This Week in Washington: HHS Secretary appears before Senate Finance and Senate Appropriations Committees

Upcoming Hearings

Congress

House

• House Energy and Commerce Committee Marks-up Health Legislation
• Health Care Affordability Act Reintroduced
• House Energy and Commerce Committee and Oversight and Accountability Committee Chairmen Request Info on CMS Ransomware Attack
• Drug Price Transparency in Medicaid Act of 2023 Introduced

Senate

• Senate Homeland Security and Governmental Affairs Committee Holds Hearing on Drug Shortage Risks
• Senate Finance Committee Holds Hearing on President’s FY 2024 Health and Human Services Budget
• Senate HELP Committee Holds Hearing on Moderna’s COVID-19 Vaccine Price Quadrupling
• Senate Appropriations Committee Labor, Health and Human Services, Education and Related Agencies Subcommittee Holds Hearing on President’s FY 2024 Health and Human Services Budget

Administration

• CMS Innovation Center Extends Medicare Advantage Value-Based Insurance Model
• CMS Announces Expansion of Medicaid Postpartum Coverage in Oklahoma
• CMS Revises State Survey Agency Guidance for Review of Home Dialysis Services
• CDC Announces Increased Spread of Antimicrobial-Resistant Fungus
• FDA Releases 2023 User Fee Rates for Over-the-Counter Monograph Drugs
• FDA Issues Final Guidances for COVID-19 Medical Device Operation Transition
• FDA Issues Draft Guidance Regarding Oncology Clinical Trials
• HHS Announces Certified Community Behavioral Health Clinic Funding Opportunities
• HHS Opens Domestic Violence Office

Proposed Rules

• FDA Proposes New Tobacco Product Manufacturing Practices Requirements
• CMS Proposed Rule Revises Medicare DSH Section 1115 Waiver Calculation
• CMS Proposes Rule to Clarify Changes to DSH Payment Calculations
• ACF Proposes Rule to Revise Foster Family Home Definition
• CMS Proposes Rule to Increase Nursing Home Transparency
• HHS Proposes Rule to Expand Access to ACA Birth Control Coverage

Final Rules

• FDA Issues Final Rule Regarding Mammography Quality Standards
• CMS Issues Final Rule Regarding Medicare Advantage Risk Adjustment Data Validation Program
• CMS Final Rule Adds Items to DMEPOS Order List and Updates Healthcare Common Procedure Coding System (HCPCS)
• FDA Delays Tobacco Product Required Warning Final Rule Effective Date
• CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

Reports

• GAO Releases Report on VA Health System Modernization
• GAO Releases Report on Improving Infection Control in Nursing Homes

Upcoming Hearings

March 28

House Appropriations Committee Budget Hearing: “Fiscal Year 2024 Request for the Department of Health and Human Services”
10:00 a.m., Rayburn House Office Building 2358C
Announced witnesses are:

• The Honorable Xavier Becerra, Secretary of the U.S. Department of Health and Human Services

House Ways and Means Committee Hearing: “Hearing on President Biden’s Fiscal Year 2024 Budget Request with Health and Human Services Secretary Becerra”
2:00 p.m., Room to be announced.
Announced witnesses are:

• The Honorable Xavier Becerra, Secretary of the U.S. Department of Health and Human Services

House Energy and Commerce Committee Health Subcommittee Hearing: “Lowering Unaffordable Costs: Examining Transparency and Competition in Health Care”
1:00 p.m., Rayburn House Office Building 2123
Witnesses to be announced.

March 29

House Energy and Commerce Committee Health Subcommittee Hearing: “Fiscal Year 2024 Department of Health and Human Services Budget”
10:00 a.m., Rayburn House Office Building 2123
Witnesses to be announced.

House Appropriations Committee Budget Hearing: “Fiscal Year 2024 Request for the Food and Drug Administration”
1:00 p.m., Rayburn House Office Building 2362A
Witnesses to be announced.

