All About OMB

The Office of Management and Budget (OMB) may not get as much attention as other Cabinet-level agencies like the Departments of Defense and the Treasury, but that doesn’t mean OMB is any less important.  In fact, OMB plays a critical role in managing the operations of the federal government and the budget process.  More so, OMB is responsible for reviewing regulations that shape Americans’ daily lives.  So, how does OMB do this?

The History of OMB

OMB’s origins date back to 1921, when the Budget and Accounting Act of 2021 established the Bureau of the Budget at the Department of the Treasury.  The bureau was eventually moved to the Executive office of the President in 1939, where it was reorganized into the Office of Management and Budget in 1970. 

OMB Today

Comprised of nearly 500 career staff, The mission of OMB is to “assist the President in meeting policy, budget, management, and regulatory objectives and to fulfill the agency’s statutory responsibilities.”  OMB mainly carries out this mission through 5 main functions:

  1. Preparing a budget proposal to Congress;
  2. Supervising executive branch agencies;
  3. Reviewing all rulemaking and regulatory actions;
  4. Reviewing agency testimony, legislative proposals, and other communications with Congress; and
  5. Clearing Presidential Executive Orders.

Current Leadership

The organization is led by three-Senate confirmed positions: Director, the Deputy Director, the Deputy Director for Management.  The current Acting Director of OMB is Shalanda Young, who was confirmed as Deputy Director in March 2021.  The Biden Administration’s latest nominee for OMB Director is Kiran Ahuja, who previously served as Chief of Staff of the Office of Personnel Management and Executive Director of the White House Initiative on Asian Americans and Pacific Islanders during the Obama Administration.   While Ahuja, was favorably reported by the Senate Homeland Security and Governmental Affairs Committee, the Senate has yet to schedule a floor vote to consider her nomination. 

Extension of the President with Congress

OMB play 3 key roles for the President as the Administration interacts with Congress:  the budget, statements on legislation, and the Congressional Review Act. 

Budget.  While the Presidential budget submission to Congress typically happens around February each year, OMB is active long before the annual tome hits the streets.  OMB works on average six months prior by sending budget instructions to agencies and later reviewing and analyzing agencies’ formal budget proposals.  Additionally and throughout the year, OMB provides guidance on a range of budgetary topics, including government shutdowns, continuing resolutions, and agencies use of discretion with mandatory spending. 

SAPs.   OMB prepares Statements of Administration Policy (SAPs) on any pending legislative proposals that are not related to appropriations that communicate the President’s position on the affected legislation.  SAPs typically serve as a strong indicator of whether the President will veto or sign a bill into law.  OMB also reviews and clears congressional testimony, congressional correspondence, and draft bills from the agencies to ensure the documents are aligned with the Administration’s agenda. 

              Congressional Review Act.  The Congressional Review Act (CRA) is an oversight tool Congress can use to overturn a rule by a federal agency or department.  OMB is tasked with determining whether a rule is considered a “major rule” under the CRA.  In the case of major rules, Congress can pass a joint resolution of disapproval, which would veto the rule if signed into law by the President or approved by two-thirds of both chambers of Congress.

Role in Rulemaking

OMB plays a pivotal role in rulemaking, primarily through the Office of Information and Regulatory Affairs (OIRA).  Like its parent agency, OIRA is currently without a permanent leader; former National Labor Relations Board member Sharon Block has been serving as OIRA’s Acting Administrator since April 2021.  Under the current framework, OIRA is charged with reviewing all regulatory actions and determining whether the regulations are “significant” or “economically significant,” meaning they have an annual effect on the economy of $100 million or more.  For rules deemed significant and economically significant, however, agencies must submit several documents, including the draft text of the rule, an explanation of how the rulemaking will address a particular need, the potential costs and benefits of the rule, and in the case of rules considered economically significant, a regulatory impact analysis.

After receiving all necessary documents from agencies on significant rules, OIRA has 90 calendar days to review, with the option of extending the review period for one time by up to 30 days.  OIRA then proceeds to review the agency’s documents and return the rule to the agency in one of three ways:

  1. Consistent without change.  This means OIRA did not alter the proposed rule.
  2. Consistent with change.  This means OIRA generally agrees with the intent of the rule but made some substantive changes. This is the most common type of action OIRA takes.
  3. Returned.  This means OIRA has serious concerns with the agency’s proposed rule and does not approve the publication of a Notice of Proposed Rulemaking (NPRM). Returned rules are always accompanied by a return letter which is posted on OIRA’s online docket.   An example of a returned letter is a 2002 letter to the Office of Personnel Management rejecting proposed changes to the Federal Employee Health Benefits Program due to concerns over cost measurement and accounting principles.

Once OIRA has completed its review process, the proposed rule is published in the Federal Register in the form of a NPRM. The rule is opened to a public comment period generally lasting 60 days.  When the public comment period concludes, the agency makes any changes to the rule and resubmits it to OIRA for another round of review. Again, OIRA has 90 days to conducts its review process. When OIRA completes its final review, the agency may set a date for promulgation of the rule and publish the final rule in the Federal Register.  Members of the public can track rules under the review of OIRA at

Does OMB Matter?

Absolutely.  Even if OMB may not be mentioned as frequently as other agencies, its power cannot be understated.  OMB oversees a number of multi-trillion-dollar budgets that impact every aspect of American life, and OMB’s role in supervising federal agencies means it’s more or less in charge of 4.3 million federal employees.  Based on the goals of the Administration, OMB is an important partner with Congresson how much will be spent on health, defense, housing, and other key areas. 

Furthermore, OMB’s role in coordinating and reviewing regulatory action makes it a key player in the day-to-day actions in government.  Whether it pertains to Medicare reimbursement, FDA user fees, price transparency, or otherwise, all rulemaking and regulatory action is subject to OMB’s review.  Despite a lack of attention, OMB’s impact is far-reaching.

Did You Know?

Did you know that you can meet with OMB?  OIRA has an open door policy, which means the office takes meetings with outside stakeholders on regulations under review.  Meeting participants and materials are publicly disclosed and provide an interesting window into additional input the agency receives beyond formal written comments on the rule.  This month’s hot topic appears to be the physician fee schedule, among other health care related ruled. 

