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July 2024
In this issue we feature:
New Progress on HR 5526: Seniors’ Access to Critical Medications Act
On June 12, LUGPA’s DC staff received an important call from Ranking Member Pallone’s team. We were informed that Ranking Member Pallone would support HR 5526, the Seniors’ Access to Critical Medications Act if several modest changes we suggested were incorporated. LUGPA’s team also worked with bill sponsors and Majority staff to resolve CBO scoring concerns. The bill was subsequently unanimously reported out of the full House Energy & Commerce Committee 41-0. This is a significant milestone following successful negotiations between the Chairwoman and Ranking Member Pallone, which resulted in revised language for the bill.
The revised bill proposes a 5-year waiver of the Stark law, allowing practices to mail medications directly to their patients. This waiver requires an annual in-person visit and includes a CMS study to monitor its impact on utilization and costs. Notably, the bill is not restricted to any specific disease state, addressing a concern we raised during earlier discussions.
This progress marks a significant victory for LUGPA’s advocacy efforts, demonstrating the effectiveness of our collective efforts. We are optimistic that following the committee markup, the bill will advance to the House floor for a vote this summer and potentially be included in a year-end healthcare package.
Advocacy for Delaware’s No-Cost Prostate Cancer Screening Bill (HB 302)
In early June, LUGPA joined a coalition letter supporting Delaware's no-cost prostate cancer screening bill, HB 302. The bill’s authors have requested that our coalition send a letter to Governor Carney, urging him to sign the bill into law. Although the Delaware Senate unanimously voted our bill through on June 20th, there is uncertainty regarding the Governor's support. We are continuing our advocacy efforts to urge the Governor to sign the bill.
Hearing on the 340B Drug Pricing Program
On June 4, the House Energy & Commerce’s Oversight & Investigations Subcommittee held a hearing titled “Oversight of the 340B Drug Pricing Program.” This hearing examined the program, now the second-largest government pharmaceutical program behind Medicare Part D.
There was bipartisan acknowledgment of the program’s original intent to serve low-income and uninsured populations. However, concerns were raised about misuse, with Republicans criticizing some hospitals for not passing on discounts to patients or being transparent about the program’s benefits. Additionally, discussions highlighted the issue of healthcare consolidation and the competitive disadvantage independent physicians face.
Topics included the impact of manufacturer restrictions on contract pharmacies and increased pricing of Rx drugs on 340B growth. Reform suggestions included increased transparency, reporting requirements, and the establishment of a unified definition of a 340B patient. Many discussions revolved around Rep. Bucshon’s 340B Access Act (H.R. 8574).
In late March, working with our allies in the Community Practice Coalition, LUGPA composed and circulated a letter to Senate healthcare leaders, urging their endorsement of crucial reforms to the 340B Program. Our recommendations encompass limiting 340B eligibility for hospital-acquired physician practices, tying Medicare payments to acquisition costs, and enforcing charity care minimums while refining patient criteria for targeted assistance.
Reintroduction of the Improving Seniors’ Timely Access to Care Act
In June, Congress reintroduced the Improving Seniors’ Timely Access to Care Act, which aims to streamline the prior authorization process under Medicare Advantage (MA) plans, allowing older Americans to receive the care they need more quickly. This legislation is designed to help healthcare providers prioritize patient care over administrative paperwork, addressing one of the leading causes of administrative burden in the healthcare system.
Prior authorization requires healthcare providers to obtain pre-approval from health plans before delivering specific services, products, or medications. This process can result in communication lapses between clinicians and insurance companies, leading to longer patient wait times.
The new legislation seeks to mitigate these issues by:
- Establishing an electronic prior authorization process for MA plans, including standardization for transactions and clinical attachments.
- Increasing transparency around MA prior authorization requirements and their use.
- Clarifying CMS authority to establish timeframes for electronic prior authorization requests, including expedited determinations and real-time decisions for routinely approved items and services.
- Expanding beneficiary protections to improve enrollee experiences and outcomes.
- Mandating reports to Congress on program integrity efforts and other ways to improve the electronic prior authorization process further.
LUGPA's Position on Prior Authorization:
LUGPA has consistently opposed prior authorization policies, arguing that they create barriers to timely and appropriate patient care. Such policies delay treatment, negatively impacting patients' mental health and quality of life. LUGPA supports legislation that removes these barriers and opposes step therapy and other restrictions on drug access.
Supreme Court Overturns Chevron Deference for Federal Agencies
On June 28, the Supreme Court made a significant ruling in Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce, overturning the long-standing Chevron Doctrine. Established in 1984, Chevron required courts to defer to federal agencies' interpretations of ambiguous statutes. Chief Justice Roberts, leading a 6-3 decision, declared Chevron overruled, emphasizing the judiciary's role in independently assessing agency actions under the Administrative Procedure Act (APA).