Senate Finance Committee Subcommittee on Health Care Hearing: “An Oral Health Crisis: Identifying and Addressing Health Disparities”
2:30 p.m., Dirksen Senate Office Building 215
Announced witnesses are:

• Jonathan P. Forte, MHA, FACHE, President and CEO of RiverStone Health
• Cherae M. Farmer-Dixon, DDS, MSPH, FACD, FICD, Dean and Professor of Meharry Medical College, School of Dentistry
• Marko Vujicic, Ph.D., Chief Economist and Vice President of the American Dental Association Health Policy Institute

March 30

House Energy and Commerce Committee Health Subcommittee Legislative Hearing: “Reauthorization of the Animal Drug User Fee Programs”
9:00 a.m., Rayburn House Office Building 2123
Witnesses to be announced.

Senate Finance Committee Hearing: “Pharmacy Benefit Managers and the Prescription Drug Supply Chain: Impact on Patients and Taxpayers”
10:00 a.m., Dirksen Senate Office Building 215
Announced witnesses are:

• Robin Feldman, Arthur J. Goldberg Distinguished Professor of Law and Director of the Center For Innovation at the University of California Hastings College of Law
• Kevin Van Nuys, Ph.D., Executive Director of the Value Of Life Sciences Innovation Leonard D. Schaeffer Center at the University of Southern California Center for Health Policy and Economics
• Lawton Robert Burns, Ph.D., James Joo-Jin Kim Professor of Health Care Management and Co-Director of the Roy and Diana Vagelos Program in Life Sciences and Management at the University of Pennsylvania Wharton School
• Matthew Gibbs, Pharm.D., President of Capital Rx
• Jonathan E. Levitt, Founding Partner of Frier Levitt Attorneys at Law

Congress

House

House Energy and Commerce Committee Marks-up Health Legislation

On March 23, the House Energy and Commerce Committee met to markup 19 bills, including 5 healthcare-related bills. They were:

• R. 501, Block, Report, and Suspend Suspicious Shipments Act

This bill would require drug manufacturers, distributors, and other Drug Enforcement Agency (DEA) registrants, to report and decline suspicious orders of all controlled substances. It would also require the DEA to specify what indicators give rise to suspicious orders, and how these orders could be diverted if filled.

• R. 498, 9-8-8 Lifeline Cybersecurity Responsibility Act

This bill would require the Department of Health and Human Services (HHS) to maintain internal coordination to protect the 9-8-8 lifeline from cybersecurity threats. It would also require the 9-8-8 network administrator to immediately report potential cybersecurity threats to the Substance Abuse and Mental Health Services Administration (SAMSHA), and would require the Comptroller General to conduct a study on 9-8-8 lifeline cybersecurity flaws and risks.

• R. 485, Protecting Health Care for All Patient Act of 2023

This bill would prohibit all federal health care programs and federally-funded state health care programs from considering quality-adjusted life years (QALYs) or other similar measures that discount the value of life based on disability, when calculating thresholds for health care coverage, reimbursements, and incentive programs.

• R. 467, Halt All Lethal Trafficking of Fentanyl Act

This bill would place fentanyl-related substances (FTS) on the Controlled Substances Act Schedule I list permanently. It would also make the registration process to research Schedule I substances simpler.

• R. 801, Securing the Border for Public Health Act of 2023

This bill would amend the Public Health Services Act and expand Title 42 authority. It would allow the Secretary of Health and Human Services (HHS), following a consultation with the U.S. Attorney General, to prohibit the entry of persons and imports related to certain controlled substances from certain countries, into the United States.

For more information, click here.

Health Care Affordability Act Reintroduced

On March 22, Rep. Underwood (D-IL) reintroduced the Health Care Affordability Act. The bill would lower the cost of health care premiums by expanding the availability of health care premium tax credits. Provisions of the bill expanding health care premium tax credits were included in the Inflation Reduction Act (IRA) but are set to expire in 2025. This legislation would make the expansions permanent.

For more information, click here.

