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This week in Washington: House returns from recess and has scheduled hearing on caring for aging Americans; Senate to hold hearing on rising electronic cigarette use among youth and will hold a confirmation hearing for Dr. Stephen Hahn, Trump’s nominee to be the new FDA commissioner.
Congress
Hearings/Markups
Senate
- Durbin to Call for Vote on Drug Advertisement Price Disclosure Bill
- Grassley Expected to File Drug Pricing Bill This Week
- Peters Announces Investigation into Drug Shortages, High Drug Prices
Administration
- CMS: 2020 Medicare Parts A & B Premiums and Deductibles
- CMS: Approval of Demonstration to Expand Access to Behavioral Health Treatment
- HHS: Kidney Health Public Awareness Initiative
Final Regulations/Guidance
- CMS: Final Rules for Calendar Year (CY) 2020 Medicare Payment Rates
- CMS: New Home Infusion Therapy Benefit and Home Health Regulations
- CMS: Modernizing Payment Methodologies to Provide Kidney Patients with Better Value and Results
Proposed Regulations/Guidance
- OIG: Revisions to Safe Harbors Under the Anti-Kickback Statute, Etc.
- CMS Informal RFI: Potential Oncology Care First Model in Preparation for the November 4 Public Listening Session
- CMS Releases Kidney Care Choices Model Request for Application
- CMS: Modernizing and Clarifying the Physician Self-Referral Regulations (Stark Law Rule)
- CMS: Proposed Radiation Oncology (RO) Model
- FDA: Draft Guidance on Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff
- FDA: Draft Guidance on Developing Drugs for Hepatitis D Infection
- FDA: Drug Products Labeled as Homeopathic Guidance
- FDA: Patient-Focused Drug Development: Methods to Identify What Is Important to Patients’ Guidance
Courts
Reports
Upcoming Hearings/Markups
Wednesday, Nov. 13, 2019
Senate Health, Education, Labor and Pensions (HELP) Committee: “Examining the Response to Lung Illnesses and Rising Youth Electronic Cigarette Use”
The Senate Health, Education, Labor and Pensions (HELP) Committee will hold a hearing to examine the Food and Drug Administration’s (FDA) and Centers for Disease Control and Prevention’s (CDC) response to lung illnesses and rising youth electronic cigarette use.
Find more details on the hearing as they become available here.
Thursday, Nov. 14, 2019
House Ways and Means Committee: “Caring for Aging Americans”
The House Ways and Means Committee will hold a hearing to discuss long-term care issues, which will include discussion of care in the home, hospice, nursing homes and antipsychotic drug use in nursing homes.
Find more details on the hearing as they become available here.
Wednesday, Nov. 20, 2019
Senate Committee on Health, Education, Labor and Pensions: “Nomination of Stephen M. Hahn, MD, to serve as Commissioner of Food and Drugs”
The Senate Committee on Health, Education, Labor and Pensions will hold a confirmation hearing for Dr. Stephen Hahn, President Trump’s nominee to be the new Food and Drug Administration (FDA) commissioner. On Nov. 6, Chairman Lamar Alexander (R-TN) released a statement of support for Dr. Stephen Hahn ahead of the hearing.
Find more details on the hearing as they become available here.
Congress
Hearings/Markups
Senate Special Committee on Aging: “Veteran Scams: Protecting Those Who Protected Us”
Wednesday, Nov. 6, 2019: The Senate Special Committee on Aging held a hearing on protecting veterans from a variety of scams, including fake charities. As a result of the witness testimonies, a letter was sent to Secretary of the Department of Veterans Affairs Robert Wilkie by 13 of the committee’s 15 members asking for more protection of veterans from elder abuse scams.
Find more details on the hearing here.
Senate
Durbin to Call for Vote on Drug Advertisement Price Disclosure Bill
On Nov. 6, Sen. Dick Durbin (D-IL) said he will soon request a floor vote on the Drug-Price Transparency in Communications Act (S. 1437) that requires that direct-to-consumer advertisement for drugs disclose their list prices. The bill is cosponsored by Sen. Chuck Grassley (R-IA). Sen. Patrick Toomey (R-PA) has objected to the bill because he said other direct-to-consumer advertising for other products is not required to list prices.
