Health Policy Report – September 13, 2022

The Network Submits Comments to CMS on the Physician Fee Schedule Proposed Rule
On September 6, The US Oncology Network submitted formal comments to the Centers for Medicare & Medicaid Services (CMS) in response to the CY 2023 Physician Fee Schedule (PFS) proposed rule. If implemented as proposed, the rule would lead to a 4.4% decrease in the conversion factor at a time of unprecedented challenges.

In its comment letter, the Network pointed out that the 4.4% cuts are extremely harmful to community cancer care providers as the United States faces the highest inflation rate in over 40 years (9.1 % as of June 2022). The Network cited a recent Avalere analysis that found that the conversion factor has increased a mere 12.5% since being introduced in 1992, while overall inflation has soared by 101.9% during the same period. The failure for the PFS to keep up with inflation, and its failure to account for the costs of many specialized oncology resources, make it difficult for community oncology practices to remain financially sustainable. 

The Network pointed out that the proposed PFS, if finalized, would exacerbate the payment disparities across sites of service since the rates governed by the Hospital Outpatient Prospective Payment System have actually been increasing. As a result, Medicare currently spends roughly 50% more for the exact same radiation oncology services provided in the hospital outpatient setting than those provided in an independent oncologist’s office. The Network states that the growing disparity across sites is unsustainable, encourages vertical integration, hurts patients’ access to care, and actually increases cost to the Medicare system and patients in the long run.  

In recent years, Congress has acted to offset PFS cuts, most recently providing a 3% increase in 2022, which is set to expire on December 31. Unless addressed again, the proposed cuts would exacerbate existing challenges in cancer care including workforce challenges, delays in screening, increased therapeutic complexity, and increasing risk of comorbid illness for patients with cancer. The Network urged CMS to work closely with Congress to address these looming fiscal challenges by providing a positive adjustment to the PFS conversion factor, waiving the statutory 4% Pay-As-You-Go (PAYGO) Act requirement, and providing inflationary relief.

To read the Network’s comment letter to CMS on the proposed rule, CLICK HERE.

To read the proposed rule, CLICK HERE.

To read the Avalere study on how statutory management of healthcare inflation impacts providers, CLICK HERE.

President Biden Delivers Historic Speech on Cancer Moonshot Initiative Alongside his Nominee to Lead ARPA-H

On September 12, President Biden delivered a speech about his signature Cancer Moonshot initiative, which aims to cut cancer death rates over the next 25 years in half. The speech, which was held at the John F. Kennedy Presidential Library and Museum on the 60^th anniversary of President Kennedy’s iconic “moonshot” address, outlined the Biden administration’s efforts to prevent cancer and improve oncological treatment. 

Specifically, the President highlighted more than $200 million in Centers for Disease Control and Prevention (CDC) grants to help advance cancer screening programs; the new, voluntary Enhancing Oncology Model; and Department of Veterans Affairs rulemaking efforts to add specific rare respiratory cancers to its list of presumed service-connected disabilities related to toxic exposure. In the lead-up to the speech, the White House announced the President will sign an executive order to establish the National Biotechnology and Biomanufacturing Initiative, which will help support grow domestic capacity for cutting-edge biotechnologies and drive research and development into innovative new therapies. 

“The goal is to cut cancer death rates by 50% — at least 50% — in the next 25 years. To turn more cancers from death sentences into chronic diseases people can live with, to create more supportive experiences for patients and families,” President Biden said during his speech.

President Biden was joined for the speech by Dr. Renee Wegrzyn, his nominee to be the first ever director of the Advanced Research Projects Agency for Health (ARPA-H). Dr. Wegrzyn is an acclaimed biomedical scientist who has previously worked for the two agencies that ARPA-H is modeled after: the Defense Advanced Research Projects Agency (DARPA) and the Intelligence Advanced Research Projects Activity (IARPA). She currently serves as the Vice President for Business Development at Ginkgo Bioworks, a Boston-based company specializing in biological engineering.  

To read a White House fact sheet about the Cancer Moonshot initiative, CLICK HERE.

To read the text of the speech, CLICK HERE.

To read a statement on President Biden’s intent to appoint Dr. Renee Wegrzyn as inaugural director of ARPA-H, CLICK HERE.

To read a fact sheet on the Executive Order to launch a National Biotechnology and Biomanufacturing Initiative, CLICK HERE.

Patient Advocacy Groups Sue HHS, CMS Over Co-Pay Accumulator Program Rule  

On August 30, a coalition of patient advocacy groups filed a lawsuit against the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) over a federal rule, finalized during the Trump Administration, that permits insurance companies and pharmacy benefit managers (PBMs) to prevent manufacturer assistance from being counted toward patients’ out-of-pocket costs and deductibles. The 2021 Notice of Benefit and Payment Parameters rule expressly allowed health plans to decide whether they wanted to adopt “copay accumulator” programs.

