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March 16, 2020

Health Headlines – March 16, 2020


King & Spalding Client Alert: CMS Releases Section 1135 Waiver in Response to the Novel Coronavirus Pandemic – On March 13, 2020, President Trump declared the coronavirus pandemic a national emergency, invoking powers under the National Emergency Act and the Stafford Act. The President’s declaration, coupled with Secretary Azar’s earlier declaration of a public health emergency under Section 319 of the Public Health Service Act[i], authorized the Secretary to waive certain Medicare, Medicaid and Children’s Health Insurance Program (CHIP) requirements and conditions of participation under Section 1135 of the Social Security Act.  On the same day as the President’s declaration, CMS announced that it had used this authority to activate blanket waivers of several Medicare and Medicaid requirements to give healthcare providers more flexibility in responding to the pandemic.  Click here to read the full King & Spalding Client Alert prepared by the Healthcare Team’s Crisis Practice. King & Spalding will be hosting a Roundtable webinar on Thursday, March 18 to discuss the waiver in greater detail as well as the potential for providers to request individual Section 1135 waivers and other strategies for addressing the coronavirus pandemic.  An invitation will be distributed imminently.

House Passes COVID-19 Relief Bill, H.R. 6201 “Families First Coronavirus Response Act” On March 14, 2020, the House of Representatives passed H.R. 6201, an emergency relief package intended to mitigate the economic damage stemming from COVID-19. 

The legislation provides for short-term paid leave benefits with two weeks of paid sick leave and up to three months of paid family and medical leave.  However, large employers with more than 500 employees are exempt from the legislation.  H.R. 6201 applies only to government and small business employees who are infected by the virus, quarantined, have a sick family member or are affected by school closings.  The bill also limits benefits to individuals who are sick, subject to a quarantine or caring for a family member and excludes “certain health care providers and emergency responders” from the benefits.  Companies covered by the policy will receive new tax credits to offset the costs of the mandate and the economic impact of the outbreak.

Most importantly, the bill allows for free coronavirus testing for all, including the uninsured.  The testing will be covered by insurance and federal government programs through a number of waivers and a 6.2-percentage point increase in federal payments to Medicaid for states.  The bill also includes approximately $1 billion for food security programs aimed at assisting low-income minors and other individuals.  These funds will include $500 million for low-income women as well as unemployed mothers with young children and pregnant women who lose their jobs due to the virus.  Lastly, the legislation provides for $1 billion in emergency grants for state unemployment insurance.  A copy of H.R. 6201, the Families First Coronavirus Response Act, is available here.

The new House legislation is separate from H.R. 6074, the Coronavirus Preparedness and Response Supplemental Appropriations Act, that was signed by President Trump on March 6, 2020.  A detailed overview of H.R. 6074 is available here.  

H.R. 6201, the House bill, now heads to the Senate where voting is not yet set.  Senate Leader Mitch McConnell cancelled a planned recess and senators are scheduled to return on Monday.

Reporter, Kathryn T. Han, Los Angeles, +1 213 443 4336, khan@kslaw.com.

Coronavirus Update: CMS Guidance Issued this Month – As the number of coronavirus cases across the country continue to rise, CMS has issued several coronavirus-specific memorandums to healthcare providers and laboratories.  In the past two weeks, CMS has issued disease-specific coverage and billing guidance, developed new HCPCS billing codes for COVID-19 laboratory tests, outlined screening, treatment, and transfer protocols for hospitals with emergency departments, and suspended certain state survey activities to prioritize focus on infection control. 

CMS Fact Sheet: Coverage and Payment Related to COVID-19 – Medicare

On March 5, 2020, CMS issued a fact sheet with guidance for healthcare providers and patients that describes various benefits in the Medicare program.  The fact sheet is part of a broader effort by CMS and the White House Coronavirus Task Force to educate the public about benefits that can be used to contain the disease.  The fact sheet is organized into two main sections, the first covering Original Medicare and the second covering Medicare Parts C and D. CMS continued to supplement the fact sheet throughout last week with additional information covering new benefit categories.  The fact sheet currently includes brief sections addressing: diagnostic tests; vaccines; inpatient hospital services; inpatient hospital quarantines; ambulatory services; telehealth and other communication-based technology services; requests for prescription refills; emergency ambulance transportation; Medicare Advantage coverage and cost sharing; and Part D coverage, as well as other topics. 

