Washington Watch Roundups

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Regulatory Developments. The Administration has issued several regulations making changes to operational policies, payment provisions, and other standards applicable to health plans and Health Insurance Exchanges under the Affordable Care Act. CMS also has issued a final rule that increases Medicare payments for low-volume hospitals. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/.

– Other CMS Developments. Recent CMS announcements have addressed: ACA insurance coverage and exchange policies; the Medicare electronic health record “Meaningful Use” hardship exception; a new “Medicare Care Choices Model” to allow certain hospice patients to seek curative care; Medicare payment for hospice enrollees’ drug expenses; an upcoming deadline for using the revised 1500 form for Medicare paper claims; Medicare Part B drug payment files; and Medicare inpatient admissions criteria. See https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/.

– Legislative Developments. The clock is winding down for Congress to pass Medicare physician fee schedule reform legislation before steep payment cuts are triggered, and Congressional hearings have examined health policy issues. See https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

– Fraud & Abuse Developments. The OIG has released its Annual Report on Medicaid Fraud Control Unit Activities, along with reports on Medicare Part B drug pricing and diabetic test strip cost and compliance concerns (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). Medicare contractors have issued a joint open letter to physicians warning about DMEPOS Supplier “Marketing Schemes” (https://www.healthindustrywashingtonwatch.com/articles/fraud-and-abuse-developments/).

– Odds & Ends. MedPAC and MACPAC have issued reports to Congress making Medicare and Medicaid payment policy recommendations, respectively (see https://www.healthindustrywashingtonwatch.com/articles/odds-ends/).

– Health Industry Events. Upcoming CMS events will focus on HCPCS coding applications, clinical laboratory payments, and the Medicare Shared Savings Program (see https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– FY 2015 Obama Administration Proposed Budget. Yesterday the Obama Administration released its proposed FY 2015 budget, which includes a number of legislative proposals to reduce Medicare and Medicaid spending. See https://www.healthindustrywashingtonwatch.com/articles/obama-transition-news/.

– Regulatory Developments. CMS is inviting comments on potential changes to Medicare reimbursement for DMEPOS that could impact payment to suppliers nationwide regardless of whether they participate in competitive bidding. CMS also published preliminary federal share disproportionate share hospital allotments for FY 2014. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/ HHS has proposed updated electronic health record certification criteria and ACA health coverage waiting period regulations (https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/). FDA is seeking input on direct-to consumer television ads and the Nutrition Facts label (https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/fda-developments/).

– Other CMS Developments. CMS has announced that it is “pausing” Recovery Audit Contractor (RAC) audits and making a number of changes to the RAC program. CMS also has proposed updates to Medicare Advantage and Part D drug plan policies and rates, and it is allowing retroactive ACA insurance subsidies in certain cases, including for certain non-Marketplace plans. CMS is requesting suggestions for advanced diagnostic imaging quality and safety regulations. In addition, CMS continues to modify implementation of the two-midnight inpatient admissions policy, and it has posted HIPAA administrative simplification transaction testing checklists. See https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/.

– Legislative Developments. A number of Congressional panels have held hearings on health policy issues (https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/).

– Fraud & Abuse Developments. The OIG has issued reports on the Medicare hospital “DRG window” and adverse events among Medicare beneficiaries in SNFs, and the Obama Administration cites record-breaking recoveries under the Health Care Fraud and Abuse Control Program (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/).

– Health Industry Events. Upcoming CMS events will focus on hospital outpatient services and HCPCS coding applications. The FTC is holding a workshop on health care competition, MedPAC is meeting this week to address a variety of Medicare payment policies, and FDA Is meeting to discuss modernizing over-the-counter drug reviews. See https://www.healthindustrywashingtonwatch.com/articles/events/.

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading Medicare/Medicaid Provisions in Obama Administration’s Proposed FY 2015 Budget; Other New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Regulatory Developments. CMS has expanded its moratoria on the enrollment of home health agencies and ambulance suppliers in designated areas, and it is inviting applications under the Bundled Payments for Care Improvement Initiative and the Frontier Community Health Integration Demonstration (https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/). HHS has published a final rule to amend HIPAA and CLIA regulations expand direct access to lab test reports (https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/). The IRS has released ACA “shared responsibility” guidance that delays compliance deadlines for certain employers (https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/).