House Energy and Commerce Committee and Oversight and Accountability Committee Chairmen Request Info on CMS Ransomware Attack

On March 20, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) and House Oversight and Accountability Committee Chairman James Comer (R-KY) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, requesting information on the ransomware attack that CMS subcontractor Healthcare Management Solutions, LLC. suffered on Oct. 8, 2022. CMS determined that the ransomware attack likely resulted in the breaching of sensitive Medicare beneficiary data. Both committees are requesting that CMS submit any documents and communications related to the attack, to facilitate their respective investigations of the incident.

For more information, click here.

Drug Price Transparency in Medicaid Act of 2023 Introduced

On March 17, Reps. Carter (R-GA), Gonzalez (D-TX), Stefanik (R-NY), Ross (D-NC), Allen (R-GA), and Auchincloss (D-MA) introduced the Drug Price Transparency in Medicaid Act of 2023. The bipartisan legislation would improve transparency of prescription drug prices and would prohibit pharmacy benefit managers (PBMs) from using spread pricing in Medicaid programs. The bill would also establish an oversight and accountability program, which would monitor PBMs for predatory prescription drug pricing tactics.

For more information, click here.

Senate

Senate Homeland Security and Governmental Affairs Committee Holds Hearing on Drug Shortage Risks

On March 22, the Senate Homeland Security and Governmental Affairs Committee held a hearing to discuss the health and national security risks of drug shortages. Witnesses included:

• Andrew Shuman, M.D., Associate Professor of Otolaryngology-Head and Neck Surgery and Chief of the Clinical Ethics Service Center for Bioethics and Social Sciences in Medicine at the University of Michigan Medical School
• Vimala Raghavendran, Vice President of Informatics Product Development at U.S. Pharmacopeia
• Erin Fox, Pharm.D., Associate Chief Pharmacy Officer of Shared Services and Adjunct Professor at the University of Utah College of Pharmacy
• John C. Goodman, Ph.D., President of the Goodman Institute for Public Policy Research

For more information, click here.

Senate Finance Committee Holds Hearing on President’s FY 2024 Health and Human Services Budget

On March 22, the Senate Finance Committee held a hearing on the President’s Fiscal Year (FY) 2024 budget for the Department of Health and Human Services (HHS). Witnesses included:

• The Honorable Xavier Becerra, Secretary of the U.S. Department of Health and Human Services (HHS)

For more information, click here.

Senate HELP Committee Holds Hearing on Moderna’s COVID-19 Vaccine Price Quadrupling

On March 22, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on the quadrupling of the Moderna COVID-19 price. Witnesses included:

• Stéphane Bancel, MBA, MEng, MSc, Chief Executive Officer and Director of Moderna, Inc.
• Christopher J. Morten, Ph.D., J.D, Associate Clinical Professor of Law at Columbia Law School
• Ameet Sarpatwari, Ph.D., J.D, Assistant Professor of Medicine at Harvard Medical School
• Craig Garthwaite, Ph.D., MPP, Herman Smith Research Professor in Hospital and Health Services Management at Northwestern University Kellogg School of Management

For more information, click here.

Senate Appropriations Committee Labor, Health and Human Services, Education and Related Agencies Subcommittee Holds Hearing on President’s FY 2024 Health and Human Services Budget

On March 22, the Senate Appropriations Committee held a hearing on the President’s Fiscal Year (FY) 2024 budget for the Department of Health and Human Services (HHS). Witnesses included:

• The Honorable Xavier Becerra, Secretary of the U.S. Department of Health and Human Services (HHS)

For more information, click here.

Administration

CMS Innovation Center Extends Medicare Advantage Value-Based Insurance Model

On March 23, the Centers for Medicare and Medicaid Services (CMS) Innovation Center announced that it was extending its Medicare Advantage (MA) Value-Based Insurance Design (VBID) Model for calendar years 2025 through 2030. CMS announced that it intends on implementing changes to better address the health-related social needs of patients and to improve health equity and care coordination.

For more information, click here.

CMS Announces Expansion of Medicaid Postpartum Coverage in Oklahoma

On March 23, the Centers for Medicare and Medicaid Services (CMS) announced that Oklahoma would be extending its Medicaid postpartum coverage period to 12 months. Medicaid and the Children’s Health Insurance Program (CHIP) currently mandate states to provide postpartum coverage for a period of 60 days. States recently became eligible to extend Medicaid and CHIP postpartum coverage by provisions included in the Consolidated Appropriations Act (CAA) of 2023. 29 states and the District of Columbia have already extended their postpartum coverage.