The Promise of Non-Profit Drug Companies

With trust in pharmaceutical companies waning and drug prices climbing, it’s clear providers and patients are frustrated with drug manufacturers.  Out of this frustration, providers and philanthropists have banded together to form non-profit drug companies, which aim to deliver low-cost generics by eschewing the profit-driven focus of other drug makers and embracing a mission to make drugs accessible and affordable.  But in an industry dominated by for-profit players, do non-profit drug companies stand a chance at making a difference?

The Major Non-Profit Players

Over the past few years, a handful of non-profit companies have emerged. 

  • Civica Rx, the most prominent non-profit drug maker, formed in September 2018 when several major health systems teamed up to manufacture their own generics.  The company grew out of a need to bring competition to the pharmaceutical industry, with the hopes of reigning in high prices for generics.  Civica first began manufacturing two antibiotics in March 2019 and signed agreement to produce injectable medications later that year.  In January 2021, Civica announced plans to build a 120,000 square foot facility just south of Richmond, VA to produce sterile injectable drugs for hospitals.  Civica has also expanded into drug development – in  January 2020, it signed a deal with Thermo Fisher Scientific to develop and manufacture its own drugs.  The company also notably partnered with 18 Blue Cross and Blue Shield companies in January 2020 to form a new subsidy to reduce the cost of generics.
  • Phlow Pharmaceuticals formed in January 2020 to produce active pharmaceutical ingredients (APIs) used in drug manufacturing.  Beginning in May 2020, the federal government awarded Phlow a total of $812 million to manufacture medicines at risk of shortage, including medicines for the COVID-19 response.  Notably, Phlow partnered with Civica on the new facility near Richmond, VA.
  • Harm Reduction Therapeutics formed in 2017 with the goal of preventing opioid overdose deaths by bringing a low-cost, over-the-counter naloxone spray to market.  In June 2020, the company received $6.5 million in financial support from Purdue Pharma, which produces opioids for prescription use. 
  • Medicines360 formed in 2015 to develop and provide low-cost contraceptives to women.  In October 2019, the Food and Drug Administration (FDA) approved a hormonal intrauterine device (IUD) Medicines360 developed with Allergan that prevents pregnancy for six years, the longest approved duration for IUD use in the US.

Advantages of Non-Profit Drug Makers

When it comes to delivering lower-cost drugs, non-profit pharmaceutical companies have several advantages

  • Non-profit drug companies focus on generic drugs, meaning they are out of the patent protection period and in the public domain. 
  • Additionally, thanks to their non-profit model, these companies don’t need to raise prices to honor fiduciary obligations to shareholders.  Excess funds can also be invested back into the organization to enable it to continue its non-profit mission.
  • Civica specifically operates on a membership model for hospitals that allows the company to make long-term commitments to members at a fair price.  This arrangement also allows Civica to offer the same price per unit to each hospital member.

Challenges for Non-Profit Drug Makers

Success for non-profit drug companies is not guaranteed, and they face major obstacles to fulfilling their mission.

  • Despite financial assistance from philanthropy, grants, and other means, non-profit companies lack access to capital through multiple investment streams that for-profit companies can more readily access.  This leaves non-profits at a serious disadvantage when it comes to research and development, which involves raising large amounts of capital.
  • When it comes to certain rules and regulations, the non-profit status of companies like Civica doesn’t entitle them to many breaks or special treatment.  For instance, the FDA imposes user feels on all drug manufacturers, regardless of their status or mission. 
  • Some reimbursement and payment policies may present obstacles  for non-profits to offer lower prices, particularly Medicaid’s “best price” rule.  To remain sustainable, non-profit drug makers may offer higher prices for some purchasers while keeping prices low for uninsured or low-income patients.  By offering low prices to the aforementioned groups, non-profits would be required to offer the same low price across Medicaid. 

Will Non-Profit Drug Companies Make a Difference?

Non-profits like Civica Rx and Phlow are new entrants to the drug market, and only time will tell if their efforts will pay off in the form of lower drug prices.  However, non-profits could follow a few strategies to increase their odds of success.  While Civica Rx and Medicines360 have become involved in drug development, non-profit drug manufacturers would be better off focusing on generics given their disadvantage in research and development.  Additionally, non-profit drug makers could push for policy and regulatory changes to give them a more favorable position in the market, such as reducing or waiving user fees for non-profits, increasing price transparency, or creating an exemption under the Medicaid “best price” rule.

The Week in Review: May 24-28

Moderna Says Its COVID-19 Vaccine Is 100% Effective in Teens

On May 25, Moderna announced that its COVID-19 vaccine is 93% effective in children aged 12-17 after the first dose and 100% effective after the second.  Additionally, data from the company’s phase 2/3 clinical trial consisting of 3,700 adolescents identified no serious side effects.  Moderna plans to ask the Food and Drug Administration “in early June” to amend its emergency use authorization to allow individual as young as 12 to receive the vaccine.  Currently, only Pfizer’s COVID-19 vaccine is authorized for use in teens.  If approved, Moderna’s COVID-19 vaccine would greatly increase the supply of shots available to middle and high school students ahead of the next school year. 

“Lab Leak” Theory on Virus’s Origin Gains Steam

Following growing concerns that COVID-19 may have originally escaped from a laboratory, President Biden directed the intelligence community to “redouble” its efforts to investigate the origins of the COVID-19 pandemic.  These concerns are fueled by reports that three employees at China’s Wuhan Institute of Virology were hospitalized with symptoms consistent with COVID-19 and “common seasonal illness” in November 2019.  However, hard evidence that COVID-19 originated in a lab has yet to be found, and NIAID Director Anthony Fauci told a Senate committee on May 26 that he still believes the “most likely scenario is that [COVID-19] was a natural occurrence.”  The intelligence community is expected to report its findings to the President in 90 days.