The fact sheet is available here.

Two New HCPCS Billing Codes for Coronavirus Diagnostic Tests

CMS developed two, new Healthcare Common Procedure Coding System (HCPCS) codes that laboratories can use to bill for certain COVID-19 diagnostic tests.  The first HCPCS code (U0001) can be used to bill for CDC testing laboratories to test patients for COVID-19.  The second HCPCS billing code (U0002) allows providers to bill for non-CDC laboratory tests. Last month, the FDA issued guidance for laboratories to develop their own tests.  The use of coronavirus-specific HCPCS billing codes will permit CMS to encourage more testing and to enhance pandemic tracking efforts.  The Medicare claims processing system will begin to accept the HCPCS billing codes on April 1, 2020 for dates of service after February 4, 2020. CMS has tasked the regional MACs with developing reimbursement rates for these new codes until a national payment rate is established.

More information on the new HCPCS billing codes is available here.

Guidance to Hospitals with Emergency Departments on Patient Screening, Treatment and Transfer Requirements

On March 9, 2020, CMS published a memorandum to State Survey Agency Directors providing guidance to hospitals with emergency departments (EDs) on patient screening, treatment and transfer requirements to prevent the spread of infectious disease and illness, including COVID-19.  The memorandum, “Emergency Medical Treatment and Labor Act (EMTALA) Requirements and Implications Related to Coronavirus Disease 2019 (COVID-19),” advises that hospitals should continue to follow both CDC guidance for infection control and EMTALA requirements.  In the memorandum, CMS emphasizes that every hospital and critical access hospital (CAH) with an ED is required to conduct an appropriate medical screening examination (MSE) of all individuals who come to the ED, including those who are suspected of having COVID-19.  Every hospital with an ED is expected to have the capability to apply appropriate COVID-19 screening criteria, to immediately identify and isolate individuals who meet COVID-19 screening criteria, and to contact their state or local public health officials to determine next steps.

Consistent with the obligations imposed by EMTALA, hospitals with capacity and the specialized capabilities needed for stabilizing treatment are required to accept appropriate transfers from hospitals without the necessary capabilities.  The memorandum advises that, in assessing whether a hospital had the requisite capabilities and capacity for COVID-19 treatment, CMS would take into account the CDC’s recommendations at the time of the event in question. The CDC’s most current infection prevention and control recommendations for hospital patients with suspected or known COVID-19 are available here.

The memorandum also describes three options available to hospitals for managing extraordinary ED surges under existing EMTALA requirements.  First, hospitals may set up alternative screening sites on campus, outside the ED.  Individuals may be redirected to these sites after being logged in, and this process can even take place outside the ED’s entrance. Second, hospitals may set up screening at off-campus, hospital-controlled sites. Hospitals and community officials may encourage the public to go to these sites instead of the hospital for screening for influenza-like illness (ILI).  However, a hospital may not tell individuals who have already come to its ED to go to the off-site location for the MSE.  EMTALA requirements do not apply to such off-campus sites, unless the off-campus site is already a dedicated ED of the hospital.  Third, communities may set up screening clinics at sites not under the hospital’s control, and hospitals and community officials may encourage the public to go to such sites for ILI screening.  Such sites are not subject to EMTALA’s requirements.

The memorandum is available here.

Guidance to Medicare Advantage and Part D Plans

On March 10, 2020, CMS issued a memorandum that outlines the flexibilities that Medicare Advantage Organizations (MAOs) and Part D sponsors have to waive certain requirements to help prevent the spread of COVID-19.  Most significantly, the memorandum advises that MAOs may waive or reduce enrollee cost-sharing for beneficiaries enrolled in their MA plans.  For example, MAOs may waive or reduce cost-sharing for COVID-19 laboratory tests, telehealth benefits or other services to address the outbreak, provided cost-sharing is waived or reduced for all similarly situated plan enrollees on a uniform basis. The OIG has advised that should a MAO choose to voluntarily waive or reduce enrollee cost-sharing, such waivers or reductions would satisfy the safe harbor to the federal Anti-Kickback Statute for increased coverage, reduced cost-sharing amounts, or reduced premium amounts offered by health plans, set forth at 42 C.F.R. § 1001.952(l).

