CMS on Tuesday (July 13) proposed to continue covering certain Medicare telehealth services through the end of 2023 as part of the 2022 physician fee schedule and laid out plans for expanded coverage of telehealth for mental health care, just one day after a bipartisan group of House lawmakers asked HHS Secretary Xavier Becerra to use that regulation to avoid a so-called telehealth cliff at the end of the COVID-19 public health emergency.
Reps. John Curtis (R-UT), Doris Matsui (D-CA), Peter Welch (D-VT) and Michael Burgess (R-TX) also asked HHS what criteria it will use to decide which telehealth services are clinically appropriate, when the agency anticipates sharing telehealth use data from the public health emergency, how it will determine fair pay levels for telehealth and how telehealth will work with value-based pay programs.
One lobbyist said the lawmakers are asking the right questions, and stakeholders need the answers from CMS.
In a July 12 letter to HHS Secretary Xavier Becerra, the lawmakers say they want Congress and the department to work together to permanently expand telehealth after the public health emergency. As part of that, they ask for Becerra to lay out the gaps in HHS’ authority where Congress will need to step in to permanently expand telehealth.
Telehealth coverage is expected to continue via waiver through the end of the public health emergency, which the Biden administration said earlier this year would likely last through the end of 2021. A stakeholder letter spearheaded by the Alliance for Connected Care, expected to go to House and Senate leadership later this month, says the expiration of telehealth coverage at the end of the emergency “would have a chilling effect on access to care.”
CMS on Tuesday said the agency is evaluating the temporary expansion of telehealth services during the public health emergency — though Becerra has indicated telehealth services are unlikely to go away.
“As CMS continues to evaluate the temporary expansion of telehealth services that were added to the telehealth list during the COVID-19 PHE, CMS is proposing to allow certain services added to the Medicare telehealth list to remain on the list to the end of December 31, 2023, so that there is a glide path to evaluate whether the services should be permanently added to the telehealth list following the COVID-19 PHE,” a CMS fact sheet on the rule says.
CMS also proposes to require an in-person, non-telehealth service be offered by a physician that provides mental health telehealth services within the six months prior to an initial telehealth service, and at least once every six months after that. However, the Alliance for Connected Care and others are gathering stakeholder support for a letter that seeks to remove what they allege are arbitrary restrictions on telehealth services for mental health.
“Not only is there no clinical evidence to support these requirements, but they also exacerbate clinician shortages and worsen health inequities by restricting access for those individuals with barriers preventing them from traveling to in-person care. Removing geographic and originating site restrictions only to replace them with in-person restrictions is short-sighted and will create additional barriers to care,” the stakeholders’ planned letter says.
CMS also proposes to allow audio-only telehealth for the diagnosis, evaluation, or treatment of mental health disorders furnished to established patients in their homes — but that allowance would be limited. The agency proposes to allow audio-only telehealth for mental health services providers who have the capacity for two-way, audio/video communications, but the beneficiary can’t, or does not consent to, using two-way, audio/video technology.
The agency asks for feedback on whether additional documentation should be required in beneficiaries’ medical records to support the clinical appropriateness of audio-only telehealth for mental health; whether CMS should preclude audio-only telehealth for some high-level services; and any additional guardrails the agency should put in place to minimize program integrity and patient safety concerns.
CMS proposes to allow Rural Health Clinics and Federally Qualified Health Clinics to use telehealth for mental health visits, as well.
“RHCs and FQHCs are not authorized to serve as distant site practitioners for Medicare telehealth services after the end of the COVID-19 public health emergency. However, this proposed change would allow RHCs and FQHCs to report and receive payment for mental health visits furnished via real-time telecommunication technology in the same way they currently do when visits take place in-person, including audio-only visits when the beneficiary is not capable of, or does not consent to, the use of video technology,” the fact sheet says.
CMS also proposes to allow opioid treatment providers to furnish counseling and therapy services using audio-only interactions once the COVID-19 public health emergency ends when audio/visual communication is not available to beneficiaries.
“The COVID-19 pandemic has put enormous strain on families and individuals, making access to behavioral health services more crucial than ever,” said CMS Administrator Chiquita Brooks-LaSure. “The changes we are proposing will enhance the availability of telehealth and similar options for behavioral health care to those in need, especially in traditionally underserved communities.”
The Medical Group Management Association said the proposed 2022 physician fee schedule is a mixed bag. Senior Vice President for Government Affairs Anders Gilberg said the group is “encouraged that CMS heeded our call to expand coverage for audio-only mental health services and views this proposal as a positive step to increase access to vulnerable populations,” but it is concerned by a proposed 3.75% reduction to the conversion factor due to budget neutrality requirements. He said in a statement that MGMA “will seek congressional intervention to avert the cut.”
Stakeholders had been watching to see how CMS would handle the Trump administration’s policies around evaluation and management code changes and other associated policies. CMS’ fact sheet says the agency is “engaged in an ongoing review of payment for E/M visit code sets.” The agency also put forward proposals to change how shared evaluation and management visits are handled, including having the clinician that provides the substantive portion of the evaluation and management bill for the visit.
CMS also proposes to clarify that that the time when a teaching physician is present can be included when determining what kind of evaluation and management code to bill, and how critical care visits should be handled.
The agency also proposes to allow Medicare Part B to directly pay physician assistants starting in 2022, among other policy changes.
