Healthcare Roundup: October 1, 2021

In the Lede

Congress passed – and the President signed into law – a short-term continuing resolution (CR) to avoid a government shutdown and fund government operations through December 3, while also providing $28.6 billion in disaster relief and $6.3 billion to support Afghan evacuees. The House in July passed nine of the 12 mandatory spending bills, but at allocations Republicans oppose because funding increases are heavily weighted to non-defense programs. The Senate Appropriations Committee has approved only three appropriations bills and hasn't reached agreement on overall subcommittee allocations. Suspension of the debt ceiling limit was not included in the CR as Senate Republicans continued to force Democrats to try to lift the limit on their own. The Treasury Department estimates it has until about Oct. 18 before needing to severely curtail federal spending virtually across the board. Earlier this week, the House passed, along a mostly party-line vote of 219-212, a stand-alone debt limit bill, which would suspend the borrowing cap until after the mid-term elections on Dec. 17, 2022. Republicans have argued that Democrats be responsible for lifting the debt limit on their own since Democrats are working on a $3.5 trillion reconciliation package to implement the President's Build Back Better domestic agenda covering climate change, health care, and other social programs. Democratic leadership, however, have struggled to cobble together an agreement between competing interests within the Democratic caucus. Moderate Democratic Sens. Joe Manchin (D-WV) and Kyrsten Sinema (D-AZ) have raised concerns with the $3.5 trillion domestic package, while House progressive Democrats continued to use the $1.2 trillion infrastructure package that passed the Senate in August as leverage to push through the domestic agenda package. Despite a promise to moderates to put a vote on the $1.2 trillion infrastructure bill for a vote earlier this week, House Speaker Nancy Pelosi (D-CA) has been forced to delay floor action as progressives threatened to vote against the bill until a clear framework agreement on the reconciliation package has been reached. In addition to the topline figure for the reconciliations package – Sen. Manchin has declared that he would not support a bill that cost more than $1.5 trillion – lawmakers continued to fight over a slew of competing health care priorities, including:

Addressing the Medicaid coverage gap for individuals living in states that have not expanded coverage through the Affordable Care Act.
Expanding Medicare coverage to include dental, hearing and vision benefits – a top priority for Senate Budget Committee Chairman Bernie Sanders (I-VT).
Covering home and community-based services.
Extending the enhanced Affordable Care Act tax credits.

In addition, Democrats have struggled to come to an agreement on the scope of Medicare pricing negotiation aimed at lowering the cost of prescription drugs – with potential savings driving what Medicare, Medicaid and Affordable Care Act reforms can be squeezed into the reconciliation package.

On the Hill

House Judiciary Committee approved four drug patent bills aimed at lowering the cost of prescription drugs by enhancing competition of generic drugs and biosimilars:

The Stop Stalling Access to Affordable Medications Act (H.R. 2883), legislation that would prohibit the abuse of citizen petitions by branded-drug companies to keep lower-cost generic competitors off the market.
The Preserve Access to Affordable Generics and Biosimilars Act (H.R. 2891), legislation that would prohibit anti-competitive settlements, also called pay-for-delay agreements, that block access to affordable prescription drugs.
The Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (H.R. 2873), legislation that would end product hopping, an abusive tactic that involves making a minor change to a product that is facing the end of patent exclusivity – such as a change to its dosage or delivery mechanism – to avoid generic competition.
The Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act (H.R. 2884), legislation that would limit the number of patents that a brand-name manufacturer can assert in litigation, which forces the manufacturer to focus on its key patents with the goal of streamlining the resolution of disputes with companies that want to sell biosimilar versions of that biologic.

Drug patent reforms are also included in the Administration's September comprehensive plan for addressing high drug prices by accelerating generic and biosimilar competition, including shortening exclusivity periods and banning pay-for-delay agreements and other tactics drug makers use to stall generic and biosimilar competition.

The Bipartisan Addiction and Mental Health Task Force, led by Reps. Annie Kuster (D-NH), Brian Fitzpatrick (R-PA), David Trone (D-MD), and Jaime Herrera Beutler (R-WA), unveiled the Task Force’s 2021 Legislative Agenda. The comprehensive approach outlines ongoing bipartisan efforts in Congress to address the dual addiction and mental health public health crises that have been exacerbated by the COVID-19 pandemic. The 2021 Legislative Agenda outlines steps Congress can take to address the ongoing mental health and substance use crisis by:

Increasing access to recovery resources.
Ending the stigma surrounding addiction and mental health.
Building the public health infrastructure needed to address the addiction crisis.
Creating safeguards against the flow of dangerous drugs in our communities.

