ONC Updated Electronic Health Information Privacy/Security Guidance

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.

Obama Administration Announces Plan to Combat Antibiotic Resistant Bacteria

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:

  1. 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;
  2. Strengthen national “One-Health” surveillance efforts to track resistant bacteria in diverse settings in a timely fashion.
  3. 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.
  4. Accelerate basic and applied research and development, including through streamlining the drug development process and increasing the number of candidate drugs in development.
  5. 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.

CMS Launches Health Care Payment Learning and Action Network

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.

CMS Proposes Removing Two NCDs under Expedited Process

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. 

Obama Administration Releases FY 2016 Budget Proposal with Medicare/Medicaid Provisions

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.

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ONC Seeks Comments on Draft Health IT Interoperability Roadmap, Standards Advisory

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.

HHS Sets Ambitious Goals for Medicare Quality/Value-Based Purchasing, Alternative Payment Models

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.

OIG Questions Incentives for Hospice Care in Assisted Living Facilities

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 Guidance on Provider Timeframes for Responding to Additional Documentation Requests

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 Announces DMEPOS/Home Health/Hospice RAC, Improvements to RAC Process

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).

OIG Examines Appropriateness of Medicare Ophthalmology Claims

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.”

Comment Opportunity on Federal Health IT Strategic Plan

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

OCR Releases Ebola Bulletin

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 Delaying Enforcement of HIPAA Health Plan Enumeration/Health Plan Identifier Regulations

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.

ONC Invites Applications for "Market R&D Pilot Challenge"

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.

Medicare Beneficiary Costs at Critical Access Hospitals

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. 

CDC Guidance for Health Care Industry Regarding Patients with Ebola Virus

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.

HHS Guidance HIPAA Privacy Rule and Same-sex Marriage

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.

HHS "Settlement Conference Facilitation" Pilot Provides Alternative to ALJ Hearing

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.

Older Entries

July 25, 2014 — HHS Launches Medicaid Innovation Accelerator Program

July 25, 2014 — Territories Not Bound by Key ACA Insurance Market Provisions

July 23, 2014 — HRSA Issues Interpretive Rule on 340B Orphan Drug Exclusion

June 25, 2014 — HHS Provides Update on ACA Insurance Costs and Choices, Announces Management Changes

June 20, 2014 — HRSA Stands by its Interpretation of the 340B Orphan Drug Exclusion Despite District Court Ruling

June 9, 2014 — HHS Secretary Nominee Burwell Confirmed by Senate

May 15, 2014 — CMS to Implement Ordering/Referring Denial Edits for HHA Certifying Physicians, Effective July 1, 2014

May 14, 2014 — CMS Announces Reforms to Quality Improvement Organization Program

May 14, 2014 — CMS Extends "Hardship Exemptions" Policy for Health Insurance Purchasers

May 13, 2014 — Stolen Unencrypted Laptops Results in HIPAA Settlements for Two Health Companies

May 13, 2014 — HRSA Releases 340B Audit Results

April 22, 2014 — Sebelius Stepping Down from HHS; Burwell Nominated

April 8, 2014 — HHS Releases HIPAA Security Risk Assessment Tool

March 5, 2014 — Obama Administration Proposes FY 2015 Budget with Medicare, Medicaid Savings Provisions

January 28, 2014 — FDA Provides Direction on "Dear Doctor" Letters

January 27, 2014 — Medicare Appeals Backlog Prompts Hold on New Provider Appeals

January 7, 2014 — FDA Releases Final Guidance on Qualification Process for Drug Development Tools

November 14, 2013 — HHS Allows Grandfathering of Certain Insurance Policies Cancelled under ACA Rules

November 14, 2013 — Obama Administration Releases Initial Health Insurance Marketplace Enrollment Numbers

November 14, 2013 — CMS Announces Medicare DMEPOS Bidding Round 1 Recompete Contract Suppliers