– Other CMS Developments. CMS is requesting comments on episode-based payment models for outpatient specialty practitioner services. CMS has made announcements regarding implementation of the “2 midnight” inpatient admissions criteria, “Sunshine Act” Open Payments Program registration and data submission, and Qualified Health Plan issuer requirements. See https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/.

– Legislative Developments. Congress has approved legislation that extends Medicare sequestration. In addition, a major bipartisan, bicameral Medicare physician fee schedule reform bill has been released, and a House hearing examined drug shortages. See https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

– Fraud & Abuse Developments. The OIG has released its FY 2014 Work Plan and a report on the 340B discount drug program, and there have been recent developments involving physician-owned distributors (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). A GAO report urges CMS to finalize pending Medicaid drug pricing reforms https://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/). The DOJ has announced updated health care fraud recovery statistics (https://www.healthindustrywashingtonwatch.com/articles/fraud-and-abuse-developments/).

– Health Industry Events. Upcoming CMS events will focus on the future of the Physician Compare website, hospital outpatient services, and the National Partnership to Improve Dementia Care in Nursing Homes. The FTC is holding a workshop on health care competition. See https://www.healthindustrywashingtonwatch.com/articles/events/.

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Legislative Developments. The Congressional Budget Office has raised the specter that pending Medicare physician fee schedule reform legislation could result in the Affordable Care Act’s Independent Payment Advisory Board (IPAB) mechanism being triggered. The President has signed into law an omnibus spending bill that specifies funding for HHS agencies and initiatives, and a number of Congressional hearings have focused on health policy issues. For details, see https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

– Regulatory Developments. CMS has published a final rule to expand Medicaid home- and community-based service options, and the agency has loosened restrictions on disclosure of physician-specific Medicare payment data (https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/). HHS has published FY 2015 FMAP amounts. The FDA is seeking comments on drug company social media guidance. Reed Smith has issued a client alert on recent CMS and OIG rules extending protections for electronic health record (EHR) donations. See https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/.

– Other HHS Developments. A Medicare appeals backlog has prompted a hold on new provider appeals. The FDA has issued guidance for industry on “Dear Doctor” letters. See https://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/.

– Fraud & Abuse Developments. OIG reports have addressed inconsistencies in local Medicare coverage policies, Medicare vulnerabilities associated with EHR use, enforcement of the HIPAA Security Rule, and organ procurement organization billing (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). The GAO has issued a report on the effect of prior health insurance coverage on Medicare beneficiaries (https://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/).

– Odds & Ends. An advisory panel has recommended access standards for medical diagnostic equipment (https://www.healthindustrywashingtonwatch.com/articles/odds-ends/).

– Health Industry Events. Upcoming CMS events will focus on Medicare inpatient hospital admission and medical review criteria, new medical technologies under the inpatient prospective payment system, hospital outpatient services, and the National Partnership to Improve Dementia Care in Nursing Homes, and the HHS Office of Medicare Hearings and Appeals is hosting a Medicare Appellant Forum (https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

— Regulatory Developments. CMS has issued regulations regarding emergency preparedness requirements for Medicare and Medicaid providers, Medicare Advantage/Part D policies, Medicare Secondary Payer rules, the ACA Basic Health Program, and 2014 Exchange enrollment deadlines. Other recent HHS rules have addressed electronic health records (EHR), solicitation of anti-kickback safe harbor and fraud-alert proposals, health plan certification of compliance requirements, HIPAA amendments pertaining to gun background checks, and CMS/FDA parallel reviews of medical products. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/.

— Other HHS Developments. New CMS policy announcements address “recalcitrant” Medicare providers and suppliers, hospice enrollees’ drug expenses, hospital equipment maintenance requirements, Medicare DMEPOS payments, and accountable care organizations (https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/). Other HHS policies have addressed health insurance policy cancellations and drug development tools (https://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/).

— Fraud & Abuse Developments. The Department of Justice has released updated False Claims Act recovery statistics. The OIG has issued reports on HHS management challenges, clinicians with high cumulative Medicare payments, and hospital EHR technology, and it released its Fall 2013 Semiannual Report. A GAO report examined ZPIC program integrity efforts. See https://www.healthindustrywashingtonwatch.com/articles/fraud-and-abuse-developments/.

— Legislative Developments. The President has signed into law a budget bill with Medicare provisions, and an upcoming House hearing will review Medicare “extenders” policies (https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/).