Biden’s Two-Track Economic Agenda Hits Turbulence in SenateBloomberg | July 13, 2021
Coalition says health workers should be required to get coronavirus vaccineWashington Post | July 13, 2021
Congress starts summer sprintThe Hill | July 12, 2021
Biden says he’ll enforce Trump-era rules requiring hospitals to post their pricesWashington Post | July 12, 2021
WSC Brief: House Appropriations FY 2022 Labor-HHS Spending BillWSC | July 12, 2021
Biden’s Push for More Competition: What’s in the Executive OrderBloomberg | July 9, 2021
Schumer Warns of Possible August Work on BudgetBloomberg | July 9, 2021
HHS Updates Interoperability Standards to Support the Electronic Exchange of Sexual Orientation, Gender Identity and Social Determinants of HealthHHS Press Release | July 9, 2021
Biden EO Directs HHS To Create Standardized Health Plan OptionInside Health Policy | July 9, 2021
Providers Seek Medicaid Reimbursement Hike For Opioid TreatmentInside Health Policy | July 8, 2021
HHS: Burden Of Proof On Provider Relief Recipients When ReportingInside Health Policy | July 8, 2021
Senate Could Take Up Infrastructure, Budget Resolution As Soon As July 19Inside Health Policy | July 8, 2021
WSC Brief – Site-Neutral Payment: Legislation, Regulation, and LitigationWSC | July 8, 2021
WSC has selected, and provided links, to particular WSC policy briefs and news articles from the past week that our clients may have missed.
Lawmakers are starting to return to Washington, D.C., for a weeks-long summer sprint with some of their biggest priorities hanging in the balance.
The Senate will return on Monday from a two-week July 4 recess. The House will return next week after a three-week break.
Democrats have two big priorities heading into the crucial summer session: Infrastructure and trying to find a path forward on voting rights, after a bill stalled last month in the Senate.
Democrats still need to work out major questions on the strategy for getting President Biden’s sweeping spending plan through Congress with razor-thin majorities and competing factions.
A bipartisan group of more than 20 senators are still working to turn their bipartisan framework, which would spend $1.2 trillion over eight years, into legislation amid skepticism that they’ll be able to find a way to convincingly pay for the bill. Meanwhile, Democrats are still haggling over a top-line figure for a separate, larger bill that they want to pass under reconciliation, which allows them to bypass the 60-vote filibuster in the Senate.
Senate Majority Leader Charles Schumer (D-N.Y.) has vowed to take up both the bipartisan bill and a budget resolution that paves the way for the Democratic-only bill, likely later in the year, before the Senate leaves for a summer recess.
“As Senate Democrats prepare for the upcoming work period, we must approach our work with the same unity and urgency that we have embraced all year. … My intention for this work period is for the Senate to consider both the bipartisan infrastructure legislation and a budget resolution with reconciliation instructions, which is the first step for passing legislation through the reconciliation process,” Schumer wrote in a letter late last week to his caucus.
To get the bipartisan bill through the Senate, Biden and the group are going to have to win over nearly a dozen Republicans and balance demands from progressives who are wary of allowing the smaller bill to move without an “ironclad” guarantee from their moderate colleagues on the details of the larger Democratic bill.
Senate Minority Leader Mitch McConnell (R-Ky.) hasn’t said if he will support the bipartisan plan, saying in Kentucky last week that he believes it needs to be “credibly” paid for.
“I think there’s a decent chance that may come together. All I’ve said is, I would like for it to be paid for,” he said.
Democrats are expected to get no GOP help to pass their second bill under reconciliation, meaning they will need total unity from their 50-member Senate caucus and near unity in the House.
Meanwhile, the party is under growing pressure from outside groups, as well as some members of the House, to figure out a way to break the stalemate on voting rights.
Democrats were able to put up 50 votes last month to advance a sweeping bill known as the For the People Act, after Schumer cut a deal with Sen. Joe Manchin (D-W.Va.) to allow him to get an amendment vote on his narrower version of the bill.
A Senate Judiciary subcommittee is expected to hold a hearing this week on the Voting Rights Act and Sen. Amy Klobuchar (D-Minn.), the chairwoman of the Senate Rules Committee, will hold a hearing next week in Georgia on voting and election access.
Schumer also reiterated in his letter to the caucus that he reserves the right as majority leader to bring the For the People Act back up for a vote. But any election or voting legislation faces a buzzsaw in the Senate because of the legislative filibuster, which requires 60 votes for most legislation to pass.
Biden is under growing pressure to try to sway the holdouts on changing the legislative filibuster to at least support a carveout, warning if they don’t state-level laws will restrict access to the ballot for key voting groups.
House Majority Whip James Clyburn (D-S.C.) told Politico that Biden should “endorse” the idea of creating a carveout to the filibuster specifically for legislation that applies to the Constitution.
Biden could “pick up the phone and tell [Sen.] Joe Manchin, ‘Hey, we should do a carveout,’ ” Clyburn said. “I don’t care whether he does it in a microphone or on the telephone — just do it.”
Capitol Police funding
Senators are at a stalemate over funding for the Capitol Police as it faces a cash squeeze.
The House passed a $1.9 billion emergency supplemental package in May that included roughly $44 million for Capitol Police, would also reimburse the National Guard and D.C. police for their work at the Capitol after the Jan. 6 attack and also includes funding to help “harden” the Capitol and start a Quick Reaction Force to help bolster the Capitol Police.
That bill stalled in the Senate amid Republican skepticism, but the funding crunch sparked new warning bells late last week amid reports that, without an influx of new money, the Capitol Police could be forced to enact furloughs. Sources told The Hill that the Capitol Police could shift around funding from other areas to prevent the furloughs.
Senate Republicans suggested they are open to a more narrow bill that focuses on funding for the National Guard and Capitol Police. The roughly $632 million proposal includes nearly $521 million to the National Guard, roughly $97 million for the Capitol Police and $15 million for the Architect of the Capitol.
“We should pass now what we all agree on: The Capitol Police and National Guard are running out of money, the clock is ticking, and we need to take care of them,” Sen. Richard Shelby (Ala.), the top Republican on the Appropriations Committee, said in a statement.
Republicans would then return to the broader question of funding to help strengthen security measures around the Capitol once an assessment and plan about what steps need to be taken is complete around the Capitol complex, where the last layer of fencing that went up after the attack was taken down over the weekend.
But Sen. Patrick Leahy (D-Vt.), the chairman of the Appropriations Committee, indicated that he wants to go further and will release his proposal, previously made to Republicans, this week.
Leahy argued that the GOP plan didn’t adequately cover the resources needed to secure the Capitol, the cost of investigating and prosecuting the attack or reimburse agencies that assisted. He also signaled that he wants to tie an unrelated issue, special immigrant visas for Afghans who aided the U.S. military, into the bill.