November 14, 2013 — CMS Guidance on Medicare Inpatient Hospital Admissions Two-Midnight Policy

November 14, 2013 — CMS Launches Virtual Research Data Center

November 14, 2013 — Applications for 2015 HCPCS Codes Due Jan. 3, 2014

November 14, 2013 — OIG Examines Inappropriate Medicare Payments on Behalf of Deceased or Unlawfully-Present Beneficiaries

October 10, 2013 — ACA Health Insurance Marketplace Opens for Business to Mixed Reviews

October 10, 2013 — CMS Limits Compliance Reviews under New "2 Midnight" Inpatient Admissions Policy

October 10, 2013 — CMS Posts Revised Gapfill Payments for New Molecular Pathology Codes; Reconsideration Requests Due Oct. 30, 2013

October 9, 2013 — Government Shutdown Update: Medicare Claims Processing Continues, but Other Key Functions on Hold

October 9, 2013 — CMS Sets 1% Payment Update for Medicare Ambulance Rates in 2014

October 8, 2013 — HHS OCR Releases HIPAA Privacy Rule Guidance Documents

October 7, 2013 — Medicare Rates to Fall by Average of 37% under DMEPOS Competitive Bidding "Round 1 Recompete" Contracts

August 2, 2013 — New Draft Guidances from FDA Address Expedited Review, Safety Labeling and More

July 29, 2013 — OIG Self-Disclosure Protocol Submissions

June 28, 2013 — CMS Delays DME Face-to-Face Requirement until Oct. 1, 2013

June 11, 2013 — Medicare Trustees Forecast Longer Medicare Solvency

May 13, 2013 — HHS Releases Enhanced National Standards for Culturally and Linguistically Appropriate Services (CLAS) in Health Care, Highlights Compliance Efforts

May 13, 2013 — HHS Update on HIT Activities

April 15, 2013 — FDA Draft Guidance on Biosimilar Product Development Now Available

March 13, 2013 — CMS Issues First Guidance on Sequestration Impact on Medicare

March 13, 2013 — HHS Suspends Enrollment in Pre-Existing Condition Insurance Plan (PCIP)

March 13, 2013 — CMS Offers Tips and Timelines for ICD-10 Implementation

March 12, 2013 — 2013 Medicare Participation Enrollment Period for DMEPOS Suppliers Extended until April 15, 2013

March 12, 2013 — April 2013 Update to Medicare ASP Files

March 12, 2013 — FDA Issues New Guidance Documents

January 29, 2013 — CMS Issues Revised CMS-855S, 855O Medicare Enrollment Applications

January 29, 2013 — CMS Previews Medicaid Core Set of Health Home Quality Measures

January 29, 2013 — PCORI Seeking Nominations for Advisory Panels

January 29, 2013 — New FDA Draft Guidance Addresses Combination Product Postapproval Modification Submissions

January 14, 2013 — CMS Announces 90-Day Enforcement Discretion Period for HIPAA Eligibility & Claim Status Operating Rules

January 14, 2013 — ONC Seeks Comments on Health IT Patient Safety Action and Surveillance Plan

January 11, 2013 — CMS Releases Updated Draft Medicaid FUL Files

January 9, 2013 — OCR Announces First HIPAA Breach Settlement Involving Less than 500 Individuals

December 3, 2012 — OCR Issues Guidance on De-identifying Protected Health Information

November 12, 2012 — CMS Releases 2013 HCPCS Update

September 28, 2012 — Hospitals Return Fire After Administration Warns Hospitals Against Gaming Payments through Electronic Health Records

September 27, 2012 — CMS Invites Comments on Preliminary Supervision Level Decisions for Selected Hospital Outpatient Services

September 27, 2012 — CMS Releases October 2012 Update to Medicare Part B Drug ASP Files

September 27, 2012 — CMS Releases Medicare Beneficiary Ombudsman Report

September 27, 2012 — HHS Report Details Savings from ACA Insurance Premium Standards