Senators Take Action on Public Option, Rural Health Care Workforce

On May 25, top Democrats on bicameral health committees issued a request for information (RFI) to gather feedback on a proposal to create a government-run public health insurance option.  Among the issues the RFI seeks feedback on are the criteria used for determining prices, the role of states, and how a public option would interact with Medicare and Medicaid.  While President Biden campaigned on creating a public option, the proposal faces an uphill battle from Republicans and health care stakeholders who are strongly opposed.   In other congressional news, four bipartisan senators reintroduced legislation on May 27 to extend a program that allows international doctors to remain in the US upon completing their residency, so as long as they practice in rural areas that are suffering from physician shortages.  Notably, the bill would expand the number of physicians who can participate in the program and would open participation to physicians’ spouses.

Former Virginia Sen. John Warner Dies at Age 94

On May 25, former Virginia Senator John Warner died of heart failure in his Alexandria home at 94 years old.  Warner, who represented Virginia in the Senate from 1979 to 2009, was a moderate Republican who occasionally broke ranks with his party on high-profile issues.  For instance, Warner opposed Robert Bork’s nomination to the Supreme Court and supported several gun control bills.  Warner, a veteran of both World War II and the Korean War, chaired the Rules and Armed Services committees for several years each in the Senate.  In his post-Senate career, Warner worked as a Senior Advisor for the Washington, DC law firm Hogan Lovells.

CMS Delays Medicaid “Best Price” Policy for 6 Months

On May 26, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to delay the effective date of a rule requiring drug manufacturers to include discounts they offer to patients when calculating the “best price” for drugs under Medicaid’s drug rebate program.  According to CMS, the delay is intended to provide the agency, states, and drug makers time to address concerns over patient access and make changes necessary to implement the new requirements.  The rule, which was initially set to go into effect on January 1, 2022, received mixed feedback from stakeholders.

ICMYI: Congress Set to Review Intelligence Report on UFOs

US intelligence agencies are expected to deliver a report to Congress next month on UFOs, or “unidentified ariel phenomena” (UAPs) in the military’s parlance.  The report is a result of the FY 2021 omnibus appropriations bill that was signed into law in December 2021. Interest in UFOs has grown among both the general public and lawmakers after the Department of Defense declassified videos taken by the US Navy of strange objects flying near warships and aircraft.  Pentagon officials say they’re studying UAPs to determine whether the objects represent a threat to national security.  It remains to be seen to what extent the report will contain newly declassified information.

All About Executive Orders

A hallmark of President Joe Biden’s first 100 days in office were 52 executive orders aimed at reversing the previous Administration’s actions and addressing the COVID-19 pandemic.   In comparison, Donald Trump had issued 39 executive orders in his first 100 days, while Barack Obama and George W. Bush respectively clocked in at 34 and 13.  Given this trend for new Administrations to issue more and more executive orders, it’s no surprise why people are asking just what executive orders are and why they matter.

What Is an Executive Order?

An executive order is an official, legally binding mandate passed down from the President to agencies under the executive branch that gives agencies instructions on how to interpret and carry out federal law.  Executive orders are printed and numbered consecutively in the Federal Register, alongside other federal regulatory actions.  Additionally, executive orders have the force and effective of law, so as long as the order is based on power vested in the President by the US Constitution or delegated to the President by Congress. 

While the Constitution does not contain the term “executive order,” it does provide broad authority for the President to issue executive directives.  This authority derives from the “vesting clause” of the Constitution, which grants the President “executive power,” which has come to refer to the administrative actions of running the federal government.

Notably, executive orders are not legislation, and they do not require approval from Congress.  However, Congress may pass legislation that might make it difficult, or even impossible, to carry out the order, such as removing funding necessary to implement the order.  Congress can also pass legislation to override an executive order, although this legislation would be subject to a presidential veto.  Only a sitting US President has the authority to overturn an existing executive order by issuing another executive order.

Important Examples of Executive Orders

Many impactful executive orders have been issued of the years – here are a handful of them:

  • Abraham Lincoln suspended the writ of habeas corpus during the Civil War via executive order in 1861.  Lincoln cited his authority to issue the executive order under the powers under the Constitution’s Suspension Clause, which states, “the privilege of the writ of habeas corpus shall not be suspended, unless when in cases of rebellion and invasion the public safety may require it.”  Later, Lincoln issued two executive orders that comprised the Emancipation Proclamation, which he justified under wartime powers. 
  • Franklin Roosevelt established internment camps during World War II via an executive order.  He also used an executive order to create the Works Progress Administration.
  • Harry Truman signed an executive order in 1948 to end segregation in the armed forces.
  • Dwight Eisenhower used an executive order to put the Arkansas National Guard under federal control and to enforce desegregation in Little Rock, Arkansas in 1957.

Biden’s Executive Orders on Health Care to Date

President Biden’s executive orders so far have focused on the COVID-19 pandemic, including creating a response coordinator and requiring masks in airports.  Additionally, he established an additional special enrollment period via, and set up a health equity task force to address the needs of communities of colors and underserved populations.

So, Do Executive Orders Really Matter?

The answer is…it depends.  Historically, most executive orders have been for administrative purposes, such as requesting reports or forming task forces.  Beyond that, the impact of an executive order is limited to both the power of the President and the law.  For instance, President Donald Trump’s executive order to construct a border wall along the US southern border was technically meaningless because only Congress has the power to appropriate funds for border wall construction. 

In practice, however, the impact of executive orders can be profound.  Even if executive orders do not change federal law, they serve as indicators of how the Executive Branch can be reshaped to carry out federal law in a way that reflects an Administration’s priorities.  While the Trump Administration’s executive order on the border wall did not immediately spark new construction on the southern border, it did represent a shift in how the executive branch carries out immigration law that Biden Administration has had a tough time reversing.  For instance, many federal agencies began to view legal immigration as something to restrict, contributing to a slowdown in legal immigration and changes personnel policies within relevant agencies.

Should Payment Parity for Telehealth Continue?

