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What Does Health Care Rulemaking Look Like This Year?

Even Congress tries to complete $4.5T in domestic policy changes plus appropriations in the next 3 months, the Biden Administration is cranking away on health care rulemaking.  Here’s a quick overview of some key rules on the horizon from the Department of Health and Human Services (HHS).

Go deeper:  Refresh your memory on OMB and rulemaking here.

Below are the health care rules currently under review at www.reginfo.gov.  At the moment, the public is unable to comment on the any of the rules listed until their publication in the Federal Register.

Title Category Type Status
Streamlining HHS
Guidance Practices		 Internal HHS Policy Proposed Rule Received at OMB on
6/28/21
Reporting Requirements Related to Air
Ambulance and Agent
and Broker Services and HHS Enforcement
Provisions		 Insurance Proposed Rule Received at OMB on
7/7/21
Establishing
Over-the-Counter
Hearing Aids and
Aligning Other
Regulations		 Medical Devices Proposed Rule Received at OMB on
8/18/21
Medicare Coverage of
Innovative Technology (MCIT) and Definition of “Reasonable and
Necessary”		 Medicare Proposed Rule Received at OMB on
8/27/21
Securing Updated and Necessary Statutory
Evaluations Timely		 Internal HHS Policy Proposed Rule Received at OMB on
8/31/21
Premarket Tobacco
Product Applications
and Recordkeeping
Requirements		 Tobacco Products Final Rule Received at OMB on
4/5/21
Format and Content of Reports Intended to
Demonstrate
Substantial Equivalence		 Tobacco Products Final Rule Received at OMB on
4/5/21
Medical Device De
Novo Classification Process		 Medical Devices Final Rule Received at OMB on
6/28/21
Updating Payment
Parameters and
Improving Health
Insurance Markets for
2022 and Beyond		 Insurance Final Rule Received at OMB on
8/19/21

Don’t Be Caught “Surprised”

HHS has more rules coming out on the No Surprises Act.

  • By October 1, the Biden administration is required to publish a rule on an audit process to ensure that plans and insurers are complying with the QPA calculation and requirement.
  • By December 27, the administration must outline the details of an independent dispute resolution (IDR) process if providers and health plans fail to agree on an out-of-network rate.

Annual Payment Rules

Expected around late October/early November, CMS will post the final Medicare payment policies and reimbursement rates for FY 2022, including the Home Health Prospective Payment System, the Hospital Outpatient Prospective Payment System (HOPPS), and the Physician Fee Schedule.

  • Stakeholders can still comment on the proposed HOPPS and Physician Fee Schedule at regulations.gov through September 13 and September 17, 2021, respectively.

All eyes may be on Congress this fall as lawmakers work to finish FY 2022 appropriations, a $1.2T bipartisan infrastructure bill, and a $3.5T “human” infrastructure package.  However, keen observers would be remiss to ignore the Executive Branch, where forthcoming rulemaking will surely impact health care providers of all stripes.

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What Happened, What You Missed: August 30-September 3

CDC Advisory Committee Takes More Cautious Approach on Boosters

Members of the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) agreed in an August 30 meeting that booster shots of COVID-19 vaccines should be prioritized for residents of long-term care facilities, followed by front-line health care workers.  While the advisory committee did acknowledge that booster shots could eventually be needed for the rest of the US population, the panel declined to endorse the White House’s strategy to make booster shots available to all adults who were eight months past the date of their final vaccine shot as soon as September 20.  While ACIP members did say they would meet at a later date to discuss whether boosters are necessary for the rest of the population, they did not say when.  Two days later, the Food and Drug Administration (FDA) announced that its vaccine advisory committee will meet on September 17 to discuss the necessity of booster shots.

