The Office of the National Coordinator for Health Information Technology (ONC) has released a revised Guide to Privacy and Security of Electronic Health Information. The guide is intended to help health care providers – especially those from smaller organizations – address federal health information privacy and security requirements in their practices. The new version updates information regarding compliance with privacy and security requirements under the Medicare and Medicaid EHR Incentive Programs, along with the HIPAA Privacy, Security, and Breach Notification Rules.
On March 27, 2015, the Obama Administration released its National Action Plan for Combating Antibiotic Resistant Bacteria (NAP), a five-year, government-wide plan to address the spread of resistant bacteria. The main components of the strategy, which identifies roles for the public and private sectors, are as follows:
- Slow the emergence of resistant bacteria and prevent the spread of resistant infections through the judicious use of antibiotics in health care and agriculture settings;
- Strengthen national “One-Health” surveillance efforts to track resistant bacteria in diverse settings in a timely fashion.
- Advance development and use of rapid and innovative diagnostic tests to allow health care providers to distinguish between viral and bacterial infections and recommend appropriate, targeted treatment.
- Accelerate basic and applied research and development, including through streamlining the drug development process and increasing the number of candidate drugs in development.
- Improve international collaboration and capacities to monitor antibiotic resistance, spur therapeutics and diagnostics development, and strengthen regional networks and global partnerships that help prevent and control the emergence and spread of resistance.
On March 25, 2015, CMS formally launched the Health Care Payment Learning and Action Network, a public-private partnership intended to support HHS’s goal of moving Medicare and the broader health industry from a fee-for-service model towards alternative payment models that emphasize value. According to CMS, more than 2,800 entities have registered to join the Network, with 44 state, payer, health system, corporate, association, and other stakeholder partners already adopting organization-specific goals for alternative payment models.
In 2013, CMS adopted an expedited administrative process to remove certain national coverage determinations (NCDs) older than 10 years since their most recent review. In December 2014, CMS removed seven NCDs under this process. On March 18, 2015, CMS proposed removing two more NCDs under this process, addressing coverage of Apheresis (therapeutic pheresis) and Smoking and Tobacco-Use Cessation Counseling (NCD Manual Section 201.4; Section 210.4.1 would remain). Public comments on this proposal will be accepted until April 17, 2015, and CMS expects to publish its determination by fall 2015. Local MACs are authorized to determine coverage for items and services that were previously governed by NCDs that were removed.
On February 2, 2015, the Obama Administration released its proposed federal budget for fiscal year (FY) 2016. The budget would impact all types of health care providers, health plans, and drug manufacturers if adopted as proposed – which is unlikely given Republican control of the House and Senate. Nevertheless, Congress can be expected to consider the Medicare and Medicaid savings proposals (many of which are carry-overs from prior budgets) during expected debate in the coming months on Medicare physician fee schedule (MPFS) reform legislation or during future budget negotiations.
The following is a summary of the major Medicare, Medicaid, and related policy proposals contained in the FY 2016 budget proposal.Continue Reading...
On January 30, 2015, the HHS Office of the National Coordinator for Health Information Technology (ONC) released a draft “Roadmap” to promote safe and secure exchange and use of electronic health information. The document “Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Version 1.0,” focuses on actions intended to reach the ambitious goal of enabling a majority of individuals and providers to send, receive, find, and use a common set of electronic clinical information at the nationwide level by the end of 2017. To that end, the report focuses on: (1) establishing a coordinated governance framework and process for nationwide health IT interoperability; (2) improving technical standards and implementation guidance for sharing and using a common clinical data set; (3) enhancing incentives for sharing electronic health information according to common technical standards; and (4) clarifying privacy and security requirements that enable interoperability. Comments on the draft Roadmap document will be accepted until April 3, 2015.
ONC also released a draft of the 2015 Interoperability Standards Advisory, containing an initial version of what ONC currently considers to be the best available standards and implementation specifications for many clinical health data interoperability purposes. The public comment period for the Standards Advisory closes May 1, 2015.
Today HHS Secretary Sylvia M. Burwell announced ambitious plans to move from “volume to value in Medicare payments” by accelerating the share of Medicare fee-for-service (FFS) payments that are tied to quality and value and reimbursed through alternative payment models. The first goal in the initiative is for 30% of Medicare provider payments to be in alternative payment models – such as accountable care organizations, medical homes, bundled payments -- by 2016 (up from about 20% today). The goal would rise to 50% by 2018.
Under the second component of the plan, HHS seeks to tie 85% of Medicare FFS payments to quality by 2016, rising to 90% in 2018. In addition to the various alternative payment models, such quality programs include the Hospital Value Based Purchasing Program, the Hospital Readmissions Reduction Programs, and the Physician Value-Based Modifier.