In response to the COVID-19 pandemic, the Centers for Medicare and Medicaid Services issued rulemaking to require Medicare to pay the same rates for telehealth and in-person care for the duration of the public health emergency (PHE).  Now that the end of the pandemic may be in sight, stakeholders are debating whether Medicare should continue offering payment parity for telehealth services post-pandemic.  Since Medicare’s actions often inform what private payers do, stakeholders will be watching closely what the agency decides to do. 

Against Payment Parity

A chief argument against payment parity is that it could lead to overutilization and higher spending.  For patients with the right technology, accessing telehealth can be very convenient, leading health experts to suggest some patients may use telehealth more than necessary.  Corollary to this, some experts are worried about telehealth’s potential to create more opportunities for waste, fraud, and abuse.

Additionally, opponents to payment parity contend that telehealth requires fewer resources and less clinical effort than in-person visits.  For example, a 2017 study from Health Affairs found the average cost of a telehealth visit for an acute respiratory infection was $79 compared to $146 for in-person visits.  Simple virtual check-ins may also require less decision-making, time, and other factors considered “clinical effort” when compared to in-person appointments. 

Furthermore, some worry payment parity in telehealth may propagate low-value care.  For certain conditions, telehealth may prove limiting for providers, and there is no substitute for the type of evaluation physicians can provide through in-person visits.  Parity opponents argue that higher reimbursement rates tied to in-person visits will ensure patients can more regularly receive a full evaluation, thus preventing the likelihood symptoms missed during telehealth visits progress to become more expensive chronic conditions down the road.

For Payment Parity

Those in favor of continuing payment parity post PHE say there is no evidence that telehealth has resulted in overutilization.  Most instances of telehealth usage, parity proponents say, has been to substitute in-person to visits as a result of the COVID-19 pandemic.  According to data from electronic health record company Epic, the number of telehealth visits declined rapidly by summer 2020 following an initial increase in April 2020.  This data suggests that patients are so far not opting for more telehealth visits over in-person visits out of ease or convenience.  Additionally, some physicians argue some diagnoses can require as much clinical effort as in-person visits.  According to a 2020 study from the University of Michigan, surgeons reported spending more time on telehealth than in-person visits.   

Proponents of payment parity also say telehealth services utilize far more resources than patients realize.  While telehealth may not seem to require the same “brick and mortar costs” as in-person visits, providers assert that telehealth requires an investment in technology, both to set-up virtual visits and keep up with changes in technology.  For certain medical conditions, digital monitoring and home-based care products may require additional resources.  Providers also say that some diagnoses can involve just as must clinical effort as do in-person appointments.

Moreover, parity supporters contend that clinical guidelines about when telehealth and in-person care is appropriate can prevent low-value care.  For instance, the American College of Obstetricians and Gynecologists has issued guidance on when patients should require a physical examination. 

What Happens Next?

CMS can continue to pay the same rates or the agency could propose a differential payment rate.  Either way, the decision would be subject to the rulemaking with notice and comment.  For the part of Congress, the legislative branch hasn’t weighed in.  While legislators have introduced a slew of bills to permanently expand telehealth coverage and abolish pre-pandemic restrictions on telehealth, none address how telehealth should be paid for.  A lone exception is H.R. 8308, the Telehealth Coverage and Payment Parity Act.  Introduced by Rep. Dean Phillips (D-MN) in September 2020, the legislation would require commercial insurers to pay the same level for the same level for telehealth services as it would for in-person services.  However, this legislation does not affect Medicare, and as of this writing, the bill has yet to be reintroduced in the 118th Congress.

In their January 2021 public meeting, the members of the Medicare Payment Advisory Commission (MedPAC) suggested that Medicare continue telehealth payment parity for 1-2 years following the end of the PHE as a “pilot program” to evaluate how to telehealth services should be reimbursed permanently.  However, MedPAC’s comments have yet to be taken up in any legislative proposal.

The Week in Review: May 17-21

Pfizer, Moderna CEOs Say Booster COVID-19 Shots May Be Needed       

During a May 19 virtual event hosted by Axios, the CEOs of Pfizer and Moderna said some Americans may need a COVID-19 booster shot within 8-12 months from the original vaccination.  While it is unknown how long protection from COVID-19 vaccines lasts, NIAID Director Anthony Fauci commented during the same event that immunity against most coronaviruses “is generally not lifelong.”  However, some experts say the rhetoric from Pfizer and Moderna on booster shots may be tied to business goals, and they stress there is no evidence that shows immunity from COVID-19 vaccines has declined.

Emergent BioSolutions CEO Says J&J Vaccine Production Could Restart Soon

The CEO of Emergent BioSolutions told the House Coronavirus Crisis Subcommittee on May 19 that production of the Johnson & Johnson COVID-19 vaccine could resume within days.  The Food and Drug Administration (FDA) ordered Emergent BioSolutions to halt production of the vaccine in April after FDA inspectors found overcrowding and unsanitary conditions at the biopharmaceutical company’s Baltimore facility.  Just a week before FDA ordered the pause, Emergent BioSolutions was forced to toss out 15 million J&J vaccine doses after the company had accidentally mixed J&J ingredients with those used for AstraZeneca’s COVID-19 vaccine. 

Mask Guidance Partially Relaxed in Congress

Recently, the Office of the Attending Physicians issued new guidance saying fully vaccinated individuals in House Office Buildings are no longer required to wear masks and maintain social distancing.  The new guidance also lifted its maximum telework recommendation, meaning individual House offices can begin bringing remote staff back to the Hill.  Despite the new guidance, Speaker Nancy Pelosi (D-CA) has said the mask mandate on the House floor will remain in effect until all members have been vaccinated.  In response, some Republican members have been pushing the Speaker to drop all mask requirements.  On  May 14, 34 House Republicans sent a letter to Pelosi urging her to waive all mask rules, and on May 19, nearly a dozen Republican lawmakers were fined for not wearing masks on the House floor.  Senate Majority Leader Chuck Schumer (D-NY) has yet to officially weigh in on changes to mask guidelines for the Senate floor, where members of both parties have recently been spotted without masks. 