Grassley Expected to File Drug Pricing Bill This Week
On Nov. 5, Senate Finance Committee Chair Chuck Grassley(R-IA) suggested that he would file an updated drug-pricing bill this week. The Senate Finance Committee has already passed the Prescription Drug Pricing Reduction Act (S. 2543), by Sen. Grassley, and Senate Finance ranking member Ron Wyden (D-OR). The new version can be filed and bypass the committee process because an earlier version was already passed by the committee.
Last week, Sen. Grassley defended the bill’s inflationary rebates on the Senate floor, a measure of the bill that Republicans do not approve. The Trump administration would prefer a version of the Senate Finance Committee bill over Speaker Pelosi’s plan, H.R. 3.
Peters Announces Investigation into Drug Shortages, High Drug Prices
On Nov. 5, Senate Homeland Security and Governmental Affairs Committee ranking member Gary Peters (D-MI) announced an investigation of high drug prices and drug shortages, after a Food and Drug Administration (FDA) report that showed drug manufacturers need financial incentives to produce older, less profitable drugs. The report also concluded that the drug manufacturers need to be rewarded for implementing mature quality management systems in their manufacturing processes.
Find the press release here.
Administration
CMS: 2020 Medicare Parts A & B Premiums and Deductibles
On Nov. 8, 2019, the Centers for Medicare and Medicaid Services (CMS) released the 2020 premiums, deductibles, and coinsurance amounts for the Medicare Part A and Part B programs. Each year the Medicare premiums, deductibles, and copayment rates are adjusted according to the Social Security Act. For 2020, the Medicare Part B monthly premiums and the annual deductible are higher than the 2019 amounts.
The standard monthly premium for Medicare Part B enrollees will be $144.60 for 2020, an increase of $9.10 from $135.50 in 2019. The annual deductible for all Medicare Part B beneficiaries is $198 in 2020, an increase of $13 from the annual deductible of $185 in 2019. The increase in the Part B premiums and deductible is largely due to rising spending on physician-administered drugs. These higher costs have a ripple effect and result in higher Part B premiums and deductible.
Find Medicare Part A details here.
Find Medicare Part B details here.
CMS: Approval of Demonstration to Expand Access to Behavioral Health Treatment
On Nov. 6, the Centers for Medicare and Medicaid Services (CMS) announced the approval of a Medicaid demonstration project that broadens treatment services available to Medicaid beneficiaries living in the District of Columbia (the District) diagnosed with serious mental illness (SMI) and/or serious emotional disturbance (SED). At the same time, CMS is approving the District’s request to begin providing new services for its beneficiaries diagnosed with substance use disorder (SUD).
Find more information here.
HHS: Kidney Health Public Awareness Initiative
On Nov. 4, the Department of Health and Human Services (HHS) announced a collaboration with the National Kidney Foundation (NKF) and the American Society of Nephrology (ASN) on a public awareness initiative about kidney disease that President Trump called for in an executive order earlier this year. The collaborative partnership among HHS, NKF and ASN will provide education about the risks of kidney disease and promote the early detection, treatment and management of kidney disease to improve patient outcomes. This initiative will also share information to enhance awareness of the causes and consequences of kidney disease.
Find more details here.
Final Regulations/Guidance
CMS: Final Rules for Calendar Year (CY) 2020 Medicare Payment Rates
On Nov. 1, the Centers for Medicare and Medicaid Services (CMS) issued a final rule that includes updates to payment policies, payment rates, and quality provisions for services furnished under the Medicare Physician Fee Schedule (PFS) effective on or after January 1, 2020. The changes in the final rule implement provisions of President Trump’s Executive Order on Protecting and Improving Medicare for Our Nation’s Seniors.
The final rule revises the times, medical decision-making process for all evaluation and management (E/M) codes and requires performance of history, and exam only when medically appropriate. A physician can choose the E/M visit level based on either medical decision making or time. The final rule also reduces the number of levels to four, from five levels of coding, for office/outpatient visits for new patients and revises some code definitions. It cuts payments for psychologists and social workers by 7%, and to physical therapists by 8% starting in 2021.