The memorandum also advises that MAOs may provide enrollees access to Part B services through telehealth in any geographic area and from a variety of places, including beneficiaries’ homes. To combat the COVID-19 outbreak, MAOs may expand coverage of telehealth services for similarly situated enrollees beyond those approved by CMS in the plan’s benefit package, until CMS determines such expansion is no longer necessary in conjunction with the outbreak.  OIG has advised that such an expansion of coverage by a MAO would also qualify for the safe harbor at 42 C.F.R. § 1001.952(l).

The memorandum describes several options available to Part D sponsors.  Sponsors may relax their “refill-too-soon” edits if circumstances are reasonably expected to result in a disruption in access to drugs.  Sponsors may also permit affected enrollees to obtain the maximum extended day supply available under their plan, if requested and available.  Further, to ensure enrollees have adequate access to covered drugs when those enrollees cannot reasonably be expected to obtain such drugs from network pharmacies, sponsors may reimburse enrollees for prescriptions obtained from out-of-network pharmacies.  Finally, where it would be difficult or impossible for an enrollee to access a retail pharmacy (due to a disaster, emergency, or quarantine situation), sponsors may voluntarily relax any plan-imposed policies that discourage certain methods of delivery (e.g., mail or home delivery).

The memorandum is available here.

CMS Suspends Certain Survey Activities to Focus on Infection Control

On March 4, 2020, CMS issued a memorandum to State Survey Agency Directors that suspended non-emergency inspections across the country and prioritized a focus on infection control deficiencies.  In the memorandum, CMS limited survey activity to the following priorities: (i) immediate jeopardy complaints and allegations of abuse and neglect; (ii) complaints with allegations of infectious disease control concerns; (iii) recertification surveys that are statutorily required for nursing homes, home health, hospice, and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID facilities); (iv) re-visits needed to resolve enforcement actions; (v) initial certifications; (vi) surveys of facilities with a history of infectious disease control issues at the immediate jeopardy level within the past three years; and (vii) surveys of facilities with a history of infectious disease control deficiencies at lower levels than immediate jeopardy.

The memorandum is available here.

Reporters, Kyle Gotchy, +1 916 321 4809, kgotchy@kslaw.com and Taylor Whitten, Sacramento, +1 916 321 4815, twhitten@kslaw.com.

King & Spalding Mobilizes Coronavirus Task Force—2019 Novel Coronavirus (COVID-19) continues its rapid proliferation across the globe with complex and widening implications. While there are still many unknowns, King & Spalding mobilized early to assist our clients, helping them to address early stage responses across their operations, while considering the long-term commercial and legal impact. King & Spalding’s Crisis Practice brings experience and judgment to help the c-suite, legal team and the Board triage as pressures compound. 

On top of our national healthcare practice, our team brings together highly skilled lawyers from our Special Matters and Government Investigations, Employment, Corporate Governance, Class Action, Litigation, International Arbitration, Insurance Coverage and Recovery, Labor and Employment, Government Advocacy and Public Policy, Leverage Finance, Restructuring, Trade, Government Contracts and Data, Privacy and Security teams, offering our clients a wide range of advice and perspectives. Our clients also benefit from our premier FDA and Life Sciences practice, which works closely with FDA and other regulatory bodies. Lawyers within our healthcare practice are in regular contact with the CDC and other regulatory agencies that are coordinating the U.S. government’s response to this situation. Our team has advised clients on a range of issues, including:

  • Coordination of care between hospitals, health systems, academic medical centers, post-acute facilities and other provider organizations and state and local healthcare agencies
  • Impact of CMS’s decision to grant section 1135 waiver in response to the novel coronavirus pandemic
  • Financial impact of increased staffing and required overtime, higher supply costs and waste disposal needs and new and potentially expensive treatment protocols and testing measures
  • Employment issues including unexcused absenteeism and Workers Compensation, FMLA, ADA and paid leave implications for exposed or infected workers and family members
  • Employment and public safety issues, including quarantines, privacy and travel restrictions
  • Supply chain disruptions impacting manufacturing, product distribution and U.S. and EU regulatory compliance
  • Incident response plans to address issues of surge capacity, allocation of limited healthcare resources such as MCMs or PPE, staffing shortages, securing vital drugs & supplies and training of healthcare personnel
  • Reimbursement and regulatory issues when hospitals create testing or treatment sites outside of their walls
  • Regulatory and reimbursement obstacles faced when using telemedicine or off-site locations
  • Other demonstrations and waivers that may be deployed by the federal government (for HIPAA as well as in the Medicare and Medicaid context, potentially including telehealth)
  • Developing a crisis response team consisting of the right people with identified skills and including both in-house personnel and outside experts
  • Communication strategies to ensure the protection of patient privacy, transparency with employees, patients and the public, communicating with the media, and HIPAA compliance including understanding the limited waivers available during a declared public health emergency
  • Contractual issues relating to supply chain impacts, such as enforceability of force majeure agreements
  • Impact on clinical studies, including recruiting and retaining study subjects due to the quarantines and travel restrictions, delays in ongoing clinical studies and launching new studies, and disruptions in monitoring clinical study sites
  • Types of litigation faced during a public health emergency, such as rights triggered and risks faced by affected entities, and evaluating insurance coverage options for significant business losses and legal expenses
  • Best practices for legal teams, boards, CEOs, and senior management to prevent and respond to business and reputational risks with respect to coronavirus
  • Strategy development to provide an integrated response to address inquiries regarding all aspects of the impact of coronavirus, including legal, congressional, regulatory, investor and public
  • Internal and external resource identification including cross-disciplinary teams to effectively address issues resulting from coronavirus
  • Corporate reviews of high-risk areas to prevent future similar crises
  • Event cancellation policies

Reporter, Bency McClain, Washington, D.C., +1 202 661 7897, bmmclain@kslaw.com.

CMS and ONC Release Interoperability and Patient Access Final Rules – On March 9, 2020, CMS released its final rule creating certain interoperability and patient access standards (CMS Final Rule).  On the same day, the ONC released a rule that addressed interoperability as well (ONC Final Rule), with a focus on technology developers.  The interoperability provisions in both rules implement certain sections of the 21st Century Cures Act (Cures Act), creating a regulatory framework for the exchange of information among providers, patients and payers.  The finalized policies in the CMS Final Rule include patient access application programming interface (API) to facilitate the retrieval of patient data from payers, and the public reporting of “information blocking” to make public the providers that do not attest to full compliance with certain interoperability requirements. 

In the CMS Final Rule and ONC Final Rule, the agencies finalized the following policies described below.

Standards-Based Patient Access API

CMS regulated payers will be required to implement and maintain a standards-based Patient Access API and permit third-party applications to retrieve certain enrollee data with the approval and at the direction of a current enrollee. 

The Patient Access API must meet the technical, content, and vocabulary standards in the ONC Final Rule (including Health Level 7 Fast Healthcare Interoperability Resources (FHIR) Release 4.0.1) as well as content and vocabulary standards provided in HIPAA regulations and Medicare Part D regulations.  The Patient Access API must, at a minimum, make available adjudicated claims (including provider remittances and enrollee cost-sharing), encounters with capitated providers, and clinical data, including laboratory results.  Such data must be available within one business day after a claim is adjudicated or encounter data are received.  Beginning January 1, 2021, impacted payers must make available through the Patient Access API the specified data they maintain with a date of service on or after January 1, 2016. 

This requirement applies to the following CMS regulated payers: Medicare Advantage organizations, Medicaid Fee-For-Service (FFS) programs, Medicaid managed care plans, CHIP FFS programs, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs), excluding issuers offering only stand-alone dental plans and QHP issuers offering coverage in the Federally-facilitated Small Business Health Operations Program.

Public Reporting and Information Blocking

The Cures Act defines “information blocking” generally as “a practice that is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information,” and, in the case of health care providers, the provider knows that such practice is unreasonable and is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information (EHI).  The Cures Act authorizes the OIG to investigate any claim that a health care provider engaged in information blocking and impose penalties of up to $1 million per violation. 