— Health Industry Events. Upcoming CMS events will focus on Medicare inpatient hospital admission and medical review criteria, the Medicare ESRD Quality Incentive Program, new medical services and technologies under the Medicare hospital inpatient prospective payment system, and hospital outpatient services, and the HHS Office of Medicare Hearings and Appeals is hosting a Medicare Appellant Forum (https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Regulatory Developments. CMS has issued several major Medicare payment rules for 2014, including rules updating reimbursement for hospital outpatient departments, ambulatory surgical centers, physicians and other Part B providers, end-stage renal disease facilities, durable medical equipment suppliers, and home health agencies. Other recent CMS rules and notices have addressed enrollment fees, quality ratings, and payment parameters for Affordable Care Act (ACA) exchange plans. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/.

– Other CMS Developments. CMS has made subregulatory announcements regarding Medicaid drug pricing policy, implementation of the Stage 3 meaningful use criteria, 2014 HCPCS codes and clinical lab rates, Medicare national coverage policies, Medicare Part B drug rates, the ACA insurance grandfathering policy, and Medicaid and CHIP integrated care models (https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/).

– OIG Developments. Recent OIG reports examine Medicare acute hospital outlier payments and hospitalization of nursing home patients (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/).

– Legislative Developments. The House has approved the “Keep Your Health Plan Act.” Congressional hearings continue to focus on ACA implementation and other health policy issues. President Obama has signed several bills into law, including major drug distribution security legislation. The Senate Finance Committee is scheduled to consider Medicare physician payment reform. For more information, see https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

– Health Industry Events. Upcoming CMS events will focus on Medicare physician quality reporting, new medical services and technologies under the Medicare hospital inpatient prospective payment system, and hospital outpatient services (https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Regulatory Developments. The Obama Administration has published final mental health/substance abuse parity regulations, along with corrections to an ACA benefit and payment parameter rule and a notice soliciting nominations for the Advisory Panel on Hospital Outpatient Payment. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/.

– Other HHS Developments. The Obama Administration will grandfather certain health insurance policies cancelled under ACA rules, and it has released initial health insurance marketplace enrollment numbers (https://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/). CMS has announced the implementation date for “Phase 2” ordering/referral denial edits, the names of Medicare DMEPOS bidding Round 1 Recompete contract suppliers, updated “Sunshine Act” reporting thresholds, guidance on the hospital admissions “two-midnight” policy, and the launch of its Virtual Research Data Center. See https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/. The OIG has examined inappropriate Medicare payments on behalf of deceased or unlawfully-present beneficiaries (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/).

– Legislative Developments. The House has scheduled a vote on the “Keep Your Health Plan Act.” Congressional hearings continue to focus on HealthCare.gov enrollment and other health policy issues. Congress has taken action on the HIV Organ Policy Equity Act, the Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Reauthorization Act, and the Children’s Hospital GME Support Reauthorization Act. Key House and Senate panels have unveiled a bipartisan, bicameral SGR reform plan. The CBO has presented to Congress a number of health-related budget options. For more information, see https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

– Health Industry Events. CMS is hosting calls on LTCH quality reporting, the Medicare IVIG Demonstration, the National Partnership to Improve Dementia Care in Nursing Homes, and provider/supplier access to PECOS, the EHR Incentive Program, and NPPES (https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Regulatory Developments. CMS is warning of delays in the release of major final Medicare payment rules for CY 2014. CMS also has issued a final rule on ACA Health Insurance Exchange program integrity standards, final Medicare conditions of participation for community mental health centers, and notices on Medicare deductible and coinsurance amounts for 2014. See https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/.

– Other CMS Developments. CMS has issued guidance to align the Exchange enrollment deadline and the “Shared Responsibility” penalty trigger. CMS expects a delay in the release of the 2014 HCPCS update. IPPS new technology add on applications for FY 2015 are due next month. See https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/.

– OIG & GAO Reports. An OIG report highlights the volume of spinal surgeries tied to physician-owned distributors (https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/oig-developments/). The GAO has issued reports tying Medicare supplemental coverage to higher health spending and providing updated data on Medicare electronic health record incentive payments (https://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/).

