Pardon Our Dust
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This week in Washington: The House and Senate are in recess.
Congress
House
- Bipartisan Legislation Introduced on Accurate Provider Directories
- Ways & Means Chair’s Surprise Billing Plan Directs Price Negotiations to HHS, Labor and Treasury
Senate
Administration
- President Trump Signs Executive Order: Protecting and Improving Medicare for Our Nation’s Seniors
- FDA Warns of Cybersecurity Concerns with Devices, Health Care Networks
- CMS Sends Draft 2021 Notice of Benefit and Payment Parameters Rule for OMB Review
Proposed Regulations/Guidance
- SAMHSA: Proposed Rule to Loosen 42 CFR Part 2
- CMS: Proposed Radiation Oncology (RO) Model
- FDA: Patient-Focused Drug Development: Methods to Identify What Is Important to Patients’ Guidance
- FDA: New Required Health Warnings with Color Images for Cigarette Packages and Advertisements to Promote Greater Public Understanding of Negative Health Consequences of Smoking
Final Rules/Guidance
- CMS: Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals and Home Health Agencies, and Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility and Improvement in Patient Care
Reports
- GAO: Indian Health Service – Facilities Reported Expanding Services Following Increases in Health Insurance Coverage and Collections
- GAO: Veterans Health Care – VA Needs to Improve Its Allocation and Monitoring of Funding
Congress
House
Bipartisan Legislation Introduced on Accurate Provider Directories
On Sept. 27, Reps. Phil Roe (R-TN) and Kim Schrier (D-WA) introduced legislation to improve the accuracy of the information listed on health plans’ provider directories to prevent patients from receiving surprise out-of-network bills. The Improving Provider Directories Act (H.R. 4575) requires health plans to establish a process to address inaccurate information listed in publicly accessible provider directories.
Monitor H.R. 4575 here.
Ways & Means Chair’s Surprise Billing Plan Directs Price Negotiations to HHS, Labor and Treasury
On Sept. 27, House Ways & Means Committee Chairman Richard Neal (D-MA) proposed a surprise billing plan in a letter to Ranking Member Kevin Brady (R-TX) that gives responsibility for negotiated rulemaking to the Department of Health and Human Services (HHS), Department of Labor and the Department of Treasury. The agencies would set out-of-network payment rates and determine when to use arbitration. Then respective secretaries would propose a rule and ask for public comment. Rep. Neal said that the legislation would be worked on during the current two-week recess.
Senate
Grassley Warns Senate Finance Drug Pricing Package Could Face Delay Until 2020
On Sept. 27, Senate Finance Chair Chuck Grassley (R-IA) said there is a possibility that the drug pricing package introduced by Finance Ranking Member Ron Wyden (D-OR), S. 2543, the Prescription Drug Pricing Reduction Act of 2019, could be delayed from being considered on the Senate floor until next year. Without a vote on S. 2543 this year, the bill cannot be attached to the end-of-year appropriations bill.
Find more details on S. 2543 here.
Administration
President Trump Signs Executive Order: Protecting and Improving Medicare for Our Nation’s Seniors
On Oct. 3, President Trump signed an executive order directing the Department of Health and Human Services (HHS) to develop proposals for expanding plan options for seniors, encouraging innovative plan designs and payment models and improving the enrollment process to make it easier for seniors to choose plans. By aligning Medicare fee-for-service with Medicare Advantage rates through the order, the Trump administration intends to bring more competition to the health care industry.
The executive order also pushes for providers to spend more time with their patients by focusing less on billing requirements. The order directs HHS within one year to propose a regulation that would “eliminate burdensome regulatory billing requirements, conditions of participation, supervision requirements, benefit definitions, and all other licensure requirements of the Medicare program that are more stringent than applicable Federal or State laws require.”
In addition, the order calls for changes that would streamline CMS coverage of innovative medical devices, including medtech breakthroughs. The EO specifically states that, within one year, “the Secretary shall propose regulatory and sub-regulatory changes to the Medicare program to encourage innovation for patients by … streamlining the approval, coverage, and coding process so that innovative products are brought to market faster, and so that such products, including breakthrough medical devices and advances in telehealth services and similar technologies, are appropriately reimbursed and widely available, consistent with the principles of patient safety, market-based policies, and value for patients.”
FDA Warns of Cybersecurity Concerns with Devices, Health Care Networks
On Oct. 1, the Food and Drug Administration (FDA) notified device manufacturers, providers and patients that connected medical devices and health care networks that use certain communication software are vulnerable to potential cybersecurity attacks. The vulnerability is called URGENT/11, and could affect certain devices connected to a communications network, Wi-Fi and public or home internet, or equipment such as routers, connected phones and critical infrastructure equipment.
Find the press release here.
CMS Sends Draft 2021 Notice of Benefit and Payment Parameters Rule for OMB Review
The proposed 2021 Notice of Benefit and Payment Parameters is under review by the White House Office of Management and Budget (OMB). The rule is expected to include updated guidance on drug copay coupons that was delayed for 2020. It is not expected to change silver-loading practices.
Proposed Regulations/Guidance
SAMHSA: Proposed Rule to Loosen 42 CFR Part 2
On Aug. 22, the Substance Abuse and Mental Health Services Administration (SAMHSA) proposed a rule that would loosen substance use record privacy restrictions. The proposed rule is part of the Department of Health and Human Services’ (HHS) “Regulatory Sprint to Coordinated Care,” championed by HHS Deputy Secretary Eric Hargan. The rule is one of four expected as part of the sprint, including changes to the Health Insurance Portability and Accountability Act (HIPAA), Stark Law and the anti-kickback statute. HHS Secretary Alex Azar commented that HHS does not have the authority to fully align 42 CFR Part 2 with HIPAA but expressed support in Congress for legislation to do so.