For more information, click here.

CMS Revises State Survey Agency Guidance for Review of Home Dialysis Services

On March 22, the Centers for Medicare and Medicaid Services (CMS) released a revised guidance for state survey agencies (SAs) tasked with reviewing home dialysis services delivered within Long-Term Care (LTC) facilities. The revised guidance builds upon a 2018 guidance that CMS issued regarding home dialysis services. The guidance incorporates stakeholder feedback, public comments, and models of care that are being implemented for home dialysis care of nursing home residents.

For more information, click here.

CDC Announces Increased Spread of Antimicrobial-Resistant Fungus

On March 20, the Centers for Disease Control and Prevention (CDC) announced that the antimicrobial-resistant (AR) fungus Candida auris (C. auris) is spreading rapidly among U.S. healthcare facilities. The CDC has labeled C. auris an urgent AR threat, due to its high resistance against antifungal drugs and ability to cause severe infections and death among sick individuals. Recent data obtained by the CDC shows that cases of C. auris infection tripled between 2020 and 2021, and continued rising in 2022.

For more information, click here.

FDA Releases 2023 User Fee Rates for Over-the-Counter Monograph Drugs

On March 24, the Food and Drug Administration (FDA) released the fee rates for the over-the-counter (OTC) monograph drug user fee program (OMUFA) for fiscal year (FY) 2023. The FDA is authorized to assess and collect monography drug user fees from OTC monograph drug facilities and submitters of qualifying order requests by a provision in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. OTC monograph drugs are nonprescription drugs that do not have approved new drug applications. OMUFA fees vary depending on facility type and the role that respective facilities play in the manufacturing process of OTC monograph drugs. The fees outlined in this guidance are effective until Sept. 30, 2023.

For more information, click here.

FDA Issues Final Guidances for COVID-19 Medical Device Operation Transition

On March 24, the Food and Drug Administration (FDA) issued two final guidances regarding the phasing out of medical device operation policies that were adopted during the COVID-19 pandemic. The two guidances intend to remind industry stakeholders on what devices fall under current COVID-19 enforcement policies and inform them on what steps should be taken to transition to normal medical device operation policies. The FDA is implementing a 180-day transition period to allow for a smooth transition.

For more information, click here.

FDA Issues Draft Guidance Regarding Oncology Clinical Trials

On March 24, the Food and Drug Administration (FDA) issued draft guidance regarding the design of clinical trials for cancer therapeutics. The guidance seeks to assist anti-cancer drug and biological product manufacturers with developing clinical trials that will support accelerated approval of their respective products. The guidance also explains how clinical trial data should be collected and analyzed.

For more information, click here.

HHS Announces Certified Community Behavioral Health Clinic Funding Opportunities

On March 24, the Department of Health and Human Services (HHS) announced two new funding opportunities for Certified Community Behavioral Health Clinics (CCBHC). CCBHCs are tasked with providing mental health and substance use disorder care in communities. The CCBHC Planning, Development, and Implementation (CCBHC-PDI) grant and the CCBHC Improvement and Advancement (CCBHC-IA) grant, seek to help clinics establish new CCBHC programs and expand existing ones. Both grants total $123.6 million.

For more information, click here.

HHS Opens Domestic Violence Office

On March 20, the Department of Health and Human Services (HHS) announced that it was opening a new office to strengthen domestic violence prevention. The Office of Family Violence Prevention and Services (OFVPS), which will be managed by the Administration for Children and Families (ACF), will identify and oversee domestic, intimate partner, and dating violence. The OFVPS will be tasked with developing an action plan to prevent and respond to domestic violence across various social service programs and agency partners.

For more information, click here.