Top CDC Officials Step Down

On May 17, Centers for Disease Control and Prevention (CDC) Principal Deputy Director Anne Schuchat announced she plans to retire in the summer.  Schuchat, the CDC’s second highest-ranking official since 2015, has spent over 30 years at the agency.  Schuchat’s retirement announcement follows the early May resignation announcement of Nancy Messonnier, Director of CDC’s National Center for Immunization and Respiratory Diseases.  Messonnier had spent 20 years at the CDC and most recently led the agency’s COVID-19 task force.  While Schuchat and Messonnier have not specifically commented on their reasons for leaving CDC, reports suggest tension between the two and CDC Director Rochelle Walensky may have been a factor.  The high-level departures follow over a year of scrutiny of the CDC and its approach to issuing COVID-19 guidelines. 

ICYMI: New Mask Policy for Nationals Park, DC Bars in Effect May 21

Starting on May 21, fully vaccinated individuals are no longer required to wear a mask while visiting Nationals Parks or going to a bar or restaurant in Washington, DC.  Additionally, bars and restaurants in the District are once again permitted to offer bar service to customers and allow customers to stand in common areas.  However, bars and restaurants still have the option of requiring guests to wear a mask when not eating or drinking.

Will Momentum on Maternal Health Legislation Continue?

The state of maternal health is quite bleak in the US, where women are more likely to die from childbirth or pregnancy-related causes than their counterparts in other developed countries.  After years of advocacy, legislation was enacted that allows states to extend post-partum health care coverage.  Could this mean more legislative proposals on maternal health could be enacted soon?

Pregnancy Crisis

There are significant maternal health disparities in the US, as black and Native Americans women are about three times more likely to die from pregnancy-related causes than white women.  The COVID-19 pandemic has further exacerbated the nation’s maternal health crisis by negatively impacting social determinants of health, reducing access to care, and straining social support networks.

Medicaid Postpartum Coverage

Signed into law on March 11, 2021, the American Rescue Plan Act gives states the option to extend Medicaid postpartum coverage from 60 days to 12 months.  Under this new coverage option, participating states must provide full Medicaid benefits both during pregnancy and the extended post-partum period.  However, questions remain about the potential impact of the new coverage option, which does not go into effect until April 1, 2022 and only lasts for five years.  For instance, it is not known how many states will elect the postpartum coverage option, particularly those that have expanded Medicaid coverage.  The impact of the law in non-expansion states remains uncertain, as well.

Status of State Efforts to Expand Postpartum Coverage Beyond 60 Days

Source: Health Affairs

Mommy Bills in the Hopper

Additional efforts to bolster maternal health are underway in Congress.  Key legislation introduced so far includes:

  • The Maternal Health Momnibus Act (S. 346/H.R. 959).  This bill would promote maternal vaccinations, encourage innovative payment models to support high-quality maternal care, and improve data collection to better understand the drivers of poor maternal health.

MOMMA’s Act (S. 916/H.R. 1897).  This legislation would expand Medicaid and CHIP benefits for pregnant women to include oral health services, give states the option to extend SNAP benefits to women for two years postpartum, and establish Centers of Excellence on cultural competency training for health care providers.

  • The Maternal Health Quality Improvement Act (H.R. 4995).  This bill would require the Health Resources and Services Administration to establish programs aimed at improving maternal health care in rural areas, including physician training grant programs and grants for networks that can increase access and coordinate care for pregnant women.  The bill advanced in the House but failed to be enacted.

For his part, President Biden’s American Families Plan, while centered around childcare, education, and paid leave, will “invest in maternal health” according to a fact sheet.  The American Families Plan could ultimately provide a legislative vehicle, to enact maternal health proposals, much like the Medicaid postpartum coverage bill was attached to the American Rescue Plan.  

The Week in Review: May 10-14

CDC: Vaccinated Americans Do Not Need to Wear Masks Indoors, Outdoors          

On May 13, the CDC announced people fully vaccinated against COVID-19 do not need to wear masks indoors or outdoors.  However, the CDC still recommends individuals continue to wear masks while in large crowds or while riding in planes, trains, or buses.  The update comes as US virus cases reach their lowest rate since September 2020 and COVID-19 deaths reach their lowest point since April 2020.  However, some warn the new guidance is likely to cause confusion, as there is no simple way for businesses or others to determine an individual’s vaccination status.   

House GOP Replaces Cheney with Stefanik as Conference Chair

Republican members of the House of Representatives voted to remove Rep. Liz Cheney (R-WY) from her role as House Republican Conference on May 12 in a closed-door meeting.  The effort to remove Cheney from her House leadership role follows the Wyoming Congresswoman’s public criticism over former President Donald Trump.  On May 14, House Republicans voted to install Rep. Elise Stefanik (R-NY) as Cheney’s successor. While Stefanik has the backing of former President Trump, House Republican Leader Kevin McCarthy (R-CA), and House Republican Whip Steve Scalise (R-LA), some Republican members including Rep. Chip Roy (R-TX) have raised concerns over Stefanik’s moderate voting record.

Over 100 Republicans Threaten to Form Rival Party

Over 100 former Republican officials issued a joint statement on May 13 threatening to create an alternative party if current GOP elected officials continue to espouse falsehoods about the 2020 General Election.  Among the influential Republicans to sign the letter are former Republican National Committee Chairman Michael Steele, former Pennsylvania Governor Tom Ridge, and former Virginia Congresswoman Barbara Comstock.  The statement also outlines 13 core principles based on preserving democracy, supporting market-based economics, and maintaining ethical governance. 

Nominations for HHS Deputy Secretary, CMS Administrator Advance

On May 11, the confirmed 61-37 Andrea Joan Palm to serve as Deputy of Health and Human Services.  Palm previously served as Deputy Assistant Secretary of Health and Human Services under the Obama Administration and had most recently served as Secretary of the Wisconsin Department of Health Services.  Two days later, the Senate voted 51-48 to advance the nomination of Chiquita Brooks-LaSure to serve as Administrator of the Centers for Medicare and Medicaid Services.  Brooks-LaSure’s nomination was previously stalled due to a hold from Sen. John Cornyn (R-TX) in protest of the Biden Administration’s decision to rescind Texas’s Section 1115 Medicaid waiver.  The procedural vote to advance Brooks-LaSure’s nomination indicates she is likely to be confirmed soon.  Notably, Sens. Jerry Moran (R-KS) and Susan Collins (R-ME) joined Democrats in the vote to bring Brooks-LaSure’s nomination to the floor.