– Legislative Developments. Congress has taken action to temporarily fund government operations while a budget panel considers a broader spending plan. Several House hearings have focused on the rocky HealthCare.gov site rollout. See https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

– Health Industry Events. CMS is hosting calls on dementia care in nursing homes and providers/supplier access to PECOS, EHR, and NPPES files (https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Top Stories. The Affordable Care Act’s Health Insurance Marketplace has opened for business to mixed reviews, and the ongoing partial federal government shutdown is having a varied impact on health care provider operations. For details, see https://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/.

– Regulatory Developments. HHS has published a proposed rule that would establish the ACA Basic Health Program. CMS has issued rules on disproportionate share hospital payment calculations, a new Medicare Federally Qualified Health Center PPS, and enforcement actions for proficiency testing referrals. CMS also has released updated “amount in controversy” threshold amounts and technical corrections to the FY 2014 IPPS/LTCH and SNF PPS final rules. See https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/.

– Other HHS Developments. CMS has announced that Medicare rates will drop sharply under the DMEPOS competitive bidding “Round 1 Recompete” contracts. Other HHS policy developments involve Medicare ambulance rates for 2014, compliance reviews under the new “2 midnight” inpatient admissions policy, clinical laboratory tests, and the HIPAA Privacy Rule. See https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/.

– Fraud & Abuse Developments. The Obama Administration has warned consumers about potential “Obamacare” fraud, and the OIG has issued reports on Medicare ambulance transport utilization and Medicare appeals volumes, Medicare polysomnography claims, and timeliness (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Regulatory Developments. CMS has finalized financial integrity and oversight standards for Affordable Insurance Exchanges and state Medicaid disproportionate share hospital allotments under the Affordable Care Act (ACA). CMS also has released technical corrections to the CY 2014 proposed rule updating the Medicare Hospital Outpatient Prospective Payment System (OPPS) and ambulatory surgical center payments. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/. HHS has published notices seeking comments on its latest draft Departmental Strategic Plan, a draft National Action Plan for Adverse Drug Event Prevention, and options for streamlining HHS regulations (https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/). The Internal Revenue Service (IRS) has finalized ACA individual “shared responsibility” payment requirements (https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/).

– Other CMS Developments. CMS has delayed enforcement of an ACA provision requiring a face-to-face encounter as a condition of Medicare payment for durable medical equipment (DME) items. The agency also issued guidance on admission order and certification requirements for inpatient admissions, released updated Medicare drug payment files, and requested input on the Advanced Diagnostic Imaging (ADI) program. See https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/.

– OIG & GAO Reports. The OIG has issued reports on potential Medicare Part B drug rebates, Medicaid drug pricing changes, critical access hospital qualifications; Medicare diabetes test strip payments, Medicaid DME reimbursement, and Medicare program integrity efforts (see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/oig-developments/). GAO reports have addressed self-referral of anatomic pathology and IMRT services (https://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/).

– Legislative Developments. The House has approved a bill to require verification of ACA individual subsidy eligibility, and Congressional panels have addressed a variety of health policy issues. Several hearings this week will focus on ACA implementation. See https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

– Health Industry Events. CMS is hosting a call on the 2015 Value-Based Payment Modifier (see https://www.healthindustrywashingtonwatch.com/articles/events/).
For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Regulatory Developments. CMS has released a number of final FY 2014 Medicare payment rules, including rules updating the acute inpatient prospective payment system, the long-term care hospital prospective payment system (PPS), the inpatient rehabilitation facility PPS, the skilled nursing facility PPS, hospice rates and policies, and inpatient psychiatric facility PPS rates. CMS also has issued notices on the Medicare national coverage determination process and Medicaid disproportionate share hospital allotments. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/. HHS is seeking comments on implementation of an ACA provision preventing discrimination in certain health programs, and FDA has proposed regulations on its detention authority with respect to drugs intended for human or animal use (see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/).

– Other HHS Developments. CMS is seeking comments on the release of physician-specific payment data. It also has updated its list of HCPCS codes that it considers to be off-the-shelf orthotics – and therefore subject to inclusion in a future round of the Medicare DMEPOS competitive bidding program. Further, CMS also suspended certain Medicaid drug data collection. See https://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/. FDA has issued a number of draft guidance documents. See https://www.healthindustrywashingtonwatch.com/articles/other-fda-developments/.

– OIG Reports. The HHS Office of Inspector General has issued reports on Medicare billing for cancelled elective surgeries, hospital use of observational stays, and clinical trial data and safety monitoring boards (see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/oig-developments/).