Impact on Healthcare Policy:
- Regulatory Flexibility: Healthcare agencies like HHS face increased scrutiny in regulatory interpretations, potentially leading to more cautious rulemaking.
- Judicial Review: Courts can now scrutinize agency decisions more rigorously, affecting healthcare policy outcomes and allowing for challenges to regulatory changes.
- Stability and Change: Existing regulations remain valid, but future interpretations face stricter judicial scrutiny, potentially hindering rapid policy changes.
Overturning Chevron prompts HHS to adopt more cautious policies to avoid judicial challenges. Healthcare stakeholders can now challenge policies more effectively, fostering a fairer regulatory environment but requiring careful navigation of new legal landscapes.
This landmark ruling signals a shift in administrative law, urging stakeholders to engage in strategic planning for future regulatory actions amidst evolving judicial standards.
HHS Issues New Final Rule on Information Blocking
As part of the 21st Century Cures Act, HHS has issued a final rule to address information blocking by healthcare providers. The rule introduces penalties for providers who obstruct access to, exchange or use electronic health information (EHI).
Key Disincentives:
- Medicare Promoting Interoperability Program:
- Hospitals and Critical Access Hospitals (CAHs) found to be blocking information will lose their meaningful EHR user status, affecting Medicare payments.
- Merit-based Incentive Payment System (MIPS):
- MIPS-eligible clinicians and group practices guilty of information blocking will receive a zero score in the MIPS Promoting Interoperability category, impacting their financial rewards.
- Medicare Shared Savings Program:
- ACOs and related entities involved in information blocking may face a one-year ineligibility for the program, resulting in potential revenue loss.
Implementation Timeline:
- Disincentives take effect 30 days after publication in the Federal Register, except for Medicare Shared Savings Program penalties, effective January 1, 2025.
- No retroactive investigations for pre-effective date information blocking.
Regulatory Approach:
- CMS will apply disincentives with discretion, considering the severity and duration of information blocking and efforts to rectify it.
- Investigations will prioritize cases harming patients, disrupting care, or causing financial losses.
This rule aims to improve patient care coordination and efficiency by ensuring the accessibility and exchange of electronic health information. LUGPA members should ensure compliance to avoid penalties and disruptions in program participation.
HHS Reduces Prices on 64 Prescription Drugs Through Medicare Rebate Program
In June, the Centers for Medicare & Medicaid Services (CMS) announced that Medicare enrollees would pay less for 64 prescription drugs from July through the end of September due to drug companies raising prices faster than the rate of inflation. This discount, a result of the Inflation Reduction Act (IRA), includes medications for osteoporosis, cancer, and infections, potentially saving over 750,000 enrollees up to $4,593 daily.
Notable drugs in this round of cost reductions include Padcev, which is used to treat bladder cancer, and Crysvita, which treats a genetic disorder causing impaired growth. Additionally, urology-related drugs like Prolia and Xiaflex are also included.
Starting in 2025, out-of-pocket prescription drug costs will be capped at $2,000, relieving financial pressure on seniors. While the Biden administration celebrates these provisions, conservative groups and some political adversaries argue that price restrictions could stifle innovation and manufacturing. Republican lawmakers have recently received a letter urging Congress to repeal the IRA’s drug pricing provisions. Accountable.US, a nonpartisan watchdog, noted that PhRMA, a lobbying group for the pharmaceutical industry, has contributed nearly $1 million to conservative organizations opposing the IRA.
With these changes in mind, starting discussions with distributors is crucial to ensure there are no financial losses on any buy-and-bill drugs. This proactive approach will help maintain stability and ensure patients receive essential medications without disruption.
LUGPA Signs on to Coalition Letter Supporting Site-Neutrality Bill
In early July, LUGPA signed a new coalition letter supporting the SITE Act, a bill introduced by Senators Maggie Hassan, Mike Braun, and John Kennedy to address rising healthcare costs driven by hospital consolidation. Hospital prices comprise a significant portion of healthcare spending and have surged due to increased hospital acquisitions of physician practices.
This consolidation often leads to higher prices for patients receiving care in hospital-owned settings than in independent offices, such as a threefold increase in chemotherapy costs. The SITE Act proposes two main reforms:
- Ending Dishonest Billing: The bill would prohibit hospitals from billing patients at higher hospital rates for services performed at newly acquired doctor's offices. This practice, known as "dishonest billing," significantly increases out-of-pocket patient costs and contributes to higher healthcare premiums and deductibles.
- Implementing Site Neutral Payment: The SITE Act advocates for Medicare to reimburse healthcare providers equally for the same services, regardless of whether they are provided in hospital-owned clinics or independent offices. This reform is projected to save taxpayers $140 billion over a decade and reduce Medicare beneficiaries' premiums and cost-sharing by $94 billion.
These measures are designed to promote fairer billing practices and reduce healthcare costs for patients, seniors, employers, and taxpayers.
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