Find the final rule here.
CMS: New Home Infusion Therapy Benefit and Home Health Regulations
On Oct. 31, the Centers for Medicare and Medicaid Services (CMS) finalized changes to the Home Health Prospective Payment System (HH PPS), including a new home infusion therapy benefit. The final rule with comment period implements the executive order on Protecting and Improving Medicare for Our Nation’s Seniors, signed by President Trump, by eliminating requirements of the Medicare program that are more stringent than applicable federal or state laws for maintenance therapy. The final rule with comment period also increases Medicare payments to home health agencies (HHAs) by an estimated 1.3 percent ($250 million) for calendar year (CY) 2020.
Find a link to the final rule with comment period, here.
CMS: Modernizing Payment Methodologies to Provide Kidney Patients with Better Value and Results
On Oct. 31, the Centers for Medicare and Medicaid Services (CMS) finalized changes to the Medicare rules for Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS), the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and the ESRD Quality Incentive Program (QIP). These changes support the development and use of innovative technologies, provide more access to new treatments in kidney care and attempt to modernize program integrity methods to better combat waste, fraud and abuse in the Medicare program. They are also aligned with the goals of President Trump’s two recent executive orders on Advancing American Kidney Health and Protecting and Improving Medicare for Our Nation’s Seniors.
Find the final rule here.
Proposed Regulations/Guidance
OIG: Revisions to Safe Harbors Under the Anti-Kickback Statute, Etc.
On Oct. 9, the Department of Health and Human Services Office of Inspector General (OIG) proposed a rule that creates three new safe harbors for certain remuneration exchanged between or among eligible participants: care coordination arrangements aimed at improving quality and outcomes; value-based arrangements with substantial downside financial risk; and value-based arrangement with full financial risk. Modifications to existing AKS safe harbors include more flexibility for part-time and outcomes-based arrangements, removing the part-time schedule requirement and the aggregate compensation set-in-advance requirement. Modifications were also made to expand and modify mileage limits to rural areas and for transportation of patients discharged from inpatient facilities. As for electronic health records, the proposal extends the interoperability provision.
Find the proposed rule here.
Public comments must be submitted by Dec. 31, 2019.
CMS Informal RFI: Potential Oncology Care First Model in Preparation for the November 4 Public Listening Session
On Nov. 1, the Centers for Medicare and Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (Innovation Center) announced that at its Public Listening Session, which invites feedback on value-based payment for high-quality oncology care, it hopes to gather feedback on an informal Request for Information (RFI) that outlines a potential Oncology Care First (OCF) Model.
Written feedback on the informal RFI will be accepted until Nov. 25, 2019, and can be sent to OCF@cms.hhs.gov.
Find the informal RFI here.
CMS Releases Kidney Care Choices Model Request for Application
On Oct. 24, the Center for Medicare and Medicaid Innovation (Innovation Center) announced that the request for applications (RFA) for the Kidney Care Choices (KCC) Model has been posted here. The deadline to submit an application is Jan. 22, 2020.
The KCC Model is a voluntary model to reduce Medicare expenditures while preserving or enhancing quality of care for beneficiaries with end-stage renal disease (ESRD) and chronic kidney disease (CKD). The KCC Model contains the following four options:
- The CMS Kidney Care First (KCF) option
- The Comprehensive Kidney Care Contracting (CKCC) Graduated option
- The CKCC Professional option
- The CKCC Global option
Stay up to date on the latest Kidney Care Choices Model news and updates by subscribing to the KCC Model listserv.
CMS: Modernizing and Clarifying the Physician Self-Referral Regulations (Stark Law Rule)
On Oct. 9, the Centers for Medicare and Medicaid Services (CMS) proposed a rule that will create new, permanent exceptions to the Stark Law for value-based arrangements. These exceptions would apply broadly to care provided to all patients, not just Medicare beneficiaries. The proposed rule requires health care entities to provide written documentation that explains arrangements and patient populations being targeted, and the outcomes being measured in terms of value. There is a new exception to protect compensation not exceeding an aggregate of $3,500 per calendar year if certain conditions are met, for limited remuneration to a physician.