New Report Pegs Date of Medicare Insolvency in 2026

According to the Medicare Trustees 2021 report, the Medicare hospital insurance trust fund is projected to become insolvent in 2026, which is unchanged from the previous year’s report.  While some experts had feared that the COVID-19 pandemic would exacerbate the program’s financial woes, the report found that spending for non-COVID care in late 2020 and early 2021 more than offset the cost of pandemic-related care throughout 2020.  However, the trustees noted in their report that there is still “an unusually large degree of uncertainty” regarding the impact of the pandemic.  On a related note, the report found the projected insolvency of the Social Security trust fund to be 2034 instead of last year’s estimated date of 2035.

HHS Establishes a New Climate, Health Equity Office

On August 30, the Department of Health and Human Services (HHS) established the Office of Climate Change and Health Equity in response to President Joe Biden’s Executive Order on Tackling the Climate Crisis at Home and Abroad.  The new office is tasked with addressing health disparities driven by climate change, developing requirements for providers to reduce carbon emissions, and offering training for the health care and climate workforce.  In a statement, HHS Assistant Secretary for Health Rachel Levine pointed out that many of the same communities disproportionately affected by the COVID-19 pandemic are likely to struggle the most with the effects of climate change.  Therefore, to find solutions and form initiatives, the office will partner with the health care sector, which accounts for 8.5% of the nation’s carbon emissions.

Census to Deliver User-Friendly Redistricting Data Two Weeks Early

The US Census Bureau announced on September 1 that it will release easier-to-use formats of the 2020 Census Redistricting Data on September 16, two weeks before an initially planned release on September 30.  While the bureau already released 2020 redistricting data on August 25, it was presented in a “legacy” format that requires additional steps before it can be processed, whereas, the data to be released on September 16 can be more quickly utilized by states to redraw their congressional maps ahead of 2022 midterm elections.  Also on September 1, the Department of Justice issued guidance for states on redistricting that promises enforcement of the Voting Rights Act, which prohibits congressional districts from being formed around membership in a racial or language minority group.

ICYMI: Is the US Capitol Fence Coming Back?

According to reports, the US Capitol Police is considering if a perimeter fence needs to be restored around the US Capitol ahead of a planned September 18 demonstration, where members of far-right extremist groups are expected to rally in support of the people charged in connection with the January 6 riot.  A perimeter fence was installed immediately after the January 6 riot before being fully removed in July.   The Capitol Police Board are currently weighing several security plans for September 18 with some involving restoring the fencing and others taking different approaches. (www.sacredmusicstudio.com)

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What Happened to the Cancer Moonshot?

In his final State of the Union address in January 2016, then-President Barack Obama asked then-Vice President Joe Biden to lead the Cancer Moonshot initiative, a new national effort to accelerate research in cancer treatment.  Over the past five years, however, attention on the Cancer Moonshot has seemingly waned to the point that it barely pops up in the national discourse on health policy.  Is the Cancer Moonshot still around, and if so, what has it even accomplished?

Background

The Cancer Moonshot is far from being the federal government’s first push to deliver new cancer treatments.  The National Cancer Institute (NCI) was first established in 1937 to support cancer research.  Incorporated within the National Institutes of Health (NIH) in 1944, NCI remains the oldest center and has the largest budget among the other 27 centers and institutes of NIH. Decades later, President Richard Nixon signed the National Cancer Act of 1971 into law, which provided NCI with more autonomy within NIH and authorized $1.6 billion in funding for NCI over three years.  Additionally, the Orphan Drug Act of 1983 spurred many pharmaceutical companies to invest in drugs to treat rare diseases like cancer.

Beyond NCI,  the federal government has done little to invest large sums of money focusing on research into the prevention and treatment of cancer, which  has limited the progress in the war against cancer.  The overall death rate from cancer has only declined 5% since 1950, and new cancer drugs produced between 2003 and 2013 has only boosted overall survival by 3.4 months.  Given the technical and scientific difficultly of developing cancer treatments, a more concerted effort rather than a piecemeal approach may be necessary to deliver progress.