In the lawsuit, the HIV + Hepatitis Policy Institute, Diabetes Leadership Council, and the Diabetes Patient Advocacy Coalition argued that the rule violates the Affordable Care Act, which set annual limits on out-of-pocket spending and defined what counts as cost sharing. The patient advocacy groups argue that copay accumulator programs result in higher out-of-pocket costs for patients and disproportionately affect people with chronic diseases that require the use of expensive drugs. CMS and insurers have argued that patient assistance provided by drug manufacturers steers patients toward more expensive drugs. 

To read the formal complaint filed in federal court, CLICK HERE.

To read a press release about the groups’ lawsuit, CLICK HERE.

Providers and Advocates Urge Prior Authorization Reform for Medicare Advantage Plans

In response to a Centers for Medicare & Medicaid Services (CMS) request for information (RFI) on how to improve the Medicare Advantage (MA) program, hundreds of healthcare providers, patient groups, and other advocates submitted comment letters calling on CMS to limit MA plan spending on administrative costs, reduce out-of-pocket costs, and to standardize prior authorization policies. 

MA plans receive flat monthly payments for each beneficiary based on their individual health risk factors, meaning the plans often employ utilization management techniques like prior authorization or step therapy. The comments submitted largely focused on reigning in these practices and increasing oversight to ensure MA plans are not abusing them. 

The RFI comes at a time when Medicare Advantage enrollment is experiencing seemingly rapid growth and is expected to provide coverage for the majority of Medicare beneficiaries for the first time by 2023. Despite concerns from healthcare groups, the MA program remains popular, particularly among low-income and minority beneficiaries, with a 94 percent satisfaction rate among enrollees and strong Congressional support. 

Relatedly, the House of Representatives could vote as soon as this week on H.R. 3173, the Improving Seniors’ Timely Access to Care Act, which aims to lessen the burden of prior authorization on providers and patients by requiring Medicare Advantage plans to implement an electronic prior authorization program and establish real-time decision-making processes for items and services that are routinely approved. The bill, introduced by Representatives Suzan DelBene (WA-01), Mike Kelly (PA-16), Ami Bera, M.D. (CA-07), and Larry Bucshon, M.D. (IN-08), was approved by the House Ways and Means Committee in July. 

To read more about the issue, CLICK HERE.

To read the federal government’s RFI, CLICK HERE.

Employer Group Launches Tool to Negotiate Prices for Hospital Services

On September 8, the National Alliance of Healthcare Purchaser Coalitions (National Alliance) released a new tool to help plan sponsors create successful strategies to identify and negotiate fair prices for hospital services.

A playbook titled, “Beyond Hospital Transparency: Getting to Fair Price,” is designed to help purchasers understand how to best leverage newly available hospital price and quality data.  The National Alliance playbook offers guidance for plan sponsor fiduciaries to determine fair prices for hospital services, market- and policy-based approaches, and tips for achieving fair pricing when working individually or with coalition partners.

The playbook also includes a resource – “Myths and Facts: Revealing Hospital Price Transparency Truths” – which provides a comprehensive overview of the Consolidated Appropriations Act and addresses additional issues around hospital pricing.

To download the National Alliance Playbook, CLICK HERE.

To download the Myths and Facts Report, CLICK HERE.

To read the National Alliance press release, CLICK HERE.

OIG Releases Two New Reports on Telehealth Use During Pandemic

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new reports this month on the use of telehealth services by Medicare beneficiaries in the first year of the COVID-19 pandemic. 

The first report, “Certain Medicare Beneficiaries, Such as Urban and Hispanic Beneficiaries, Were More Likely Than Others To Use Telehealth During the First Year of the COVID-19 Pandemic,” examined the characteristics of beneficiaries who used telehealth from March 1, 2020, to February 28, 2021. The report concluded: 

• Beneficiaries in urban areas were more likely than those in rural areas to use telehealth.
• Dually eligible, Hispanic, younger, and female beneficiaries were also more likely than others to use telehealth.
• Almost one-fifth of beneficiaries used certain audio-only telehealth services; the vast majority of these beneficiaries used them exclusively.
• Older beneficiaries were more likely to use certain audio-only services, as were dually eligible and Hispanic beneficiaries.

The second report, “Medicare Telehealth Services During the First Year of the Pandemic: Program Integrity Risks,” examined whether providers are billing for telehealth services appropriately over the same time period. The OIG found a very limited number of claims for telehealth services pose a high risk to Medicare. The OIG identified only 1,714 out of approximately 742,000 providers whose billing for telehealth services pose a high risk to Medicare. Based on a set of seven measures that focus on different types of billing for telehealth services that may indicate fraud, waste, or abuse, the OIG examined Medicare fee-for-service claims data and Medicare Advantage encounter data for the first year of the pandemic. Other conclusions included:

• Effective, targeted oversight of telehealth services to maximize benefits and minimize risk continues to be important to the overall integrity of the Medicare program.
• Providers the OIG identified as high-risk are generally a part of the same medical practice as at least one other provider whose billing poses a high risk.

To view the OIG report on beneficiary characteristics, CLICK HERE.
To view the OIG report on program integrity risks, CLICK HERE.