Proposed Rules

FDA Proposes New Tobacco Product Manufacturing Practices Requirements

On March 8, the Food and Drug Administration (FDA) released a proposed rule that would improve the manufacture, design, packing and storage of tobacco products. The proposed rule seeks to ensure that tobacco products comply with the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA has noted that it will help minimize and prevent tobacco product contamination, as well as inconsistencies in e-cigarette liquid concentrations and labeling. The proposed rule will also:

• Establish tobacco product design and development controls
• Ensure that tobacco products meet established specifications
• Crack down on tobacco products that do not meet specifications
• Require manufacturers to take action in cases of product contamination
• Require investigations of products that do not meet specifications
• Establish the ability to trace all components, ingredients, additives and materials used by tobacco product manufacturers

Public comments will be accepted until Sept. 6, 2023. For more information, click here.

CMS Proposed Rule Revises Medicare DSH Section 1115 Waiver Calculation

On Feb. 28, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would change how it defines Medicaid-eligible patients who can be included in Medicare disproportionate share hospital (DSH) payment calculations. CMS is proposing to do this by limiting the types of Medicaid Section 1115 waiver days that can be used by hospitals when calculating their disproportionate patient percentage (DPP) Medicaid fraction. CMS is proposing to allow hospitals to only count Section 1115 waiver days for patients who received a health insurance plan directly from a Section 1115 demonstration, that covers inpatient hospital services or who received, with the help of Section 1115 demonstration premium assistance, a health insurance plan that covers 100 percent of the patient’s premium costs.

Public comments will be accepted until May 1, 2023. For more information, click here.

CMS Proposes Rule to Clarify Changes to DSH Payment Calculations

On Feb. 24, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would clarify changes made to the Medicaid disproportionate share hospital (DSH) payment limit calculation by the Consolidated Appropriations Act of 2021. The proposed rule is intended to give states and hospitals a better understanding of how the limit is calculated. It also outlines technical and administrative changes CMS made recently to the DSH program.

Public comments will be accepted until April 25, 2023. For more information, click here.

ACF Proposes Rule to Revise Foster Family Home Definition

On Feb. 14, the Department of Health and Human Services (HHS) Administration for Children and Families (ACF) released a proposed rule that would revise the current definition of “foster family home” and allow Title IV-E agencies to adopt foster family home licensing and approval standards for foster family homes of individuals related to children by “kin” (blood, marriage or adoption). Title IV-E agencies would also be allowed to adopt licensing and approval standards for individuals related by emotionally significant relationships. The proposed rule would also allow Title IV-E agencies to claim federal financial participation (FFM) for the costs of foster care maintenance payments (FCMP) and would make changes to the requirement that Title IV-E agencies review FCMP amounts to ensure that children placed in “kin” foster homes receive the same FCMP as those in non-kin foster family homes.

Public comments will be accepted until April 17, 2023. For more information, click here.

CMS Proposes Rule to Increase Nursing Home Transparency

On Feb. 15, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that seeks to increase the transparency of nursing home facility information. The proposed rule would require Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities to disclose the following information:

• Names, titles and period of service for every member of the nursing home facility’s governing body
• Names, titles and period of service for the nursing home facility’s officer, director, member, partner, trustee and managing employee
• Names, titles and period of service for any additional disclosable parties of the nursing home facility
• A description of the relationship the additional disclosable parties have with the nursing home facility and other disclosable parties

Public comments will be accepted until April 14, 2023. For more information, click here.

HHS Proposes Rule to Expand Access to ACA Birth Control Coverage

On Jan. 30, the Department of Health and Human Services (HHS) released a proposed rule that seeks to strengthen and expand health insurance birth control coverage for women. The proposed rule would prevent private health plans and insurers from excluding coverage of contraceptive services based on moral exemptions. It would also establish an independent birth control pathway for women covered under an objecting entity, which would allow them to access contraceptive services from a willing provider without any cost. Private health plans and insurers would still be allowed to deny birth control coverage based on religious exemptions and objecting private employers and universities would still have the right to choose whether to allow plan participants access to optional contraceptive services.

Public comments will be accepted until April 3, 2023. For more information, click here.