ICYMI: Jurisdictions Use Cash, Beer to Urge Vaccinations

Ohio Governor Mike DeWine (R) announced the state will give away $1 million each to five vaccinated Ohio residents as a way to entice more Ohioans to get vaccinated.  DeWine’s announcement comes as state and local governments are creating incentives to encourage more people to get their shots.  In Washington, DC, for instance, individuals who received a Johnson & Johnson vaccine at the Kennedy Center on May 4 were offered a free beer.  Additionally, West Virginia began offering a $100 savings bond for state residents aged 16-35 who receive a vaccine shot. 

The PHE Was Just Extended. What Does That Mean?

So, what exactly happens to those regulatory flexibilities and emergency measures when the pandemic ends?  On April 15, the Department of Health and Human Services (HHS) extended the PHE for a 90-day period beginning on April 21 and ending on July 19.  HHS won’t keep doing this forever – so what happens when the PHE is no longer renewed? 

The PHE So Far

HHS first declared the COVID-19 PHE on January 27, 2020, and HHS has since renewed the PHE four times, each for 90 days.  When Acting Health and Human Services Secretary Norris Cochran  sent a letter to state governors on January 21, 2021 estimating  the PHE will likely remain in place for the entirety of 2021,” many thought the current extension would run through the calendar year, but Secretary Xavier Becerra extended the PHE through July 19, following the pattern of 90-day renewals as stipulated by the Public Health Service Act.  The January 2021 letter indicated that when HHS decides to terminate the declaration and/or let the PHE expire, the Department will provide states with 60 days’ notice. 

When Will the PHE End?

Do you remember when President George W. Bush relayed the message that the war in Iraq was over during his famed aircraft carrier speech on May 1, 2003, and then the war continued for many years?  Is that what will happen with the PHE?

As it goes, there isn’t a requirement that  HHS outline any specific criteria to be met for the PHE to end.  The Health and Human Services Secretary has the option of declaring the PHE over, or he may simply not extend the current emergency.  For their part,  the American Health Care Association offered one suggestion – that the  PHE be lifted if roughly 70% of the population has been vaccinated, or less than 500 COVID-19 deaths have occurred for 14 consecutive days . 

Key Measures Linked to the PHE

Both Congress and the Administration have advanced key COVID-19 relief measures whose expiration dates are linked to the termination of the PHE.  Below is a list of pivotal relief measures and their central provisions.

  • Certain measures included in COVID-19 relief legislation.  Many policies tied to the PHE are included in the Families First Coronavirus Response Act, enacted March 18, 2020, the CARES Act, enacted March 27, 2020, and the American Rescue Plan Act, enacted March 11, 2021.  Some of these measures expire at the conclusion of the PHE, while others have a specific end date beyond the PHE, such as the one year or one calendar quarter after the termination of the PHE.  Key provisions include:
    • Enhanced coverage and no cost-sharing for COVID-19 testing and vaccines under Medicare, Medicare Advantage, Medicaid, CHIP, and TRICARE.
    • Waived or modified Medicare requirements for telehealth, such as the restriction on use of a telephone and the requirement for face-to-face visits between home dialysis patients and physicians.
    • Increased Medicaid federal match rate to 6.2%.
    • Waived site-neutral payment rate provisions for long-term care hospitals.
    • Continued payments to providers via the Medicare Hospital Accelerated Payment Program.
    • Recalculated Medicaid disproportionate share hospital allotment.
  • Temporary regulatory flexibilities under CMS.  In interim final rules published on March 31, May 8, September 2, and November 2, 2020, the Centers for Medicare and Medicaid Services (CMS) has relaxed numerous Medicare and Medicaid rules for the duration of the PHE.  Examples include testing and reporting requirements for long-term care facilities, enhanced Medicare reimbursement for certain COVID-19 treatments, and price transparency requirements for COVID-19 tests.  The interim final rules also include a number of telehealth provisions, with notable examples including:
    • Waived requirements on the types of practitioners that can furnish Medicare telehealth services to include all practitioners eligible for Medicare reimbursement, including physical therapists, occupational therapists, and speech language pathologists.   
    • Modified reporting requirements for remote physiological monitoring services.
    • Payment parity for audio-only telephone services.
    • Allowing hospitals to bill for services provided remotely by hospital-based practitioners to Medicare beneficiaries registered as outpatients.
    • Allowing teaching physicians to review services provided by resident physicians remotely via audio-visual communications technology.
  • Section 1135 Waivers.  Since the start of the pandemic, CMS has invoked Section 1135 waiver authority to issue a blanket waiver and a series of state-specific waivers that expand telehealth coverage, allow clinicians to practice across state lines, and suspend some reporting requirements.  All of these waivers are set to expire at the conclusion of the PHE.
  • HIPAA Enforcement.  The HHS Office of Civil Rights has relaxed certain HIPAA privacy rules for the duration of the PHE that apply to telehealth technologies, testing sites, and web-based scheduling platforms for COVID-19 vaccination appointments.  
  • Stark and Anti-Kickback Statute.  The HHS Office of the Inspector General has issued guidance discouraging enforcement of pandemic response activities until the end of the PHE that could be viewed as problematic under the anti-kickback statute and the Stark Laws. 
  • Controlled Substances. Both the Substance Abuse and Mental Health Services Administration and the Drug Enforcement Administration have issued guidance allowing more flexibility for providers and opioid treatment programs to prescribe controlled substances during the PHE.

