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An Overhaul for Medicare’s Pay Transformation Program

The Biden administration recently finalized an overhaul of an initiative known as the Medicare Shared Savings Program that seeks to pay health providers based on patient outcomes instead of the number of services they perform. In this Axios article, McDermott+Consulting’s Mara McDermott offers insight into providers’ Congressional push to extend a 5% pay increase for participants in advanced alternative payment models.

“If the bonus is not continued, it will soften or dampen the momentum toward alternative payment models, because it would create this mentality, or the view, that we’re not serious about that transformation,” McDermott said.

Access the article.




Medicare Drug Price Negotiation Program and Drug Pricing Reform: Eligible Drugs to Know and Understanding What’s Next

On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (IRA), which contains prescription drug pricing reform provisions. The three main Medicare prescription drug pricing reform provisions included are as follows:

  • Drug Price Negotiations: Allows the federal government to negotiate for a select number of vaccines and/or drugs
  • Inflation-Based Rebates: Mandates that manufacturers pay a rebate to the federal government when the list prices of Part B or Part D drugs grow at a faster rate than the inflation rate
  • Part D Benefit Redesign: Implements an out-of-pocket maximum for beneficiaries at $2,000 and redistributes liability among manufacturers, health plans, patients and the federal government across phases of the Part D benefit starting in 2024.

Leveraging data from the Centers for Medicare and Medicaid Services’ (CMS’s) Medicare Drug Spending Dashboard and FDA databases, McDermott+Consulting has identified the potential list of drugs subject to negotiations.

This information is particularly valuable for pharmaceutical companies, health plans, patients, pharmacies and other stakeholders as they evaluate and consider the implications of this legislation. In less than one year, on September 1, 2023, the Health and Humans Services (HHS) Secretary will publish the first list of selected drugs subject to drug price negotiations. Understanding the statutorily mandated negotiations framework, timeline and potential drugs that may be included is critical to support stakeholders’ efforts to obtain optimal outcomes.

This report describes the drug price negotiation program, an implementation timeline for drug price reforms from the IRA and information on which drugs are likely to be first subject to price negotiation.

Download the report.




GAO Releases Report on Telehealth

On September 26, the US Government Accountability Office (GAO) released a report titled “Medicare Telehealth: Actions Needed to Strengthen Oversight and Help Providers Educate Patients on Privacy and Security Risks.” The 75-page report describes the utilization of Medicare telehealth services under current pandemic-related waivers, the Centers for Medicare & Medicaid Services (CMS) efforts to identify and monitor risks posed by the current waivers, and a change made by the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) to the enforcement of regulations governing patients’ protected health information during the COVID-19 public health emergency (PHE).

GAO made four recommendations—three directed to CMS and one directed to OCR—aimed at remedying the issues set forth in the report:

  • CMS should develop an additional billing modifier or clarify its guidance regarding billing of audio-only office visits to allow the agency to fully track these visits.
  • CMS should require providers to use available site of service codes to indicate when Medicare telehealth services are delivered to beneficiaries in their homes.
  • CMS should comprehensively assess the quality of Medicare services, including audio-only services, delivered using telehealth during the PHE.
  • OCR should provide additional education, outreach or other assistance to providers to help them explain the privacy and security risks to patients in plain language when using video telehealth platforms to provide telehealth services.

Among its utilization findings, the GAO report found that the use of telehealth services increased from about five million services pre-waiver (April to December 2019) to more than 53 million services post-waiver (April to December 2020) and that, post-waiver, 5% of providers delivered more than 40% of telehealth services, and 5% of beneficiaries accounted for almost 40% of telehealth utilization.

The report noted that CMS lacks complete data on the use of audio-only technology and telehealth visits furnished in patients’ homes, because there is no billing mechanism for providers to identify all instances of audio-only visits, and because providers are not required to use available codes to identify visits furnished in homes. The GAO report also noted that OCR did not advise providers about specific language to use or give direction on explaining risks to patients, with respect to OCR’s March 2020 policy that it would not impose penalties against providers for noncompliance with privacy and security requirements in connection with the good faith provision of telehealth during the PHE.

This GAO report comes on the heels of a recent report from the HHS Office of Inspector General that found little evidence of waste and fraud related to Medicare telehealth services during the first year of the pandemic. These reports are part of a broader push by Congress and the Biden administration to examine current telehealth flexibilities and determine how to extend them beyond the COVID-19 PHE.




The Inflation Reduction Act of 2022: Healthcare Provisions

After almost a year of negotiations among congressional Democrats and the White House, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022. It passed in the US Senate by a vote of 50–50, with the vice president breaking the tie, on August 7, 2022. The bill passed the US House of Representatives August 12, 2022, by a party-line vote of 220-207. This McDermott+Consulting article summarizes the key healthcare provisions of the IRA, including prescription drug reform, inflationary rebates, a cap on insulin costs, a Medicare Part D benefit redesign and a new pharmacy benefit manager rebate rule.

Read more here.




US House Passes Telehealth Extension Through 2024

The US House of Representatives approved a bipartisan bill that would extend Medicare telehealth flexibilities through the end of 2024; immediate US Senate action on the bill is unlikely, however.