– Legislative Developments. A House panel is inviting comments on draft legislation to reform Medicare post-acute care policy, and legislation has been introduced to narrow the in-office ancillary services exception to the Stark law (see https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/).

– Odds & Ends. MedPAC has released its 2013 Data Book on Health Care Spending and the Medicare Program. Recent Reed Smith blog posts address a case in which hard drives on used photocopiers resulted in HIPAA violations, and a China life sciences regulatory crackdown impacting the medical device sector. See https://www.healthindustrywashingtonwatch.com/articles/odds-ends/.

– Health Industry Events. CMS is hosting a call on a draft electronic clinical template for lower limb prostheses (see https://www.healthindustrywashingtonwatch.com/articles/events/).
For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Regulatory Developments. CMS has announced the first temporary moratoria on provider enrollment in high fraud risk areas under its Affordable Care Act (ACA) authority. CMS has issued proposed rules to update Medicare payment and other policies under the physician fee schedule, hospital outpatient prospective payment system, the ambulatory surgical center prospective payment system (PPS), the end-stage renal disease PPS, and the home health PPS. CMS also has proposed updates to durable medical equipment (DME), prosthetics, orthotics, and supplies payment policies. CMS has issued final ACA regulations regarding Affordable Insurance Exchange “Navigators” and Medicaid enrollment and eligibility rules. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/. The Obama Administration also has announced a delay in employer ACA “shared responsibility” payments and reporting requirements, and it has issued ACA contraceptive coverage requirement rules. HHS also has released its spring 2013 semiannual regulatory agenda, and HRSA has finalized policies on exclusion of orphan drugs under the 340B program (see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/).

– Other HHS Developments. CMS has delayed enforcement of its DME face-to-face requirement and has released information on the Physician Payment Sunshine Act. The OIG has announced an online submission process for the Self-Disclosure Protocol. See https://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/.

– Legislative Developments. The House has approved legislation to amend the ACA to delay insurance mandates, Congressional panels have approved bipartisan physician fee schedule reform legislation and the HIV Organ Policy Equity Act, Congressional leaders are seeking feedback on Medicare cost sharing proposals, and Congressional hearings have addressed a number of health policy issues (https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/).

– Health Industry Events. Upcoming events include meetings/calls on Medicare hospital outpatient payments, ICD-10 basics, PQRS reporting, and the Value-based Payment Modifier (see https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Regulatory Developments. CMS has issued rules addressing Affordable Care Act (ACA) shared responsibility payments, financial integrity and oversight standards for participants in ACA Affordable Insurance Exchanges, requirements for long term care facilities providing hospice services, and corrections to the proposed Medicare inpatient prospective payment system and long-term acute care hospital prospective payment system rule for FY 2014. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/. Other recent regulations address orphan drug rules and institutional review board assessment of risks in standard of care interventions research (https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/).

– Other HHS Developments. CMS has released information on Medicare outpatient hospital payments, new beneficiary Medicare Summary Notices, insurance premium savings under the ACA, and preparation for ACA Exchanges (https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/). Draft FDA guidance recommends cybersecurity risk assessments and management plans for premarket medical device submissions (https://www.healthindustrywashingtonwatch.com/articles/other-fda-developments/).

– OIG & GAO Developments. The OIG has issued reports on inappropriate prescribing of Medicare Part D drugs and Medicare reimbursement for clinical lab tests (see https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). The GAO has highlighted gaps in the Medicare imaging accreditation framework, and it has reviewed the status of ACA insurance exchange development (https://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/).

– Legislative Developments. Congressional leaders are seeking feedback on Medicare post-acute care payment reform, and Congressional hearings have addressed a number of health policy issues (https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/).

– Odds & Ends. The Medicare Payment Advisory Commission (MedPAC) and the Medicaid and CHIP Payment and Access Commission (MACPAC) have released reports to Congress on Medicare and Medicaid policy issues (https://www.healthindustrywashingtonwatch.com/articles/odds-ends/).

– Health Industry Events. Upcoming events include meetings/calls on Medicare clinical laboratory test payment determinations, Medicare hospital outpatient payments, PQRS reporting and the Value-based Payment Modifier, and dementia care in nursing homes (see https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Regulatory Developments. CMS has issued rules addressing the Affordable Care Act (ACA) Pre-Existing Condition Insurance Plan Program and Small Business Health Option Program, Medicare Advantage and Part D plan medical loss ratio rules, the Bundled Payments for Care Improvement initiative, and state Medicaid disproportionate share hospital allotments. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/. The OIG has issued a final rule on data mining by State Medicaid Fraud Control Units (https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/oig-developments/). The Administration has issued final ACA wellness program rules and guidance to employers on ACA insurance exchange notices, and a bioethics commission seeks comments on “incidental findings” in research and testing (https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/).