Previewing a Post-PHE World

As vaccinations increase and jurisdictions gradually reopen, the fate of temporary policies that expire at the end of the PHE remains unclear.  Fortunately, recent actions by federal officials offer clues as to how some of temporary policies may be retained, particularly those relating to telehealth.  As expressed by then-CMS Administrator Seema Verma in December 2020, congressional action will be essential to ensuring expanded telehealth coverage and other flexibilities can be made permanent.  Since then, policymakers have been providing suggestions to lawmakers on what to do with telehealth after the PHE ends.  In its March 15, 2021 report to Congress, for example, the Medicare Payment Advisory Commission recommended continuing some telehealth flexibilities one to two years following the end of the PHE to evaluate whether the temporary policies should be adopted permanently.  The report also provided the following recommendations to Congress:

  • Continue Medicare coverage for telehealth services, regardless of a beneficiary’s location.
  • Discontinue allowing providers to reduce or waive cost-sharing for telehealth.
  • Continue coverage of audio-only services if there is a clinical benefit.

Additionally, members of Congress have put forth their own proposals to permanently expand telehealth.  Key legislation introduced so far includes:

  • H.R. 366, the “Protecting Access to Post-COVID–19 Telehealth Act of 2021,” introduced by Rep. Mike Thompson (D-CA), which would eliminate most geographic and originating site restrictions on the use of telehealth in Medicare and authorize CMS to continue reimbursement for telehealth for 90 days beyond the end of the PHE.
  • H.R. 787, the “Expanding Student Access to Mental Health Services Act,” introduced by Rep. Rick Allen (R-GA), which would permanently expand telehealth services for students.
  • H.R. 937, the “Tech to Save Moms Act,” introduced by Rep. Eddie Bernie Johnson (D-TX), which would integrate telehealth models into maternity care services.

While the federal government may not yet have a specific plan on how it intends to handle temporary regulatory flexibilities once the pandemic expires, recent action from legislators and policymakers suggest a desire to keep at least some policies around permanently. 

The Week in Review: May 3-7

Biden Announces Goal to Partially Vaccinate 70% by July 4

On May 4, President Biden announced a new goal to have 70% or more Americans with at least one shot of a COVID-19 vaccine and 160 million Americans fully vaccinated by July 4.  The President also announced a new vaccination strategy that will try to reallocate vaccine supply from states with weaker demand to areas with a stronger interest in shots.  At the moment, 57% percent of Americans have received at least one dose of a COVID-19 vaccine, while nearly 105 million are fully vaccinated.  While public health experts believe the Administration’s goal is attainable, pockets of vaccine hesitancy in the country present an obstacle. 

Pfizer, Moderna Vaccines Poised for Full FDA Approval

On May 7, Pfizer filed for full Food and Drug Administration (FDA) approval for its COVID-19 vaccine for people ages 16 to 85.  Earlier in the week, Moderna announced in its First Quarter 2021 earnings report plans to seek full FDA approval by the end of May for its COVID-19 vaccine for people ages 18 to 65.  Full approval would provide employers and organizations greater legal authority to require employees and students to get vaccinated. 

Federal Government Likely to Approve COVID Vaccine for Adolescents Next Week

On May 6, the CDC Advisory Committee on Immunization Practices (ACIP) announced it will hold meeting on May 12 vote on whether to extend the Emergency Use Authorization (EUA) for Pfizer’s COVID-19 for adolescents ages 12-15.  While ACIP’s decision is non-binding, the FDA is all but certain to follow through with the committee’s recommendation.  Many states have already begun allowing adolescents to register early for the vaccine, and President Biden has pledged that 20,000 pharmacy sites across the nation will be ready to vaccinate adolescents as soon as the FDA formally extends the EUA.  Pfizer is planning to seek an emergency use authorization for children ages 2 to 11 in September. 

Stefanik Soon to Succeed Cheney as House GOP Chair

Rep. Elise Stefanik (R-NY) is all but certain to succeed Rep. Lynne Cheney (R-WY) as Chair of the House Republican Conference after Cheney’s criticism of former President Trump and his role in the January 6th riot drew strong rebukes from prominent Republicans.  House Republican Leader Kevin McCarthy (R-CA) was recently caught on a hot mic saying he had “lost confidence” in Cheney, while House Republican Whip Steve Scalise (R-LA) and former President Trump have publicly backed Stefanik.  The New York Congresswoman, who served in the Bush White House and has been long considered a moderate in the GOP, rose to national prominence in her defense of the former President during his 2020 impeachment trial.  Many interpret Cheney’s ouster as a sign of Trump’s continued influence on the Republican Party.

ICYMI: Breyer Faces Calls to Retire

Some progressive groups and several members of Congress including Reps. Mondaire Jones (D-NY) and Jared Huffman (D-CA) are calling on 82-year-old US Supreme Court Justice Stephen Breyer to resign.  Their concerns over Breyer are likely rooted in the political fallout from the death of liberal Justice Ruth Bader Ginsburg, who was replaced by conservative Justice Amy Coney Barrett.  Some Democrats feel Breyer should retire while Democrats have control of the White House and Senate, meaning he could be replaced with another liberal-leaning justice.  However, Sen. Dianne Feinstein (D-CA), a member of the Judiciary Committee, has said it would be a “great loss” if Breyer opted to retire.

How to Rock the Virtual Hill Meeting

With things opening up soon, staff and members of Congress whom we talk to anticipate virtual meetings will continue.  This is because virtual meetings allow more efficient use of time for the members and staff, as well as the potential for greater participation from constituents and advocates who can’t travel to DC.  While not great for relationship building, virtual advocacy can be productive and definitely worth the time and effort.

