Physician Shortage Reduction Act.
That same spending package passed in December included the Supporting Graduate Medical Education at Community Hospitals Act, sponsored by Sens. Menendez and Cory Booker and Reps. Pascrell and Josh Gottheimer (N.J.-05). The bill removed the arbitrary cap on GME slots, paving the way for the additional 1,000 slots to be added, and was designed to help community hospitals like Holy Name Medical Center in Teaneck, N.J., allowing them to invest in teaching programs that will keep New Jerseyâs health workforce competitive.
âTraining medical studentsâthe next generation of doctorsâis more important than ever having just come through this global health crisis,â said Michael Maron, president and CEO of Holy Name Medical Center. “Without the hard work and support from Senator Menendez and Congressman Pascrell, the impact of New Jerseyâs critical physician shortage would be felt by every resident in the state. We are grateful for their efforts and look forward to having the resources to continue to care for New Jersey families.â
New Jersey currently suffers from a shortage of physicians. According to data from NJHA, a third of New Jerseyâs practicing physicians are over 60 years-old, the third highest in the nation, and the state ranks 46th in the nation in the percentage of doctors under 40, according to the Association of American Medical Colleges.
Each year, New Jersey has approximately 3,100 physician residents in training at 43 hospitals. At the same time, NJHA estimates that New Jersey has approximately 32 medical students and resident physicians in training per 100,000 residents compared to 81 and 62 in neighboring New York and Pennsylvania, respectively.
The House this week is expected to vote on a bill, the Workplace Violence Prevention for Health Care and Social Service Workers Act (H.R. 1195), a bill that requires the Labor Department to issue a standard requiring health care and social service employers to implement workplace violence prevention plans. The bill would define workplace violence as any act or threat of force against an employee that could result in a physical injury, psychological trauma, or stress. It also would include any act where a firearm or an improvised weapon was used.Â
On Wednesday, March 10, 2021, the U.S. House of Representatives passed the Senate version of the budget reconciliation package, the American Rescue Plan Act of 2021 (H.R. 1319). The $1.9 trillion legislation includes mandatory funding, program changes, and tax policies aimed primarily at mitigating the continuing effects of the COVID-19 pandemic.Â
Infrastructure, appropriations, and more are on the congressional to-do list now that President Joe Biden has signed the $1.9 billion Covid-19 relief package into law.
Bloomberg Government legislative analysts held a webinar today, looking back at the American Rescue Plan Act and to whatâs ahead for the rest of 2021.
All eyes are on Bidenâs next big proposal, which could top $3 trillion and cover a wide range of issues including infrastructure, climate change, health care, and taxes. In the meantime, House Democrats have moved aggressively to advance their high-priority bills, which face an uncertain fate in the Senate because of the filibuster.
The analysts also examined other items that Congress could address in the coming months, including immigration, technology, and foreign policy.
Download the Post-Covid Aid Agenda webinar slides here
On March 6, 2021, the U.S. Senate voted 50-49 along party lines to approve an amended version of the American Rescue Plan Act of 2021 (S. Admt. 891 to H.R. 1319). One of the most contentious provisions of the House-passed bill was the inclusion of roughly $360 billion to help state, local, tribal, and territorial governments mitigate fiscal effects tied to the Covid-19 emergency. The amended Senate version of the bill retained this provision. The U.S. House of Representatives is expected to pass the final version of the $1.9 trillion coronavirus relief package as soon as Wednesday, March 10.Â
Through the Coronavirus Aid, Relief, and Economic Security (CARES) Act and the Paycheck Protection Program and Health Care Enhancement Act (PPPCHE), the federal government has allocated $175 billion in payments to be distributed through the Provider Relief Fund (PRF). Qualified providers of health care, services, and support may receive Provider Relief Fund payments for healthcare-related expenses or lost revenue due to COVID-19. Separately, the COVID-19 Uninsured Program reimburses providers for testing and treating uninsured individuals with COVID-19.Â
By Sara Hansard | January 22, 2021 5:31AM ET
Health-care costs could escalate depending on how the Biden administration writes regulations implementing a new law that bans hospitals and doctors from issuing surprise medical bills.
The bar on such bills is included in the omnibus spending and virus legislation signed at the end of 2020 by former President Donald Trump (H.R. 133). Starting in 2022, it will prohibit health-care providers from billing patients in emergencies or for services from out-of-network caregivers at facilities that are in patientsâ insurance networks.
Bills from out-of-network emergency room doctors, anesthesiologists, radiologists, pathologists, and air ambulances can run in the thousands of dollars or more.
The crucial issue that must be resolved through regulations is whether arbitrators are allowed to favor providers or insurers in settling billing disputes. Arbitration cases in Texas,New York, and New Jersey have resulted in high payment rates to providers based on high charges originally billed. That in turn results in higher premiums.