“A violent insurrection happened. A pandemic happened. And the President announced the withdrawal of American troops from Afghanistan. These events created urgent needs that must be met,” he said.
AUMF
The Senate is poised to wade into the debate over repealing a 2002 war authorization passed for the Iraq War, as Congress ramps up its efforts to rein in the executive branch’s war authority.
The closed-door briefing, which is expected to focus on recent strikes in Iraq and Syria, comes after the Senate Foreign Relations Committee postponed an expected vote on a measure from Sens. Tim Kaine (D-Va.) and Todd Young(R-Ind.) that would repeal the 1991 and 2002 authorizations for the use of military force, which are both related to Iraq.
Republicans requested more information from the administration before the committee vote and Foreign Relations Committee Chairman Robert Menendez (D-N.J.) agreed to schedule the briefing. The panel is still expected to vote later this month on the Kaine-Young resolution, which is expected to have enough support to pass out of committee.
Nominations
President Biden is putting his foot down on a price transparency rule that many hospitals have skirted over the past seven months.
On Friday, Biden released an executive order instructing the Secretary of Health and Human Services to “support” price transparency regulations issued by the Trump administration.
Starting on Jan. 1, hospitals were required to post the prices they charge cash-paying customers and the rates they negotiate with insurers — figures that were largely obscured from public scrutiny. Proponents of greater hospital transparency championed the change, saying it would help patients shop for better deals and drive down health care prices. Until now, it was unclear exactly how the Biden administration would approach the Trump-era rules, even as advocates and some lawmakers urged stronger enforcement amid signs of widespread noncompliance.
Friday’s executive order still didn’t provide many details, but it signaled that the new administration views the transparency rules as valuable, even if they ultimately don’t pack as much of a punch as former president Donald Trump had claimed.
Many hospitals provided a price estimator tool for patients, the JAMA study found, but far fewer provided an easy-to-use file with the prices the hospital negotiated with different insurers.“Because patient-oriented price estimator tools make prices visible only for a given patient and insurance plan and not to payers or the public, selective compliance may fail to expose abuses of market power, affect price negotiations, or support broad analysis of price variation to the extent intended by the transparency initiative,” the study authors write.
Biden’s executive order is sparse on details, saying that the health secretary should “support existing price transparency initiatives for hospitals” along with any future transparency requirements. But the Department of Health and Human Services began in April to send letters to hospitals that weren’t complying with the rule and indicated it plans to audit a sample of hospitals.
Transparency advocates, who’d been disappointed by hospitals’ lack of compliance, are hoping the fresh attention from the Biden administration could signal stronger enforcement.
“Biden’s executive order hands the torch to both [Health and Human Services Secretary Xavier] Becerra and Health and Human Services to boldly enforce the rules. It gives them the power to do what they need to do even if it means they need harsher penalties and stricter enforcement,” said Cynthia Fisher, the founder of Patient Rights Advocate, a nonprofit that pushes for price transparency.
The response from hospitals themselves was muted, but Molly Smith, vice president for public policy at the American Hospital Association, told Health 202 that the organization “strongly encourage[s]” hospitals to follow federal guidelines on transparency.
Experts in health care finance have said that the new transparency rules are unlikely to be a silver bullet when it comes to driving down health care costs.
Many Americans are insulated from the direct cost of treatment because their insurance picks up the tab, and even those patients who pay directly may have a hard time wading through hundreds of pages of complex pricing documents.
Even when hospitals do post their prices, many Americans don’t know to look for them. Fewer than 1 in 10 Americans say they are aware that hospitals are required to post their prices, according to a recent Kaiser Family Foundation poll.
“Healthcare goods are very complex. We care a lot about quality, and we in essence listen to what our doctor recommends,” said Zack Cooper, a professor of health policy and economics at Yale University. “I think the idea somebody is going to be out there with a price transparency tool figuring out where to go in this market is just not realistic.”
The health care provisions come in a sweeping executive order that has 72 initiatives aimed at scaling back monopolies and offering consumers more options in technology, finance, and health care.
The order encourages Federal Trade Commission to crack down on hospital mergers that are harmful to patients and to ban “pay-for-delay” tactics that allow brand name drug manufacturers to pay generic manufacturers to keep their products off the market.
It also directs the Food and Drug Administration to work with states on importing drugs from Canada, another initiative started during Trump’s time in office, as our colleague Amy Goldstein reports.
“Just a handful of companies control the market for many vital medicines, giving them leverage over everyone else to charge whatever they want,” the president said before a signing ceremony at the White House. “As a result, Americans pay two and a half times more for prescription drugs than any other leading country.”
The House Appropriations Committee on Sunday, July 11, released the draft fiscal year 2022 Labor, Health and Human Services, Education, and Related Agencies funding bill, which will be considered in subcommittee on Monday, July 12. The bill is scheduled for full committee consideration on Thursday, July 15. This WSC Brief outlines the major health care-related provisions of the bill.
NOTE: The current draft of the bill is limited to top-line appropriations and does not include the specific, granular provisions of the eventual final bill; these will be available as part of the committee report that is likely to be released on Wednesday, July 14.
President Joe Biden’s executive order to bolster competition includes 72 initiatives by more than a dozen federal agencies, affecting everything from restricting noncompete agreements for workers to allowing imports of prescription drugs from Canada.
While there’s a long way to go from a presidential directive to final regulations, the president’s directive seeks to address the sharp increase in consolidation of industries over the last two decades, which has raised worries that the biggest companies are choking off competition and innovation.
The White House blames declining competition across the economy for raising prices of necessities like prescription drugs, lowering wages for workers and acting as a drag on growth and innovation.
Here are details on some of the initiatives outlined in the order and reaction from industry groups:
The Federal Communications Commission is asked to reinstate net neutrality rules that barred internet service providers from blocking or slowing certain content or speeding up delivery for a price. Those rules had been implemented under former President Barack Obama but rolled back under former President Donald Trump.