To extend these value initiatives beyond Medicare and reach a “critical mass of payers,” HHS is announcing the establishment of the Health Care Payment Learning and Action Network to coordinate the efforts of the private, public and non-profit sectors, including private payers, large employers, providers, consumers, and state and federal partners. The goal of the Learning and Action Network is to facilitate joint implementation and expansion of new models of payment and care delivery; collaborate to generate evidence and share approaches; develop common approaches to core issues such as beneficiary attribution, financial models, benchmarking, and risk adjustment; and create implementation guides for payers and purchasers. The Network will hold its first meeting in March 2015.
For additional details, see Secretary Burwell’s “Perspectives” article in the New England Journal of Medicine.
Today the OIG issued a report examining the growing use of Medicare hospice care in the assisted living facility (ALF) setting. According to the OIG, Medicare payments for hospice care in ALFs grew by more than 119% from 2007 to 2012, compared to a 38% increase in spending for hospice care provided in other settings. The OIG also reports that hospices provided care for longer periods and received higher Medicare payments for beneficiaries in ALFs compared to other settings, even though hospice beneficiaries in ALFs often had diagnoses that typically require less complex care. The median amount Medicare paid for-profit hospices for care in ALFs during the five-year period was $18,261 per beneficiary, compared to $13,941 for nonprofit hospices. The OIG contends that its findings suggest that the current payment system includes financial incentives that could encourage hospices to target beneficiaries in ALFs.
The OIG recommends that CMS take its findings into account as CMS undertakes hospice reforms mandated by the Affordable Care Act (ACA). Specifically, the OIG recommends that CMS: (1) reform payments to reduce the incentive for hospices to target beneficiaries with certain diagnoses and those likely to have long stays, (2) target certain hospices for review, (3) establish claims-based quality measures, (4) make hospice data publicly available for beneficiaries, and (5) educate hospices regarding how they compare to their peers. CMS concurred with these recommendations.
CMS has updated the Medicare Program Integrity Manual to clarify that providers and suppliers have 45 days to produce documents in response to a pre-payment review Additional Documentation Request (ADR) issued by a Medicare Administrative Contractor (MAC) or Zone Program Integrity Contractors (ZPIC). MAC and ZPIC reviewers are instructed not to grant extensions to providers who need more time to comply with such requests; instead, claims must be denied if the requested documentation is not received by day 46.
CMS has announced that it has awarded the Region 5 Recovery Audit contract to Connolly, LLC (although the General Accounting Office subsequently reported that a bid protest has been filed regarding this award). The purpose of this contract will be to identify improper Medicare payments for durable medical equipment (DME), orthotics, prosthetics, and supplies and home health/hospice (HH/H) claims and work with CMS and the DME and HH/H MACs to adjust claims to recoup overpayments and pay underpayments. CMS observes that this award marks the beginning of the new Recovery Audit contracts, and it is the first contract to incorporate a series of changes intended to reduce the provider burden and increase program transparency (e.g., ADR limits, RAC accuracy threshold).
The OIG recently assessed the appropriateness of claims submitted by providers for screening for, diagnosing, evaluating, or treating cataracts, wet age related macular degeneration (wet AMD), and glaucoma in 2012. The OIG estimates that Medicare paid $22 million for ophthalmology claims in 2012 that were potentially inappropriate, according to national and local coverage requirements, although the OIG cautions that it did not review the medical records for any claims to determine if exceptions to the coverage requirements were documented and appropriate. The OIG recommends that CMS strengthen claims processing edits, and determine the appropriateness of ophthalmology claims identified in the report, and take appropriate action. CMS concurred with the recommendations in the report, “Medicare Paid $22 Million in 2012 for Potentially Inappropriate Ophthalmology Claims.”
The HHS Office of the National Coordinator for Health Information Technology (ONC) is seeking comments on its Federal Health IT Strategic Plan 2015-2020. The plan represents a broad federal strategy for collecting, sharing, and using interoperable health information to improve health care and public health, and advance research within the federal government and in collaboration with private industry. Comments will be accepted until February 6, 2015
The recent Ebola outbreak has prompted the HHS Office for Civil Rights (OCR) to release a new bulletin for covered entities and business associates regarding their privacy obligations under HIPAA in emergency situations. The bulletin, “HIPAA Privacy In Emergency Situations,” provides an overview of the limited ways in which covered entities and business associates may use and disclose protected health information in emergencies, such as the Ebola outbreak.