âThere are a lot of pieces that are left open to regulationâ under the No Surprises Act, which was folded into H.R. 133, Loren Adler, associate director of the USC-Brookings Schaeffer Initiative for Health Policy, said in an interview.
The Department of Health and Human Services will determine what arbitrators can be used to resolve billing disputes and what the rules for arbitration will be, James Gelfand, senior vice president of health policy for the ERISA Industry Committee (ERIC), said. ERIC represents large employers on benefit policies.
Employer groups and health insurers lobbied lawmakers against giving arbitration a large role in determining payments, while hospitals and doctors pushed for heavier reliance on arbitration.
There will be extensive rulemaking on factors arbitrators must consider in making a decision, Gelfand said. Arbitrators must choose between the two offers made by the competing parties and canât award any other amount.
The median network rate for the area in which the service takes place is among the factors arbitrators are required to consider under the law. But additional questions need clarifying through regulation. âWhat is the median in-network rate for a given procedure in a given area? How is that determined?â Gelfand said.
âYou have to have a referenceâ to determine network rates, he said. For example, âthereâs plenty of places where there virtually are no in-network air ambulances.â
Even if there is a reference price, it isnât clear if rates should be calculated âitem by agonizing item,â comparing small hospital charges for things like Band-Aids, or whether the prices should be based on episodes of care, such as normal charges for births.
The geography defined for network prices could also be difficult to define. Medical markets âdo not neatly align necessarily with state lines,â and it may not be based on the area covered by the insurer, he said.
Factors such as the training and experience of the provider, and the complexity of the services provided also must be considered under the law. Arbitrators are expressly prohibited from considering the high âbilled chargesâ set by providers or rates set through government programs such as Medicare, which hospitals say are below the cost of providing care.
âAll that needs to be sort of built out,â Gelfand said. âThe language in the legislation isnât enough to inform the arbitrator what to do.â
Lobbying on the regulations will likely be fierce, and the American Hospital Association will be one of the foremost organizations involved. The AHA declined a request for comment, saying it is too early to comment on regulations.
The AHA sent a letter to congressional health leaders in December, after broad agreement had been reached on surprise billing provisions but before the final legislation was passed.
Among the list of concerns listed by the AHA were requirements that providers give patients good faith estimates of costs when procedures are planned. Requiring hospitals to provide the estimates regardless of whether a patient requests it or has access to other cost estimator tools would add âsignificant burden and cost to the health care system without clear additional benefit to patients,â it said.
Americaâs Health Insurance Plans also raised concerns about the measure. âWe remain deeply concerned that hardworking American families and businesses will face increased costs and higher premiums as private-equity firms exploit arbitration processes,â AHIP President and CEO Matt Eyles said in a statement.
An example of the ambiguities of the law is the inclusion of the market share of providers or insurers as another factor for arbitrators to consider.
However, âIt doesnât say which directionâ arbitrators should view market share, Jack Hoadley, research professor emeritus in Georgetown Universityâs Health Policy Institute, said in an interview.
âIt could be thought of as either way,â with a high market share seen as justification for receiving higher payments, or it could go against the party if arbitrators donât want to reward them for dominating the market, Hoadley said.
The administration could let arbitrators decide how to interpret the law, âor they could try to provide more guidance, perhaps for the purpose of getting to lower settlements,â he said.
The law allows for multiple cases to be combined into a single arbitration case as long as they involve the same provider or facility, involve the same insurers, involve treatment of similar medical conditions, and occur within 30 days.
Whether the arbitration fee charged for combined cases is based on each underlying case, or whether the fee is set as one fee for the combined cases, may affect the extent that parties are willing to go to arbitration, Hoadley said.
The loser in cases must pay the fee, which may also discourage parties from going to arbitration, he said.
âThe presumption is that itâs the providers who are going to push to arbitrate to get a higher amount,â Hoadley said.
If insurers perceive that providers are receiving higher rates in arbitration, they could offer higher rates than network rates, Hoadley said.
That could increase health-care costs and premiums.
A new feature of the law will be enforcement on providers who run afoul of the law, such as by billing patients who are supposed to be protected, said Katie Keith, a research professor with Georgetown University.
Like the Affordable Care Act, states are responsible for enforcing the law, but if they donât the federal government steps in, Keith said.
âThatâs been normal on the insurance sideâ but will be new for health-care providers, which include air ambulances, she said.
A federal complaint process will have to be created for individuals who get surprise medical bills.
âIf the feds are the ones enforcing thisânot the statesâthey can impose pretty significant penalties on the providers that are still doing that kind of thing,â Keith said.