September 5, 2012 — Preliminary 2013 Medicare Clinical Laboratory Fee Schedule Determinations

September 5, 2012 — FDA Guidance on FY 2013 Medical Device User Fee Small Business Qualification and Certification

September 5, 2012 — FDA Issues Guidance for Comment on Refuse to Accept Policy for 510(k)s

August 8, 2012 — Putting Contractors on Notice: The New Public-Private Partnership Joins DOJ, HHS, and Private Sector Partners to Combat Health Care Fraud

July 31, 2012 — Obama Administration Public-Private Partnership Targets Health Care Fraud Prevention

July 31, 2012 — HHS Announces Funding Opportunity for State Innovation Models Initiative

July 31, 2012 — FDA Issues Draft Guidance Regarding Acceptance & Filing Review for PMA Applications

July 31, 2012 — Updated Draft Medicaid Drug Payment FUL Files Released

July 19, 2012 — HIPAA Electronic Funds Transfer, Remittance Advance Standards

July 19, 2012 — CMS Nursing Home Action Plan

July 19, 2012 — CMS Guidance on Medicaid Integrated Care Models

July 19, 2012 — CMS Answers Questions on 3-Day Payment Window Impact on Physician Offices

June 27, 2012 — Health IT Pilot Targets Prescription Drug Abuse

June 27, 2012 — CMS Outlines Conditions for Provider Use of Repackaged Medications

June 27, 2012 — Insurers to Provide $1.1 Billion in Rebates Under ACA Medical Loss Ratio (MLR) Standard

June 18, 2012 — National Prevention Council Action Plan Released

June 8, 2012 — CMS Accepting Comments on Draft Methodology for Calculating National Average Drug Acquisition Cost (NADAC)

June 8, 2012 — CMS Updates Supervision Levels for Selected HOPPS Services

June 8, 2012 — HHS Resources on Patient Access to Health Data

May 31, 2012 — HHS Corrects ACA Affordable Insurance Exchanges Rule, Issues Guidance for States.

May 14, 2012 — HHS Risk Adjustment Bulletin

May 10, 2012 — New ONC Health IT Resources

April 23, 2012 — HHS Issues its Open Government Plan Version 2.0

April 23, 2012 — HHS Establishes Administration for Community Living

April 23, 2012 — HHS seeks Comments on Revised Healthcare-Associated Infections (HAI) Action Plan

March 14, 2012 — CMS Releases Redesigned Medicare Benefit Statements

March 14, 2012 — Medicare Claims Must Use Version 5010 Format By April 1, 2012

March 14, 2012 — CMS Launches Medicare Advantage (MA) Audit Initiative

March 14, 2012 — 340B Enforcement Activities.

February 28, 2012 — HHS Announces Intent to Delay ICD-10 Compliance Date

February 28, 2012 — CMS Seeks Comments on Approach to ACA Actuarial Value and Cost-Sharing Reductions

February 28, 2012 — CMS Selects Initial ACA Insurance CO-Ops

February 28, 2012 — Status Report on ACA Pre-Existing Condition Insurance Plan (PCIP) Program

February 28, 2012 — HHS Frequently Asked Questions (FAQs) on ACA Essential Health Benefits

February 28, 2012 — CMS Proposes Medical Loss Ratio (MLR) Consumer Notices

February 28, 2012 — CMS Upgrades to PECOS Enrollment System

February 28, 2012 — OIG Examines MA Organizations' Identification of Potential Fraud & Abuse

February 28, 2012 — FY 2011 Health Care Fraud and Abuse Control Program Report

February 28, 2012 — CMS Updates Data on DMEPOS Competitive Bidding Program Health Outcomes

February 25, 2012 — CMS Releases 2013 Medicare Advantage/Part D Combined Advance Notice and Draft Call Letter

February 24, 2012 — CMS Posts Draft FUL Files for November 2011