In the ONC Final Rule, ONC finalized eight exceptions for “reasonable and necessary activities” that would not be considered “information blocking.”  Under these exceptions, certain interference with access, exchange, or use of EHI is permissible —

  • to prevent harm to a patient or another natural person;
  • to protect an individual’s privacy;
  • to protect the security of EHI;
  • due to infeasibility of the request; and
  • by an actor’s practice that is implemented to maintain or improve health IT performance. 

The other three exceptions outline circumstances under which an actor may limit the content of its response, charge fees, or license interoperability elements. 

Notably, the definition of EHI does not expressly include or exclude price information.  However, ONC stated that, to the extent that protected health information includes price information and is included in a designated record set, it would be considered EHI.  

Starting with data collected for the 2019 performance year, CMS will publicly report eligible providers that may be information blocking based on how they attested to certain Promoting Interoperability Program requirements.  This policy will take effect in late 2020.

With respect to physicians, CMS will include an indicator on Physician Compare for the eligible clinicians and groups that submit a “no” response to any of the three prevention of information blocking statements for the Merit Based Incentive Payments System (MIPS).  The statements inquire regarding the provider’s actions to restrict the compatibility or interoperability of certified electronic health record technology (CEHRT), implementation of technologies, practices, and agreements to ensure the CEHRT is connected and compliant with applicable requirements, and good faith response to requests to retrieve or exchange EHI from patients, providers, and other persons.  With respect to hospitals and critical access hospitals, CMS will similarly post on its website the list of hospitals that submitted a “no” response to any of the three attestations related to the prevention of information blocking.  

Starting in late 2020, CMS will also begin publicly reporting providers that do not list or update their digital contact information in the National Plan and Provider Enumeration System.  This includes providing digital contact information such as secure digital endpoints like Direct Address and/or a FHIR API endpoint.

Admission, Discharge, and Transfer Event Notifications

CMS changed its Conditions of Participation to require hospitals to send electronic patient event notifications of a patient’s admission, discharge, and/or transfer to another healthcare facility or to another community provider or practitioner.  Specifically, a hospital will be required to demonstrate that (i) its system’s notification capacity is fully operational and that it operates in accordance with all applicable laws pertaining to exchange of patient health information; (ii) its system sends certain notifications that include at least the patient name, treating practitioner name, and sending institution name; and (iii) its system sends notifications at the time of a patient’s registration in the emergency department or admission to inpatient services, and also prior to, or at the time of, a patient’s discharge and/or transfer from the emergency department or inpatient services to post-acute care services providers and suppliers and other providers identified by the patient as primarily responsible for the patient’s care, and which need to receive notification of the patient’s status for treatment, care coordination, or quality improvement purposes.  The policy will take effect six months after the publication of the CMS Final Rule.

Payer-to-Payer Data Exchange

MA organizations, Medicaid managed care plans, CHIP managed care entities, and QHP issuers on the FFEs must coordinate care between payers by exchanging, at a minimum, the data elements specified in the content and vocabulary standard finalized in the ONC Final Rule.  These payers will be required to send, at a current or former enrollee’s request, specific information they maintain with a date of service on or after January 1, 2016 to any other payer identified by the current enrollee or former enrollee.  However, a payer will only be obligated to share data received from another payer in the electronic form and format in which the data was received.  The payer-to-payer data exchange must be fully implemented by January 1, 2022. 

Provider Directory API

CMS-regulated payers will be required to make provider directory information publicly available using a standards-based API.  The directory must include, at minimum, provider names, addresses, phone numbers, and specialties.  This policy goes into effect January 1, 2021. 

Increasing the Frequency of Federal-State Data Exchanges

States will be required to participate in daily exchange of buy-in data, which includes both sending data to CMS and receiving responses from CMS daily.  States will be required to begin submitting the MMA file data to CMS daily by April 1, 2022.  

Trusted Exchange Network

CMS did not finalize its proposal to require payers to participate in a trusted exchange network, reasoning that the Trusted Exchange Framework and Common Agreement is not sufficiently mature.

The CMS Final Rule is available here, and CMS’s fact sheet on the rule is available here.

The ONC Final Rule is available here, and ONC’s corresponding press release is available here.

Reporters, Adam Solander, Washington, D.C., +1 202 626 5542, asolander@kslaw.com; Igor Gorlach, Houston, +1 713 276 7326, igorlach@kslaw.com; and Elizabeth Han, Houston, +1 713 276 7319, ehan@kslaw.com.