In early February 2021, the U.S. Senate adopted an FY 2021 budget resolution (S. Con. Res. 5) that gives Democratic leaders an option for advancing a COVID-19 relief package with only a simple majority in the upper chamber. The Senate resolution incorporates language from the Houseâs version (H. Con. Res. 11) and includes reconciliation instructions and budget enforcement provisions for both chambers. The resolution directs 11 Senate committees and 12 House committees to produce legislation that would increase the deficit by as much as $1.9 trillion over 10 years.Â
(Inside Health Policy)
President Joe Bidenâs national COVID-19 response plan commits to expanding the social service safety net to provide for unmet basic needs exacerbated by the pandemic, which experts and advocates say will likely translate into broadening Medicaid to cover more social determinants of health down the road. But while Medicaid advocates and state officials agree access to nutrition, stable housing and other social needs should be expanded, they donât think Medicaid should absorb all the costs.
The COVID-19 pandemic has highlighted the link between social determinants like nutrition, housing and employment and health. The strategy plan shows the administrationâs understanding of that connection, said Manatt Health Partner Melinda Dutton.
âI think what we’re seeing from the administration is a recognition of that and a commitment to being more thoughtful and more directive in terms of how we’re addressing those needs,â she said.
A White House spokesperson said on a press call last Thursday (Jan. 28) that the administration is committed to addressing social determinants and making sure Medicaid properly serves beneficiaries, but the spokesperson did not share any concrete plans for broadening Medicaid coverage to tackle social determinants.
The administration already took action to strengthen Medicaid and improve access to the health care option through an executive order signed last week. The administration has also placed a focus on increasing health equity. Abner Mason, CEO of Medicaid and Medicare health plan member outreach startup ConsejoSano, said this focus ties directly into increasing social determinant programs.
âBroader coverage of SDOH services will go a long way in reducing health disparities and promoting health equity in the Black and brown communities most affected by COVID,â Mason said in an email.
J.T. Lane, chief population health & innovation officer at the Association of State and Territorial Health Officials, said it makes sense the administration would want to increase the kinds of services paid for by safety net programs like Medicaid to improve health outcomes during the pandemic. The government has already invested in these services through the CARES Act and other pandemic response legislation, he said.
âThere’s a major opportunity to strengthen the services that are there with additional investment to help people make it to that place where they can bounce forward and fully recover from this,â he said.
Lane previously told Inside Health Policy the Biden administration could end up becoming the most supportive administration of Medicaid public health partnerships to cover social determinants. Matt Salo, executive director of the National Association of Medicaid Directors, said the strategy planâs commitment to strengthening safety net programs will probably lead to the administration broadening Medicaid coverage of social determinants down the road.
But while Salo agrees access to nutrition, stable housing and other social needs should be expanded, he isnât convinced Medicaid should absorb all the costs.
âMedicaid is probably poised to more quickly and effectively address these issues,â Salo wrote in an email. But he added that itâs ânot sustainable, however, for the world to rely on Medicaid to solve all social ills.â
Medicaid is well positioned to take on social determinants when they can be tailored to an individual or small group, he said. Covering nutrition or housing for all beneficiaries would balloon Medicaid costs.
Other stakeholders agreed Medicaid canât be a catch-all. Itâs important to figure out the most efficient way to improve a beneficiaryâs situation, Dutton said. For example, it might make sense to pay for a nutritious food box for a diabetic whose condition is worsened without healthy food, she said. But coordination between CMS and other federal agencies is necessary to fully tackle social determinants.
Lane said the national strategy plan shows a commitment to this coordination by pledging to support efforts to align health and social interventions.
“To me, that says that while we want to expand and strengthen that net, we can’t expand without supporting, and even in many in some cases requiring, greater coordination across the federal apparatus, at the state level and the local level,â Lane said. — Maya Goldman (mgoldman@iwpnews.com)
With slim majorities in Congress, Democrats could use budget reconciliation to pass another coronavirus stimulus measure and other priorities without Republican votes.
Reconciliation can be used to enact legislation using expedited procedures in the Senate, but it must be budgetary in nature under whatâs known as the Byrd Rule. That can limit the types of policies that are included because they generally have to affect mandatory spending or revenue and canât increase the deficit outside the covered budget period.
The Biden administration is discussing its $1.9 trillion stimulus plan with lawmakers but some are pushing back against the price tag, especially after Decemberâs $900 billion package. Without bipartisan support, Democrats may have to drop some provisions to get a package through using reconciliation. That could include proposals to increase the minimum wage, though House Budget Chairman John Yarmuth (D-Ky.) said they may still try to include it.
Democrats could also use reconciliation to pass other items on their agenda, such as health care, tax, climate, or infrastructure legislation.
The procedure has been used more than 20 times since the 1980s to pass major legislation, including a welfare overhaul , tax cuts, and the 2010 Affordable Care Act. Most recently, Republicans used it to pass a sweeping overhaul of the tax code in 2017 under President Donald Trump.
The attached presentation covers reconciliation procedures, how Democrats could use the process, and previous laws enacted through reconciliation â and some attempts that fell short.
Invalid Email Address