The order also calls on the FCC to prevent internet providers from negotiating exclusive deals with landlords that leave renters with just one internet option, and to limit high termination fees cable companies charge when consumers switch providers.
The Federal Trade Commission is asked to establish rules on data collection by tech companies and regulations barring “unfair methods of competition” by the biggest tech platforms in order to protect businesses that depend on the companies to reach customers.
Many of the steps outlined in the order reprise Obama administration policies that were unpopular with both industry and Republicans, presaging a fight at the agencies.
A major cable group Friday called Biden’s statements “misleading,” and a group representing largest phone companies AT&T Inc. and Verizon Communications Inc.said “context and facts are largely missing” from the White House’s release outlining its broadband policies.
The order, which blames consolidation in banking for raising costs for consumers and restricting credit to small businesses, calls on the Justice Department and banking regulators to update guidelines on bank mergers to toughen scrutiny of deals.
The Consumer Financial Protection Bureau is asked to issue rules to make it easier for consumers to switch banks by allowing them to download their banking data and take it with them.
For more: Banking Merger Frenzy May Meet Early End After Biden Order
The order targets areas where it says the lack of competition increases prices and reduces access to quality care, starting with prescription drug prices.
Biden’s order will call on federal health officials to work with states to come up with plans to import medicines from Canada, where they are cheaper.
The president’s plan in some ways echoes policies that Trump proposed a year ago. Then, Canada balked at the proposal to let Americans import medicines, and the neighbor to the north later imposed measures limiting distribution of drugs to protect its supply from bulk sales across the border.
Biden has directed the Department of Health and Human Services to issue a comprehensive plan within 45 days to counter high drug prices. That could bring back proposals by Trump and some Democrats to benchmark drugs to the cheaper prices paid in countries with national health systems. It’s a move that drugmakers said would stifle innovation.
Biden will also urge the FTC to stop pharmaceutical manufacturers from paying their generic counterparts to delay entry into the market of lower-priced versions of medications. That idea is part of pending legislation in the Senate and aligns with campaign promises Biden made last year.
The Association for Accessible Medicine, the leading trade group for the generic drug industry, said it’s looking forward to working with the Biden administration to increase adoption of lower-cost generics and biosimilars “and remedy the growing number of government and payer policies that perversely reward the use of high-cost brands over generic or biosimilar competitors.”
Hospital consolidation has increased health-care costs and reduced service for some communities, especially rural areas, the order notes. The executive order directs the Justice Department and FTC to tighten their merger guidelines for hospital deals. It also directs HHS to support hospital price transparency rules and finish implementing legislation to address surprise hospital billing.
Health-care interests that could face tighter antitrust scrutiny pushed back on the order and asserted that it could block patients’ from needed care. “Miring hospitals in legal and bureaucratic red tape will simply slow critical care to the bedside,” said Chip Kahn, Chief Executive Officer of the for-profit hospital trade group Federation of American Hospitals.
The Biotechnology Innovation Organization said it’s evaluating the order, but urged Biden to focus on lowering out-of-pocket costs influenced by other companies in the supply chain. “That price is set by PBMs, insurers and the government, NOT by biopharmaceutical companies,” BIO policy chief John Murphy said.
Steve Ubl, CEO of the Pharmaceutical Research and Manufacturers of America, said the U.S. already had “the world’s most competitive market for prescription medicines” in a statement that cited falling net prices and high rates of generic drug uptake.
The order calls for new rules to benefit farmers and ranchers. It directs the Agriculture Department to make it easier for cow, pig and poultry farms to sue large processors if they are underpaid or retaliated against. It also asks the USDA to consider issuing new rules defining when meat can bear “Product of USA” labels to restrict companies from labeling food produced overseas as American-made when it was simply processed domestically.The measure also orders the Agriculture Department to help farmers access markets and receive a fair return on their goods, including supporting alternative food distribution systems like farmers’ markets and developing standards and labels so that consumers can choose to buy products that treat farmers fairly.It encourages the FTC to keep equipment manufacturers from limiting consumers’ ability to repair products at independent shops or on their own. The move is intended to especially benefit farmers, who face expensive repair costs from tractor manufacturers that use proprietary tools and software to prevent third parties from working on equipment.
Farmer advocates say the rules are much-needed to combat heavy consolidation in crops, seeds, chemicals and meat, in which a small group of multinational companies are capturing an increasingly large share of profits at the expense of family farms.
The labor market element of the order focuses on restricting the non-compete agreements that have become common in certain industries and limit worker mobility. The measure also asks for updated antitrust rules regarding companies that share wage and benefit information to avoid competing for workers.
It asks the FTC to eliminate occupational licensing requirements that can create barriers of entry for new job applicants in certain fields. Biden also reiterated his support for a pro-labor bill that passed the House and is stalled in the Senate, which would make it easier for workers to organize in unions.
Biden is also taking aim at consolidation in the airline industry, especially the extra feesfor things like baggage, on-flight services and cancellations, which are “often raised in lockstep, demonstrating a lack of meaningful competitive pressure,” according to the White House. The EO says the top 10 airlines collected $35.2 billion in assorted fees in 2018, compared to only $1.2 billion in 2007.
The order instructs the Transportation Department to make sure those fees are transparent and, when the service isn’t provided, refunded.
The order also directs DOT to examine other potentially controversial issues, including consumer protections for airline passengers and how carriers are awarded slots at congested hubs.
DOT and the Justice Department must also consult on how to “ensure competition in air transportation and the ability of new entrants to gain access,” which could prompt reviews of recent agreements between carriers.
For railroads, currently dominated by just a handful of freight rail companies, the measure would require track owners to give right of way for passenger rail and to treat other freight companies equally. The measure also addresses shipping fees, which domestic manufacturers are currently forced to pay to foreign companies.
Freight railroad and shipping trade groups expressed opposition to Biden’s order, saying that there’s sufficient competition among their industries and the order would put them at a disadvantage.
“We urge everyone to make decisions based on the real facts about the situation before we create long-term negative results through ill-considered regulatory changes to handle a temporary situation,” John Butler, president and CEO of the trade group World Shipping Council, said in a statement.
