By: Shannon Firth

A bill to improve care for Medicare beneficiaries with chronic conditions advanced in the Senate, while the FDA issued a boxed warning on an increased risk of foot and leg amputations for some type 2 diabetes drugs.

Senate Committee Advances Chronic Care Bill

The Senate Finance Committee unanimously approved a bill Thursday aimed at improving care for Medicare beneficiaries with chronic conditions.

The Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 would increase access to telehealth for Medicare beneficiaries with chronic illnesses — including those in Medicare Advantage plans — as well as provide more incentives for enrollees to receive care through accountable care organizations (ACOs). It also would extend the Independence at Home demonstration program to keep people in their homes rather than hospitals, allow reimbursement for more non-health and social services, and extend permanently MA Special Needs plans that target chronically ill beneficiaries.

“One thing we hear a lot from ACOs is they have trouble keeping beneficiaries in-house rather than going to a provider outside the ACO, and that makes it harder to coordinate their care,” a committee aide said. “This bill says that if you go to a primary care doctor in the ACO, we’ll reduce or eliminate your cost-sharing for that primary care service. That will make beneficiaries stick to the ACO, and bring down their costs.”

Media reports Friday indicated that when the Congressional Budget Office finally scores the American Health Care Act, the repeal-and-replace bill passed by the House in a close vote, it may need to be modified and voted on again.

“The CBO score will … determine whether the bill meets Senate requirements,” The Hill explained. If the review finds that the legislation would expand the federal deficit, then it can’t be passed under the so-called reconciliation process. Republicans have hoped to use that process to short-circuit an expected Democratic filibuster in the Senate. Consequently, an unfavorable review may impel GOP House leaders to amend the bill once again and submit it for another floor vote.

The Hill said the CBO score is expected to be released Wednesday.

FDA: Boxed Warning for Canagliflozin on Amputation Risk

Labels for type 2 diabetes drugs containing canagliflozin (Invokana, Ivokamet, Invokamet XR) will now carry a boxed warning about increased risks of leg and foot amputation, the FDA said Tuesday.

The warning comes after the agency reviewed data from two randomized, placebo controlled trials (CANVAS and CANVAS-R) that showed rates of lower-extremity amputations were doubled in the active drug groups, irrespective of dose.

Among nearly 6,000 patients receiving canagliflozin in the two trials, rates of amputations were 5.9 and 7.5 per 1,000 patient-years, compared with 2.8 and 4.2 per 1,000 patient-years in the placebo groups. The differences were statistically significant.

CMS Wants to Drop Online Enrollment in SHOP Exchanges

The Trump administration is proposing to change the way small businesses can sign up for health insurance in the Affordable Care Act’s (ACA) Small Business Health Options Program (SHOP), eliminating the option for the businesses to shop and sign up online.

Under the proposed changes, which would affect SHOP enrollees who use health insurance exchanges facilitated by the federal government, “Online enrollment would be removed from and small employers would access coverage through an agent or broker, or an issuer of their choice, for plan years beginning on or after January 1, 2018,” the Centers for Medicare & Medicaid Services (CMS) said in a press release.

Employers would still use the online portal to get qualified to participate in SHOP, and small businesses with a SHOP plan for the 2017 plan year could still use the online portal for enrollment and premium payment until their plan year ends, the release noted.

“Our goal is to reduce ACA burdens on consumers and small businesses and make it easier for them to purchase coverage,” said CMS Administrator Seema Verma in the release. “The ACA has failed to provide affordable insurance to small business and to the American people. This new direction will help employers find affordable healthcare coverage for their employees and make the SHOP exchanges function more effectively.”

House Panel Voices Bipartisan Support for More NIH $$

Lawmakers on both sides of the aisle touted the need to spend more money on healthcare research at a House Appropriations subcommittee hearing Wednesday on funding for the National Institutes of Health (NIH).

House appropriations subcommittee chairman Tom Cole (R-Okla.) said he was “especially disappointed” that President Trump’s proposed budget included an $8 billion cut for NIH. “That would potentially discourage promising scientists from entering or remaining in biomedical research,” he said.

“Everyone on this committee recognizes the importance of restoring the purchasing power of NIH,” said Rep. Rosa DeLauro (D-Conn.) the subcommittee’s ranking member, who noted that as an ovarian cancer survivor, the NIH’s mission was of great personal interest to her. The proposed cut “would decimate NIH and reduce the agency’s research purchasing power to levels not seen since the 1990s … When we face a public health emergency, NIH research is often our best tool to combat the tragic loss of life.”

Next Week

On Tuesday, the House Committee on Energy & Commerce will discuss the nation’s response to the Zika virus.

On Wednesday, the Alliance for Health Reform will host a webinar discussion on where Medicaid stands now.

And a House Appropriations subcommittee will examine the Indian Health Service budget.

On Thursday, a different House Appropriations subcommittee will assess the FDA’s budget.

And the Senate Committee on Homeland Security & Governmental Affairs will explore ways to stop the synthetic shipment of opioids.

Also in the coming week, an FDA advisory committee will review a novel breast cancer drug and a biosimilar for the big-selling anemia drug epoetin alfa (Epogen, Procrit).