Healthcare Roundup: May 3, 2023

On the Hill

Senate Health, Education, Labor, and Pensions (HELP) Committee markup of several prescription drug bills – the Ensuring Timely Access to Generics Act of 2023, the Expanding Access to Low-Cost Generics Act of 2023, the Retaining Access and Restoring Exclusivity Act (RARE) Act, and the Pharmacy Benefit Manager Reform Act – was recessed until next Thursday, May 11, after Ranking Member Bill Cassidy (R-LA) raised procedural concerns with last-minute amendments proposed from Democrats. In his remarks, Sen. Cassidy stated, "I am informed that the Chair intends to support the inclusion of several policies as amendments during today’s markup that he and his staff had agreed to take off the table as part of the negotiated bipartisan deal that is essential to getting 60 votes on the Senate floor...However, as the leaders crafting and announcing this deal, there is an expectation that the Chair and I uphold the commitments we made to each other in the negotiating room. To me, this does not mean taking things off the table when we cannot reach agreement, only to circumvent our negotiation and push to include the very thing later as an amendment." Sen. Maggie Hassan (D-NH) had proposed:

as an amendment her bill, the Increasing Transparency in Generic Drug Applications Act (S. 775), to allow the Food and Drug Administration (FDA) to divulge specific ingredient ratios of brand name drugs to generic manufacturers;
as an amendment a bill, the Ensuring Access to Generic Medications Act (S. 1128), that would rein in patents for drugs when it’s discovered the drug works for an indication for which it was not originally studied;
as an amendment a bill, the Increasing Prescription Drug Competition Act (S. 574), that would block drugmakers from patenting safety protocols.

Sen. Tammy Baldwin (D-WI) also offered as an amendment a bill, the Fair Accountability and Innovative Research Drug Pricing Act of 2023 (S. 935), that would require drugmakers to publicly justify planned price increases that exceed 10 percent over the course of a year or 25 percent over three years. Some Senators, including Sens. Mitt Romney (R-UT) and Tim Kaine (D-VA), questioned holding a markup of the bills before a hearing next Wednesday that will include testimonies from top executives of major insulin manufacturers and pharmacy benefit managers (PBMs). HELP Committee Chairman Bernie Sanders (I-VT) said after the markup that the amendments offered by Sens. Hassan and Baldwin are “strong amendments to lower the cost of prescription drugs, which I and a number of Republicans on the committee strongly support. Unfortunately, there was a difference of opinion on the process to include these amendments.”

In a letter to the President, Sen. Sanders warned that he would vote against "any future nominee to a major federal health agency who is not prepared to significantly lower the price of prescription drugs in this country." Noting that there are several strategies the Federal Government can use to substantially lower the cost of prescription drugs, the Senator said that the "time is long overdue for fundamental changes in the way that federal agencies...relate to drug companies."

Ahead of a Senate Finance Committee hearing today on mental health care provider directory, Committee Democratic staff released a study finding that more than 80% of the listed, in-network, mental health providers within the Medicare Advantage (MA) program were considered "ghost networks" as they were either unreachable, not accepting new patients, or not in-network. The Democratic staff conducted a brief secret shopper study to examine the extent of mental health provider ghost networks in the MA program. Staff reviewed directories from 12 different plans in a total of 6 states, calling 10 selected providers from each plan, for a total of 120 calls. Of the total 120 provider listings contacted by phone, 33% were inaccurate, non-working numbers, or unreturned calls. Staff could only make appointments 18% of the time. The report called for the Centers for Medicare and Medicaid Services (CMS) to increase its oversight efforts to audit health plan directories to ensure they hold MA plans accountable for these directories and for accurately documenting their networks. In addition, the report recommended that Congress require additional steps to ensure provider directory accuracy including regular audits, transparency, and financial penalties for non-compliance.

Senate Finance Committee Chairman Ron Wyden (D-OR) and Sen. Michael Bennet (D-CO) introduced the Better Mental Health Care for Americans Act, legislation aimed at expanding access to mental and behavioral health care for Medicare, Medicare Advantage, Medicare Part D, and Medicaid beneficiaries. Specifically, the bill would:

Require parity for mental and behavioral health services in Medicare Advantage, Medicare Part D, and Medicaid;
Ensure that Medicare Advantage plans maintain accurate and updated provider directories so beneficiaries understand who is in-network;
Encourage mental and behavioral health integration with physical care by increasing reimbursement rates for Medicare and Medicaid;
Establish a demonstration project to increase access to integrated mental and behavioral health care for children across different settings, like schools;
Increase accountability and oversight of integrated mental and behavioral health care under Medicare, Medicaid, and private health insurance plans; and
Require the CMS to develop and implement plans to better align payments, measure access and quality, and improve prevention services for mental and behavioral health care.

The Senators noted that the 2008 Mental Health Parity and Addiction Equity Act extended mental and physical health care parity to private and employer-provided plans, but government plans through the Centers for Medicare and Medicaid Services (CMS) were not subject to this requirement.