CMS Announces Part D Senior Savings Model for Seniors Requiring Insulin – Citing the high cost of insulin as a common barrier to proper diabetes treatment, CMS has announced a new model to allow beneficiaries additional Part D plan options with lower out-of-pocket costs for insulin.  Under the Part D Senior Savings Model (Model), a broad range of plan-formulary insulin will cost no more than $35 for a 30-day supply.  The Model will apply to beneficiaries receiving Part D coverage via standalone prescription drug plans and through Medicare Advantage.  The agency has also instituted a Request for Applications process to allow eligible pharmaceutical manufacturers and Part D sponsors to apply to participate.

Part D out-of-pocket costs vary depending on what “phase” of coverage a beneficiary is in – deductible, initial coverage, coverage gap, or catastrophic coverage.  During the coverage gap phase, manufacturers give a discount (70% of negotiated price), with beneficiaries paying 25% and plan sponsors 5% of negotiated price.  This is the only phase in which drug manufacturers participate.

Medicare allows “enhanced plans” to offer lower cost sharing or cover more drugs than typical, but such plan sponsors charge additional premiums.  Under the current model, however, plans are disincentivized from reducing cost sharing in the coverage gap to under 25% because manufacturers will discount only 70% of the remaining amount, rather than 70% of the negotiated price, leaving plan sponsors to pay the difference.  Therefore, few plan sponsors reduce cost sharing in the coverage cap and “virtually” none do for insulin, according to CMS.

The Model seeks to reduce the disincentive that exists for plans to provide supplemental benefits for insulin in the coverage gap.  Under the Model, where a participating Part D sponsor offers such benefits, participating pharmaceutical manufacturers will pay the 70% on the negotiated price, before application of supplemental benefits.  In other words, plan sponsors will not be left with higher costs.

To encourage participation, CMS will give participating Part D sponsors the option of additional risk corridor protection for calendar years 2021 and 2022 for benefit packages that have higher-than-average enrollment from insulin-dependent diabetic patients.  Because manufacturers pay substantial rebates for insulin prescriptions, attracting more insulin users will increase manufacturer rebate payments for plan sponsors, which may offset premium increases.  CMS anticipates that manufacturers will be incentivized to participate because they will see increased utilization for their products and a more adherent patient population.

Manufacturers wishing to participate in the Model must apply by March 18, 2020.  Shortly thereafter, CMS will make available to plan sponsors the list of participating manufacturers.  Plan sponsors must submit a letter of intent by April 10, 2020 and apply to participate in the Model by May 1, 2020.

The CMS fact sheet is available here.  The agency’s press release is available here.  The pharmaceutical manufacturers request for applications is available here.  The plan sponsor request for applications is available here.  Finally, a March 12, 2020 webinar hosted by CMS discussing the Model is available here.

Reporter, Elizabeth Swayne, Washington, D.C., +1 202 383 8932, eswayne@kslaw.com.

ALSO IN THE NEWS

CMS Announces New Measures to Protect Nursing Home Residents from the Spread of COVID-19 – As part of the broader announcement by the Trump Administration in connection with the emergency declaration, CMS announced new measures on March 13, 2020 to protect nursing home residents from COVID-19 based on latest recommendations from the CDC. These measures, which supersede prior CMS guidance, include the following:

  • Restricting all visitors, with exceptions for compassionate care, such as end-of-life situations;
  • Restricting all volunteers, nonessential healthcare personnel, and other personnel (e.g., barbers);
  • Cancelling all communal dining and all group activities; and
  • Implementing active screening of residents and healthcare personnel for fever and respiratory symptoms.

A copy of the President’s emergency declaration can be found here. CMS’s press release concerning the emergency declaration can be found here, and press call remarks from CMS Administrator Seema Verma can be found here.

Joel McElvain Discusses in Politico the Payment Pressures Hospitals Face as They Confront Coronavirus– King & Spalding Washington, D.C. partner Joel McElvain was quoted in an article discussing hospitals’ reaction to CMS’s recent regulatory actions that have sought to limit reimbursement to hospitals from Medicare and Medicaid, and how those payment cuts are posing additional challenges in light of the coronavirus pandemic. The article, published by Politico, is available here.