Find the proposed rule here. Public comments are due by Oct. 25, 2019.
CMS: Proposed Radiation Oncology (RO) Model
On July 10, the Centers for Medicare and Medicaid Services (CMS) proposed a Radiation Oncology (RO) Model as a payment model that tests if site-neutral payments, in which providers are paid the same rate no matter the care setting, for a 90-day episode of care, can improve the quality of treatment and save Medicare money. The experiment targets radiation treatment for 17 different types of cancer. Payment will be based on proposed national base rates and trend factors and will be adjusted for geography and the mix of patients the provider treats.
Participants in the model could earn back a share of dollars that are withheld based on the quality of care and patient experience. The model is scheduled to begin next year and end in December 2024.
Find the proposed rule here.
FDA: Patient-Focused Drug Development: Methods to Identify What Is Important to Patients’ Guidance
On Sept. 30, the Food and Drug Administration (FDA) released a second draft guidance in a series of four patient-focused drug development guidances, as required under the 21st Century Cures Act. The series looks at how to collect and submit information from patients and caregivers for medical product development and regulatory decision-making. This draft guidance explains three research methods to do so: qualitative research, quantitative research and mixed-method research.
Find the draft guidance here.
Public comments must be submitted by Dec. 30, 2019.
FDA:New Required Health Warnings with Color Images for Cigarette Packages and Advertisements to Promote Greater Public Understanding of Negative Health Consequences of Smoking
On Aug. 15, the Food and Drug Administration (FDA) proposed a rule to require new health warnings on cigarette packages and in advertisements to promote greater public understanding of the negative health consequences of smoking. The proposed warnings feature photorealistic color images depicting the health risks of cigarette smoking. When finalized, this rule would fulfill a requirement in the Family Smoking Prevention and Tobacco Control Act.
The new warnings would appear prominently on cigarette packages and in advertisements, occupying the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette advertisements. The warnings would be required to appear on packages and in advertisements 15 months after a final rule is issued.
Find the proposed rule here.
Public comments must be submitted by Oct. 15, 2019.
Final Rules/Guidance
CMS: Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals and Home Health Agencies, and Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility and Improvement in Patient Care
On Sept. 26, the Centers for Medicare and Medicaid Services (CMS) issued a final rule revising the discharge planning requirements that hospitals (including long-term care hospitals, critical access hospitals [CAHs], psychiatric hospitals, children’s hospitals and cancer hospitals), inpatient rehabilitation facilities and home health agencies must meet to participate in Medicare and Medicaid programs. It requires the discharge planning process to focus on a patient’s goals and treatment preferences. Additionally, hospitals are mandated to ensure each patient’s right to access their medical records in an electronic format.
The rule also implements requirements from the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) that includes how facilities will account for and document a patient’s goals of care and treatment preferences. Additionally, if a patient is discharged to a post-acute care provider, the rule requires the facility’s care team assist patients, their families or the patient’s representative in selecting a post-acute care (PAC) provider by sharing key performance data.
This rule finalizes the provisions of the following three distinct proposed rules:
- Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (“Omnibus Burden reduction”), published September 20, 2018;
- Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care, published June 16, 2016; and
- Fire Safety Requirements for Certain Dialysis Facilities, published November 4, 2016.
Find the final rule here.
Reports
GAO: Indian Health Service – Facilities Reported Expanding Services Following Increases in Health Insurance Coverage and Collections
On Oct. 1, the Government Accountability Office (GAO) analyzed the health care coverage from 2013 to 2018 at Indian Health Service locations that provide care to American Indians and Alaska Natives through a system of facilities. The GAO found that federal facility data showed the proportion of patients with insurance grew from 64 percent to 78 percent from fiscal years 2013 through 2018. Facilities in states that expanded access to Medicaid saw the largest increases. Officials interviewed by the GAO from 17 facilities said the increased coverage helped federally and tribally operated facilities expand services.
Find the full report here.
GAO: Veterans Health Care – VA Needs to Improve Its Allocation and Monitoring of Funding
On Sept. 23, the Government Accountability Office (GAO) reviewed how the Veterans Health Administration (VHA) will spend about $81 billion on care for about 6.9 million patients this year. Higher-than-expected needs have prompted it to repeatedly request supplemental funds, and the GAO analyzed how the VHA allocated and monitored use of these funds. The GAO found that when VHA allocated funds to regional networks and medical centers, and did not use the most recent data on workloads. The VHA also did not adequately monitor how regional networks changed the allocations to the medical centers in their areas.
Find the GAO’s five recommendations here.
Find the full report here.
If you have any questions, contact the following individuals atMcGuireWoods Consulting:
Stephanie Kennan, Senior Vice President
Mariam Eatedali, Research Associate
Founded in 1998,McGuireWoods Consulting LLC(MWC) is a full-service public affairs firm offering infrastructure andeconomic development, strategic communications & grassroots, and governmentrelations services. McGuireWoods Consulting is a subsidiary of theMcGuireWoods LLPlaw firm and has been named in The National Law Journal’s special annualreport, “The Influence 50,” for the past several years. In the most recentreport, McGuireWoods Consulting was ranked 15th of the 1,900 governmentrelations firms in Washington, D.C.
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