Here are some tips —-

  • Platform choice goes to the member of Congress or staff.  Unlike most other professional settings, Hill still prefers telephone so don’t be surprised.  While more and more offices on Capitol Hill have adopted videoconferencing as their go-to platform for meetings, some individual staffers prefer phone calls.  Whatever the case, let the congressional staffer decide the best way to conduct a virtual meeting.
  • Send materials ahead of time.  3-4 page powerpoints are great.  You can email other advocacy papers too as attachments, but don’t except the people you’re meeting with to read it all ahead of time.
  • Use visual aids.  Don’t simply email a congressional staffer the handouts you’d otherwise share during an in-person meeting.  If you’re using a videoconferencing platform to conduct a meeting, there are more opportunities to convey your message, whether it be through images, a PowerPoint presentation, or videos.
  • Location, location, location.   With a virtual meeting, you have the chance to bring a legislator or a staffer into your world.  Consider broadcasting your virtual meeting from a safe location that helps to tell your story or convey your message.  For example, if you’re a health care provider, consider participating in a virtual meeting from your workplace, whether it be a hospital or another medical setting.  
  • Plan ahead and select a “meeting captain.”  Plan ahead what to say – it will make the virtual visit go smoother.  Create a few simple talking points, 3-4 messages you can make sure get across in your conversation.  If your virtual meeting contains multiple advocates, give each individual specific messages or issues to discuss so that everyone’s voice is heard.  If your meeting contains more than three advocates, consider designating someone as a “meeting captain” to introduce all participants and steer the overall conversation. 
  • Check your tech!  Familiarize yourself with Zoom and whichever other platforms you may be using to ensure that your message isn’t held back by any technical difficulties.  Make sure all links work appropriately and your devices handle whichever virtual meeting platforms you may be using.   If you supplied the dial-in number, check to see if you sent the correct passcode.

Even when the pandemic subsides, virtual meetings are likely to continue to play a role in advocacy.  Advocates who would otherwise be unable to travel to a legislator’s office due to geography or scheduling conflicts can make a difference by connecting virtually.  In time, virtual meetings may complement in-person meetings and serve to strengthen an overall advocacy message.

The “Dark Money” Pushing for Price Transparency

If you were one of the nearly 10 million people who tuned in to watch the 93rd Academy Awards on April 25, one television ad may have jumped out.  An organization called Power for Patients aired a 30-second spot featuring actresses Susan Sarandon and Cynthia Ervio that urged hospitals to follow through on a “law” requiring them to disclose their prices.  The law in question undoubtedly stems from a final rule issued in November 2019 that obligates hospitals, beginning January 1, 2021, to post comprehensive lists of various charges for all items and services.   This raises two questions: who is behind the ad, and why?

Dark Money and Health Care Advocacy

As of this writing, Power for Patients has yet to disclose which organizations covered the cost of its $2 million ad.  This suggests Power for Patients is a “dark money” entity, meaning the group receives funding from undisclosed donors to influence public opinion. 

Dark money isn’t new to health care advocacy.  In 2019, a group known as Doctor Patient Unity spent $28.6 million on ads aimed at thwarting legislation on surprise medical bills.  The ads, which aired during August recess, were targeted at legislation that would resolve out-of-network medical bills through benchmark rates set by the federal government.  Eventually, Doctor Patient Unity confirmed reports from the New York Times that physician staffing firms Envision Healthcare and TeamHealth were among the groups sponsoring the ads. 

Who’s Funding Power for Patients?

No one really knows yet who is funding Power for Patients, but recent activity in in DC may provide a clue.   On March 23, Marni Jameson Carey, Executive Director of the Association of Independent Doctors (AID), testified before a House Energy and Commerce Health Subcommittee hearing on legislation to expand health care coverage.  During the hearing, Carey said the price transparency rule has not been enforced as it stands, and that hospitals need to be held accountable.  Carey also spoke out against facility fees, which are often charged at clinics that are owned by hospitals to cover the costs of maintaining the facility.  It is also worth noting that Carey retweeted the Power for Patients ad on April 25.

Based in Florida, AID lists the elimination of facility fees and increased price transparency as its chief policy goals, both of which were discussed in Carey’s appearance before the Health Subcommittee.  Facility fees are required to be disclosed under the price transparency rule, and perhaps AID and independent physicians hope greater enforcement of the rule could shine a light on facility fees, raising questions from patients and potentially drumming up support for the total elimination of the fees.  AID’s website also lists several sponsors whose businesses center on providing services to independent physicians.  These sponsors include AdvancedMD, a billing solutions platform for independent practices, ISMIE Mutual Insurance Company, a medical liability insurer, and SVN Senior Commercial Real Estate, which specializes in medical real estate for independent physicians.  Given Carey’s testimony and IAD’s policy goals, it’s certainly plausible independent doctors and organizations with mutual interests could be donors to Power to Patients.

Lax Enforcement?

Beyond ending facility fees, Carey’s testimony on March 23 also included pleas to step up enforcement of the hospital price transparency rule, which carries a $300 a day penalty for noncompliance.  Indeed, multiple reports have found compliance among hospitals to be mixed.  A report conducted by consulting firm ADVI Health in January 2021 found less than half of 20 of the nation’s largest health systems were fully compliant with the price transparency law.  Additionally, a study from Health Affairs published in March 2021 found 65 of the nation’s 100 largest hospitals to be largely noncompliant. 

In cases where hospitals are compliant with the rule, pricing information can be difficult for consumers to find.  An analysis from consulting firm Milliman released in April 2021 found that while 37 of 55 major health systems were in compliance with the law, the pricing data itself were presented in a variety of ways, often without any supplemental documentation or in “very complex hierarchical structures.”  Similarly, the Wall Street Journal reported in March 2021 that some hospitals were using special coding on their website to keep pricing data hidden from search result.

Lawmakers and regulators are paying attention.  On April 13, bipartisan leaders of the House Energy and Commerce Committee sent a letter to Health and Human Services (HHS) Secretary Xavier Becerra urging HHS to conduct “vigorous oversight” and enforce “full compliance” of the final rule.  Additionally, a Center for Medicare and Medicaid Services spokesperson told Fierce Healthcare in March 2021 that the agency plans to enforce the rule.  However, in the absence of more widespread compliance, Power for Patients and its supporters may be using the ad campaign to generate public awareness that could pressure the federal government to step up enforcement. 

More Dark Money Ahead?

That said, the purpose of the price transparency rule was to make the health care system more consumer-friendly and give patients the option to compare prices.  However, by pushing for greater compliance and enforcement, stakeholders such as independent doctors may be using the rule to push patients toward non-hospital-based physician practices.   Isn’t it a little ironic that a group who is pushing for transparency not be transparent about their own organizational structure and donor base?