HealthCare Roundtable e-News – October 16, 2019

CMS, OIG Unveil Proposals to Modify Anti-Kickback Statute

Last Wednesday (Oct. 9), the Department of Health and Human Services released new proposals modifying the so-called anti-kickback statute to account for the system’s shift to value-based arrangements. Among the proposals are new, permanent exceptions to the Stark Law, which prohibits physician self-referral, for value-based pay arrangements within and outside Medicare. Also included is a new safe harbor under the anti-kickback statute with certain incentives that beneficiaries can access through CMS demonstrations. (InsideHealthPolicy)

The rule states, “We seek comment regarding whether this approach-designed to provide needed flexibility for parties participating in alternative payment models (including those sponsored by CMS) to succeed in the transition to value-based payment-poses a risk of program or patient abuse that should be addressed through a revised definition of ‘value-based arrangement’ that requires care coordination and management.” (InsideHealthPolicy).

The proposals themselves do not include safe harbors for value-based pay arrangements, though HHS Secretary Alex Azar confirmed the agency is looking for opportunities to include them as soon as possible. (InsideHealthPolicy).

Azar confirmed that under the new proposals, a dialysis facility or another provider could give patients monitoring technology to allow two-way, real-time communication about a patient’s condition. But while many of the changes will be welcomed by the industry, pharmaceutical manufacturers, durable medical equipment manufacturers, and suppliers, and laboratories are currently excluded from the value-based and patient engagement arrangements, according to Jennifer Michael, a healthcare attorney at Epstein Becker Green.

CMS Begins Auto-Enrollment for the 2020 Plan Year Ahead of Open Enrollment on November 1

The Centers for Medicare and Medicaid Services (CMS) will begin to auto-enroll consumers into its 2020 marketplace plans today (Oct. 15), ahead of the open enrollment period starting November 1st. Consumers who are currently enrolled can expect to be re-enrolled into their current plan or automatically enrolled in an alternative plan if their previous plan is no longer available. According to the agency, 81% of beneficiaries with drug coverage will be in a plan that earned a rating of four stars or more.

CMS had previously considered terminating auto-enrollment during the 2020 plan year, but those who opposed the termination, including CMS Administrator Seema Verma, advised that the agency obtain feedback first from insurers and consumers. CMS researchers estimated that up to 28% of consumers who were automatically re-enrolled in 2016 would have lost coverage without the policy.

CMS is also expected to introduce changes to re-enrollment in the draft exchange rule for 2020 that is currently under review by the Office of Management and Budget. Agency slides from Oct. 7 indicate that some issuers will start receiving notices about regulator and alternate enrollments on or around Oct 15. Consumers matched to an alternative plan will receive an electronic notice about their new policy on the same day that issuers receives the transaction, and beneficiaries will be notified by mail within about a week. (InsideHealthPolicy)

PhRMA Outlines Policies It Supports to Lower Drug Costs

Last week, the Pharmaceutical Research and Manufacturers of America unveiled a range of drug cost policies that the group will support, including the Roundtable-supported Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which would prohibit brands from using Risk Evaluation and Mitigation Strategies to refuse generic drug makers the samples needed for FDA reviews. (InsideHealthPolicy).

While PhRMA supports lower drug costs for seniors, many of their member companies do not support the policies put forward in the Congress and by the Trump Administration to directly lower drug prices. PhRMA President and CEO Stephen Ubl said drugmakers instead are shifting their focus towards policies that make it difficult for brand-name drug companies to pay generic drug companies to delay market entry. (InsideHealthPolicy).

Ubl also recently told reporters that it will not support House Speaker Nancy Pelosi’s (D-Calif.) recent drug price negotiation plan, saying that “if H.R. 3 becomes law, it is lights out for a lot of very small biotech companies that are pre-revenue and depend on attracting capital.” Pelosi’s bill is expected to pass the House later this month.