How the Moonshot Got Started

Shaped by his oldest son’s death from brain cancer in 2015, Biden declared after the 2016 State of the Union that the goal of the Cancer Moonshot was to double the rate of progress towards a cure for cancer. Shortly thereafter, Biden convened a Cancer Moonshot Task Force that established a BlueRibbon Panel charged with outlining research priorities to help the new initiative meet its goals.  Comprised of clinicians, scientists, cancer patients, and advocates, the panel issued a report in October 2016 that established seven working groups to identify research opportunities and offer recommendations on how the Cancer Moonshot can support those opportunities.  Since then, Congress authorized the Cancer Moonshot through enactment of the 21st Century Cures Act in December 2016, which set up the initiative within NCI and provided $1.8 billion funding over seven years.  For FY 2021, the Cancer Moonshot was appropriated $195 million.

Progress So Far

The Cancer Moonshot initiative uses its funding to invest in research that aligns with the initiative’s key priorities, such as generation of human tumor atlases, expanded use of early detection strategies, and establishing a network for direct patient engagement.  According to a midpoint progress update issued in January 2021, the initiative has so far funded over 240 research projects and more than 70 cancer science programs.  The Cancer Moonshot cites over a dozen projects on its website that have yielded progress, including:

  • The Immuno-Oncology Translational Network, whose research has led to insights into ovarian cancers responses to immunotherapy and the use of immunotherapy in certain types of head and neck cancers.
  • The My Pediatric and Adult Rare Tumor Network, which has developed a pipeline for biospecimen collection/analysis rare cancers and established several new specialized rare tumor clinics around the country.
  • The Fusion Oncoproteins in Childhood Cancers Consortium, whose researchers have developed several novel cancer models to study rare cancers and have made significant advances in understanding how each fusion affects the protein’s function and localization in the cell.

Room for Improvement

However, some scientists say Cancer Moonshot has the potential to deliver on greater progress.  To achieve this, a group of scientists proposed early this year in Lancent Oncology, a “Cancer Moonshot 2.0” that can meaningfully improve outcomes for cancer patients with a “scaled up, redoubled, and accelerated” approach.  Among the research areas suggested by the group include:

  • New database formats to capture biological data.
  • Non-invasive liquid biopsy approaches that can be used to screen high-risk individuals to identify precancers and early cancers.
  • Machine learning innovations that link the molecular structure of cancer pathways to more specific and effective drugs.
  • New drug delivery systems that target specific cancer vulnerabilities, such as bispecific antibodies and nanotechnologies.

While the Cancer Moonshot is still alive and kicking, the initiative may not be subject to as much attention when it was first conceived in 2016, likely due to less-than-stellar advancements and the domination of other issues in the public health discourse.  As difficult as cancer research may be, a redoubling of efforts and additional funding could pave the way for new treatments that exemplify the term “moonshot.”

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What Happened, What You Missed: August 16-20

Biden Administration Preparing to Make Booster Shots Available in September

On August 18, President Joe Biden announced his administration is preparing to offer a third dose of the Pfizer and Moderna mRNA vaccines by the week of September 20.  The administration wants the additional doses to function as a “booster shot” after new data has indicated that the efficacy of the Pfizer and Moderna vaccines decreases over time.  The administration also anticipates offering booster shots to individuals who received the single-dose Johnson & Johnson vaccine but is awaiting further information before making a final decision.  Before the administration can officially begin distribution of additional doses, the Food and Drug Administration and the CDC’s vaccine advisory committee must review and authorize booster shots.  The Biden administration’s decision has drawn criticism from health experts who say there isn’t sufficient data to justify booster shots, especially as most of the world’s population remains unvaccinated.