Final Rules

FDA Issues Final Rule Regarding Mammography Quality Standards

On March 9, the Food and Drug Administration (FDA) issued a final rule that updates the regulations implemented by the Mammography Quality Standards Act of 1992. The FDA has decided to update the regulations due to advancements made in mammography technology and information. The final rule will:

• Improve the delivery of mammography services;
• Strengthen communication of healthcare information;
• Require mammography facilities to provide patients with additional health information;
• Ensure the availability of qualified mammography personnel;
• Bolster medical outcome audits;
• Modernize technological aspects of mammography services; and
• Implement enforcement tools to deal with noncompliant facilities.

The rule will go into effect on Sept. 10, 2024. For more information, click here.

CMS Issues Final Rule Regarding Medicare Advantage Risk Adjustment Data Validation Program

On Jan. 30, the Centers for Medicare and Medicaid Services (CMS) released a final rule that alters the audit methodology for the Medicare Advantage Risk Adjustment Data Validation (RADV) program and implements new requirements on Medicare Advantage Organizations (MAOs). The final rule establishes that CMS will begin extrapolating RADV audit findings with payment year (PY) 2018 and will not extrapolate audit findings for PYs 2011 through 2017. It also codifies CMS’ intention of not applying a fee-for-service adjustment factor to RADV program audits. The final rule will also require Medicare Advantage Organizations (MAOs) to remit improper payments identified by CMS during RADV audits.

The rule will go into effect on April 3, 2023. For more information, click here.

CMS Final Rule Adds Items to DMEPOS Order List and Updates Healthcare Common Procedure Coding System (HCPCS)

On Jan. 17, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will update the Healthcare Common Procedure Coding System (HCPCS) codes for required Face-to-Face Encounter and Written Order Prior to Delivery (F2F/WOPD) requirements applicable to Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) orders. The update follows CMS’ decision to add new non-statutorily required DMEPOS items to the F2F/WOPD list. CMS believes the addition of these items will protect Medicare enrollees and further reduce Medicare fraud, waste and abuse.

The rule will go into effect on April 17, 2023. For more information, click here.

FDA Delays Tobacco Product Required Warning Final Rule Effective Date

On Nov. 25, the Food and Drug Administration (FDA), in compliance with an order issued by the U.S. District Court for the Eastern District of Texas, delayed the effective date of a final rule published on March 18, 2020, titled “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements.” The rule, which was originally supposed to go into effect on June 18, 2021, establishes new cigarette health warnings for cigarette packages and advertisements.

The rule will go into effect on Nov. 6, 2023. For more information, click here.

CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

On Nov. 17, the Centers for Medicare and Medicaid Services (CMS) corrected a technical error that was found in a final rule published in the Federal Register on July 11, 2022. The final rule updates proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to address analytes and newer technologies.

The rule goes into effect July 11, 2024. For more information, click here.

Reports

GAO Releases Report on VA Health System Modernization

On March 20, the Government Accountability Office (GAO) released a report highlighting shortcomings in efforts taken by the Department of Veterans Affairs (VA), to modernize its health care system. In 2018, the VA developed various recommendations for modernizing its health care infrastructure, following the passage of the VA Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act of 2018. GAO reviewed the recommendations and found that the data the VA relied on when drafting them showed gaps and inconsistencies. The GAO also found that the leadership team established by the VA to oversee the implementation of the respective recommendations, lacked a clear and formal structure and strategy. The GAO conducted the study because it was asked to review the VA’s plans to address its health care infrastructure needs.

For more information, click here.

GAO Releases Report on Improving Infection Control in Nursing Homes

On March 20, the Government Accountability Office (GAO) released a report analyzing infection prevention and control measures undertaken by nursing homes. GAO met with 13 experts, including individuals from the Centers for Medicare and Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), and the National Academies of Sciences, Engineering, and Medicine, and asked them what measures nursing homes should consider implementing or expanding. GAO discovered that the experts’ recommendations were consistent with those that had been previously proposed to the Department of Health and Human Services (HHS). GAO conducted the study because it was asked to review federal oversight of nursing homes in the wake of the COVID-19 pandemic by a provision in the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

For more information, click here.