Competition within the U.S. airline industry has produced historically low inflation-adjusted air fares and expanded opportunities for travel, including from two new carriers that started operations this year, Airlines for America said in a statement Friday.
The Biden order echoes an Obama administration order in 2016 that said government agencies beyond those responsible for antitrust enforcement had a role to play in protecting consumers, workers and business from being harmed by instances of market power in the economy. Unlike the Biden order, however, Obama’s didn’t direct individual agencies to take specific actions and instead required them to come up with their own plans.
That order built off a report by the Council of Economic Advisers outlining evidence that industries across the U.S. economy suffer from rising consolidation and declining competition.
Since then, attention to the power of dominant companies has only grown as economists and policy makers raise concern that rising concentration is ailing large swaths of the economy and contributing to problems including income inequality, stagnant wages and low productivity growth.
While the drafting and implementation of new rules and regulations may take months and will be largely handled by individual departments and agencies, the White House has made clear it expects that the executive order could lead to significant changes that entail a major impact on several industries.
The measure advances the administration’s push to step up antitrust enforcement amid widespread criticism that enforcers at the Justice Department and the Federal Trade Commission haven’t gone far enough to police mergers and anticompetitive conduct.
Last month, Biden unexpectedly named Columbia Law School professor Lina Khan to lead the FTC, putting one of the most prominent advocates for a far more forceful antitrust agenda in charge of the agency.Biden has yet to nominate a chief for the Justice Department’s antitrust division, leaving the unit without political leadership five months into the administration as it forges ahead with a monopoly case against Alphabet Inc.’s Google and a lawsuit to block Aon Plc’s proposed $30 billion acquisition of Willis Towers Watson Plc.
The White House effort adds to a widespread push for stronger antitrust enforcement in Washington, where bipartisan majorities on the House Judiciary Committee in June advanced six antitrust bills, primarily aimed at the biggest tech companies. The proposals represent an effort to revamp antitrust laws and give competition enforcers more authority.
Business groups in Washington quickly criticized the order. “Today’s executive order is built on the flawed belief that our economy is over-concentrated, stagnant and fails to generate private investment needed to spur innovation,” said Neil Bradley, executive vice president of the U.S. Chamber of Commerce. “Such broadsided claims are out of touch with reality, as our economy has proven to be resilient and remains the envy of the world.”
The National Association of Manufacturers added, “some of the actions announced today are solutions in search of a problem; they threaten to undo our progress by undermining free markets and are premised on the false notion that our workers are not positioned for success.”
Senate Majority Leader Chuck Schumer warned senators Friday to be prepared to cut short their planned August recess as he seeks to pass both a bipartisan infrastructure package and a budget blueprint teeing up a larger Democrat-only tax and spending bill.
“Senators should be prepared for the possibility of working long nights, weekends, and remaining in Washington into the previously scheduled August state work period,” the New York Democrat said in a letter to senators outlining his July agenda.
The Senate currently plans to begin its monthlong recess on Aug. 9.
Schumer said committee staff members have been working during the two-week break straddling July 4 to turn the bipartisan infrastructure framework into legislative text. The Senate Budget Committee meantime has been working on a budget resolution, a vehicle that will include instructions for the reconciliation bill encompassing the tax and social spending that Democrats want to pass later this year.
Schumer said the reconciliation package will include at least three priorities — climate change, health care and the “caring economy.”
With a 50-50 Senate, Democrats can’t afford a single defection or absence in their caucus on the budget blueprint. Some liberal senators are insisting on assurances that moderate members will agree to the bigger package before they sign on to back the $579 billion bipartisan infrastructure bill.
Democrats have yet to agree on the scope of the bigger package. Senate Budget Committee Chairman Bernie Sanders wants a $6 trillion total, while moderates like Joe Manchin of West Virginia have suggested a much smaller figure that wouldn’t add to the deficit.
Schumer said that other issues could also arise in the coming month — a bipartisan group is trying to iron out a policing bill — and that the Senate will continue to confirm nominees.
“As always, Senate Democrats stand ready to expeditiously fill any potential vacancies on the Supreme Court should they arise,” Schumer added. Some Democratic-aligned groups have hoped Justice Stephen Breyer, 82, would retire this year, so the Senate could push through a younger nominee to join the other two justices on the liberal wing of the court.
The U.S. Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) today released the United States Core Data for Interoperability version 2 (USCDI v2), a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange.
With this new update, health IT stakeholders nationwide will have clearer direction toward the standardized, electronic exchange of social determinants of health (SDOH), sexual orientation, and gender identity (SO/GI) among several other updated data elements. This lays the foundation for the provider community to start systemizing the capture and use of SDOH and SO/GI data in the clinical setting. While encouraged, this update does not require health professionals, such as doctors and nurses, to record this data or individuals to share such data. It does however set a path forward for health IT to build in support for exchanging these data as they become applicable to an individual’s care.
“USCDI version 2 builds on the feedback we received from a wide variety of stakeholders,” said Micky Tripathi, Ph.D., national coordinator for health information technology. “We heard that this new version of the USCDI should reflect America’s diversity and include data elements like sexual orientation, gender identity, and social determinants of health while helping to address disparities in health outcomes for minoritized, marginalized, and underrepresented individuals and communities.”
The COVID-19 pandemic exposed many challenges in the nation’s healthcare system and among them, the need for more reliable data to better understand the public health needs of all Americans – particularly vulnerable individuals or those long felt marginalized by the medical community. Currently, many health care facilities have not developed systems to collect structured SO/GI data from all patients. Without this information, lesbian, gay, bisexual, and transgender (LGBT) patients and their specific health care needs cannot be identified, targeted, and addressed. Similarly, without insights into social determinants factors that may be impacting one’s ability to successfully manage their health, health professionals may be hampered from truly delivering quality care.