HHS to Mandate Vaccinations for Certain Long-Term Care Workers

President Biden also announced on August 18 that he is directing the Department of Health and Human Services (HHS) to require long-term care facilities to have their employees vaccinated in order to continue to receive funding from Medicare and Medicaid.  The announcement comes as vaccination rates for long-term care workers has lagged nationally, leaving elderly residents vulnerable to the virus.  According to data from the Centers for Medicare and Medicaid Services, just over 60% of nursing home staff is vaccinated, compared to nearly 83% of nursing home residents.  There have been mixed reactions from the nursing home industry regarding Biden’s announcement.  Both LeadingAge and the America Health Care Association (AHCA) have said the administration should require all health care workers to be vaccinated instead of singling out nursing homes, although LeadingAge does support requiring vaccination as a condition of employment for nursing home workers.  Additionally, AHCA has warned vaccination requirements could prompt some long-term care workers to flee to other industries.

KFF: Spending per Person for MA Enrollees Grew Higher, Faster Than Traditional Medicare

A report issued August 17 by the Kaiser Family Foundation (KFF) found the federal government spent $321 more per person for Medicare Advantage (MA) beneficiaries compared to those enrolled in traditional Medicare in 2019, resulting in an additional $7 billion in annual spending.  The report also found that spending per MA enrollee is growing faster compared to traditional Medicare, which could cause overall MA spending to double by 2029.  According to the report, several features of the MA payment system are contributing to rising costs, including how benchmarks for plan payments are set and the risk adjustment process.  The report’s release comes as the Biden administration looks to increase the solvency of the Medicare trust fund by reforming payments to privately managed plans like MA.

Pelosi Urges Moderate Democrats to Back $3.5 Trillion Budget Resolution

Speaker Nancy Pelosi (D-CA) sent a Dear Colleague letter to all House Democrats on August 17 urging the caucus to support passage of the $3.5 trillion Fiscal Year (FY) 2022 budget resolution when the House returns from recess on August 23.  Pelosi’s letter was a direct response to nine moderate House Democrats who in an August 13 letter threatened to block the FY 2022 budget resolution unless the $1 trillion bipartisan infrastructure bill is passed first.  In her Dear Colleague letter, the Speaker expressed that any delay in passing either measure could threaten a “once-in-a-generation opportunity” to enact policies that will help working families.

ICYMI: Washington Monument Closed after Lightning Strike

The Washington Monument remains closed after it was struck by lightning at 12:30 a.m. on August 15.  According to the National Park Service, the lightning strike damaged the monument’s electronic access system that operates the door and the elevators.  Work crews are waiting on parts before repairs can resume, and it remains unclear when the parts will arrive.  According to The Washington Post, lightning hits the Washington Monument several times a year, and last Sunday’s strike marks the second lightning hit in 2021.

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ARPA-H, the Proposed Agency to Transform Biomedical Research

The internet.  GPS.  The computer mouse.  These are some of the technological innovations made possible by the Defense Advanced Research Projects Agency (DARPA), a Defense Department agency tasked with advancing research and development of science and technology programs.  Now, the Biden administration wants to replicate DARPA’s success in biomedical research with a newly proposed entity called Advanced Research Projects Agency for Health (ARPA-H).

What Is ARPA-H?

The Biden administration’s Fiscal Year (FY) 2022 budget request provided a $6.5 billion investment for APRA-H, which would be directed to drive “transformational innovation” in health research and speed application and implementation of health breakthroughs.  The initial focus of ARPA-H would be cancer, disabilities, and Alzheimer’s disease.  According to a concept paper provided by the White House, examples of projects that could be pursued by ARPA-H include:

  • mRNA vaccines to prevent most cancers.
  • Molecular “zip codes” that target drugs only to specific tissues and cell types, to eliminate serious side effects.
  • Highly accurate, inexpensive, wearable monitors for blood pressure and blood sugar that provide real-time data to patients and providers.
  • Holistic systems that eliminate racial disparities in maternal morbidity and mortality rates and premature births.
  • A process to design, test, and approve a vaccine against any newly emerging human virus in 100 days.