There is also a new exception for cybersecurity technology and related services, where CMS proposes protecting arrangements involving the donation of certain cybersecurity technology and related services. Modifications to compensation exceptions were added. There rules includes the expansion of the 90-day grace period for writing requirements. CMS proposed the deletion of goal posts for when an entity knows the period of disallowance ended. And, the proposal includes modifying the physician contribution requirement to the electronic health records’ conditions and allowing certain donations of replacement technology.
CMS is soliciting comments about the role of price transparency in the context of the Stark Law and whether to require cost-of-care information at the point of a referral for an item or service.
Find the proposed rule here.
Public comments must be submitted by Dec. 31, 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: Draft Guidance on Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff
On Nov. 6, the Food and Drug Administration (FDA) released a draft guidance on best practices for drug safety surveillance, made available to the public in compliance with requirements of the 21st Century Cures Act. The draft guidance outlines the FDA’s approach for timely postmarket analyses of drugs and biologics, and includes a high-level overview of tools, methods and signal detection and evaluation activities, using varied data sources, for drug safety surveillance to provide a broader context and a general overview of our overarching effort and commitment in this area.
Find the draft guidance here. Public comments are due by Jan. 6, 2020.
FDA: Draft Guidance on Developing Drugs for Hepatitis D Infection
On Nov. 1, the Food and Drug Administration (FDA) released a draft Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance. The draft guidance will assist sponsors in the clinical development of drugs for the treatment of chronic hepatitis D virus (HDV) infection. HDV infection occurs only in people who have hepatitis B virus (HBV) infection.
The draft guidance addresses the FDA’s current recommendations regarding the overall development program and clinical trial designs for the development of drugs and biologics for the treatment of chronic HDV infection. Sponsors are encouraged to communicate with the FDA Center for Drug Evaluation and Research’s Division of Antiviral Products (DAVP) about the development of drugs to treat HDV infection.
Find the draft guidance here. Comments are due by Jan. 1, 2020.
FDA: Drug Products Labeled as Homeopathic Guidance
On Oct. 24, the Food and Drug Administration (FDA) pulled a compliance policy allowing leeway for unapproved homeopathic drugs to remain on the market if they met certain criteria, unless FDA found a quality or manufacturing issue. FDA said products should go through the formal drug approval process before they can be sold again.
To replace the older policy, the FDA released a revised draft guidance on a risk-based approach. As a result, FDA intends to prioritize enforcement and regulatory actions involving certain categories of such products that potentially pose a higher risk to public health.
Find the draft guidance here.
Public comments must be submitted by Dec. 24, 2019.
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.
Courts
Federal Judge Temporarily Stops President Trump’s Health Insurance Mandate for Immigrants
On Nov. 3, District Court Judge Michael Simon granted a 28-day temporary restraining order on President Trump’s executive order to keep legal immigrants from entering the United States if, when seeking entry, they could not prove they will have health coverage or can pay their own medical expenses. The legal immigrants are also not able to use subsidies in the ACA individual market. On Oct. 30, the State Department released an emergency notice, issued with a 48-hour comment period. It said officers would start asking immigrants about health coverage, and would not suspend entry to those able to pay for “reasonably foreseeable” costs.
Find the temporary restraining order here.
Reports
GAO: Children’s Health Insurance Program – Efforts to Measure and Address Potential Substitution for Private Health Insurance
On Oct. 11, the Government Accountability Office (GAO) released a report on low-income children who do not qualify for Medicaid using the Children’s Health Insurance Program (CHIP). Forty-two states with certain types of CHIP programs must take steps to minimize or prevent “crowd-out,” when families substitute CHIP for private health insurance. The GAO found that there is not much information on how often substitution occurs. All 42 states have at least one procedure to prevent substitution, such as searching databases to determine whether CHIP applicants have other coverage.
GAO also identified three studies published between 2013 and 2018 that estimated CHIP crowd-out. However, these studies used different methods to calculate crowd-out, and as a result produced varied estimates. For example, one study attributed a portion of increased enrollment in CHIP and other public insurance to crowd-out, while another study found no evidence of crowd-out.
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
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