– Other HHS Developments. The Medicare Board of Trustees has released a financial assessment of the Medicare trust fund (https://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/). CMS has released updated Medicare Part B drug payment files, guidance to states on facilitating Medicaid and CHIP enrollment, and draft cancer hospital quality measures (https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/). FDA has issued draft guidance on access to investigational drugs (https://www.healthindustrywashingtonwatch.com/articles/other-fda-developments/).

– OIG & GAO Developments. The OIG has issued its latest semiannual report to Congress, along with reports on high-risk compounded sterile preparations, hospice care, drugs commonly used by dual eligibles, Medicare Part B claims with “G” modifiers, Medicare dialysis payments, and inaccuracies in Medicare enrollment databases (see https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). GAO reports have examined state efforts to establish ACA insurance exchanges and government drug purchase prices (https://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/).

– Legislative Developments. The House of Representatives has approved a drug distribution security plan and ACA repeal legislation, the Senate has confirmed Marilyn Tavenner as CMS Administrator, and Congressional hearings have addressed a number of health policy issues (https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/).

– Health Industry Events. Upcoming events include meetings/calls on Medicare clinical laboratory test payment determinations, Medicare hospital outpatient payments, PQRS and eRx Incentive Program payment adjustments, the Medicare Shared Savings Program application process, Medicare and Medicaid EHR Incentive Programs, the HHS insurance market risk adjustment data validation process, and Medicare orders for lower limb prostheses (see https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Regulatory Developments. CMS has published several major proposed rules that would update FY 2014 Medicare payment policy for acute inpatient hospitals and long-term care hospitals, skilled nursing facilities, inpatient rehabilitation facilities, and hospices. CMS also has published rules addressing rewards to Medicare fraud tipsters and provider enrollment rules, along with a notice on the ACA Early Retiree Reinsurance Program. HHS is considering HIPAA Privacy Rule amendments to allow reporting of mental health data to the National Instant Criminal Background Check System. The IRS has published regulations to implement certain ACA insurance premium tax credit and medical loss ratio provisions. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/.

– Other HHS Developments. Recent CMS policy announcements have addressed Independent Payment Advisory Board (IPAB) reductions, Quality Improvement Organization service areas, ordering and referring denial edits, hospital charge data, Physician Payment Sunshine Act implementation, sequestration guidance for state surveyors and Medicare Part C & D plans, gapfill payments for new molecular pathology codes, draft Medicaid Federal Upper Limit files, and potential Physician Quality Reporting System measures. For details, see https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/. HHS has released enhanced National Standards for Culturally and Linguistically Appropriate Services (CLAS) in Health Care, and it has highlighted enforcement efforts in this area. HHS has provided an update on the status of efforts to promote health information technology (https://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/).

– OIG Developments. The OIG has released an updated Provider Self-Disclosure Protocol and an updated Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs (see https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/).

– Legislative Developments. Current legislative efforts are focusing on drug distribution security and Medicare physician fee schedule reform, and recent Congressional hearings and markups have addressed a number of health policy issues (see https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

– Health Industry Events. Upcoming events include meetings/calls on the Data.Medicare.Gov data portal, the “Sunshine Act”/National Physician Payment Transparency Program, and HCPCS code applications (see https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Proposed FY 2014 Budget. The Obama Administration has released its proposed federal budget for fiscal year 2014, which includes proposals that would save $401 billion from federal health programs over 10 years. A Reed Smith alert on the proposal is available at https://www.healthindustrywashingtonwatch.com/2013/04/articles/regulatory-developments/obama-administrations-proposed-fy-2014-budget-includes-401-billion-in-health-program-savings/.

– Regulatory Developments. Recent CMS regulations have addressed federal funding for Medicaid expansion under the Affordable Care Act, Health Insurance Exchange “Navigators,” electronic health record (EHR) donation protections, and oversight rules for accreditation organizations. Reed Smith has issued a special alert regarding recent CMS policies on hospital Part B inpatient billing. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/. The IRS has published hospital community health needs assessment regulations, and a HRSA rule addresses reporting to the Healthcare Integrity and Protection Data Bank and the National Practitioner Data Bank (see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/).