“The updated US Core Data for Interoperability takes an important step in reflecting the needs of all patients who access the nation’s healthcare system,” said Dr. Rachel Levine, HHS assistant secretary for health. “For accurate, compassionate, and safe care, it is important for a patient’s sexual orientation and gender identity to be part of their care coordination and this new version helps prioritize next steps for the healthcare community as well as help identify patients’ specific nonmedical needs— like housing, transportation, and poverty — that affect health to coordinate care and assistance to improve health outcomes.”
More than 600 data classes and elements, including merged and duplicated data elements, were submitted by the health IT community as part of USCDI version 2’s development cycle. The USCDI will continue to grow as standards mature and industry needs evolve. USCDI version 2 includes three new data classes and a total of 22 new data elements. Today’s release makes USCDI version 2 available for consideration as part of ONC’s Standards Version Advancement Process (SVAP), which will take place this fall. The SVAP allows health IT developers to update their certified health IT to support newer versions of the USCDI (among other standards) and provide those updates to their customers, including providers and hospitals, before they are required by regulation. Equally, USCDI version 2’s release will kick-off additional work within standards development organizations to update implementation guides and other technical requirements to come into alignment with version 2’s new data elements.
As required by ONC’s Cures Act Final Rule published in May 2020, and in a subsequent interim final rule extending the compliance deadline published in April 2021, certain developers of certified health IT are required to provide their customers with upgraded certified health IT that supports USCDI version 1 by December 31, 2022. Any future versions of USCDI, as approved through the SVAP, would be voluntary for implementation until a new final rule is published requiring such an update.###
President Joe Biden’s sweeping executive order to boost competition in health care and other markets directs HHS to create a standardized plan option that would be sold in the federal exchange and help people to more easily compare plans.
“Consolidation in the health insurance industry has meant that many consumers have little choice when it comes to selecting insurers. And even when there is some choice, comparison shopping is hard because plans offered on the exchanges are complicated–with different services covered or different deductibles,” the executive order says. It then directs HHS to create the standardized option.
Numerous state-based exchanges, including Covered California, have had standardized plans in place since launching in 2014. All plans provide the same benefits and cost-sharing and deductibles so that consumers get an “apples to apples” comparison and avoid surprises, according to Covered California.
CMS does not have authority to require insurers sell standardized plans, but the Obama administration did encourage adoption by displaying those plans more prominently on healthcare.gov. The policy went into effect for 2017, but the Trump administration scrapped the option in the fiscal 2019 exchange rule.
Meanwhile, a group of cities, represented by Democracy Forward, sued HHS over several provisions in the 2019 rule, arguing that they violated the Administrative Procedure Act.
In March, a federal district court in Maryland ruled in favor of the cities on four of nine provisions they’d challenged, including the standardized option, a change to medical loss ratio reporting, increased document verification for low-income consumers, and deferring review of network adequacy to the states.
CMS acknowledged the case in the third installment of the fiscal 2022 Notice of Benefit and Payment Parameters out in late June. The agency said it intended to implement the court’s decision as soon as possible. But it added the agency needed to design and propose new options — which would then need to be adopted by insurers and approved by regulators — and said that wasn’t feasible for the fiscal 2022 plan year. CMS said many of the variables used to craft the most recent iteration of the standardized options, including state cost-sharing laws, have changed considerably since they were finalized in 2018, and there’s not enough time to conducted needed analysis.
The agency said it would restart the standardized option designation and propose specific plan designs in the fiscal 2023 payment notice. “As such, we seek the views of stakeholders regarding issues related to the proposal of new standardized options, including specifically the views of states with FFEs or SBE-FPs regarding how unique state cost-sharing laws could affect standardized option plan designs to assist in our development,” the agency said.
Maura Caslyn, managing director of health policy for the Center for American Progress (CAP), says that CMS is taking the right approach to crafting the new options since so much more information is out now compared to in 2016.
As far as plan designs, Caslyn says that CAP supports efforts to encourage the use of high-value, lower-cost services. For example, policies could require very low cost-sharing for primary care or out-patient treatments. Allowing coverage pre-deductible for primary care could also make a huge difference to many families, particularly parents with young children, she adds.
Standardized plans can also form the foundation for other policies, like an auto-enrollment mechanism that could place eligible enrollees into those plans.
The insurance lobby says it’s too early to comment on specific pieces of the executive order, but in general AHIP reiterated its position that the best way to achieve high quality, affordable care is through market competition.
Opioid treatment program directors across the country say Medicaid reimbursement in their states isn’t adequate to ensure the highest quality services and some facilities might stop accepting Medicaid if they aren’t paid more — but a representative for Medicaid directors says while most Medicaid providers want more money, OTPs aren’t closing their doors en masse.
Opioid treatment programs (OTPs) are the only settings in the United States where methadone can be distributed to people with opioid use disorder. Other FDA-approved medications for opioid use disorder treatment, buprenorphine and naltrexone, can also be distributed at OTPs.
The SUPPORT Act requires state Medicaid plans to cover medication-assisted treatment (MAT) for all beneficiaries between October 2020 and Sept. 30, 2025. MAT was not a required benefit before the SUPPORT Act, and many states did not previously cover methadone. A CMS spokesperson said CMS may authorize exemptions in the case of a provider shortage. Hawaii, South Dakota, Wyoming, American Samoa, Northern Marianas Islands and Guam are currently exempt from covering MAT under Medicaid.
OTPs are particularly important for treating patients with opioid use disorder, but low Medicaid reimbursement is endemic across addiction medicine, said American Society for Addiction Medicine Chair of Legislative Advocacy Shawn Ryan, president and chief medical officer for a group of OTPs in Ohio.
Some states, like Virginia and Ohio, provide better reimbursement than others, he said. But generally, across the country, “we’re not even close to the gap, right, between population need, and services available, and they’re not going to grow or even be maintained at current level if Medicaid does not look at this very seriously,” Ryan said.
Matt Salo, executive director of the National Association of Medicaid Directors, said essentially every Medicaid provider across the country wants higher reimbursement.
“Literally everybody says that — they don’t go out of business,” Salo said.