CMS has announced that it is delaying until further notice enforcement of its regulations pertaining to health plan enumeration and use of the Health Plan Identifier (HPID) in HIPAA transactions, which were adopted in a September 5, 2012 final rule. This enforcement delay, which is effective October 31, 2014, applies to all HIPAA covered entities, including healthcare providers, health plans, and healthcare clearinghouses. This enforcement discretion period will allow HHS to consider recent recommendations by the National Committee on Vital and Health Statistics (NCVHS) that covered entities not use the HPID in the HIPAA transactions.
The Office of the National Coordinator for Health Information Technology (ONC) is launching the “Market R&D Pilot Challenge,” which will bring together health care organizations and innovative companies to test new health information technology products through pilot funding awards and facilitated matchmaking. Pilot proposals could be awarded in three domains: clinical environments (e.g., hospitals, ambulatory care, surgical centers); public health and community environments (e.g., public health departments, community health workers, mobile medical trucks, school- and jail-based clinics); and consumer health (e.g., self-insured employers, pharmacies, laboratories). Among other things, the program is intended to encourage early collaboration between entrepreneurs, medical and public health personnel, patients, and the research community in efforts to link health IT innovation to care delivery innovation. Up to 6 winning proposals will each receive a $50,000 award.
The OIG has issued a report on Medicare beneficiary copayment costs for outpatient services provided at critical access hospitals (CAH). Beneficiaries who receive services at CAHs pay Medicare coinsurance amounts based on CAH charges, in contrast to patients at acute care hospitals who are responsible for coinsurance amounts based on outpatient prospective payment system (OPPS) rates. According to the OIG report, “Medicare Beneficiaries Paid Nearly Half of the Costs for Outpatient Services at Critical Access Hospitals,” CAH charges are typically higher than the reasonable costs associated with CAH services or the OPPS rates that acute-care hospitals receive. The OIG estimates that Medicare beneficiaries paid nearly half the costs for outpatient services at CAHs in 2012 (approximately $1.5 billion of the estimated $3.2 billion cost for CAH outpatient services). The OIG recommends that CMS seek legislative authority to modify how coinsurance is calculated for outpatient services received at CAHs to reduce the percentage of costs paid by Medicare beneficiaries in coinsurance. For instance, CMS could consider (1) computing coinsurance so that it is based on interim payment rates rather than charges, and (2) processing claims for outpatient services at CAHs as if they were paid under OPPS for the purpose of calculating an OPPS equivalent coinsurance.
The Centers for Disease Control and Prevention (CDC) has issued a number of guidance documents for the health care industry on management of patients with known or suspected Ebola virus. To date, the CDC has offered recommendations regarding, among many other topics: the use of personal protective equipment by health care workers in hospitals; infection prevention and control; performing acute hemodialysis in patients with Ebola virus; transfers by emergency medical services; laboratory specimen handling; and Ebola-associated waste management. Reed Smith has formed a cross-practice Global Ebola Task Force to address legal issues emerging from the spread of the viral disease in West Africa and around the world.
HHS Office of Medicare Hearings and Appeals (OMHA) Hosting Second Medicare Appellant Forum (Oct. 29)
On October 29, 2014, the OMHA is hosting its second OMHA Medicare Appellant Forum. The meeting will update OMHA appellants on the status of OMHA operations and discuss OMHA and CMS initiatives designed to mitigate the Medicare appeals backlog at the OMHA-level of the administrative appeals process. The deadline for in-person registration is October 28, and registration for remote/webinar attendance ends October 24.
The HHS Office of Civil Rights (OCR) has released guidance on “HIPAA and Same-sex Marriage: Understanding Spouse, Family Member, and Marriage in the Privacy Rule.” The guidance stems from a Supreme Court decision in United States v. Windsor striking down Section 3 of the Defense of Marriage Act (DOMA), which had provided that federal law would recognize only opposite-sex marriages. In light of the ruling, HHS explains that legally married same-sex spouses are family members for the purposes of applying various provisions of the Privacy Rule, including standards for sharing an individual’s protected health information with a family member and the prohibition on using or disclosing genetic information of a family member for underwriting purposes. OCR intends to issue additional clarifications to address same-sex spouses as personal representatives under the Privacy Rule.
The HHS Office of Medicare Hearings and Appeals (OMHA) has announced the Settlement Conference Facilitation (SCF) program, a pilot alternate dispute resolution process designed to bring the appellant and CMS together to discuss the potential of a mutually-agreeable resolution to the claims appealed to an Administrative Law Judge (ALJ) hearing. If a resolution is reached, a settlement document is drafted by the facilitator (an employee of OMHA) to reflect the agreement and the document is signed by the appellant and CMS at the settlement conference session. As part of the agreement, the requests for an ALJ hearing for the claims covered by the settlement will be dismissed.