– Other HHS Developments. CMS has: announced the winners of the Medicare DMEPOS competitive bidding round 2/national mail order competition; announced 2014 rates and policies for Medicare Advantage and Part D prescription drug plans; provided resources on EHR incentive program audits; released guidance on participation in Federally-Facilitated and State Partnership Exchanges; and launched a “Medicare Chronic Conditions Dashboard.” See https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/. FDA has issued draft guidance on biosimilar product development (see https://www.healthindustrywashingtonwatch.com/articles/other-fda-developments/).

– Legislative Developments. Recent Congressional hearings have addressed a number of health policy issues; a Senate panel has approved the Mental Health Awareness and Improvement Act; and House committee leaders have released additional details on their Medicare physician fee schedule reform proposal (see https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

– OIG Developments. The OIG has issued reports on Medicare supplier surety bonds, private insurer reporting to the HealthCare.Gov plan finder portal, and the Medicaid Integrity Program (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/).

– Health Industry Events. Upcoming events include meetings/calls on EHR billing and coding, the Medicare ESRD low-volume payment adjustment, transitioning to ICD-10, HCPCS code applications, the comparative effectiveness data infrastructure, and medical device labeling (see https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– CMS Developments. CMS has issued regulations on hospital Part B inpatient billing policy, nursing facility closure notification rules, insurance waiting periods under the Affordable Care Act (ACA), and technical corrections to Medicare inpatient hospital regulations. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/. CMS also has provided more details on sequestration cuts impacting Medicare (see https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/).

– Legislative Developments. The President has signed a government funding bill that maintains FY 2013 Medicare sequestration cuts. Recent Congressional hearings have addressed a number of health policy issues, and a Senate panel has approved organ transplant and animal drug user fee bills. See https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

– OIG Developments. The OIG has issued a Special Fraud Alert on physician-owned distributors (PODs), and it has updated guidelines for evaluating state false claims laws (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/).

– Other Policy Developments. MedPAC has released its annual report to Congress on Medicare payment policy, and MACPAC has released its annual report to Congress on Medicaid and CHIP. Also, in case you missed them, Reed Smith attorneys have recently prepared client alerts on major regulatory issues, including the Physician Payment “Sunshine Act” Final Rule, ACA Insurance Exchanges and Qualified Health Plans, and the HITECH Final Rule. See https://www.healthindustrywashingtonwatch.com/articles/odds-ends/.

– Health Industry Events. Upcoming events include meetings/calls on the Medicare Shared Savings Program, the Physician Quality Reporting System, transitioning to ICD-10, HCPCS code applications, and medical device labeling (see https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Regulatory Developments. The Obama Administration has issued several rules to implement Affordable Care Act insurance provisions, including the essential health benefits framework and insurance market reforms. CMS also is requesting comments on forms to disclose DMEPOS competitive bidding contract supplier ownership changes, and has announced hospital payment adjustments. HHS is inviting comments on advancing interoperability and health information exchange. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/.

– Other HHS Developments. CMS has released its first guidance on the impact of sequestration on Medicare. CMS has extended the 2013 Medicare participation enrollment period for DMEPOS suppliers, and has updated Medicare drug files and offered tips on ICD-10 implementation. HHS has suspended enrollment in the ACA Pre-Existing Condition Insurance Plan, and FDA has issued new guidance documents. See https://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/.

– Legislative Developments. Congress has cleared the Pandemic and All-Hazards Preparedness Reauthorization Act, and Congressional panels have held hearings on various health policy issues (see https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/).

– GAO & OIG Developments. Recent OIG reports address DME infusion drugs, long-term care hospital reporting of co-location status, conflict-of-interest oversight for Medicare Part D pharmacy and therapeutics committees, Part B drug pricing, and skilled nursing facility care planning/discharge planning (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). GAO reports have focused on pharmacy services administrative organizations, risk adjustment for Medicare Advantage plans, and the Medicare low-volume payment adjustment for dialysis facilities (https://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/).

