2018 to see significant regulatory reform, according to CMS official

At the agencies:

At a listening session this week, Centers for Medicare and Medicaid Services (CMS) Director for Clinical Standards and Quality Kat Goodrich said that she believes 2018 will see significant regulatory reform and burden reduction. CMS and the Office of the National Coordinator for Health Information Technology (ONC) held the session to gather suggestions on reducing the burden of electronic health records. Over half of the stakeholders in the audience said they would be willing to participate in a CMS pilot for alternative quality assessment. One official noted that ONC’s priorities include streamlining quality measures and quality reporting, and that health IT is currently creating more problems rather than solving them. CMS already made some changes to reduce provider burden, including allowing providers to use medical scribes and changing long-term care facility surveys. Officials say they have many options for sub-regulatory reform.

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently told lawmakers that the shortage of saline for hospitals following the hurricanes in Puerto Rico is gradually improving. The shortage of amino acids; however, is getting worse and rationed at hospitals. While the key factories in Puerto Rico are back on the electrical grid, Gottlieb warned that the supply chain, especially for saline and IV bags, is relatively slow. FDA has not endorsed structural changes to avoid similar situations in the future, such as requiring manufacturers of critical medicines to locate their operations in non-disaster prone areas. The agency also rejected suggestions to loosen regulations on compounding. In response to the amino acid shortage, at least one supplier explained that it will sell its limited supply directly to buyers rather than to distributors and wholesalers.

Following the critique of the U.S. Public Health Service Commissioned Corps that is incorporated into the Trump Administration’s budget request, Surgeon General Jerome Adams called the budget request “guidance that reflects a conversation that’s been going on for decades.” The budget request questioned whether the corps is meeting the country’s needs and called for a comprehensive review of the corps, while stopping short of proposing specific cuts. The corps consists of physicians, nurses, dentists and other healthcare providers working in underserved areas. Adams said his priorities will include building relationships with community organizations, addressing the opioid crisis and championing health as a national security issue.

Pending White House approval, HHS Secretary Alex Azar chose Judy Stecker to serve as the department’s top communications official. Stecker is currently the executive director of media relations and strategic marketing at the American Enterprise Institute and previously worked at the Heritage Foundation and the Foundation for Defense of Democracies. Azar prioritized addressing HHS’s press operations, since department officials worry that the lack of transparency is harming its reputation.

On the Hill:

The opioid crisis recently dominated the healthcare agenda on Capitol Hill when The Senate Finance Committee requested suggestions on how to address the crisis. The American Hospital Association’s (AHA) suggestions included:

  • Increased enforcement of the Mental Health Parity Act and Addiction Equity Act
  • Preserving insurance coverage and Medicaid expansion to treat Americans with substance use disorder
  • Eliminating the IMD exclusion and increasing interstate sharing of prescription drug data

The Association for Behavioral Health and Wellness called for coverage of methadone treatments for patients on Medicare and encouraging more doctors to treat patients on Medicaid by increasing reimbursement rates.

Children’s advocates warn that despite reauthorizing the Children’s Health Insurance Program (CHIP) for ten years, Congress will still have to negotiate offsets because Republicans retained the funding cliff. The CHIP spending baseline increased by $10 billion, but that baseline assumes that income eligibility will be at 200 percent of the poverty level, while the current median eligibility is at 260 percent of poverty. Normally, when programs are funded for a decade, the baseline is reset at the level of spending in the final year. However, because the CHIP baseline was set in advance, Congress must make up for increases in actual spending when the program is renewed. The baseline for 2027 is now $15.3 billion, while actual spending is projected to be about $25 billion.

Uncertainty over the fate of the 340B drug program, for which CMS has cut payments by $1.6 billion, continues. The 340B program allows hospitals that serve a disproportionate share of low-income and uninsured patients to buy drugs at highly discounted rates without being required to pass those savings on to patients. In the U.S. House of Representatives, the Energy and Commerce Health Subcommittee listed 340B as a priority to complete this year. In the U.S. Senate, Senator Bill Cassidy (R-LA) sponsored a bill (S. 2312) that would create more reporting requirements for the program. The bill also prohibits new Disproportionate Share Hospitals from joining the 340B program for a certain amount of time. Senator Charles Grassley (R-IA) also introduced legislation to make hospitals report on savings from the program, which hospitals argue would take savings out of context.

From the administration:

The White House released a report arguing that some health IT policies, such as meaningful use and quality metrics reporting, had overly burdened smaller practices. Those practices were in turn bought by hospitals, and those consolidations resulted in price increases for patients. For prescription drug monitoring programs, the report conceded that drug-tracking databases had limited success curbing diversion and abuse.


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