House Oversight and Accountability Committee Chairman James Comer (R-KK) and Senator Ron Johnson (R-WI) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure renewing their request for information on what safeguards CMS has in place to address improper payments in the Medicaid program. Last year, the lawmakers sent a letter noting that the reported improper payments rate of 15.62 percent is likely too low as some estimates show that 27 percent, or more than $100 billion annually, could be improper. And last month, Rep. Comer sent a letter to CMS requesting information related to reducing improper payments in Medicaid redeterminations after the unwinding of pandemic-era provisions. Rep. Comer also sent a letter requesting the Government Accountability Office (GAO) review actions the CMS can take to coordinate with state auditors and improve Medicaid program integrity. Noting reports that as much as 95 percent of improper payments were a direct result of eligibility errors, Rep. Comer and Sen. Johnson said that these eligibility errors are exacerbated by inconsistent data collection and retention policies. As a result, "some states, like California, abuse the inconsistency, enabling artificially low error rates even though the Department of Health and Human Services (HHS) Inspector General (IG) found that more half of the enrollees in their Medicaid program were ineligible."

At the Agencies

The Centers for Medicare and Medicaid Services (CMS) issued two proposed rules, Ensuring Access to Medicaid Services and Managed Care Access, Finance and Quality, that would establish national standards for timely access to care for Medicaid managed care organizations and establish new payment transparency requirements in fee-for-service and managed care programs. According to CMS, the rules also proposes standards to allow enrollees to easily compare plans based on quality and access to providers through the state’s website. Other highlights from the proposed rules include:

Establishing national maximum standards for certain appointment wait times for Medicaid or CHIP managed care enrollees, and stronger state monitoring and reporting requirements related to access and network adequacy for Medicaid or CHIP managed care plans;.
Requiring states to conduct independent secret shopper surveys of Medicaid or CHIP managed care plans to verify compliance with appointment wait time standards and to identify where provider directories are inaccurate.
Creating new payment transparency requirements for states by requiring disclosure of provider payment rates in both fee-for-service and managed care, with the goal of greater insight into how Medicaid payment levels affect access to care.
Strengthening how states use state Medical Care Advisory Committees, through which stakeholders provide guidance to state Medicaid agencies about health and medical care services, to ensure all states are using these committees optimally to realize a more effective and efficient Medicaid program that is informed by the experiences of Medicaid beneficiaries, their caretakers, and other interested parties.
Requiring states to conduct enrollee experience surveys in Medicaid managed care annually for each managed care plan to gather input directly from enrollees.
Establishing a framework for states to implement a Medicaid or CHIP quality rating system, a “one-stop-shop” for enrollees to compare Medicaid or CHIP managed care plans based on quality of care, access to providers, covered benefits and drugs, cost, and other plan performance indicators.

In addition, CMS touted its proposals to advance the President's Executive Order on Increasing Access to High-Quality Care and Supporting Caregivers by improving access to, and the quality of home and community-based services (HCBS). The proposed changes would strengthen necessary safeguards to ensure health and welfare, promote health equity for people receiving Medicaid‑covered HCBS, and achieve a more consistent and coordinated approach to the administration of policies and procedures across Medicaid HCBS programs, according to CMS. Specifically, the proposed rule would:

Establish a new strategy for oversight, monitoring, quality assurance, and quality improvement for HCBS programs;
Strengthen person‑centered service planning and incident management systems in HCBS;
Require states to establish grievance systems in FFS HCBS programs;
Require that at least 80% of Medicaid payments for personal care, homemaker, and home health aide services be spent on compensation for the direct care workforce (as opposed to administrative overhead or profit);
Require states to publish the average hourly rate paid to direct care workers delivering personal care, home health aide, and homemaker services;
Require states to establish an advisory group for interested parties to advise and consult on provider payment rates and direct compensation for direct care workers;
Require states to report on waiting lists in section 1915(c) waiver programs; service delivery timeliness for personal care, homemaker and home health aide services; and a standardized set of HCBS quality measures; and
Promote public transparency related to the administration of Medicaid‑covered HCBS through public reporting of quality, performance, and compliance measures.

The rules have a 60-day public comment period.

CMS announced a policy extension providing flexibilities under the Medicare Diabetes Prevention Program (MDPP) beyond the public health emergency (PHE) declaration – scheduled to end May 11 – through the end of 2023. In the December 2020 physician fee schedule final rule, CMS allowed MDPP suppliers to suspend in-person delivery of services during the PHE and provided telehealth flexibilities and alternatives to the in-person weight measurements requirement, like using scales that transmit weights securely via wireless or cellular transmission or via self-reported weight measurements. In the notice announcing the extension, CMS stated, "Given the 3-year duration of the COVID-19 PHE, we anticipate that MDPP suppliers will need time following the end of the COVID-19 PHE to resume in-person services for reasons that may include securing an available physical location that meets organizational and beneficiary needs, recruiting coaches, educating new and existing beneficiaries about in-person sessions, and adjusting messaging regarding the delivery modality of MDPP." Based on feedback, CMS said that it anticipated that MDPP suppliers may require at least 6 additional months to adequately prepare to resume in-person services from an operational perspective. The extension will also allow the agency to consider doing additional rulemaking for the diabetes prevention program.

In the News

Wall Street Journal: Patients Lose Access to Free Medicines Amid Spat Between Drugmakers, Health Plans

The Hill: Effort to lower drug prices gets off to rocky start

Roll Call: House, Senate craft separate health care packages