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.
The COVID-19 public health emergency is expected to continue through the end of 2021, Acting HHS Secretary Norris Cochran wrote in a Jan. 22 letter to governors, signaling the temporary 6.2% bump in federal Medicaid matching funds and a slew of other Medicare and Medicaid emergency waivers put in place during the pandemic will not end soon. HHS will give states 60 days’ notice before the public health emergency ends so they can plan for the end of the higher Medicaid match rates, Cochran said.
A year-long extension of the PHE would leave in place emergency use authorizations for diagnostics, treatments, and vaccines and potentially could lead to new HHS policies to help states respond to the COVID-19 emergency.
âTo assure you of our commitment to the ongoing response, we have determined that the PHE will likely remain in place for the entirety of 2021, and when a decision is made to terminate the declaration or let it expire, HHS will provide states with 60 daysâ notice prior to termination,â Cochranâs letter says.
Cochran says the 60-days’ notice of the PHEâs end will help provide stability for states, as they can plan for the end of the 6.2% bump in federal Medicaid funding. That funding increase stops at the end of the quarter when the public health emergency ends.
âWith the extension and additional advance notice, we seek to provide you with increased budgetary stability and predictability during this challenging time,â Cochran tells governors.
Congress required states to keep Medicaid beneficiaries continuously enrolled throughout the COVID-19 public health emergency as a condition of receiving more federal Medicaid money. Experts predict up to 30% of Medicaid beneficiaries could lose insurance once the COVID-19 public health emergency ends, unless the Biden administration steps in.
Cochran notes that the extended public health emergency means waivers for Medicare, Medicaid and CHIP will remain in place, along with other waivers. This includes 1135 waivers and PREP Act waivers, both of which have been used to ease telemedicine during the pandemic, particularly in Medicare.
A recent Commonwealth Fund analysis from Jennifer Podulka, senior consultant for Health Management Associates, says that for Medicare alone, more than 200 legislative and regulatory changes have been put in place since the start of 2020. Most Medicare providers have been affected, Podulka says, though hospitals and post-acute care providers have seen the most changes.
âThe Biden administration has inherited this slate of temporary COVID-related Medicare regulatory changes and will have to decide whether and how to extend these policies given the state of the pandemic and its impact on health care providers. As the new administration addresses the ongoing pandemic with the new phase of vaccinations underway, it is likely that regulatory and subregulatory changes will continue to be introduced and modified to reflect the administrationâs COVID and Medicare policies,â Podulka says.
Cochranâs letter says HHSâ goal is to make sure enough health care services and items are available during the emergency to meet the needs of those on Medicare, Medicaid and CHIP and their providers.Â
Lobbyists and stakeholders are urging the incoming Biden administration to tackle health care changes through an administrative lens, coming as the courts face pressure to watch how the new administration acts on key policies before moving on cases involving regulations like the public charge rule. Health care advocates also enter 2021 with ambitious legislative agendas, the outcome of which could hinge on Georgiaâs special Senate elections. Yet, the immediate health care focus in 2021 will be on COVID-19.
In addition to crafting its own national COVID-19 response strategy, the new administration will need to decide how to address a slew of coronavirus regulatory waivers put in place by the Trump administration.
The outgoing Trump administration also spent its last few months instituting new demonstration projects, regulations and advisory opinions that the incoming administration — and Bidenâs HHS secretary pick Xavier Becerra — will have to factor into their plans.
Senate Finance ranking Democrat Ron Wyden (OR) and committee member Tom Carper (D-DE) are pressing Finance Chair Charles Grassley (R-IA) to quickly begin the confirmation process for Becerra the Treasury nominee so they are in a position to tackle the pandemic and the economy on day one of the new administration.
COVID-19. The federal government will wait until late January, after the new administration takes office, to begin a national campaign to combat skepticism of the COVID-19 vaccine, HHS officials told reporters Tuesday (Dec. 29). Career officials said they would have preferred starting the campaign earlier, but public health officials face high levels of public distrust under the Trump administration.