The National Institute of Health (NIH) further explains that ARPA-H will predominantly focus on “time-limited” projects with goals, metrics, and accountability.  It also states that the director of ARPA-H will be selected based on having a “proven innovation and partnership-building track-record,” and ARPA-H program managers will be recruited from industry, academia, or other sectors based on “scientific vision, judgement, and management skills. (Clonazepam) ”

ARPA-H is also included in the Cures 2.0 discussion draft that was released by Reps. Diana DeGette (D-CO) and Fred Upton (R-CO).  However, the discussion draft is still a work in progress, and it contains far fewer details on the proposed agency than those provided by the Biden administration.

How Would ARPA-H Advance Biomedical Research?

Ideally, ARPA-H would need many of the same authorities used by DARPA to accomplish its mission to delivery breakthroughs in biomedical research.  Key authorities would include:

  • The ability to hire individuals rapidly based on “a unique skill set” outside the typical civil services hiring system and pay those individuals a competitive wage, as well as the ability to recruit experienced program managers from the private sector.
  • Broad, flexible funding authority that make it possible to mix and match the best ideas with minimal bureaucracy that allow for projects that can be funded for multiple years or don’t necessarily fit into one-year intervals.
  • Exemptions from the traditional review process for biomedical research, which can take up to 18 months or longer, to get from an idea to a scientific review before the actual work begins.

According to a July 26 Federal News Network interview with NIH Director Francis Collins, an ARPA-H with “some new authorities” could make a difference for experimental drugs that show a lot promise during clinical trials but fail to attract investment from pharmaceutical companies due to an experimental products being perceived as too risky or having a limited market share.  In these cases, Collins explained ARPA-H could chose to invest in certain experimental drugs and hand them over to the private sector when necessary.

The Structure of APRA-H

The Biden administration has stipulated that ARPA-H would be a “distinct division” within NIH, with a “unique culture and organization.”  However, some medical experts have argued ARPA-H should be a stand-alone entity within the Department of Health and Human Services (HHS), including a former chair from DARPA’s advisory committee, who suggested NIH’s approach to research and innovation is too time-consuming and bureaucratic.  In response, Collins told The Washington Post in mid-June that putting ARPA-H outside of NIH would be a big mistake because it would lead to “administrative duplications” and preclude the chance for ARPA-H program managers to develop synergy with their colleagues at NIH.  While the Cures 2.0 discussion draft has yet to define ARPA-H’s structure and home, Collins has said that DeGette and Upton are leaning towards having the new agency withing NIH.

Collins also threw cold water on the notion that ARPA-H could create internal jealously within NIH in his Federal News Network interview by countering that many NIH employees are excited about the prospect of a new research agency and that “unfriendly competitiveness” exists in other parts of the government.  It’s worth noting that the administration’s FY 2022 budget request includes a major increase in NIH funding rather than diverting away funds to create a new agency.

Next Steps

APRA-H only becomes a reality when FY 2022 appropriations bills are signed into law, and the FY 2022 appropriations process has gotten off to a slow start.  The House passed an appropriations minibus for FY 2022 on July 31 that includes $3 billion for ARPA-H, while the Senate only began reviewing its FY 2022 spending proposals on August 2. , Notably, the proposals to create a new biomedical research agency been favorably viewed by members of both parties, meaning ARPA-H is unlikely to be cut from the legislation. However, given lawmakers’ slow progress on appropriations and long list of other items that require their attention in the next 60 days, all FY 2022 spending measures are unlikely to be finalized by the end of the FY 2021 on September 31.  This means NIH may not be able to take the first steps in building up ARPA-H until Congress finalizes the FY 2022 appropriations bills later in the fall or winter.

Once FY 2022 funding is squared away, Collins hopes to hit the ground running.  In his Federal News Network interview, the NIH director said he hopes to recruit 50-100 program managers for the agency’s first year, with results on research projects expected in the following one to two years as ARPA-H continues to “staff up and ramp up.”  Collins also projected to have 50-60 projects going at ARPA-H by the end of FY 2022, assuming all FY 2022 spending bills are enacted by December 2021.

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