Across the country, the number of OTPs increased by 39% between 2003 and 2016, going from 1,067 OTPs to 1,482, according to a Substance Abuse and Mental Health Administration report from 2017. SAMHSA’s website now lists 1,837 OTPs, though numbers vary greatly from state to state.
Medicaid directors describe a tension between ensuring high quality services and increasing provider reimbursement, added Lindsey Browning, program director at NAMD.
“Whenever you see Medicaid, or other payers, sort of opening the door to new services, you sort of see a floodgate of providers come in,” she said. “As a payer and particularly as a public payer, [we’re] wanting to make sure we put the necessary guardrails in place to get the highest quality services.”
But providers say low reimbursement does impact service quality — and in some cases, access to services for Medicaid beneficiaries at all.
Several OTP directors told Inside Health Policy they want and intend to keep treating patients with Medicaid coverage, but low Medicaid reimbursement rates, particularly compared to private insurance or Medicare, are not enough to cover rising costs.
Margaret Rizzo directs an OTP in New Jersey, which did update its rates in 2016 for the first time since 1985, according to Rizzo. But she previously had to cap the amount of Medicaid recipients her clinic could accept.
“We had a waiting list if you had Medicaid to come on to the program, which was devastating,” said Rizzo. “It was a budget buster — we couldn’t afford to treat a patient for $77.50 per month.”
Dave Kneesy, who oversees six OTPs in Florida, said he could easily see a point where Florida clinics stop treating Medicaid beneficiaries.
“We want to take care of as many patients as we can. [But] we got to make a living,” he said.
OTPs that treat large numbers of Medicaid enrollees say their staffing stability suffers. Linda Hurley, president and CEO of Rhode Island’s largest and oldest OTP, said she feels embarrassed to offer low wages to staff, even those with graduate degrees.
With higher Medicaid reimbursement rates, Hurley said she could retain more staff, which in turn would improve the quality of her OTP’s treatment services.
OTP directors say long periods between reimbursement increases provide another hurdle. Kneesy has been treating Medicaid beneficiaries in Florida since 2003, and he’s never seen an increase in reimbursement rates.
There’s no set formula across states for when rates need to be reset, Salo said. If rates for every service were readjusted regularly, he said that’s basically all the state Medicaid agency would do.
However, state Medicaid agencies are still bound by the Medicaid Equal Access Provision and 2015 rules that require states to measure access to a set of Medicaid services for beneficiaries who receive care through a fee-for-service system. The Trump administration proposed to roll back these regulations, but a final rule unwinding them was never released. Mark Parrino, president of OTP trade organization American Association for the Treatment of Opioid Dependence, said he’s not sure how this rule impacts OTPs as MAT didn’t become a required Medicaid benefit until last year, but he’s looking into it. Salo said the rule likely does impact OTPs, though his team isn’t focused on that issue currently.
Typically, though, a crisis like fraud or lack of providers triggers a rate change, as could political pressure from a coordinated group of providers, Salo said.
Some OTP staff are turning their frustration with low and unchanging pay rates into activism. Over the past three and a half years, Hurley has knocked on doors, gone to the statehouse and talked with business leaders and lawmakers to push for higher rates. Kneesy is in the early stages of getting a group of substance abuse and mental health stakeholders together to advocate for better Medicaid rates in Florida.
Self-advocacy was successful for OTPs in New Jersey, Rizzo said. But even with a strong provider network advocating for OTPs, it still took six years for higher rates to go into effect.
Now, it’s been five years since the New Jersey Medicaid rates were raised, and they’re already starting to feel out of date, Rizzo said. But there is talk in New Jersey of aligning the Medicaid rates with Medicare reimbursement rates, a gold standard that many providers say they’d like to see. As of January 2020, Medicare has paid OTPs through a bundled rate. The rate was established in a final rule stemming from the SUPPORT Act. OTPs weren’t recognized as Medicare providers before the final rule.
Allegra Schorr, owner and vice president of an OTP in New York, said she feels there’s a broad lack of understanding about OTPs, which has contributed to allegedly inadequate reimbursement rates. However, she added that New York officials have been quick to respond to OTP needs during the COVID-19 public health emergency and a state plan amendment was recently approved to make an emergency bundled Medicaid rate for MAT permanent.
Jan Kauffman, an OTP director in Massachusetts who’s been working in OTPs since 1973, thinks this lack of understanding is partly due to lack of education and stigma around addiction. Health professional schools need to better incorporate addiction medicine into their core curricula, Kauffman said.
“Until the schools are really training, we’re not going to see stigma diminish,” she said.
There is some evidence the political tide is turning — bipartisan bills to expand addiction medicine education in health professional schools have been introduced in Congress this year.
Ultimately, it comes down to a need to dedicate long-term funding to substance use disorder treatment, Ryan said. He and other policy watchers say this funding should come from Medicare and Medicaid.
President Joe Biden’s fiscal 2022 budget requests $6.6 billion for the Substance Abuse and Mental Health Services Administration’s substance use prevention and treatment programs, and another $2.3 billion for SAMHSA’s State Opioid Response Grants program, among several other requests. But a sustainable treatment model needs to be built around Medicare, Medicaid, commercial payers and other public funding, said Ryan.
Sustainability needs to include Medicaid rate increases for OTPs, said Hurley.
Provider relief recipients will not receive an extension beyond Sept. 30 to report use of their relief funds and the burden of proof is on them to show they used the money to prevent, prepare for and respond to the pandemic, HHS staff said Thursday (July 8) during the first COVID-19 relief reporting webinar. Those with provider relief not spent by June 30 will have until Oct. 30 to return the unspent funds to HHS.
Providers waited nearly six months before the provider relief reporting portal went live last week. HHS opened the complete portal and supporting documents after hospitals, providers and lawmakers spent weeks asking the department to extend the provider relief spending deadline, which is tied to the reporting requirements, beyond Wednesday (June 30). HHS stopped short of a complete extension in guidance released June 11 and tied spending and reporting deadlines to when providers received their relief.