Recent polls show that roughly half of the population is unsure whether to take a COVID-19 vaccine when it’s available to them. National Institutes of Allergy and Infectious Diseases Director Anthony Fauci recently said as many as 90% of Americans need to get vaccinated for the country to achieve herd immunity.
Meanwhile, FDA wants developers of at-home and over-the-counter COVID-19 tests to ensure their testing platforms are set up to report usersâ results to public health officials, but one cybersecurity consultant warns that allowing software to share user information raises the potential for cybersecurity and data integrity issues.
Innovation center and value-based care. The Trump HHS is saddling the incoming administration with a series of new Medicare demos, and stakeholders are watching to see whether the Biden team will embrace them. For example, in early December CMS released the third part of the innovation centerâs direct contracting demonstration, known as the Geographic Direct Contracting Model, or Geo, but the full-risk demo, which will require participants to take on risk for beneficiaries in an entire geographic region, isnât slated to get started until 2022, well into President-elect Joe Bidenâs term.
CMS Administrator Seema Verma has said this shouldnât be a problem, but stakeholders are split on whether the Biden administration should continue it. Americaâs Physician Groups supports the demo, while the Center for Medicare Advocacy and the National Association of Accountable Care Organizations want the Biden administration to put it on hold.
Meanwhile, the American Society for Radiation Oncology wants to work with HHS on changes to the mandatory radiation oncology demonstration once the Biden administration takes office in January. Congress in its 2020 year-end law delayed the start date of the highly criticized CMS radiation oncology model demonstration until Jan. 1, 2022, six months beyond what CMS proposed in a final rule earlier in December but in line with what stakeholders had requested.
The Health Care Transformation Task Force is urging the Biden administration to publicly support value-based pay and the innovation center overall, after Verma recently said the entire center needs a course correction as few models have seen success.
âAt the core of CMSâs current analysis appears to be a flawed approach to VBP model evaluations, and we believe a better way to evaluate models is needed. The HCTTF is actively gathering perspectives on better ways to modernize evaluations of VBP models from experts and will share with CMS any resulting recommendations in early 2021,â the task force says in a Dec. 18 letter to incoming administration.
The group also says CMSâ view âappears to be premised on the conclusion that net savings to the Medicare program is the sole measure of success. We disagree here too.â
The group calls for CMS, in the first 100 days of the new administration, to begin a national dialogue about the innovation centerâs operations, models, evaluations and lessons learned. There are circumstances where the net savings for a model might not be positive, but the CMS chief actuary could find that an expanded, permanent model would achieve savings — especially if a national model moved from voluntary to mandatory participation as part of an expansion, the group says.
Medicare administrative changes. Aside from work by the innovation center, the Center for Medicare Advocacy says there are numerous changes that the incoming administration could tackle to improve Medicare. These include long-standing requests by the group for CMS to improve the Medicare appeals system, increase access to durable medical equipment for those dually eligible for Medicare and Medicaid, enforce the Jimmo v. Sebelius court decision and hold more meetings with advocates.
The advocates also want the incoming administration to withdraw the Trump administration’s proposed SUNSET rule that they worry could lead to the expiration of critical Medicare and other regulations. The rule, proposed by HHS the morning after the election, calls for the department to review its rules every 10 years to determine whether theyâre still necessary or too burdensome.
The advocates also make the case that the incoming administration can — and should — change how beneficiariesâ time in a hospital under outpatient observation factors into whether Medicare covers a nursing home stay. They also say Medicare can, and again should, make sure it covers medically necessary dental care.
The center also says the Biden administration should rescind the so-called public charge rule, arguing the rule creates âalmost insurmountable barriers to entry into the United States for older immigrants.â
The courts. Democratic states and consumer advocates are asking the Supreme Court not to take up a lower court ruling that paused the Trump administrationâs controversial public charge policy that denies green cards for immigrants who could benefit from public programs including Medicaid, arguing in briefs filed Dec. 9 that the high court should sidestep the case because the incoming Biden administration is likely to overturn the public charge policy.