On July 27, 2022, the US House of Representatives approved the Advancing Telehealth Beyond COVID-19 Act (H.R. 4040) by a wide bipartisan margin of 416–12. This bill would extend Medicare telehealth flexibilities through the end of 2024, including geographic and originating site flexibilities, expanded eligible practitioners, reimbursement for federally qualified health centers and rural health clinics, delay of the in-person telemental health requirement, continued use of audio-only telehealth and flexibility to use telehealth to satisfy Medicare face-to-face requirements.

Immediate US Senate action on H.R. 4040 is not likely, as the Senate is working on other priorities heading into the August recess. In addition, given the limited number of legislative days on the calendar before the midterm elections, additional action on telehealth extensions is more likely to occur during Congress’s lame-duck session at the end of the year. These same provisions were extended for 151 days beyond the end of the public health emergency (PHE) through the enactment of the Consolidated Appropriations Act of 2022, making it less urgent for Congress to act on an extension before the end of the year—although this bill has significantly increased chances of Congress doing so.

Read more here.




Manchin Agrees to Expanded Reconciliation Deal

Senators Schumer and Manchin announce a bill that includes drug pricing and an extension of the advance premium tax credits, the amount individuals pay for monthly health insurance premiums when they buy health insurance on the Marketplace.

On July 27, 2022, Senate Majority Leader Schumer and Senator Manchin announced a surprise agreement to move forward with an expanded reconciliation bill titled the Inflation Reduction Act (summary here). The tentative deal includes drug pricing and expands upon a previous “healthcare-only” version of the reconciliation package that focused solely on drug pricing and a two-year extension of the advance premium tax credits (APTCs). The deal would raise an estimated $739 billion, with revenues going toward climate and healthcare initiatives, as well as reducing the federal deficit.

Leader Schumer and Senator Manchin released a joint statement outlining the agreement, which contains two key healthcare policy items: allowing Medicare to negotiate prescription drug prices and a three-year extension of APTCs. The three-year extension is one year longer than had been widely expected and reported in the previous version of the bill. The Biden-Harris Administration has also announced support for the bill. The package must go before the Senate Parliamentarian for Byrd Rule challenges before it can go to the Senate floor. It is expected to garner the Democratic support necessary to pass both the House and the Senate, and will move quickly from this point. The caveat to this is the impact of COVID-19. Several senators are already out, and Senator Dick Durbin (D-IL) announced July 28 that he has COVID-19 as well.

Read more here.




Biden Administration Takes Action to Improve Competition, Transparency and Quality for Hospitals and Nursing Homes

The Centers for Medicare & Medicaid Services (CMS) recently published detailed databases summarizing changes of ownership of Medicare-enrolled hospitals and skilled nursing facilities (SNFs). The databases currently include information from 2016 to 2022, but the data will be updated and released quarterly. CMS also released the skilled nursing facility prospective payment system (SNF PPS) proposed rule (the Proposed Rule), including proposed updates to payment based on quality and value-based care measures.

Read more here.




HHS Supreme Court Loss Previews Low-Income Drug Discount Fight

A recent US Department of Health and Human Services (HHS) US Supreme Court loss involving drug reimbursements to hospitals may impact a larger battle over drug discounts for low-income Americans. According to this Blomberg Law article, the Court ruled in June that HHS improperly cut $1 billion a year in drug reimbursements to hospitals through a government program that assists at-need populations. Now, both HHS and hospitals may be on the same side of a different skirmish—whether the agency can require pharmaceutical companies to offer discounts to specific pharmacies. McDermott Partner Emily Jane Cook said language in the Court’s opinion “suggests that the court does have a very favorable view of the 340B program and the hospitals that participate in that program.”

Read more here.




Healthcare Enforcement in the Post-Pandemic Era

As the world emerges from the COVID-19 pandemic, healthcare fraud enforcement remains a top priority for the US Department of Justice (DOJ) and other government agencies with enforcement authority. In this Westlaw Today article, McDermott Partners Laura McLane, Tony Maida and Dana M. McSherry describe some of the areas that have assumed particularly high enforcement priority, including private equity, telehealth and pandemic relief funds.

Access the article.




See What’s Next with McDermott+Consulting’s 340B Ligitation Tracking Tool

The 340B program landscape is constantly shifting. Wednesday’s US Supreme Court American Hospital Association v. Becerra decision is of critical importance to hospitals that participate in the 340B program. The Court held that the US Department of Health and Human Services (HHS) improperly imposed a payment cut of almost 30% on 340B drugs paid by Medicare. Yet, while this decision is significant, it is not the end of the litigation surrounding the payment cut. The case has been remanded for further deliberation, which will include a determination of the remedies.

McDermott+Consulting has launched the 340B Litigation Tracking Tool, an up-to-date resource following the 30+ state and federal 340B program legal challenges. No more searching online or sorting through your newsfeed for updates on important case developments. This tracker, available 24/7 and routinely monitored by our team, delivers concise updates to help you make informed risk analyses on what’s next for your business in the evolving 340B landscape.

View the 340B litigation tracking tool here.




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