On October 15, 2018, the Centers for Medicare & Medicare Services (“CMS”) in the Department for Health and Human Services proposed a rule to require prescription drug manufacturers to post the Wholesale Acquisition Cost (“WAC”) for drugs and biological products covered by Medicare or Medicaid in direct-to-consumer television advertisements. The WAC reflects the manufacturer’s list price for a drug to direct purchasers, not inclusive of any discounts or rebates. CMS is proposing this rule in the context of broadcast advertisements, an area in which the Supreme Court has recognized that the government may take special steps to help ensure that viewers receive appropriate information.[1]

CMS stated that 47 percent of Americans have high-deductible health plans and that many patients may pay the list price of the drug until they meet their deductible. The proposed rule aims to provide greater transparency into the prices charged by prescription drug manufacturers. The theory is that markets operate more efficiently with greater transparency, and that increased exposure of the list price will also provide a moderating force to discourage price increases. While wholesale prices do not equate to the patient’s out-of-pocket obligation, CMS asserts that benefit designs are impacted by WACs, and patients in high-deductible plans may pay the full list price until meeting their deductible – thus, the WAC may still be relevant to many patient and impact their decisions and market dynamics. The price required to be posted would be for a typical course of treatment for an acute medication like an antibiotic, or a thirty day supply of medication for a chronic condition that is taken every month. The posting would take the form of a legible textual statement at the end of the ad and would not apply where the list price for a thirty day supply or typical course of treatment of a prescription drug was less than $35.
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On October 3rd, the United States Senate passed a bipartisan opioids package with a sweeping vote of 98 to 1, after the U.S. House of Representatives passed the final version of the bill with a vote of 393 to 8. One of its components, the “Fighting the Opioid Epidemic with Sunshine Act,” expands the scope

Next week, on June 21, 2018, attorneys from Crowell & Moring will hold a bootcamp entitled “Early Stage Investing in Health Technology.” Crowell & Moring attorneys will present on topics of interest to entrepreneurs, investors, and early stage health technology companies. Attendees will have the opportunity to learn about a range of matters including formation

The Food and Drug Administration (FDA) has announced several new initiatives that reflect its ongoing commitment to maintain patient safety, while also championing the need and opportunity for health care innovation.

During opening day of Health Datapalooza, FDA Commissioner Scott Gottlieb highlighted the critical import of novel digital health tools in achieving patient-centered care, and outlined how the agency is committed to moving the ball forward in health care innovation through the following initiatives:
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Despite the Trump Administration’s declaration of a state of emergency on October 26, 2017, the federal response to the opioid crisis largely languished on the back burner—much to the chagrin of states in the trenches of the opioid epidemic. However, based on the flurry of activity over the past several weeks, the federal government response now seems to be gathering substantive momentum, with various agencies and government actors launching attacks on all fronts—administrative, legislative, and enforcement alike. The federal government’s recent efforts present opportunities for health care organizations, life sciences companies, and health tech companies to get involved at the ground level to help influence opioid policy and provide needed products, services, and support to reduce the incidence of opioid abuse and address the health care needs of patients.

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Building on momentum from Administrator Seema Verma’s announcement of the MyHealtheData initiative at HIMSS 2018, CMS has published more clues as to future action to liberate health information for patients.

In the CY 2019 call letter to Medicare Advantage organizations and Part D programs, CMS describes the Blue Button 2.0 project and its use of

CMS announced important changes to Medicare reimbursement for remote patient monitoring and telemedicine that can help accelerate adoption and use of these digital health tools. These changes are implemented through two rules released this week that will take effect January 1, 2018. Understanding these rules can help you incorporate these tools into clinical practice and can positively affect the business model for technology developers and innovators.

What are these new rules and do they affect me?

The 2018 Quality Payment Program Final Rule provides policy updates to the Quality Payment Program (QPP), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and will be entering its second year. MACRA offers two “tracks” for eligible clinicians to take as they move toward value-based care:

  • Participation in QPP and its scoring, or
  • Participation in an Advanced Alternative Payment Model (APM).

The majority of Medicare payments are still tied to fee-for-service, but HHS has set a goal of moving to 50 percent of Medicare payments for alternative payment models by 2018. For previous coverage of QPP proposals, visit our summary here.

The 2018 Physician Fee Schedule Final Rule addresses revised payment policies for the Medicare physician fee schedule. Any provisions in the PFS rule typically apply to fee-for-service type providers.
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The April 3, 2017 release of the 2018 Rate Announcement and Call Letter brought some welcome news for Medicare Advantage organizations and Part D sponsors (collectively, sponsors) and could signal improved transparency by the Centers for Medicare & Medicaid Services (CMS) in its regulation of sponsors. House Ways and Means Committee Chairman Kevin Brady (R-TX) and Health Subcommittee Chairman Pat Tiberi (R-OH) issued a joint statement in response to the CMS Rate Announcement:

We are encouraged the Trump Administration took steps to roll back some of the Obama Administration’s flawed payment policies that would have negatively impacted nearly 18 million seniors. We are also pleased that HHS Secretary Price recognized the importance of protecting access to Medicare Advantage, including for patients suffering from kidney disease—a bipartisan priority on our Committee. We look forward to working with the new Administration on policies that promote innovation and competition, improve the quality and coordination of care, and deliver our seniors flexibility and choice in Medicare.

MA Employer Group Waiver Plans (EGWPs).  With CMS’s waiver last year of the bid submission requirement for MA EGWPs, payment rates for these plans have been administratively set based on a blend of EGWP bids and individual market plan bids.  CMS solicited comments in the 2018 Advance Notice on whether it should use only individual market plan bids from 2017 to calculate the bid-to-benchmark ratios for the 2018 MA EGWP payment rates, or whether it should continue to use the bid-to-benchmark ratios applied in calculating the 2017 MA EGWP payment rates. CMS decided to pause the transition to 100% individual market plan bids with the result that 2018 MA EGWP payment rates will continue to reflect a blend of individual market plan bids from 2016 and EGWP bids from 2016, with individual market plan bids weighted by 50% and EGWP bids weighted by 50%.
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First 100 Days LogoOn Tuesday, April 18, 2017, our Health Care Group will hold a webinar on the health care policy and transition challenges still at play as the Trump Administration nears the end of its 100 days in power.  During the webinar, participants will hear important insights and predictions on what a Trump-led Executive Branch will mean