The agenda includes 66 bills and one resolution in different stages of the legislative process and have varying numbers of co-sponsors. Last week, Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) launched an effort to develop bipartisan legislation to address barriers to mental health care.

At the Agencies

The Substance Abuse and Mental Health Services Administration (SAMHSA) announced the awarding to $825 million in grants to 231 Community Mental Health Centers (CMHCs) to support and expand access to mental health and behavioral support as Americans continue to confront the impact of the COVID-19 pandemic. CMHCs are community-based facilities or groups of facilities that provide prevention, treatment, and rehabilitation mental health services. This grant program will enable CMHCs to more effectively address the needs of individuals who have a serious emotional disturbance (SED) or serious mental illness (SMI), as well as individuals with SED or SMI and substance use disorders, referred to as a co-occurring disorder (COD). SAMHSA is requiring the 231 CMHCs to develop a behavioral health disparities impact statement no later than 60 days after receiving their grant awards; to develop a quality-improvement plan to address under-resourced populations’ differences based on access, use and outcomes of service activities; and to identify methods for the development of policies and procedures to ensure adherence to the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care. The CMHCs also must provide services that include:

Audio and audio-visual, HIPAA-compliant telehealth capabilities.
Outpatient services for individuals with SED, SMI, and COD in service areas.
Trauma-informed screening, assessment, diagnosis and patient-centered treatment planning and treatment delivery.
Clinical and recovery support services (e.g., psychosocial rehabilitation, case management services and peer support).
Resources to address the mental health needs of CMHC staff.

Allowable services under the grant include:

Training behavioral health professionals to work with schools to address behavioral health issues for school-age youth at risk for SED, including attention to services that address the needs of children, particularly as it pertains to school reentry.
Providing staff training on behavioral health disparities, including for building cultural and linguistic competence and on using strategies to engage and retain diverse client populations.
Expanding capacity and availability of crisis beds.
Expanding mobile crisis mental health services for target populations.
Developing and implementing outreach strategies and referral pathways for vulnerable populations, such as minority populations and individuals residing in economically disadvantaged communities.
Training and supporting peer staff to serve as integral members of the team to address mental health needs that may have arisen because of the pandemic – including but not limited to trauma, grief, loneliness and isolation.

The Departments of Health and Human Services (HHS), Labor (DOL), Treasury, and the Office of Personnel Management (OPM) issued an interim final rule – the third in a series to further implement the No Surprises Act and curb the practice of surprise medical billing. According to the Administration, the rule details a process that will take patients out of the middle of payment disputes, provides a transparent process to settle out-of-network (OON) rates between providers and payers, and outlines requirements for health care cost estimates for uninsured (or self-pay) individuals. Other consumer protections in the rule include a payment dispute resolution process for uninsured or self-pay individuals. It also adds protections in the external review process so that individuals with job-based or individual health plans can dispute denied payment for certain claims. Specifically, the "Requirements Related to Surprise Billing; Part II" interim final rule:

Establishes the federal independent dispute resolution process that OON providers, facilities, providers of air ambulance services, plans, and issuers in the group and individual markets may use to determine the OON rate for applicable items or services after an unsuccessful open negotiation.
Requires provider or facility to provide a good faith estimate of expected charges for items and services to an uninsured (or self-pay) individual of expected charges for the items or services that are reasonably expected to be provided together with the primary item or service, including items or services that may be provided by other providers and facilities.
Establishes a patient-provider dispute resolution process to determine a payment amount in a situation where an uninsured (or self-pay) individual receives a good faith estimate and then is billed for an amount substantially in excess of the good faith estimate.
Expands the scope of adverse benefit determinations eligible for external review to include determinations that involve whether a plan or issuer is complying with the surprise billing and cost-sharing protections under the No Surprises Act and its implementing regulations.

Before initiating the federal independent dispute resolution process, disputing parties must initiate a 30-day “open negotiation” period to determine a payment rate. In the case of a failed open negotiation period, either party may initiate the federal independent dispute resolution process, which requires:

Parties to jointly select a certified independent dispute resolution entity, who must attest that they have no conflicts of interest with either party.
The Departments to select a certified independent dispute resolution entity if the parties cannot jointly select a certified independent dispute resolution entity or if the selected certified independent dispute resolution entity has a conflict of interest.
The certified independent dispute resolution entity to then issue a binding determination selecting one of the parties’ offers as the out-of-network (OON) payment amount.
Both parties to pay an administrative fee ($50 each for 2022), and the non-prevailing party is responsible for the certified independent dispute resolution entity fee for the use of this process.
The certified independent dispute resolution entities to begin with the presumption that the qualifying payment amount (QPA) is the appropriate OON amount when making a payment determination.
The certified independent dispute resolution entity to consider credible, additional information submitted by either party.
Any information submitted to clearly demonstrate that the value of the item or service is materially different from the QPA for the independent dispute resolution entity to deviate from the offer closest to the QPA.