In other court news, the U.S. Court of Appeals for the District of Columbia Circuit on Dec. 29Â ruled that HHS could move forward with its controversial hospital price transparency rule on Jan. 1, agreeing with a lower court just days before the rule was set to go into effect.
Becerra, meanwhile, has been a vocal opponent of the Trump administrationâs efforts to dismantle the Affordable Care Act. He led the Democratic states fighting the lawsuit, California v. Texas. The Supreme Court is expected to announce the fate of the ACA early in Bidenâs term, and the lawsuit could take center stage the first year of Bidenâs presidency.
Becerra has also waged lawsuits against Republicans on multiple other health care policies — from abortion rights to the Trump administrationâs public charge rule to drug company kickbacks.
340B. Becerra could also step into lawsuits — and an ongoing controversy — around 340B discounts at contract pharmacies, and he has said that HHS should make sure those discounts are available.
Following three lawsuits that ask the courts to force the Health Resources and Services Administration to stop Eli Lilly, Novartis, Astra Zeneca, Sanofi, United Therapeutics and Novo Nordisk from limiting 340B drug discounts through various contract pharmacies and claims sharing policies, the HHS Office of General Counsel said Dec. 30 that drug manufacturers are required to provide 340B discounts to providers in the program via contract pharmacies.
An advisory opinion from the counselâs office says the method by which 340B providers dispense drugs doesnât affect the drug makersâ obligation to provide discounts. However, HHS also notes the advisory opinion is not a final agency action and doesnât have the force of law — though it says the opinion lays out the general counselâs interpretation of the statute and thus manufacturersâ obligations.
âWe are enormously pleased that the Department of Health & Human Services has issued this opinion. The important work of repairing the damage done to these hospitals must begin as quickly as possible. We stand ready to work with the department to identify overcharges and facilitate refunds,â said 340B Health President and CEO Maureen Testoni in a statement.
Surprise Billing. The surprise billing battle may be over in the halls of Congress, but provider groups, hospitals and insurers are just beginning their battle at HHS, as the agency gears up to begin its rulemaking process now that the president has signed the year-end legislative package.
The No Surprises Act, which is tucked into Congressâ 2020 year-end spending law, says that by July 2021 the HHS secretary, along with the secretaries of Labor and Treasury, need to establish details surrounding the arbitration and payments process. The surprise billing ban is set to go into place Jan. 1, 2022.
The National Coalition on Healthcare, is urging the Biden administration to immediately work to lower health care costs by quickly implementing the surprise billing legislation, as well as extending financial assistance to struggling providers and working with Congress to incentivize states to expand Medicaid.Â
The leader of the U.S. Senate, Republican Mitch McConnell, has warned that a forthcoming wave of litigation over Covid-19 will amount to a âsecond pandemic.â Thatâs the basis for a continuing effort in Congress to shield companies from lawsuits filed by workers and consumers who get sick. Though a liability shield ended up being dropped from the economic stimulus measure passed in the final days of 2020, the issue is not going away, and some states have moved to provide their own versions of legal immunity for businesses.
A total of 1,348 lawsuits related to Covid-19 claims had been filed in the U.S. as of Jan. 5, according to Fisher Phillips LLC, a law firm tracking the litigation. Relatively few have been filed by workers who blame their employers after contracting the virus, according to several lawyers who have been following the field. Melissa Camire at Fisher Phillips, said that the most common kinds are cases filed by workers who said they needed, but were denied, time off because they contracted Covid-19 or had to take care of a sick person. The next most common categories were suits in which employment discrimination claims were tied to the pandemic, including claims by parents saying they were fired for taking care of their children, and whistle-blower cases.
Most Covid exposure suits have been against companies whose workplaces are densely staffed, such as meatpackers and food processors, according to John Beisner, a partner at Skadden Arps Slate Meagher & Flom LLP in Washington, D.C. Janie Schulman, an attorney at Morrison & Foerster in Los Angeles, said smaller companies and those in the healthcare industry are common targets. The Fisher Phillips data support her conclusion: Companies with fewer than 50 employees are defendants in 461 Covid-related lawsuits, or more than one-third of the total. Suits have also been filed against companies over conditions in warehouses and product distribution centers, including one against Amazon.com Inc.