– Health Industry Events. Upcoming events include meetings/calls on the Physician Quality Reporting System (PQRS) and Electronic Prescribing (eRx) Incentive Program, Medicare hospital outpatient payment policy, HCPCS code applications, medical device labeling, hospital value-based purchasing, and implementation of Medicare ordering/referring provider edits (see https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Regulatory Developments. The Obama Administration has proposed reforms to reduce provider regulatory burdens, ACA “shared responsibility” payment rules, and ACA contraceptive coverage requirements. CMS has proposed updates to Medicare Advantage and Part D drug policies. CMS also is seeking input on use of clinical quality measures for Medicare physician quality reporting, and it has published its ACA “Physician Payment Sunshine Act” final rule (as previously reported). For more information, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/.

– Other CMS Developments. President Obama has renominated Marilyn Tavenner to be CMS Administrator. CMS is seeking applications for a new ESRD care model, moving forward with the ACA Bundled Payments for Care Improvement initiative, and cutting Medicare reimbursement for certain DMEPOS items under the competitive bidding program. See https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/.

– Legislative Developments. House panels are inviting comments on Medicare SGR/physician fee schedule reform. The House has approved GME, pediatric research, and EMT bills, and Congressional panels have held hearings and markups on health policy issues. The Finance Committee has released a compilation of public recommendations to address health care fraud and abuse. For details, see https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

– Fraud & Abuse Developments. The Obama Administration has released reports on the Health Care Fraud and Abuse Control Program and Medicare and Medicaid recovery auditing (see https://www.healthindustrywashingtonwatch.com/articles/fraud-and-abuse-developments/).

– Health Industry Events. Upcoming events include meetings/calls on the Physician Quality Reporting System (PQRS) and Electronic Prescribing (eRx) Incentive Program, Medicare hospital outpatient payment policy, HCPCS code applications, accessible standardized medical device labeling, and ICD-9-CM and ICD-10-CM/PCS updates (see https://www.healthindustrywashingtonwatch.com/articles/events/).
For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

As has been widely reported, today the U.S. Supreme Court ruled that the Affordable Care Act’s (ACA) individual health insurance mandate does not violate the Constitution because it may be viewed as a permissible tax on individuals who do not obtain health insurance. The only provision of the law that the Court invalidated is a Medicaid provision that threatened states with the loss of existing Medicaid funding if they decline to comply with the ACA’s Medicaid coverage extension. By preserving the vast majority of the landmark health reform law, the Court avoided the policy chaos that would have resulted from striking down the ACA in its entirety. There is now legal certainty for state and federal governments, health care providers and suppliers, drug and device manufacturers, employers and individuals. As discussed below, the focus in Washington will return to continuing implementation of the law. Nevertheless, although the legal battle is over, the political fight will continue and likely reverberate through the coming Presidential and Congressional election campaigns. For our report, see https://www.healthindustrywashingtonwatch.com/2012/06/articles/legislative-developments/supreme-court-upholds-aca-insurance-mandate-limits-withholding-of-medicaid-funds-to-states/.

In other news, the Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) reports on the following recent health policy developments:

– Regulatory Developments. CMS is considering using its “inherent reasonableness” authority to establish special Medicare payment limits for retail diabetic testing supplies, and several other Medicare payment rules are awaiting final regulatory clearance (see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/). The IRS has proposed regulations to implement ACA standards for charitable hospitals (https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/).

– Other HHS Developments. HHS has announced that health insurers will pay $1.1 billion in rebates under the ACA’s medical loss ratio provision, and the Department has launched prescription drug monitoring pilot projects. CMS has outlined conditions for provider use of certain repackaged medications. See https://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/.

– Legislative Developments. Congress has approved the Food and Drug Administration Safety and Innovation Act, and the House of Representatives approved the Counterfeit Drug Penalty Enhancement Act (https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/).

– GAO & OIG Developments. The GAO has issued reports on the privacy and security of prescription drug data and home and community-based services (HCBS) waiver programs (https://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/). Recent OIG reports address Medicare claims for diabetic testing supplies, physician electronic health record use, and HCBS programs (see https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/).

– Odds & Ends. MACPAC released a report to Congress on Medicaid and CHIP policy (https://www.healthindustrywashingtonwatch.com/articles/odds-ends/.)

– Health Industry Events. Upcoming events include meetings/calls on hospital value-based purchasing, the Medicare Shared Savings Program/Advance Payment Model, the Medicare clinical lab fee schedule, and Medicare hospital outpatient payment policy (https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading Reed Smith Health Industry Washington Watch Update – Supreme Court Rules on ACA