In early September, the Departments and OPM issued a rule to help collect data on the air ambulance provider industry, while the Administration issued a rule in July on consumer protections against surprise billing. Collectively, these rules take effect January 1, 2022, and ban surprise billing for emergency services, as well as certain non-emergency care provided by OON providers at in-network facilities, and limit high OON cost-sharing for emergency and non-emergency services for patients. The interim final rule has a 60-day public comment period.

The Centers for Medicare & Medicaid Services (CMS) released the 2022 premiums, deductibles and other key information for Medicare Advantage and Part D prescription drug plans in advance of the annual Medicare Open Enrollment. The average premium for Medicare Advantage plans will be lower in 2022 at $19 per month, compared to $21.22 in 2021, while projected enrollment continues to increase. As previously announced by CMS in July, the average 2022 premium for Part D coverage will be $33 per month, compared to $31.47 in 2021. Enrollment in Medicare Advantage in 2022 is projected to reach 29.5 million people compared to 26.9 million enrolled in a Medicare Advantage plan in 2021. Medicare Advantage plans will continue to offer a wide range of supplemental benefits in 2022, including eyewear, hearing aids, both preventive and comprehensive dental benefits, access to meals (for a limited duration), over-the-counter items, fitness benefits and worldwide emergency/urgent coverage. In addition, the percentage of plans offering special supplemental benefits for chronically ill individuals will increase from 19% to 25%. CMS indicated that it will continue to test the Part D Senior Savings Model in more than 2,100 plans in 2022, increasing access and affordability to select insulins for seniors. Over 500 new Medicare Advantage and Part D prescription drug plans, and two new pharmaceutical manufacturers of insulin, are joining the model this year to provide even more opportunities for eligible seniors to reduce their out-of-pocket spending on insulin. Additionally, CMS announced that more than 1,000 Medicare Advantage plans will participate in the CMS Innovation Center’s Medicare Advantage Value-Based Insurance Design (VBID) Model in 2022, which tests the effect of offering a projected 3.7 million people customized benefits that are designed to better manage their disease(s) and meet a wide range of social needs, from food insecurity to social isolation. The VBID Model’s Hospice Benefit Component, now in its second year, will also be offered by 115 Medicare Advantage plans in portions of 22 states and U.S. territories and provides enrollees increased access to palliative and integrated hospice care. Medicare Open Enrollment begins on October 15, 2021, and ends on December 7, 2021. During this time, people eligible for Medicare can compare 2022 coverage options between Original Medicare, and Medicare Advantage and Part D prescription drug plans.

The Department of Health and Human Services (HHS) awarded nearly $1 billion, through the American Rescue Plan (ARP), in funding to nearly 1,300 Health Resources and Services Administration (HRSA) Health Center Program-funded health centers in all 50 states, the District of Columbia, and the U.S. territories to support major health care construction and renovation projects. Health centers will use this funding for COVID-19-related capital needs, constructing new facilities, renovating and expanding existing facilities to enhance response to pandemics, and purchasing new state-of-the-art equipment, including telehealth technology, mobile medical vans, and freezers to store vaccines. The funds will be awarded to health centers that serve medically underserved and other vulnerable populations and communities, which are disproportionately affected by COVID-19 and other health conditions. By constructing new facilities or renovating and expanding existing facilities, health centers will ensure that these communities will have more equitable access to high-quality primary health care. More than 91 percent of health center patients are individuals or families living at or below 200 percent of the Federal Poverty Guidelines and nearly 63 percent are racial/ethnic minorities.

In the News

Politico: Biden admin releases new protections shielding patients from 'surprise' bills; Democrats dial back drug-pricing plans to win over moderates

Kaiser Health News: As Democrats Bicker Over Massive Spending Plan, Here’s What’s at Stake for Medicaid

Axios: The U.S. is the drug industry's gold mine

The Hill: Dental coverage for Medicare recipients divides parties; Clyburn: 'UnAmerican' not to prioritize Medicaid expansion in spending package