Juno Turner, litigation director at Towards Justice, a Denver-based workersâ rights organization who filed the suit against Amazon in Brooklyn, said that many of them have been brought by low-wage, frontline or essential workers, who are disproportionately people of color. Some, like the Amazon suit, are seeking court orders requiring safe conditions. Others seek damages for employersâ egregious conduct on behalf of workers whoâve fallen ill or died, she said.
The vast majority of workers arguing they contracted Covid due to unsafe workplaces are required to pursue their claims through worker compensation programs, an administrative process that generally makes it impossible to sue employers directly over workplace injuries. Labor lawyers argue the programs donât have the teeth required to change practices at dangerous workplaces.
Some cases are being filed as âpublic nuisanceâ suits in an attempt to avoid the normal channels for such complaints. The case against Amazon accused the company of contributing to the spread of Covid-19 by telling plant workers to emphasize speed over distancing, hand-washing and sanitizing work spaces. A federal judge in Brooklyn dismissed the case in November, saying workers should bring their concerns to the federal Occupational Safety and Health Administration instead. Two of the legal non-profits that brought the Amazon lawsuit, Towards Justice and Public Justice, are separately suing OSHA in a federal court in Pennsylvania, saying the agency has arbitrarily and capriciously failed to address âimminent dangersâ to workers at a meatpacking plant in the state.
While Congress has remained gridlocked on any federal measure, at least 10 states have created their own legal shields for businesses and individuals, says Fisher Phillips lawyer Chantell C. Foley. They include Georgia, North Carolina, Utah and Wyoming. Georgiaâs law shifts the burden of proof so that instead of a company first being required to show how it complied with state and federal health guidelines, plaintiffs must prove it didnât. Workers must show their employer âwillfully and wantonly failed to follow the guidelines,â Foley says. âThatâs a pretty high burden.â California in December put in place a new rule requiring employers to implement coronavirus safety measures and setting standards for virus testing, notifying workers of infections, and paid medical leave.
As outlined by Senate Republicans in a proposed stimulus measure that failed to win Democratic support, lawsuits couldnât be brought under common law or medical malpractice statutes, only through a specially designed federal cause of action. Defendants could be found liable only if they didnât make reasonable efforts to comply with relevant public health guidelines and were either grossly negligent or engaged in willful misconduct. Thresholds for acceptable evidence would be stricter. Compensatory damages would be limited to the plaintiffâs economic losses; punitive damages, awarded only if the defendantâs willful misconduct caused the injury, could not exceed compensatory damages. An employer couldnât be held liable if it relied on, and generally followed, relevant health and safety standards. The shield would apply to virus exposure on or after Dec. 1, 2019, and until at least Oct. 1, 2024.
Several Democrats, including House Speaker Nancy Pelosi and Senate Minority Leader Chuck Schumer, say that the liability shields would place workers in dangerous conditions without giving them legal recourse to recover damages or demand change. They also object to the length of the proposed shield. Labor groups and workersâ rights organizations say the main effect of a shield would be to encourage employers to not take the required safety precautions. Turner said Republicans were âusing an exaggerated concern about purportedly frivolous litigation to justify blanket immunity for corporations that break the rules.â
No. A bipartisan group of senators has vowed to continue working in 2021 on a deal that would pair a liability shield with financial aid to state and local governments, a Democratic priority. That group had been working on a measure that would establish a nationwide gross negligence standard for COVID-19 exposure, medical malpractice and workplace testing claims. Its protections would apply to claims arising from injuries that occurred from December 2019 through the later of one year after enactment or the end of the coronavirus public health emergency.
The leader of the U.S. Senate, Republican Mitch McConnell, has warned that a forthcoming wave of litigation over Covid-19 will amount to a âsecond pandemic.â
This WSC Brief gives an overview of the flurry of activity surrounding telehealth during the closing months of 2020.Â
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