Providers who received $10,000 or more in relief before June 30, 2020 will have a hard deadline of Sept. 30 to report how they used their relief over the past year, said staff from the agency in charge of distributing the funds, Health Resources and Services Administration.
“You may not receive an extension on the deadline to report. If you do not report by the deadline, you will be deemed out of compliance with the terms and conditions of the payments and may be subject to recoupment,” HRSA staff said during the webinar.
Meanwhile, it’s up to providers to explain why they used provider relief for certain expenses and to make up for lost revenue due to COVID-19. Providers will have 30 days to respond to HRSA if it determines the provider’s calculation is not reasonable.
“So the burden of proof is on the provider to ensure that documentation is maintained to show that expenses are in fact to prevent, prepare for and respond to coronavirus,” HRSA staff said.
The next webinars on the provider relief reporting portal will be July 14 and July 20.
The Senate is aiming to move the bipartisan infrastructure bill and the fiscal 2022 budget resolution as early as July 19, and the size and framework of the budget resolution could drive which health care provisions are ultimately included in Democrats’ upcoming reconciliation bill. Sources say it’s still unclear what Medicaid, Medicare and drug-pricing provisions might make it into the bill.
Senate Budget Committee Chair Bernie Sanders (I-VT) is seeking a $6 trillion budget resolution, but moderate Democrats want it ratcheted back to $2 trillion.
House Majority Whip Jim Clyburn (D-SC) and other lawmakers and beneficiary advocates are pushing hard for a federal solution to the Medicaid gap, and Senate Democratic leadership supports a gap fix as well but is also pushing to expand Medicare benefits. Whether and what form of drug-pricing legislation — considered a key pay-for — is factored into the budget resolution could help determine what Medicaid and Medicare reforms make it into the reconciliation package.
A Democratic Senate aide Thursday (July 8) told Inside Health Policy that leadership is supportive of the effort to close the so-called Medicaid coverage gap in states that haven’t expanded Medicaid eligibility under the Affordable Care Act, and is reviewing options for the best path forward.
House Democratic leaders have also shown support for legislation to close the coverage gap. A spokesperson for Clyburn said earlier this week that closing the gap is the lawmaker’s priority for the reconciliation package.
Multiple committees are said to be discussing how to best close the coverage gap. The only concrete proposal so far is a bill introduced by Rep. Lloyd Doggett (D-TX), chair of the House Ways & Means health subcommittee, that would allow local governments to contract with CMS directly to expand Medicaid in their jurisdictions, though Doggett himself has said a more comprehensive solution would be welcome.
Meanwhile, Senate Majority Leader Chuck Schumer (D-NY) has also thrown his support behind expanding Medicare to cover dental, hearing and vision care. Doggett also introduced a bill Tuesday (July 6) to add the three benefits to Medicare Part B.
The bill has wide support among House Democrats, with more than 75 cosponsors, though a Families USA staff member said it’s possible a provision in the reconciliation bill won’t look exactly like Doggett’s proposal. A spokesperson for Rep. Robin Kelly (D-IL) said in June that there have been some discussions around including only one of the three benefits in a reconciliation package due to financial considerations.
Concerned about rising health care costs and cost differences between sites of care for the same procedures, the U.S. Congress and the Centers for Medicare and Medicaid Services (CMS) in recent years have begun implementing legislation and regulatory policies that would lower reimbursement for certain off-campus HOPDs to a level comparable with freestanding and/or non-hospital facilities.
The practice of reimbursing HOPDs (on- or off-campus) at the same rate as freestanding clinics is known as “site-neutral” payment and are intended to close the payment gap between off-campus HOPDs and other freestanding facilities.
On July 1st, the Health Resources and Services Administration (HRSA) opened the Provider Relief Fund (PRF) Reporting Portal for providers who need to report on the use of funds in Reporting Period 1. All recipients of PRF payments must comply with the reporting requirements described in the Terms and Conditions.
You may recall that, on June 11th, HRSA announced updated PRF reporting requirements, which included extending the amount of time that providers have to report from 30-days to 90-days. Providers who are required to report during Reporting Period 1 have until September 30, 2021 to enter the Portal and submit their information.
Reporting Requirements Timeline
HRSA is committed to supporting the providers who have received PRF payments in completing their reporting requirements successfully. For technical assistance, we encourage providers to call the Provider Support Line at (866) 569-3522; for TTY dial 711. Hours of operation are 7 AM to10 PM CT, Monday through Friday.
HRSA will also host a recorded webcast on July 8, 2021, at 3 PM ET to provide technical assistance on reporting requirements for PRF recipients and interested stakeholders. Interested parties can register to attend here.
Additional resources to aid providers in the reporting process, HRSA has shared the following documents with PRF payment recipients:
An Obama-era veteran of the Affordable Care Act wars and surgeon will take charge of the nation’s Medicare program under President Joe Biden, the Centers for Medicare & Medicaid Services announced.
Meena Seshamani, a head-and-neck surgeon who most recently was vice president of clinical care transformation at MedStar Health, became deputy administrator of CMS and director of the Center for Medicare Tuesday.
MedStar is a 10-hospital health system in the Washington, D.C. area.
“Dr. Meena Seshamani brings her diverse background as a health-care executive, health economist, physician and health policy expert to CMS,” said CMS Administrator Chiquita Brooks-LaSure. “Providing quality health care to the people who rely on Medicare and advancing health equity as we do it is a priority for CMS. I am delighted to say Dr. Seshamani will bring her unique perspective on how health policy impacts the real lives of patients to her leadership role as Deputy Administrator and Director of the Center for Medicare.”
Seshamani has decades of policy experience under her belt, She served as director of the Office of Health Reform under President Barack Obama, where she helped lead implementation of the ACA, including coverage policy, delivery-system reform, and public-health policy, the CMS said.
She also served as Biden administration’s transition team for the Department of Health and Human Services.
At MedStar, Seshamani helped design and carry out population-health and value-based care initiatives in the areas of community health, geriatrics, and palliative care.
She also cared for patients as an assistant professor of Otolaryngology-Head and Neck Surgery at the Georgetown University School of Medicine, the CMS said.
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